Scheriproct Suppositories

INTENDIS

Scheriproct
Ointment

(1.9 mg prednisolone hexanoate / 5.0 mg cinchocaine hydrochloride per 1 g)

Scheriproct
Suppositories

(1.3 mg prednisolone hexanoate / 1.0 mg cinchocaine hydrochloride per suppository)

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms
  are the same as yours.


• If you experience any side effect and this becomes serious, tell your doctor or pharmacist.

In this leaflet:

• 
  1. What Scheriproct is and what it is used for
  


• 
  2. Before you use Scheriproct
  


• 
  3. How to use Scheriproct
  


• 
  4. Possible side effects
  


• 
  5. How to store Scheriproct
  


• 
  6. Further information
  

What Scheriproct is and what it is used for

Scheriproct contains a substance which reduces inflammation (predinisolone) and a local anaesthetic (cinchocaine) which
relieves pain.

This medicine is used for the relief of the inflammation, swelling, itching and soreness of piles (haemorrhoids) and to relieve itching of the anus (back passage). It is used short-term usually for 5 to 7 days.

Before you use Scheriproct

Do not use Scheriproct if you:

• are allergic (hypersensitive) to prednisolone hexanoate, cinchocaine hydrochloride, other local anaesthetics or any of the other ingredients of Scheriproct.


• have a viral infection (e.g. herpes, shingles, chicken-pox)


• have any bacterial or fungal infections of the skin or elsewhere for which you are not receiving treatment.

Take special care with Scheriproct

• Long-term continuous treatment should be avoided because it increases the possibility of side effects. This is
  particularly important for infants and small children because continuous treatment with Scheriproct for long periods may reduce the activity of the adrenal glands and so lower resistance to disease. Also, long-term treatment can cause the skin to thin and deteriorate in the affected area (see section 4, “Possible Side Effects”) and some of the medicine may be absorbed into the blood stream.


• If the area treated with Scheriproct is also infected your doctor should prescribe another medicine, to use with
  Scheriproct, to treat the infection.


• Do not use a waterproof dressing to cover areas where you have applied the cream.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Contact your doctor for advice before using this medicine if you are pregnant or intending to become pregnant or are breast-feeding. There may be a very small risk to the development of a baby in pregnant women treated with Scheriproct. As with most medicines, this risk is likely to be greatest during the first 3 months of pregnancy.

Driving and using machines

Scheriproct has no influence on the ability to drive and use machines.

How to use Scheriproct

Always use Scheriproct exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Do not use Scheriproct for more than 7 days.

Always wash your hands before and after applying Scheriproct.

How to use Scheriproct Ointment:

• 1. Before you use the ointment, gently but thoroughly wash and dry the anus (back passage) and the skin around it.


• 2. If the ointment is to be used for the area around the anus:

• Squeeze a small quantity (about the size of a pea) on to the top of your finger.


• Spread it gently over the skin and just inside the anus.


• Do not rub it in.

• 3. If the ointment is to be used inside the anus:

• Put the separate nozzle (applicator) onto the tube.


• Squeeze the tube until the nozzle is full of ointment. The amount of ointment in the nozzle is one dose.


• Insert the nozzle very carefully into the anus until the whole length of the nozzle is inside.


• Then, while squeezing the tube gently, withdraw the nozzle.


• Wash the nozzle carefully in hot soapy water and rinse thoroughly.

Generally, the ointment should be applied twice a day, but it may be applied three or four times on the first day, to obtain quick relief.

How to use Scheriproct Suppositories:

• 1. Before you insert a suppository find the small tear in the foil packet and remove the covering foil, by tearing it in half.


• 2. If the suppositories have become softened, owing to warm temperature, they can be hardened by putting them into cold water before you remove the covering foil.


• 3. Insert the whole suppository into the anus.


• 4. To make insertion easier, either stand with one foot raised on a chair or squat down.

The usual treatment is one suppository a day, to be inserted preferably after a bowel movement. However, if your discomfort is severe, you should insert one suppository two or three times a day at the start of treatment.

If you use more Scheriproct than you should or if you accidentally swallow some Scheriproct

If you use too much Scheriproct or accidentally swallow Scheriproct it is unlikely to be dangerous but contact your doctor or pharmacist if you are worried.

If you forget to use Scheriproct

Do not use a double dose to make up for a forgotten dose. When you remember, use the next prescribed dose and continue with the treatment. See your doctor or pharmacist, if you are worried.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Scheriproct Suppositories Side Effects

Like all medicines, Scheriproct can cause side effects, although not everybody gets them.

Some thinning of the skin may occur if too much Scheriproct is applied for long periods of time (much longer than 5 to 7 days).

Allergic skin reactions may occur in rare cases. Castor oil, one of the ingredients of Scheriproct Ointment may cause a skin reaction.

If you experience any of these side effects and this becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Scheriproct

• 
  Store Scheriproct out of the reach and sight of children.
  


• There are no special storage precautions for Scheriproct Ointment.


• Do not store Scheriproct Suppositories above 25ºC.


• Do not use Scheriproct after the expiry date which is stated on the pack.


• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Scheriproct Ointment contains

• The active substances are prednisolone hexanoate and cinchocaine hydrochloride. 1 g of Scheriproct Ointment contains 1.9 mg prednisolone hexanoate and 5.0 mg cinchocaine hydrochloride


• The other ingredients are polyethylene glycol 400 monoricinoleate, hydrogenated castor oil, castor oil, 2
  octyldodecanol, chypre perfume oil.

What Scheriproct Suppositories contain

• The active substances are prednisolone hexanoate and cinchocaine hydrochloride. Each suppository contains 1.3 mg
  prednisolone hexanoate and 1.0 mg cinchocaine hydrochloride


• The other ingredient is hard fat.

What Scheriproct looks like and contents of the pack

• 
  Scheriproct Ointment is a colourless to slightly yellowish ointment supplied in tubes of 30g.


• 
  Scheriproct Suppositories are yellowish-white and are supplied in packs of 12 suppositories.

Marketing Authorisation Holder

Intendis GmbH

Max-Dohrn-Strasse 10

D-10589

Berlin

Germany

Manufacturer

The ointment is manufactured by:

Intendis Manufacturing, S.p.A

Milan

Italy

The suppositories are manufactured by:

Istituto de Angeli S.r.l.

Reggello

Italy

or

Intendis Manufacturing, S.p.A

Milan

Italy

Distributor in the UK

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop Stortford

CM22 6PU

UK

This leaflet was last approved in July 2009

Scheriproct is a registered trademark of Intendis GmbH.

438850/GB/4

64013336

Claritin Liqui-Gels

Generic Name: loratadine (lor AT a deen)

Brand Names: Alavert, Alavert Allergy, Claritin, Claritin 24 Hour Allergy, Claritin Hives Relief, Claritin Liqui-Gels, Claritin Reditab, Clear-Atadine, Clear-Atadine Children's, Dimetapp ND, Loratadine Reditab, ohm Allergy Relief, Tavist ND, Wal-itin

What is Claritin Liqui-Gels (loratadine)?

Loratadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Loratadine is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions.

Loratadine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Claritin Liqui-Gels (loratadine)?

You should not take this medication if you are allergic to loratadine or to desloratadine (Clarinex).

Ask a doctor or pharmacist before taking this medicine if you have liver or kidney disease.

Do not give this medication to a child younger than 6 years old without the advice of a doctor.

Loratadine disintegrating tablets (Claritin Reditab) may contain phenylalanine. Talk to your doctor before using this form of loratadine if you have phenylketonuria (PKU).

What should I discuss with my healthcare provider before taking Claritin Liqui-Gels (loratadine)?

You should not take this medication if you are allergic to loratadine or to desloratadine (Clarinex).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• kidney disease; or


• liver disease.

FDA pregnancy category B: This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Loratadine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Loratadine disintegrating tablets (Claritin Reditab, Alavert) may contain phenylalanine. Talk to your doctor before using this form of loratadine if you have phenylketonuria (PKU).

Do not give this medication to a child younger than 6 years old without the advice of a doctor.

How should I take Claritin Liqui-Gels (loratadine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Loratadine is usually taken once per day. Follow your doctor's instructions.

Do not crush, chew, or break the regular loratadine tablet. Swallow the pill whole.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To take loratadine orally disintegrating tablet (Claritin RediTab, Alavert):

• 
  

  Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

  
  


• 
  

  Using dry hands, remove the tablet and place it on your tongue. It will begin to dissolve right away.

  
  


• 
  

  Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

  
  


• 
  

  Swallow several times as the tablet dissolves. If desired, you may drink water to help swallow the dissolved tablet.

  
  

Call your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, drowsiness, and fast or pounding heartbeat.

What should I avoid while taking Claritin Liqui-Gels (loratadine)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Claritin Liqui-Gels (loratadine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  fast or uneven heart rate;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  seizures (convulsions).

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  nervousness;

  
  


• 
  

  feeling tired or drowsy;

  
  


• 
  

  stomach pain, diarrhea;

  
  


• 
  

  dry mouth, sore throat hoarseness;

  
  


• 
  

  eye redness, blurred vision;

  
  


• 
  

  nosebleed; or

  
  


• 
  

  skin rash.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Claritin Liqui-Gels (loratadine)?

There may be other drugs that can interact with loratadine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Claritin Liqui-Gels resources

• Claritin Liqui-Gels Side Effects (in more detail)
• Claritin Liqui-Gels Use in Pregnancy & Breastfeeding
• Drug Images
• Claritin Liqui-Gels Drug Interactions
• Claritin Liqui-Gels Support Group
• 9 Reviews for Claritin Liqui-Gels - Add your own review/rating

• Claritin Liqui-Gels MedFacts Consumer Leaflet (Wolters Kluwer)


• Loratadine Professional Patient Advice (Wolters Kluwer)


• Loratadine Monograph (AHFS DI)


• Alavert Prescribing Information (FDA)


• Alavert Syrup MedFacts Consumer Leaflet (Wolters Kluwer)


• Claritin Prescribing Information (FDA)


• Claritin Consumer Overview


• Claritin 24 Hour Allergy MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Claritin Liqui-Gels with other medications

• Hay Fever
• Urticaria

Where can I get more information?

• Your pharmacist can provide more information about loratadine.

See also: Claritin Liqui-Gels side effects (in more detail)

Novolin 70/30 Innolet

Generic Name: insulin isophane and insulin regular (IN su lin EYE soe fane and IN su lin REG ue lar)

Brand Names: HumuLIN 50/50, HumuLIN 70/30, HumuLIN 70/30 Pen, NovoLIN 70/30, NovoLIN 70/30 Innolet, NovoLIN 70/30 PenFill, Relion NovoLIN 70/30 Innolet, ReliOn/NovoLIN 70/30

What is Novolin 70/30 Innolet (insulin isophane and insulin regular)?

Insulin isophane and insulin regular is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin isophane and insulin regular is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Insulin isophane and insulin regular is used to treat diabetes.

Insulin isophane and insulin regular may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Novolin 70/30 Innolet (insulin isophane and insulin regular)?

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

What should I discuss with my healthcare provider before using Novolin 70/30 Innolet (insulin isophane and insulin regular)?

Do not use this medication if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using insulin isophane and insulin regular, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (by mouth) diabetes medications.

Insulin isophane and insulin regular is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin isophane and insulin regular passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Novolin 70/30 Innolet (insulin isophane and insulin regular)?

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Insulin isophane and insulin regular is given as an injection (shot) under your skin. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Choose a different place in your injection skin area each time you use this medication. Do not inject into the same place two times in a row.

Carefully shake or rotate the insulin vial (bottle) several times to thoroughly mix the insulin isophane and insulin regular before each use. Shake the mixture until it looks cloudy or milky. Do not use the mixture if has clumps or white particles in it after mixing, or if the white substance remains at the bottom of the vial. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your insulin isophane and insulin regular dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic. Storing unopened vials or injection pens: Keep in the carton and store in a refrigerator. Do not freeze. Throw away any insulin not used before the expiration date on the medicine label. Storing after your first use: Keep the "in-use" vials or injection pens at cool room temperature, away from heat and light, and use prior to the expiration date. Throw an in-use injection pen 10 days after the first use, even if there is still medicine left in it.

Do not freeze insulin isophane and insulin regular, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Since insulin isophane and insulin regular is used before meals or snacks, you may not be on a timed dosing schedule. Whenever you use insulin isophane and insulin regular, be sure to eat a meal or snack within 30 to 60 minutes. Do not use extra insulin isophane and insulin regular to make up a missed dose.

It is important to keep insulin isophane and insulin regular on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using Novolin 70/30 Innolet (insulin isophane and insulin regular)?

Do not change the brand of insulin isophane and insulin regular or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using insulin isophane and insulin regular.

Novolin 70/30 Innolet (insulin isophane and insulin regular) side effects

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin isophane and insulin regular. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject insulin isophane and insulin regular.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Novolin 70/30 Innolet (insulin isophane and insulin regular)?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

• 
  

  albuterol (Proventil, Ventolin);

  
  


• 
  

  clonidine (Catapres);

  
  


• 
  

  reserpine;

  
  


• 
  

  guanethidine (Ismelin); or

  
  


• 
  

  beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

  
  

There are many other medicines that can increase or decrease the effects of insulin isophane and insulin regular on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Novolin 70/30 Innolet resources

• Novolin 70/30 Innolet Side Effects (in more detail)
• Novolin 70/30 Innolet Use in Pregnancy & Breastfeeding
• Novolin 70/30 Innolet Drug Interactions
• Novolin 70/30 Innolet Support Group
• 0 Reviews for Novolin 70/30 Innolet - Add your own review/rating

• Humulin 50/50 Pens MedFacts Consumer Leaflet (Wolters Kluwer)


• Humulin 50/50 Prescribing Information (FDA)


• Humulin 70/30 Prescribing Information (FDA)


• Novolin 70/30 Prescribing Information (FDA)


• Novolin 70/30 InnoLets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Novolin 70/30 Innolet with other medications

• Diabetes, Type 1
• Diabetes, Type 2
• Gestational Diabetes

Where can I get more information?

• Your pharmacist can provide more information about insulin isophane and insulin regular.

See also: Novolin 70/30 Innolet side effects (in more detail)

Kogenate FS

Generic Name: antihemophilic factor (Intravenous route)

an-tee-hee-moe-FIL-ik FAK-tor

Commonly used brand name(s)

In the U.S.

• Advate


• Helixate FS


• Hemofil-M


• Hyate:C


• Koate DVI


• Kogenate FS


• Kogenate FS w/BIO-SET


• Monarc-M


• Monoclate-P


• Recombinate


• Refacto


• Xyntha

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

Uses For Kogenate FS

Antihemophilic factor (AHF) injection is used to treat serious bleeding episodes in patients with a bleeding problem called hemophilia A. The bleeding episode may be related to an injury (trauma) or a surgical procedure. AHF is a protein that is produced naturally in the body. It helps the blood form clots to stop bleeding and prevents bleeding problems from happening as often.

Hemophilia A, also called classical hemophilia, is a condition where the body does not make enough AHF. If you do not have enough AHF and you become injured, your blood will not form clots properly. You might bleed into and damage your muscles and joints. AHF injection is given to increase the levels of AHF in the blood.

There are several different types of AHF. They are made from human blood or artificially by a man-made process (recombinant). AHF made from human blood has been treated and is not likely to contain harmful viruses, such as hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made AHF products do not contain these viruses.

This medicine is available only with your doctor's prescription.

Before Using Kogenate FS

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of antihemophilic factor injection in children.

No information is available on the relationship of age to the effects of Hemofil® M in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of Advate® have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related medical problems, which may require caution and an adjustment in the dose for patients receiving Advate®.

No information is available on the relationship of age to the effects of antihemophilic factor injection in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to hamster or mouse proteins, history of or


• von Willebrand disease—Should not be used in patients with these conditions.

Proper Use of antihemophilic factor

This section provides information on the proper use of a number of products that contain antihemophilic factor. It may not be specific to Kogenate FS. Please read with care.

A doctor or other trained health professional will give you or your child this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.

This medicine may also be given at home to patients who do not need to be in a hospital or clinic. If you or your child are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Make sure you understand all of the instructions before giving yourself an injection. Your dose may change based on where you are bleeding. Do not use more medicine or use it more often than your doctor tells you to.

Use only the brand of this medicine that your doctor prescribed. Not all brands are prepared in the same way and the dose may be different.

Every package of medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To prepare the medicine using 2 bottles (vials) or containers:

• Take the bottles of powder medicine and liquid (diluent) out of the refrigerator and warm them to room temperature.


• Wipe the rubber surface of the bottles with an alcohol swab and allow them to dry.


• Follow the specific directions for your brand of medicine when you prepare the injection.


• Add the liquid to the powder using the special transfer needle or transfer device that comes with the package.


• When injecting the liquid into the dry medicine, aim the stream of liquid against the wall of the container of dry medicine to prevent foaming.


• Swirl the bottle gently to dissolve the medicine. Do not shake the bottle. Shaking will create foam in the mixture.


• Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.


• Use a plastic disposable syringe to remove the mixture from the bottle. Use a special filter needle if your brand of medicine provides one.


• Give the injection as directed by your doctor.


• If you are using more than one bottle of medicine for your dose, prepare the second bottle the same way. Add the mixture from the second bottle to the same syringe.

To prepare the medicine using a prefilled dual-chamber syringe (Xyntha®):

• Take the prefilled dual-chamber syringe out of the refrigerator and warm it to room temperature.


• The dual-chamber syringe has the powder medicine in one part and the liquid (diluent) in the second part of the syringe.


• Attach the plunger rod to the syringe according to the directions. Keep the syringe pointed up to prevent leaking of the liquid.


• Remove the white seal and the grey rubber tip cap. Put the blue vented cap on the syringe. Do not touch the open ends of the syringe and the blue cap.


• Slowly push the plunger until the 2 stoppers inside the syringe are together. This will push all of the liquid into the chamber with the powder medicine.


• Keep the syringe pointed up and gently swirl the syringe to mix the liquid and powder.


• Check the mixture to make sure it is clear. Do not use the medicine if you can see anything solid in the mixture or if the mixture is cloudy.


• Keep the syringe pointed up and push the plunger until most of the air is removed.


• A special infusion set comes with the package. Remove the blue cap and attach the infusion set to the syringe.


• Give the injection as directed by your doctor.


• If you are using more than one syringe of medicine for your dose, prepare the second dual-chamber syringe the same way. The mixture from each syringe will be combined together in a separate syringe before your injection. Your doctor will show you how to do this.

Use the mixture within 3 hours after it is prepared. It must not be stored and used later. Do not put the mixture in the refrigerator.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.

Talk to your doctor before traveling. You should plan to bring enough medicine for your treatment when traveling.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (injection):
  
  • For bleeding episodes in patients with hemophilia A:
    
    • Adults and teenagers—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your doctor.
    
    
    • Children—Dose is based on body weight and the type of bleeding episode. The dose must be determined by your child's doctor.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

The AHF products should be stored in the original container in the refrigerator. Do not let the packages freeze. They can also be kept at room temperature for short periods of time, such as 3 to 6 months. Store the medicine as directed by your doctor or by the manufacturer of the brand you are using. Protect the container from heat and direct light.

If you move the medicine from the refrigerator to room temperature, write the date you take it from the refrigerator on the container. The length of time the medicine can remain at room temperature will depend on the brand you use. If you have already stored the medicine at room temperature, do not return it to the refrigerator. If you do not use the medicine within the time recommended by the manufacturer, you must destroy the medicine.

Precautions While Using Kogenate FS

It is very important that your doctor check you or your child closely while you are receiving this medicine to make sure it is working properly. Blood tests may be needed.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; lightheadedness or dizziness; or any swelling of your hands, face, or mouth after you receive this medicine.

It is recommended that you carry an identification (ID) card or letter stating that you have hemophilia A and the type of medicine you are using. If you have any questions about what kind of identification to carry, check with your doctor.

Check with your doctor right away if you have any symptoms of parvovirus infection: fever, chills, drowsiness, runny nose, and followed by a rash or joint pain.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during manufacture of these medicines. Although the risk is low, talk with your doctor if you have any concerns.

The stopper of the bottle (vial) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Kogenate FS Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Fever

Less common or rare

• Changes in facial skin color


• chills


• fast or irregular breathing


• nausea


• puffiness or swelling of the eyelids or around the eyes


• sensation of burning, warmth, heat, numbness, tightness, or tingling


• shortness of breath


• skin rash, hives, or itching


• tightness in the chest


• troubled breathing


• unusual tiredness or weakness


• wheezing

Incidence not known

• Bluish color of the fingernails, lips, skin, palms, or nail beds


• blurred vision


• chest pain or discomfort


• confusion


• cough


• deep or fast breathing with dizziness


• difficult or labored breathing


• difficulty with swallowing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fast, pounding, or irregular heartbeat or pulse


• noisy breathing


• numbness of the feet, hands, and around the mouth


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• slow or irregular heartbeat


• sweating


• swelling of the face, throat, or tongue


• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Less common

• Burning, stinging, or swelling at the place of injection


• diarrhea


• dizziness or lightheadedness


• dry mouth or bad taste in the mouth


• lack or loss of strength


• nosebleed


• redness of the face


• vomiting

Rare

• Change in taste


• loss of taste

Incidence not known

• Abdominal or stomach pain


• feeling of warmth


• increased sweating


• irritability


• muscle or bone pain


• redness of the eye


• redness of the face, neck, arms, and occasionally, upper chest


• redness of the skin


• trouble seeing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Kogenate FS side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Kogenate FS resources

• Kogenate FS Side Effects (in more detail)
• Kogenate FS Use in Pregnancy & Breastfeeding
• Kogenate FS Support Group
• 0 Reviews for Kogenate FS - Add your own review/rating

• Kogenate FS MedFacts Consumer Leaflet (Wolters Kluwer)


• Kogenate FS Prescribing Information (FDA)


• Antihemophilic Factor Professional Patient Advice (Wolters Kluwer)


• Advate MedFacts Consumer Leaflet (Wolters Kluwer)


• Advate Consumer Overview


• Advate Prescribing Information (FDA)


• Antihemophilic Factor (Human) Monograph (AHFS DI)


• Antihemophilic Factor (Recombinant) Monograph (AHFS DI)


• Helixate FS Prescribing Information (FDA)


• Kogenate Consumer Overview


• Monoclate-P Prescribing Information (FDA)


• Recombinate Prescribing Information (FDA)


• Xyntha Prescribing Information (FDA)


• Xyntha Consumer Overview


• Xyntha MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Kogenate FS with other medications

• Hemophilia A

Emtriva

Pronunciation: EM-trye-SYE-ta-been
Generic Name: Emtricitabine
Brand Name: Emtriva

Emtriva may cause a serious and sometimes fatal condition called lactic acidosis. The risk of lactic acidosis may be greater if you are a woman, are very overweight, or have liver problems. The risk may also be increased in patients who have taken certain HIV medicines for a prolonged period of time. Contact your doctor right away if you notice symptoms such as fast or difficult breathing; unusual muscle pain or tenderness; nausea or vomiting; sluggishness; fast, slow, or irregular heartbeat; unusual drowsiness, dizziness, or light-headedness; or unusual weakness or tiredness. Contact your doctor right away if you start to feel unusually cold or if you have a general feeling of being unwell.

Severe and sometimes fatal liver problems have been reported with this type of medicine (nucleoside analogs). Contact your doctor right away if you have dark urine; persistent loss of appetite; severe or persistent stomach pain or tenderness; or yellowing of the eyes or skin.

Emtriva is not approved to treat chronic hepatitis B virus (HBV) infection. Some patients with both HBV and HIV infection experience worsening of HBV infection after they stop taking Emtriva. Your doctor will check your liver function while you take Emtriva and for several months afterwards if you stop taking it. Be sure to keep all doctor and lab appointments. Do not stop taking Emtriva without checking with your doctor. Your doctor may need to prescribe other medicine if you experience worsening of your HBV infection.

Emtriva is used for:

Treating HIV infection. It must be used in combination with other HIV medicines. It may also be used for other conditions as determined by your doctor.

Emtriva is a nucleoside reverse transcriptase inhibitor (NRTI). It works by blocking the growth of HIV.

Do NOT use Emtriva if:

• you are allergic to any ingredient in Emtriva


• you are taking other medicines that contain emtricitabine or lamivudine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Emtriva:

Some medical conditions may interact with Emtriva. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have chronic hepatitis B, kidney problems, liver problems (eg, enlarged liver), or abnormal liver function test results, or if you are very overweight


• if you have a history of lactic acidosis

Some MEDICINES MAY INTERACT with Emtriva. However, no specific interactions with Emtriva are known at this time.

Ask your health care provider if Emtriva may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Emtriva:

Use Emtriva as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Emtriva. Talk to your pharmacist if you have questions about this information.


• Take Emtriva by mouth with or without food.


• Take Emtriva at the same time each day to keep a constant amount of medicine in your body. Do not skip doses of Emtriva.


• If you miss a dose of Emtriva, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take more than 1 dose in a day. Do not take 2 doses at once. It is important not to miss doses of Emtriva.

Ask your health care provider any questions you may have about how to use Emtriva.

Important safety information:

• Emtriva may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Emtriva with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do NOT take more than the recommended dose without checking with your doctor. Exceeding the prescribed dose of Emtriva may not provide additional benefits and may increase the risk of side effects.


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking medicines for HIV. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.


• Emtriva may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Emtriva.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Emtriva (or other HIV medicines), even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Emtriva is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• Emtriva does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Lab tests, including liver and kidney function, may be performed while you use Emtriva. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Emtriva should be used with extreme caution in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Emtriva while you are pregnant. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Emtriva to the baby.

Possible side effects of Emtriva:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal dreams; change in color of skin on palms or soles of feet; cough; diarrhea; dizziness; headache; indigestion or stomach upset; joint or muscle pain; mild stomach pain; nausea; runny nose; sleeplessness; tiredness; vomiting; weakness or lack of energy.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; depression; fast or difficult breathing; fast, slow, or irregular heartbeat; feeling unusually cold; fever, chills, or sore throat; general feeling of being unwell; muscle pain or tenderness; severe or persistent cough; severe or persistent nausea or vomiting; severe or persistent stomach discomfort, pain, or tenderness; sluggishness; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the eyes or skin); unusual drowsiness, dizziness, or light-headedness; unusual muscle pain or tenderness; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Emtriva side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Emtriva:

Store Emtriva at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Emtriva out of the reach of children and away from pets.

General information:

• If you have any questions about Emtriva, please talk with your doctor, pharmacist, or other health care provider.


• Emtriva is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Emtriva. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Emtriva resources

• Emtriva Side Effects (in more detail)
• Emtriva Dosage
• Emtriva Use in Pregnancy & Breastfeeding
• Drug Images
• Emtriva Drug Interactions
• Emtriva Support Group
• 0 Reviews for Emtriva - Add your own review/rating

• Emtriva Prescribing Information (FDA)


• Emtriva Consumer Overview


• Emtriva Monograph (AHFS DI)


• Emtriva Advanced Consumer (Micromedex) - Includes Dosage Information


• Emtricitabine Professional Patient Advice (Wolters Kluwer)

Compare Emtriva with other medications

• HIV Infection
• Nonoccupational Exposure

Local injectable anesthetics

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Local injectable anesthetics numb the surrounding area (where it is injected) by blocking pain signals from being sent to the brain. Local anesthetics are used during dental procedures, during labor and for other minor operative procedures.

See also

Medical conditions associated with local injectable anesthetics:

• Anesthesia
• Arrhythmia
• Burning Mouth Syndrome
• Cesarean Section
• Labor Pain
• Local Anesthesia
• Pain
• Postoperative Pain
• Ventricular Fibrillation
• Ventricular Tachycardia

Drug List:

Sensorcaine-Mpf

Marcaine-Solution

Polocaine

Anestacaine

Articadent

Carbocaine

Carbocaine-Hcl

Citanest-Forte-Dental-Injection

Dentipatch

Exparel

Isocaine

Lidosite

Marcaine-Hcl

Marcaine-Spinal-Solution

Naropin

Naropin-Polyamp

Naropin-Sdv

Nesacaine

Novocain

Orabloc

Polocaine-Mpf

Sensorcaine-Solution

Sensorcaine-Mpf-Spinal-Solution

Septocaine

Uad-Caine

Vivacaine

Xylocaine-Mpf

Xylocaine-Hcl

silodosin

sil-oh-DOE-sin

Commonly used brand name(s)

In the U.S.

• Rapaflo

Available Dosage Forms:

• Capsule

Pharmacologic Class: Alpha-1 Adrenergic Blocker

Uses For silodosin

Silodosin is used to treat benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder. As the prostate gland gets larger, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. This can cause problems with urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely.

Silodosin helps relax the muscles in the prostate and in the opening to the bladder. This may help increase the flow of urine and/or decrease the symptoms.

Silodosin should not be given to women.

silodosin is available only with your doctor's prescription.

Before Using silodosin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For silodosin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to silodosin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Silodosin is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of silodosin in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution in patients receiving silodosin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking silodosin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using silodosin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir


• Clarithromycin


• Indinavir


• Itraconazole


• Ketoconazole


• Nefazodone


• Nelfinavir


• Ritonavir


• Saquinavir


• Telithromycin

Using silodosin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine

Using silodosin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Sildenafil


• Tadalafil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of silodosin. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease, moderate—Use with caution. The effects of silodosin may be increased because of slower removal from the body.

• Kidney disease, severe or


• Liver disease, severe—Should not be used in patients with these conditions.

• Low blood pressure—Use with caution. May make this condition worse.

Proper Use of silodosin

Take silodosin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

It is best to take silodosin with a meal.

Dosing

The dose of silodosin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of silodosin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For benign prostatic hyperplasia (BPH):
    
    • Adults—4 to 8 milligrams (mg) taken as a single dose once a day.
    
    
    • Children—Use is not recommended in children.
    
    
  
  

Missed Dose

If you miss a dose of silodosin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using silodosin

It is very important that your doctor check you at regular visits for any unwanted effects that may be caused by silodosin.

Do not use silodosin if you are also taking clarithromycin (Biaxin®), ketoconazole (Nizoral®), itraconazole (Sporanox®), or ritonavir (Norvir®).

Low blood pressure (hypotension) may occur while taking silodosin. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness.

silodosin may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to silodosin before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Before you have eye surgery for a cataract (clouding of the eye), tell the ophthalmologist (eye doctor) that you are taking silodosin.

silodosin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Chills


• cold sweats


• confusion


• dizziness


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

Incidence not known

• Abdominal or stomach pain


• clay-colored stools


• dark urine


• fever


• headache


• itching


• loss of appetite


• nausea


• pinpoint red or purple spots on the skin


• rash


• skin blisters


• unpleasant breath odor


• unusual tiredness or weakness


• vomiting of blood


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Change or problem with discharge of semen

Less common

• Diarrhea


• muscle aches


• sore throat


• stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: silodosin side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More silodosin resources

• Silodosin Side Effects (in more detail)
• Silodosin Dosage
• Silodosin Use in Pregnancy & Breastfeeding
• Silodosin Drug Interactions
• Silodosin Support Group
• 29 Reviews for Silodosin - Add your own review/rating

• Silodosin Professional Patient Advice (Wolters Kluwer)


• Silodosin Monograph (AHFS DI)


• Silodosin MedFacts Consumer Leaflet (Wolters Kluwer)


• Rapaflo Prescribing Information (FDA)


• Rapaflo Consumer Overview

Compare silodosin with other medications

• Benign Prostatic Hyperplasia

Otrivine Mu-Cron

1. Name Of The Medicinal Product

Otrivine^® Mu-Cron

2. Qualitative And Quantitative Composition

Active ingredient	mg/tab
Paracetamol Ph Eur Pseudoephedrine hydrochloride BP	500.0 60.0

3. Pharmaceutical Form

Tablets

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of the symptoms of colds and influenza including feverishness, aches and pains, headache, nasal and sinus congestion (blocked nose and sinuses).

For oral administration.

4.2 Posology And Method Of Administration

Adults and children over 12 years

One tablet to be taken three or four times a day, up to a maximum daily dose of 4 tablets (240mg pseudoephedrine and 2g paracetamol).

Elderly

Although no specific studies have been carried out in this age group, there is no need for dosage reduction in the elderly.

Children 6 to 12 years

Half a tablet to be taken four times a day, up to a maximum daily dose of 2 tablets (120mg pseudoephedrine and 1g paracetamol).

This medicine is contraindicated in children under 6 years of age (see section 4.3).

Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

Administration in those with hepatic disorders

Care should be taken in administering this product to patients with severe hepatic impairment.

Administration in those with renal disorders

Care should be taken in administering this product to patients with moderate to severe renal impairment.

Warning: Do not exceed the stated dose.

Keep all medicines out of the sight and reach of children.

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients.

Severe renal impairment

Cardiovascular disease including hypertension and peripheral vascular disease.

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma or where intraocular pressure is raised

Severe liver disease

Concomitant use of other sympathomimetic decongestants

Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)

Beta-blockers – (see section 4.5)

Not to be used in children under the age of 6 years

4.4 Special Warnings And Precautions For Use

Caution in moderate to severe renal impairment.

Should be taken with caution by patients with hepatic impairment, prostatic enlargement and alcohol dependence.

If any of the following occur, the product should be stopped:

Hallucinations

Restlessness

Sleep disturbances

Not to be given to children under 6 years.

Do not take for longer than five days, unless your doctor agrees.

If symptoms persist, consult your doctor.

Do not take with any other decongestant-containing products.

Do not take with any other paracetamol-containing products.

Label

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet or combination label/leaflet

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Pseudoephedrine

MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Antihypertensives (including adrenergic neurone blockers & beta-blockers): this product may block the hypotensive effects.

Cardiac glycosides: increased risk of dysrhythmias.

Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.

Oxytocin – risk of hypertension.

Enhances effects of anticholinergic drugs (such as TCAs).

Concomitant use of this medicine with tricyclic antidepressants and sympathomimetic agents such as decongestants may cause a rise in blood pressure.

Paracetamol

Drugs which induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptive steroids, may increase the rate at which paracetamol is metabolised, leading to a reduced plasma concentration of the drug.

Alcohol may reduce the capacity of the liver to metabolise paracetamol.

Chronic use of paracetamol enhances the effects of anticoagulants.

Concurrent use of paracetamol with NSAIDs may increase the risk of adverse renal effects. The prolonged combined use of these compounds may increase the risk of renal damage.

4.6 Pregnancy And Lactation

The safety of this medicine during pregnancy and lactation has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, the use of the product during pregnancy should be avoided. The amounts of paracetamol and pseudoephedrine secreted into breast milk are considered to be too small to be harmful.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Pseudoephedrine

Cardiovascular disorders: Tachycardia, palpitations, other cardiac dysrhythmias.

Gastrointestinal disorders: Nausea and/or vomiting.

General disorders and administration site conditions: Irritability.

Immune system disorders: Hypersensitivity reactions, including cross-sensitivity that may occur with other sympathomimetics.

Nervous system disorders: Headache, tremor, anxiety, restlessness, excitability, insomnia, hallucinations (particularly in children) and paranoid delusions.

Psychiatric disorders: Sleep disturbance.

Renal and urinary disorders: Urinary retention.

Skin and subcutaneous tissue disorders: Skin reactions including rash.

Vascular disorders: Hypertension.

Paracetamol

Blood and lymphatic system disorders: There have rarely been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

4.9 Overdose

Immediate symptoms of overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia, abdominal pain, irritability, restlessness, palpitations, hypertension, difficulty in micturition, thirst and convulsions.

Liver damage may become apparent 12 to 48 hours after ingestion. Though hepatic enzymes may become elevated and prothrombin time prolonged within 10-12 hours of paracetamol overdosage, clinical symptoms may not be apparent for 1 to 6 days following ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatits have been reported.

In paracetamol overdosage with hepatic damage, paracetamol half life is often prolonged from around 2 hours in normal adults to 4 hours or longer. Liver damage and nephrotoxic effects have been reported after the daily ingestion of excessive amounts of paracetamol.

Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Immediate treatment is essential in the management of overdosage. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage and activated charcoal administered to reduce paracetamol absorption. As peak plasma concentrations may be delayed by up to 4 hours following overdose, to accurately assess the risk of hepatotoxicity, plasma paracetamol levels should be measured at least 4 hours post-ingestion.

Generally treatment is required if the blood-paracetamol concentration is higher than a line drawn on semi-log/linear paper joining the points 200mg per litre (1.32 mmol/litre) at 4 hours and 30mg per litre (0.2mmol/litre) at 15 hours following ingestion. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after overdose, may be required. It has been proposed that the threshold for treatment with N-acetylcysteine should be reduced by 30-50% in patients taking drugs which induce hepatic enzymes, who abuse alcohol long-term or who are chronically malnourished. These patients may be more susceptible to toxic effects of paracetamol.

Symptomatic and supportive measures should be undertaken, particularly with regard to the cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is a peripherally acting analgesic with antipyretic activity.

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.

5.2 Pharmacokinetic Properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1-4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose-dependent.

The rate and extent of paracetamol absorption is normal in the elderly but plasma half life is longer and paracetamol clearance lower than in young adults.

In renal impairment though the mean plasma half-life of paracetamol is similar in normal and renally impaired subjects at 2-8 hours, from 8-24 hours paracetamol is eliminated less rapidly. An increase in the interval between doses of paracetamol has been recommended for adults with chronic renal failure.

With severe hepatic impairment the mean plasma half life of paracetamol is significantly prolonged (by approximately 75%). The clinical significance of this is however unclear, as no evidence exists of drug accumulation or hepatotoxicity in patients with liver disease.

Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life is pH dependent. Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3L/Kg bodyweight.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pregelatinised maize starch

Microcrystalline cellulose

Sodium lauryl sulphate

Magnesium stearate

Quinoline yellow (E104)

Croscarmellose sodium

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 30°C.

Store in the original package.

6.5 Nature And Contents Of Container

A child-resistant push through pack of opaque 250 micron PVC/40gsm PVdC blisters, heat sealed to 35gsm Glassine paper/9 micron soft temper aluminium foil.

Pack sizes: 6, 12.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC	or	The Boots Company PLC
1 Thane Road West		trading as BCM
Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/0594

9. Date Of First Authorisation/Renewal Of The Authorisation

First authorisation: 29 July 1999

10. Date Of Revision Of The Text

March 2009

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