CANESTEN HC

Posology:

Canesten HC Cream should be thinly and evenly applied to the affected area twice daily and rubbed in gently. Treatment should be for a maximum of 7 days. A total daily dose of 10 mg cream per kg body weight should not be exceeded. For an adult weighing 50 kg the maximum daily dose is 500 mg cream which equals approximately 2 cm of cream to be divided into 2 applications per day.

There is no separate dosage schedule for the elderly or the young. However, long-term therapy to extensive areas of skin should be avoided particularly in infants and children.

Treatment duration:

If the acute symptoms have subsided after about 7 days but treatment is still required, this may be carried out with the corticoid-free preparation intended for this purpose.

4) After use on large areas (more than 10% of the body surface) and/or after long- term use (longer than 2-4 weeks) or use under occlusive dressings, local skin alterations such as skin atrophy, teleangiectasias, hypertrichosis, striations, hypopigmentation, secondary infection and acneiform symptoms 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.

Because of its corticosteroid content, Canesten HC should not be applied: • to large areas (more than 5 - 10% of the body surface). • in long term continuous therapy. • under occlusive dressings (such as nappies and bandages). These restrictions apply particularly in: • Infants, where the nappy can act as an occlusive dressing and increase systemic absorption.

• Infants and children, where increased systemic absorption may occur resulting in adrenocortical suppression. g. contact dermatitis). The cream also contains benzyl alcohol which may cause allergic reactions and mild local irritation.

Do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Visual disturbance:

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

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