DICLOFENAC SODIUM

Posology Adults Sufficient solution of Diclofenac Sodium Spray Gel should be sprayed onto the skin of the affected site. 0 g of spray containing 32-40 mg of diclofenac sodium) should be applied 3 times daily in regular intervals. 0 g of the product should not be exceeded.

0 g of spray containing 120 mg of diclofenac sodium). Diclofenac Sodium Spray Gel should be massaged gently into the skin. After this the hands should be washed unless they are the site to be treated. After application some minutes for drying should be allowed before dressing or binding the treated area.

The treatment may be discontinued when the symptoms (pain and swelling) have subsided. Treatment should not be continued beyond 7 days without review. The patient is requested to consult the doctor if no improvement is seen after 3 days or if symptoms worsen.

3). In children aged 14 years and older, 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. Patients with hepatic impairment In patients with hepatic impairment no dose reduction is required.

Elderly No special dose adjustment is required. Due to possible adverse effect profile the elderly should receive particularly careful monitoring. Patients with renal impairment In patients with renal impairment no dose reduction is required.

Patients with hepatic impairment In patients with hepatic impairment no dose reduction is required. Method of administration For cutaneous use only.

Skin disorders are commonly reported. 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 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not to be estimated from available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. d. (120 patients) or placebo (116 patients) for 14 days. When Diclofenac Sodium Spray Gel is applied on large areas of skin and over a prolonged period, the occurrence of systemic undesirable effects cannot be excluded.

Reactions such as abdominal pain, dyspepsia, gastric, hepatic or renal disorders and systemic hypersensitivity reactions may occur. 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 possibility of systemic adverse events from application of Diclofenac Sodium Spray Gel 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).

Diclofenac Sodium Spray Gel 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. Diclofenac Sodium Spray Gel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

Patients should be warned against exposure to sunlight or solarium radiation in order to reduce the incidence of photosensitivity. Discontinue the treatment if a skin rash develops after applying the product. 5). Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration.

Bronchospasm may be precipitated in patients suffering from or with previous history of bronchial asthma or allergenic disease. Diclofenac Sodium Spray Gel should only be used with caution in patients with a history of peptic ulcer, hepatic or renal insufficiency, bleeding diathesis or inflammatory bowel disease as isolated cases with topical diclofenac have been reported.

Diclofenac Sodium Spray Gel contains propylene glycol (E1520) which may cause skin irritation in some people. Diclofenac Sodium Spray Gel contains peppermint oil which may cause allergic reactions. 3% w/w. It can cause a burning sensation on damaged skin.

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1. • Hypersensitivity to acetylsalicylic acid or other non-steroidal anti- inflammatory drugs (NSAIDs). • Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents (NSAIDs).

• Use on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes. • During the third trimester of pregnancy. • Children and adolescents aged less than 14 years.