DICLOFENAC GLENMARK

Posology Use in Adults:

Diclofenac 3% gel is applied locally to the affected area twice daily, with the gel smoothed into the skin gently. The amount needed depends on the size of the affected area. 5 g (the size of a pea) of the gel is used on a 5 cm x 5 cm lesion site.

The maximum daily amount of 8 g of gel allows simultaneous treatment of up to 200 cm² skin surface area. The usual duration of therapy is from 60 to 90 days. Maximum efficacy has been observed with treatment duration towards the upper end of this range.

Complete healing of the lesion(s) or optimal therapeutic effect may not be evident for up to 30 days following cessation of therapy.

Use in the Elderly:

The usual adult dose may be used.

Paediatric population:

Actinic keratosis (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 30 mg/g gel in children and adolescents have not been established.

No data are available. Method of administration For cutaneous use.

Most frequently reported adverse reactions include skin reactions such as contact dermatitis, erythema and rash or application site reactions such as inflammation, irritation, pain and blistering. In studies there appeared to be no age specific increase or 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, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000); Not known: frequency cannot be estimated from the available data.

Table 1:

Treatment-related adverse reactions reported by body system and frequency Infections and infestations Very rare Rash pustular Immune system disorders Very rare Topical application of large amounts may result in systemic effects including all types of hypersensitivity (including urticaria, angioneurotic oedema) Nervous system disorders Common Hyperesthesia, hypertonia, localised paraesthesia Eye disorders Common Conjunctivitis Uncommon Eye pain, lacrimation disorder Vascular disorders Uncommon Haemorrhage Respiratory, thoracic and mediastinal disorders Very rare Asthma Gastrointestinal disorders Uncommon Abdominal pain, diarrhoea, nausea Very rare Gastrointestinal haemorrhage Skin and subcutaneous tissue disorders Common Dermatitis (including contact dermatitis), eczema, dry skin, erythema, oedema, pruritus, rash, scaly rash, skin hypertrophy, skin ulcer, vesiculobullous rash Uncommon Alopecia, face oedema, maculopapular rash, seborrhoea Rare Dermatitis bullous Very rare Photosensitivity reaction Renal and urinary disorders Very rare Renal failure General disorders and administration site conditions Common Application site reactions (including inflammation, irritation, pain and tingling or blistering at the treatment site) Temporary hair discolouration at the application site has been reported.

The likelihood of systemic adverse reactions occurring following the topical application of diclofenac gel is very small compared to the frequency of adverse reactions with oral diclofenac, owing to low systemic absorption with diclofenac gel.

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 (see product information on systemic forms of diclofenac).

This medicinal product should be used with caution in patients with a history of and/or active gastrointestinal ulceration or bleeding, or reduced heart, liver or renal function, since isolated cases of systemic adverse reactions consisting of renal affection, have been reported with topically administered anti-inflammatory medicinal products.

It is known that nonsteroidal anti-inflammatory drugs (NSAIDs) can interfere with platelet function. Although the likelihood of systemic adverse reactions is very low, caution should be used in patients with intracranial haemorrhage and bleeding diathesis.

Direct sunlight, including solarium, should be avoided during treatment. If sensitivity skin reactions occur, discontinue use. The gel should not be applied to skin wounds, infections or exfoliative dermatitis. It should not be allowed to come into contact with the eyes or mucous membranes and should not be ingested.

The treatment should be discontinued 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 10 mg benzyl alcohol in each g.

Benzyl alcohol may cause mild local irritation.

1. Because of cross-reactions, the gel must not be used by patients who have experienced hypersensitivity reactions such as symptoms of asthma, allergic rhinitis or urticaria, to acetylsalicylic acid or other non-steroidal anti-inflammatory agents.

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