MOBIGEL

Posology Adults and adolescents over 14 years of age Sufficient amount of solution should be sprayed locally to the skin on the affected area 3 times a day at regular intervals. The amount needed depends on the size of the treated area.

0 g of spray corresponding to 32-40 mg of diclofenac sodium) would be required. The maximum single dose should not exceed 1g of spray (5 pump strokes). 0 g of spray corresponding to 120 mg of diclofenac sodium). Mobigel Spray 40mg/g cutaneous spray, solution should be rubbed gently into the skin.

After application, the hands should be washed, unless they are the site to be treated. After application, several minutes should be allowed for drying the treated area before it is covered with dressing or bandage.

Duration of treatment:

The treatment may be discontinued when the symptoms (pain and swelling) have subsided. Treatment should not be continued beyond 7-8 days without doctor’s recommendation. The patient is advised to consult the doctor if there is no improvement after 3 days or if symptoms get worse.

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 patient/parents of the adolescent is/are advised to consult a doctor. Elderly The posology is the same as for adults.

3). Patients with hepatic or renal impairment For the use of Mobigel Spray 40mg/ml cutaneous spray, solution in patients with hepatic or renal insufficiency, see section

The following skin disorders are commonly reported: rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus* Adverse reactions are listed by system organ classes based on frequency 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 category, adverse reactions are presented in order of decreasing seriousness. d. (120 patients) or placebo (116 patients) for 14 days. e. more than 600 square centimetres of the body surface) there is a possibility of systemic adverse reactions.

Reactions like abdominal pain, dyspepsia, gastric and renal disorders 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.

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4. Method of administration For cutaneous use. 1. Patients with a history of asthma attacks, urticaria or acute rhinitis in response to acetylsalicylic acid or other non-steroidal anti-inflammatory agents (NSAIDs). Third trimester of pregnancy.

Paediatric population: the use in children and adolescents aged less than 14 years is contraindicated. 4 Special warnings and precautions for use Adverse reactions may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

The possibility of systemic adverse events from application of Mobigel Spray 40mg/g cutaneous spray, solution cannot be excluded if the product is used on large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac).

Mobigel Spray 40mg/g cutaneous spray, solution must be applied only to intact non-diseased skin, and not to skin wounds or open injuries. It must not be allowed to come into contact with the eyes or mucous membranes and it must not be ingested.

Mobigel Spray 40mg/g cutaneous spray, solution can be used with non- occlusive bandages but should not be used with an airtight occlusive dressing. Direct sunlight, including solarium, should be avoided during treatment in order to reduce the incidence of photosensitive reaction.

If sensitivity skin reactions occur, the use of this product should be discontinued. The treatment should be discontinued if a skin rash develops after applying the product. 5). e. e. more than 4 weeks), the possibility of systemic side-effects cannot be completely excluded.

If such use is envisaged, the product information of diclofenac oral dosage forms should be consulted (for example, there is the potential for hypersensitivity, asthmatic and renal adverse reactions). Bronchospasm may be precipitated in patients suffering from or with previous history of bronchial asthma or allergenic disease.

1. Patients with a history of asthma attacks, urticaria or acute rhinitis in response to acetylsalicylic acid or other non-steroidal anti-inflammatory agents (NSAIDs). Third trimester of pregnancy. Paediatric population: the use in children and adolescents aged less than 14 years is contraindicated.