ISOTREX

Adults and adolescents Apply Isotrex Cream sparingly over the entire affected area once or twice daily, preferably after washing and drying the skin. 05% is recommended. 1% is recommended because of its greater effectiveness in treating comedonal acne and its quicker onset of action.

05% is recommended as an alternative. If undue irritation (redness, peeling, or discomfort) occurs, patients should reduce frequency of application or temporarily interrupt treatment. The normal frequency of application should be resumed once the irritation subsides.

Treatment should be discontinued if the irritation persists. Patients should be advised that, in some cases, six to eight weeks of treatment may be required before the therapeutic effect is observed. 2 Patients should wash their hands after application of Isotrex Cream.

Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. Use in Children The safety and efficacy of topical isotretinoin in children prior to puberty have not been established, therefore isotretinoin is not recommended for use in this population.

Use in the Elderly No specific recommendations as acne vulgaris rarely presents in the elderly.

The frequency of adverse reactions listed below is defined using the following convention: 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

1% cream, are generally moderate and usually subside with continued treatment. The following adverse drug reactions are based on post-marketing reports. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency, however in reality the following reactions are rarely seen.

Not known:

Skin hyperpigmentation, skin hypopigmentation, photosensitivity reaction 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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Contact with the mouth, eyes and mucous membranes and with abraded skin should be avoided. Care should be taken not to let the medicine accumulate in skin fold areas and in the nasolabial folds. Due to the irritant nature of Isotrex Cream, caution should be used when applying to sensitive areas of skin, such as the neck, or in patients with concomitant rosacea or perioral dermatitis.

Isotrex should also be used with caution in patients who have had a problem tolerating this or similar retinoid products in the past. Due to the potential for severe irritation, application to eczematous skin should be avoided. Isotrex Cream should be used with caution in patients with a history of photoallergy.

As Isotrex Cream may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing.

Due to the potential for photosensitivity, resulting in greater risk for sunburn, Isotrex Cream should be used with caution in patients with a personal or family history of skin cancer. If a patient has sunburn, this should be resolved before using Isotrex Cream.

Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur. If irritancy or dermatitis occur, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides.

Treatment should be discontinued if the irritation persists. Propylene glycol may cause skin irritation. g. contact dermatitis). Chlorocresol may cause allergic reactions. g. contact dermatitis), or irritation to the eyes and mucous membranes.

Isotrex Cream should not be used in patients with known hypersensitivity to the active substance or to any of the ingredients. 6).