1. Name Of The Medicinal Product
Voltarol® 1.16% Emulgel®, gel
2. Qualitative And Quantitative Composition
Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.
1g of Voltarol Emulgel contains 11.6mg of the active substance diclofenac diethylammonium, which corresponds to 10mg diclofenac sodium.
For full list of excipients, see section 6.1
3. Pharmaceutical Form
Gel for topical administration
Oil emulsion in an aqueous gel. White to off white, soft, homogeneous, cream like
4. Clinical Particulars
4.1 Therapeutic Indications
For the local symptomatic relief of pain and inflammation in:
- trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises
- localised forms of soft tissue rheumatism
It is recommended that treatment be reviewed after 14 days in these indications.
For the treatment of osteoarthritis of superficial joints such as the knee.
In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.
4.2 Posology And Method Of Administration
Adults: Voltarol Emulgel should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4g (a circular shaped mass approximately 2.0-2.5cm in diameter) should be applied 3 - 4 times a daily. After application, the hands should be washed unless they are the site being treated.
Use in the elderly: The usual adult dosage may be used.
Children and adolescents: There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraindications section 4.3). In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
Voltarol Emulgel is suitable for the transmission of ultrasound and may be used as a couplant in combination with ultrasound therapy. If large areas of the body are covered with gel, systemic absorption will be greater and the risk of side-effects increased, especially if the therapy is used frequently.
4.3 Contraindications
• Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents (NSAIDs).
• Hypersensitivity to the active substance or any of the excipients ,
• Hypersensitivity to propylene glycol, isopropanol or other components of the gel base.
• The use in children and adolescents aged less than 14 years is contraindicated.
4.4 Special Warnings And Precautions For Use
Warnings
The likelihood of systemic side effects with topic diclofenac is small compared to the frequency of side effects in patients using oral diclofenac. However when Voltarol Emulgel is applied to relatively large areas of skin over a prolonged period of time, as described in the product information on systemic forms the possibility of systemic side effects cannot be excluded.
Voltarol Emulgel contains propylene glycol, which may cause mild, localised skin irritation in some people.
Precautions
Concomitant use of oral NSAID's should be cautioned as the incidence of untoward effects, particularly systemic side effects, may increase. (See also 'Interactions')
Voltarol Emulgel should not be co-administered with other products containing diclofenac.
Voltarol Emulgel should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should be not be used with occlusion. It should not be allowed to come into contact with the eyes or mucous membranes, and should never be taken by mouth.
Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Systemic absorption of Voltarol Emulgel is low and hence the risk of an interaction is small. There are no known interactions with Voltarol Emulgel but for a list of interactions known with oral diclofenac the data sheet for oral dosage forms should be consulted.
4.6 Pregnancy And Lactation
Pregnancy
Since no experience has been acquired with Voltarol Emulgel in pregnancy or lactation, it is not recommended for use in these circumstances.
During the last trimester of pregnancy the use of prostaglandin synthetase inhibitors may result in premature closure of the ductus arteriosus, or in uterine inertia.
Animal data has shown an increased incidence of dystonia and delayed parturition when drug administration is continued into late pregnancy (see section 5.3 Preclinical safety data).
Lactation
It is not known whether topical diclofenac is excreted in human milk, and Voltarol Emulgel is therefore not recommended during breast-feeding, if there are compelling reasons for using Voltarol Emugel during breast feeding it should not be applied to the breast or to large areas of skin, nor should it be used for a prolonged period.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: common (
Table 1
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4.9 Overdose
Signs and symptoms
The low systemic absorption of Voltarol Emulgel renders overdosage extremely unlikely. However, undesirable effects, similar to those observed following an overdose of Voltarol tablets, can be expected if Voltarol Emulgel is inadvertently ingested (1 tube of 100g contains the equivilant of 1000mg of diclofenac sodium). In the event of accidental ingestion, resulting in significant systemic side-effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be used.
Treatment
Management of overdosage with NSAIDs essentially consists of supportive and symptomatic measures. There is no typical clinical picture resulting from Voltarol overdosage. Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastro-intestinal irritation, and respiratory depression; specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Topical products for joint and muscular pain, anti inflammatory preparations, non-steroids for topical use (ATC code M02A A15)
Voltarol Emulgel is a non-steroidal anti-inflammatory (NSAID) and analgesic preparation designed for external application. Due to an aqueous-alcoholic base the gel exerts a soothing and cooling effect.
5.2 Pharmacokinetic Properties
When Voltarol Emulgel is applied locally, the active substance is absorbed through the skin. In healthy volunteers approximately 6% of the dose applied is absorbed, as determined by urinary excretion of diclofenac and its hydroxylated metabolites. Findings in patients confirm that diclofenac penetrates inflamed areas following local application of Voltarol Emulgel.
After topical administration of Voltarol Emulgel to hand and knee joints diclofenac can be measured in plasma, synovial tissue and synovial fluid. Maximum plasma concentrations of diclofenac are about 100 times lower than after oral administration of Voltarol.
5.3 Preclinical Safety Data
None known
6. Pharmaceutical Particulars
6.1 List Of Excipients
Diethylamine, carbomer, macrogol cetostearyl ether, cocyl caprylocaprate, isopropyl alcohol, liquid paraffin heavy, perfume creme 45, propylene glycol dist., and water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Three years.
6.4 Special Precautions For Storage
Protect from heat (store below 30°C).
Voltarol Emulgel should be kept out of reach and sight of children.
6.5 Nature And Contents Of Container
Aluminium tubes with protective inner coating, available in packs of 20g and 100g
6.6 Special Precautions For Disposal And Other Handling
None
7. Marketing Authorisation Holder
Novartis Consumer Health UK Ltd.
Trading as:
Novartis Consumer Health
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
8. Marketing Authorisation Number(S)
PL 00030/0420
9. Date Of First Authorisation/Renewal Of The Authorisation
11 July 1997
10. Date Of Revision Of The Text
26 October 2011
LEGAL CATEGORY
POM
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