DICLOFENAC

Posology Adults and adolescents aged 14 years and over Apply thin layers of Diclofenac 1% Gel in the affected area, 3-4 times daily according to the need of the situation (about 2-4 g, quantity as big as a cherry or a walnut) and rub gently.

The treatment duration depends on the indications and the patient’s response to the treatment. It is recommended that the treatment should be evaluated 7 days after its beginning. In adolescents aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patients/parents of the adolescent is/are advised to consult a doctor.

Diclofenac 1% Gel can be used as additional treatment to the oral administration of non-steroidal anti-inflammatory drugs. 3). Hepatic and renal impairment No dosage adjustment is required in patients with hepatic impairment. Diclofenac 1% Gel is contraindicated in patients with renal impairment.

Elderly The usual adult dosage may be used. Method of administration Cutaneous use. Apply on healthy skin only. After application, the hands should be washed, unless these are being treated. Diclofenac 1% Gel can be used as additional treatment to the oral administration of non-steroidal anti-inflammatory drugs.

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 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:

Rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus Rare: Dermatitis bullous Very rare: Photosensitivity reaction 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 from application of topical diclofenac 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).

). 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 1% Gel should be discontinued at the first signs of rash, mucosal injuries or other hypersensitivity manifestations. 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 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 1% Gel contains propylhydroxybenzoate (E216) and methylhydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). Diclofenac 1% Gel also contains propylene glycol which may cause skin irritation.

1. - Patients with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis 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.