1. Name Of The Medicinal Product
Voltarol® Gel Patch 1 %, medicated plaster
2. Qualitative And Quantitative Composition
Each 10 cm x 14 cm medicated plaster contains diclofenac epolamine corresponding to 140 mg of diclofenac sodium (1% w/w).
For excipients, see 6.1.
3. Pharmaceutical Form
Medicated plaster.
White to pale yellow paste spread as a uniform layer onto unwoven support.
4. Clinical Particulars
4.1 Therapeutic Indications
Local symptomatic treatment of pain in epicondylitis and ankle sprain.
4.2 Posology And Method Of Administration
Cutaneous use only
Article I. Posology
Adults
- Treatment of ankle sprains : 1 application a day
- Treatment of epicondylitis: 1 application morning and evening
Article II. Duration of administration
Voltarol Gel Patch is to be used for as short as possible depending on the indication:
- Treatment of ankle sprains : 3 days
- Treatment of epicondylitis : max. 14 days.
If there is no improvement, during the recommended duration of treatment, a doctor should be consulted.
Elderly
This medication should be used with caution in elderly patients who are more prone to adverse events. See also Section 4.4.
Children
Since no specific study has been performed, the use of Voltarol Gel Patch in children under 15 years old is not recommended.
Patients with hepatic or renal insufficiency
For the use of Voltarol Gel Patch in patients with hepatic or renal insufficiency see section 4.4.
Article III. Method of administration
Cut the envelope containing the medicated plaster as indicated. Remove one medicated plaster, remove the plastic film used to protect the adhesive surface and apply it to painful joint or region. If necessary it can be held in place with an elastic net. Carefully reseal the envelope with the sliding closure.
The plaster should be used whole.
4.3 Contraindications
This medicinal product is contraindicated in the following cases:
- Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) or any excipients of the finished medicinal product.
- damaged skin, whatever the lesion involved: exudative dermatitis, eczema, infected lesion, burn or wound.
- from the beginning of the 6th month of pregnancy (see 4.6 Pregnancy and lactation).
- Patients with active peptic ulceration.
4.4 Special Warnings And Precautions For Use
- The medicated plaster should not come into contact with or be applied to the mucosae or the eyes.
- Not for use with occlusive dressing.
- Discontinue the treatment immediately if a skin rash develops after applying the medicated plaster.
- Do not administer concurrently, by either the topical or the systemic route, any medicinal product containing diclofenac or other NSAIDs.
- Although systemic effects should be low, the plaster should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulceration or inflammatory bowel disease or bleeding diathesis. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients who are more prone to adverse events.
- This medicinal product contains methylparahydroxybenzoate and propylparahydroxybenzoate. It may cause allergic reactions (possibly delayed). It also contains propylene glycol, which may cause skin irritation.
- Patients should be warned against exposure to direct and solarium sunlight in order to reduce the risk of photosensitivity.
- Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergenic disease or allergy to acetylsalicylic acid or other NSAID. The medicated plaster should be used with caution in patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other nonsteroidal anti-inflammatory agents (see 4.3 Contraindications).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
In view of the low rate of systemic transfer during normal use of the medicated plasters, the drug interactions reported for oral diclofenac are unlikely to be observed.
4.6 Pregnancy And Lactation
By analogy with the other routes of administration
Pregnancy
There is insufficient experience for the use during pregnancy. Animal studies have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Therefore Voltarol Gel Patch should be avoided during the first 5 months of pregnancy and is contra-indicated from the beginning of the 6th month of pregnancy.
During the last trimester of pregnancy, the use of prostaglandine synthetase inhibitors may result in:
- Inhibition of uterine contractions, prolongation of pregnancy and delivery
- Pulmonary and cardiac toxicity in the foetus (pulmonary hypertension with preterm closing of the ductus arteriosus)
- Renal insufficiency in the foetus with oligohydramnios
- Increased possibility of bleeding in the mother and child and increased oedema formation in the mother.
Lactation
Experimental data regarding excretion of diclofenac epolamine in human or animal milk are not available therefore, Voltarol Gel Patch is not recommended in nursing mothers.
4.7 Effects On Ability To Drive And Use Machines
Patients who experienced dizziness or other central nervous disturbances while taking NSAID's should refrain from driving or operating machinery, but this would be very unlikely using topical preparations such as Voltarol Gel Patch.
4.8 Undesirable Effects
Skin disorders are commonly reported.
Skin: pruritus, redness, erythema (including in very rare cases erythema bullosum), rashes, application site reactions, allergic dermatitis.
1252 patients were treated with Voltarol Gel Patch and 734 with Placebo in clinical trials. The following adverse drug reactions were reported:
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Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration.
In patients using topical NSAID preparations, in isolated cases, generalised skin rash, hypersensitivity reactions such as angioedema and reactions of anaphylactic type and photosensitivity reactions have been reported.
Systemic absorption of diclofenac is very low compared with plasma levels obtained following administration of oral forms of diclofenac and the likelihood of systemic side-effects reactions (like gastric and renal disorders) occurring with topical diclofenac is very small compared with the frequency of side-effects associated with oral diclofenac. However, where Voltarol Gel Patch is applied to a relatively large area of skin and over a prolonged period, the possibility of systemic side-effects cannot be excluded.
4.9 Overdose
Not applicable
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Antiinflammatory preparations, non-steroids for topical use.
ATC Code: M02AA15
Diclofenac hydroxyethylpyrrolidine or diclofenac epolamine is a water soluble salt of diclofenac.
Diclofenac is a nonsteroidal anti-inflammatory drug derived from phenylacetic acid which belongs to the aryl carboxylic acid group of compounds.
In the form of a medicated plaster, it has topical anti-inflammatory and analgesic activity.
5.2 Pharmacokinetic Properties
Following cutaneous application of the medicated plaster, diclofenac epolamine is absorbed through the skin.
The absorption kinetics at steady state show a prolonged release of the active ingredient with a maximum diclofenac plasma level (Cmax) of 17.4 ±13.5 ng/ml, which is reached after about 5 hours (Tmax 5.4±3.7 hours).
Diclofenac is extensively bound to plasma protein (about 99 %).
Systemic transfer in healthy volunteers when using the medicated plaster, compared with oral forms of diclofenac, is of the order of 2%, as estimated from the urinary excretion of the drug and its metabolites and from a between study comparison.
5.3 Preclinical Safety Data
In the rat and rabbit, diclofenac epolamine, epolamine monosubstance and N-oxide epolamine (main metabolite of epolamine in humans) have caused embryotoxicity and increased embryolethality after oral use.
Other preclinical data reveal no special hazard for humans, beyond the information included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Supporting layer:
Unwoven polyester support.
Adhesive layer (active Gel):
Gelatin, povidone (K90), liquid sorbitol (non crystallising), heavy kaolin, titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate (E385), tartaric acid, aluminium glycinate, carmellose sodium, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, Dalin PH perfume (propylene glycol, benzyl salicylate, phenylethyl alcohol, alpha amylcinnamic aldehyde, hydroxycitronellal, phenyethyl phenylacetate, cinnamyl acetate, benzyl acetate, terpineol, cinnamic alcohol, cyclamenaldehyde), purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
3 years.
After first opening the sealed envelope : 3 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Sealed envelopes made of paper/PE/aluminium/ethylene and methacrylic acid copolymer contain 2 or 5 medicated plasters.
Pack size: 2, 5, 10 and 14 medicated plasters per box.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Remaining active ingredient of the plaster may pose a risk to the aquatic environment. Do not flush used plasters down the toilet. The plasters should be disposed of according to local requirements.
7. Marketing Authorisation Holder
Novartis Consumer Health
Wimblehurst Road
Horsham, West Sussex
RH12 5AB
8. Marketing Authorisation Number(S)
PL 00030/ 0206
9. Date Of First Authorisation/Renewal Of The Authorisation
10 March 2004
10. Date Of Revision Of The Text
14 November 2005
Legal category
POM
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