1. Name Of The Medicinal Product
Voltarol® Pain-eze Emulgel®
2. Qualitative And Quantitative Composition
Diethylammonium-{-o-[2,6-dichlorophenyl)-amino]-phenyl}-acetate.
100g of Voltarol Pain-eze Emulgel contains 1.16g of the active substance diclofenac diethylammonium, which corresponds to 1g diclofenac sodium.
For excipients, see section 6.1.
3. Pharmaceutical Form
Gel for topical administration.
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
4.2 Posology And Method Of Administration
Adults and children aged 14 years and over: Voltarol Pain-eze 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 day. After application, the hands should be washed unless they are the site being treated.
A period of at least 4 hours should be left between applications. The dose should not be applied more than 4 times in a 24 hour period.
If symptoms persist after 7 days or get worse at any time, medical advice should be sought.
Not to be used for more than 7 days unless recommended by a doctor.
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.
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.
Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Hypersensitivity to any other ingredient of the gel.
Concomitant use of oral NSAID's.
Voltarol Pain-eze Emulgel should not be co-administered with other products containing diclofenac.
The use in children and adolescents aged less than 14 years is contraindicated.
4.4 Special Warnings And Precautions For Use
Voltarol Pain-eze Emulgel should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should 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.
Patients with a history of, or active, peptic ulceration. Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac and other NSAIDs can precipitate bronchospasm if administered to patients suffering from or with a previous history of asthma or allergic disease.
Discontinue if rash develops.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Systemic absorption of Voltarol Pain-eze Emulgel is low and hence the risk of an interaction is small. There are no known interactions with Voltarol Pain-eze Emulgel but for a list of interactions known with oral diclofenac the Summary of Product Characteristics for oral dosage forms should be consulted.
Concurrent use of aspirin or other NSAIDs may result in an increased incidence of adverse reactions.
4.6 Pregnancy And Lactation
Since no experience has been acquired with Voltarol Pain-eze 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.
Following oral doses of 50mg diclofenac administered every 8 hours, diclofenac passes into breast milk in quantities so small that no undesirable effects on the infant are to be expected.
4.7 Effects On Ability To Drive And Use Machines
See side effects.
4.8 Undesirable Effects
Local reactions:
Voltarol Pain-eze Emulgel is usually well tolerated.
Occasional: allergic or non-allergic contact dermatitis (with symptoms and signs such as itching, reddening, oedema, papules, vesicles, bullae or scaling of skin).
Systemic reactions:
Hypersensitivity reactions have been reported following treatment with NSAIDSs. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea or (c) assorted skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema, and less commonly, bullous dermatoses (including epidermal necrolysis, erythema multiforme and exfoliative dermatitis.
Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.
General: Systemic absorption of Voltarol Pain-eze Emulgel is low compared with plasma levels obtained following administration of oral forms of Voltarol and the likelihood of systemic side-effects occurring with topical diclofenac is small compared with the frequency of side-effects associated with oral diclofenac. However, where Voltarol Pain-eze Emulgel is applied to a relatively large area of skin and over a prolonged period, the possibility of systemic side-effects cannot be completely excluded. If such usage is envisaged, the data sheet on Voltarol oral dosage forms should be consulted.
Gastro-intestinal: abdominal pain, dyspepsia.
Bronchospasms may be precipitated in patients suffering from or with a previous history of asthma or allergic disease.
4.9 Overdose
Signs and symptoms
The low systemic absorption of topical diclofenac renders overdosage extremely unlikely. 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 diclofenac 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
Voltarol Pain-eze Emulgel is an anti-inflammatory 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 Pain-eze Emulgel is applied locally, the active substance is absorbed through the skin. In healthy volunteers approximately 6% of the dose applied is absorbed when determined by urinary excretion of diclofenac and its hydroxylated metabolites. Findings in patients confirm that diclofenac penetrates inflamed areas following local application of Voltarol Pain-eze Emulgel.
Synovial fluid and tissue levels of diclofenac are higher than those detected in plasma.
5.3 Preclinical Safety Data
None known.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Diethylamine, carbomers, cetomacrogol, cocoyl caprylocaprate, isopropyl alcohol, liquid paraffin, perfume creme 45, propylene glycol, purified water.
6.2 Incompatibilities
None Stated
6.3 Shelf Life
Three years
6.4 Special Precautions For Storage
Do not store above 30°C.
Voltarol Pain-eze Emulgel should be kept out of reach and sight of children.
6.5 Nature And Contents Of Container
Sealed aluminium tubes with protective inner coating, closed with a polypropylene screw cap.
Packaging available in packs of 10g, 30g and 50g.
Aluminium laminated tube (low density polyethylene /aluminium/high density polyethylene (internal layer)) fitted with a high density polyethylene shoulder and closed by a moulded seal. The tube is closed with a polypropylene screw cap, incorporating a moulded feature used to insert, twist and remove the seal before first use.
Packaging available in packs of 30g and 50g.
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
UK
8. Marketing Authorisation Number(S)
PL 00030/0212
9. Date Of First Authorisation/Renewal Of The Authorisation
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10. Date Of Revision Of The Text
13 July 2011.
LEGAL CATEGORY
GSL
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