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  • Voltaren Emulgel
    / GSK


    Active Ingredient

    Status in Israel
    OTC

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Gel

    20 g X 1%

    full basket chart 72266 22278

    Gel

    50 g X 1%

    full basket chart 7689 22205

    Gel

    100 g X 1%

    full basket chart 8040 22215

    Gel

    150 g X 1%

    full basket chart 23569 22318

    Gel

    Forte: 100 g X 2%

    not in the basket chart 76651 22394

    Dosage

    Adults and adolescents aged 12 years and over: Voltaren Emulgel should be applied over the affected area 3 or 4 times daily and rubbed gently into the skin. The amount needed depends on the size of the painful area: 2 g to 4 g Voltaren Emulgel (a quantity ranging in size from a cherry to a walnut) is sufficient to treat an area of about 400-800 cm². After application, the hands should be washed, unless they are the site being treated.
    The duration of treatment depends on the indication and clinical response. The gel should not to be used for more than 14 days for soft-tissue injuries or soft tissue rheumatism unless recommended by a doctor, or 21 days for arthritis pain When used without medical prescription, patients should consult their doctor if the condition does not improve within 7 days, or if it gets worse.
    Children: Voltaren Emulgel is not recommended for use in children below 12 years of age.
    The elderly: The usual adult dosage may be used.


    Indications

    Self medication for the following indications:
    Local treatment of pain, inflammation and swelling due to:
    – Pain and inflammation and swelling in trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and/or bruises and/or backache (e.g. sports injuries);
    – Localized forms of soft tissue rheumatism such as tendonitis (e.g. tennis elbow), bursitis.
    By Physicians order:
    – Pain caused by osteoarthritis of the peripheral joints, as of the knee or fingers.


    Contra-Indications

    – Patients with or without chronic asthma in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
    – Hypersensitivity to diclofenac, acetylsalicylic acid or non-steroidal anti-inflammatory drugs or any of the excipients.
    – Third trimester of pregnancy.
    – Concomitant use of oral NSAID’s
    – Voltaren Emulgel should not be co-administered with other products containing diclofenac.
    – The use in children and adolescents aged less than 12 years is contraindicated.


    Special Precautions

    The possibility of systemic adverse events from application of Voltaren Emulgel cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac). Voltaren Emulgel should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be allowed to come into contact with the eyes or mucous membranes, and should not be ingested.
    Discontinue the treatment if a skin rash develops after applying the product.
    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.
    Voltaren Emulgel contains propylene glycol, which may cause mild, localised skin irritation in some people.
    Voltaren Emulgel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
    The product contains alcohol. Do not light a cigarette or expose yourself to fire until the gel is completely dried.


    Side Effects

    Common: Rash, eczema, erythema, dermatitis (including dermatitis
    contact), pruritus.
    See prescribing information for full details.


    Drug interactions

    Since systemic absorption of diclofenac from a topical application of Voltaren Emulgel is very low, such interactions are very unlikely. There are no known interactions with Voltaren 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.


    Pregnancy and Lactation

    Pregnancy: During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
    Lactation: Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Voltaren Emulgel no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance,Voltaren Emulgel should not be applied on the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time.
    See prescribing information for full details.


    Overdose

    Signs and symptoms: The low systemic absorption of topical diclofenac renders overdose very unlikely.
    However undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected if Voltaren Emulgel is inadvertently ingested (1 tube of 100 g contains the equivalent of 1000 mg diclofenac sodium). In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicines should be used. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.
    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, gastrointestinal 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.


    Manufacturer
    Novartis Consumer Health, Switzerland
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