DICLOFENAC SODIUM

Posology Adults:

Diclofenac sodium gel should be applied to the affected skin areas twice daily and smoothed into the skin gently. The amount used depends on the size of the area to be treated. 5 g of gel (about the size of a pea) is applied to a 5x5 cm lesion site.

The maximum daily amount of 8 grams of product allows simultaneous treatment of up to 200 cm² skin surface area. The usual duration of treatment is 60 to 90 days. Maximum effect has been observed with treatment durations at the upper end of this time range.

Complete healing of the lesion(s) or optimal therapeutic effect may not be seen for up to 30 days after completion of therapy.

Elderly people:

The normal dosage can be used.

Paediatric population:

AK is a condition not generally seen within the paediatric population and was not studied. Therefore, dosage recommendations and indications for the use of Diclofenac sodium have not been established for use in children and adolescent.

Method of administration Cutaneous use. Afterwards, the hands should be wiped on a paper towel and then washed, unless they are the area to be treated. The paper towel should be disposed of in the residual waste. This helps to significantly reduce diclofenac release into the waste water system (water pollutant).

Common adverse reactions:

The most frequently reported adverse reactions are local skin reactions such as contact dermatitis, erythema and rash or application site reactions such as inflammation, skin irritation, pain and blistering. In clinical studies to date there has appeared to be no age-related increase or age- specific pattern of reactions.

Adverse reactions are listed in Table 1 according to Medical Dictionary for Regulatory Activities (MedDRA) system organ class and in decreasing frequency defined as follows: 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) Not known (cannot be estimated from the available data) Table 1: Treatment-related adverse reactions reported by body system and frequency Organ system 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) Infections and infestations Pustular rash Immune system disorders All types of hypersensitivity reactions (including urticaria, angio- oedema) Nervous system disorders Hyperaesthesia, hypertonia, localised paraesthesia Eye disorders Conjunctivitis Eye pain, lacrimation disorder Vascular disorders Haemorrhage (skin bleeding) Respiratory, thoracic and mediastinal disorders Asthma Gastrointestinal disorders Abdominal pain, diarrhoea, Gastrointestinal haemorrhage feeling sick Skin and subcutaneous tissue disorders Dermatitis (including contact dermatitis), eczema, dry skin, erythema, oedema, pruritus, rash, scaly rash, skin hypertrophy, skin ulcer, vesiculobullous rash Alopecia, facial oedema, maculopapular rash, seborrhoea Bullous dermatitis Photosensitivity reactions Renal and urinary disorders Renal insufficiency General disorders and administration site conditions Application site reactions (including inflammation, skin irritation, pain and tingling or blistering at the treated site) Temporary hair discolouration at the application site has been reported.

This is usually reversed on stopping treatment. 18% probability of sensitisation to diclofenac, triggering allergic contact dermatitis (type IV). The clinical relevance is as yet unknown. Cross-reactions with other NSAIDs are unlikely.

Serum tests in more than 100 patients revealed no (type I) anti-diclofenac antibodies. 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.

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Due to the low systemic absorption of Diclofenac sodium gel, the likelihood of systemic adverse reactions following the external use of Diclofenac sodium gel is small compared to the frequency of adverse reactions with oral diclofenac.

However, 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 of time (see medicinal product information for systemic formulations of diclofenac).

This medicinal product should be used with caution in patients with a history of and/or active gastrointestinal ulceration and/or bleeding, or reduced heart, liver or kidney function because there have been isolated reports of systemic adverse reactions (such as kidney disorders) associated with externally used anti-inflammatory medicinal products.

Non-steroidal anti-inflammatory medicinal products are known to have anti-platelet activity. Therefore, although the likelihood of systemic adverse reactions is small, caution should be used in patients with intracranial haemorrhage and bleeding diathesis.

Exposure to direct sunlight and solarium use should be avoided during treatment. If hypersensitivity reactions of the skin occur, treatment must be stopped. Topical diclofenac should be applied only to intact skin, and not to skin wounds, open injuries, infected skin areas or exfoliative dermatitis.

The gel must not come into contact with the eyes or mucous membranes and should not be ingested. Discontinue the treatment if a (generalised) skin rash develops after applying the medicinal product. Topical diclofenac can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.

This medicinal product contains 15 mg benzyl alcohol in each gram of gel. Benzyl alcohol may cause allergic reactions and mild local irritation.

1. Because of the potential for cross-reactions, the gel should not be used in patients who have experienced hypersensitivity reactions such as symptoms as asthma, allergic rhinitis or urticaria to 2-acetoxybenzoic acid (acetylsalicylic acid) or any other non-steroidal anti-inflammatory medicinal products (NSAIDs).

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