DICLOFENAC SODIUM

For cutaneous use only.

Adults and children 14 years and over:

The gel should be rubbed gently into the skin 3-4 times daily. 5cm in diameter) of gel should be applied 3-4 times a day. 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.

The maximum daily dose is 16g. Therefore, the maximum weekly dose is 112g. After application, the hands should be washed unless they are the site being treated. If symptoms do not improve by day 7, or if they worsen within the first 7 days, a consultation with a doctor should be sought.

Consultation with a doctor is recommended if more than two major joints in the body are affected. Do not use for more than 7 days unless recommended by a doctor.

Use in the elderly:

The usual adult dosage may be used.

Children and adolescents:

The product should not be used in children under 14 years of age. 3). Inchildren aged 14 years and over, if this product is required for more than 7 days for pain reliefor if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (> 1/10); common (>1/100, <1/10); uncommon (≥1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (<1/10,000), not known: cannot be estimated from the available data.

Table 1 – Adverse Reactions Immune system disorder:

Very rare: Hypersensitivity (including urticaria), angioneurotic oedema.

Infections and infestations:

Very rare: Rash pustular.

Respiratory, thoracic and mediastinal disorders:

Very rare: Asthma.

Skin and subcutaneous tissue disorders:

Common: Rare: Very rare: Not known: Rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus. Dermatitis bullous. Photosensitivity reaction. Burning sensation at the application site. Dry skin. Although less likely with the topical administration, some side effects normally associated with systemically administered diclofenac may also occur.

The prolonged use of diclofenac in a relatively extensive area can cause systemic side effects such as nausea, vomiting, diarrhoea or epigastric pain. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

The occurrence of systemic undesirable effects with the topical use of diclofenac is low when compared with the frequency of undesirable effects with the oral use of diclofenac. The possibility of systemic adverse events (those associated with the use of systemic forms of diclofenac) from application of topical diclofenac cannot be excluded if the preparation is used at higher dosage/large amounts on large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac).

). Apparently, the risk of occurrence of these reactions is higher at the beginning of the treatment and in most cases these reactions are manifested during the first month of treatment. Concomitant use of oral NSAID's should be cautioned as the incidence of untoward effects, particularly systemic side effects, may increase.

Diclofenac Sodium 1% Gel should be discontinued at the first signs of rash, mucosal injuries or other hypersensitivity manifestations. Patients with a history of, or active, peptic ulcerations. 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. Topical diclofenac 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. The area treated with Diclofenac Sodium 1% Gel should not be exposed to sunlight. Topical diclofenac can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

Diclofenac Sodium 1% Gel contains propylhydroxybenzoate (E216) and methylhydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). Diclofenac Sodium 1% Gel also contains propylene glycol which may cause skin irritation.

Hypersensitivity to diclofenac, acetylsalicylic acid (aspirin), other non- steroidal anti-inflammatory drugs or any of the excipients. - Patients with or without chronic asthma in whom attacks of asthma, angioedema urticaria or acuterhinitis are precipitated by acetylsalicylic acid or other non- steroidal anti- inflammatory drugs (NSAIDs).

- The use in children and adolescents aged less than 14 years is contraindicated. - Third trimester of pregnancy. - Patients with renal impairment. - Concomitant use of oral NSAIDs and other products containing diclofenac.