Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS Trading as Stiefel: Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Isotrex Gel is intended for use in the treatment of mild to moderate inflammatory and non-flammatory acne vulgaris.
Apply Isotrex Gel sparingly over the entire affected area once or twice daily, preferably after washing and drying the skin.
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 6-8 weeks of treatment may be required before the therapeutic effect is observed.
Patients should wash their hands after application of Isotrex Gel.
Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation.
This product is flammable. Keep the gel away from open fire and flames and all sources of ignition during and immediately after you’ve used it
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.
No specific recommendations as acne vulgaris rarely presents in the elderly.
Oral ingestion of a 30g tube of topical isotretinoin would result in less exposure than achieved with the recommended dosage of oral isotretinoin. Consequently, the theoretical occurrence of symptoms of overdosage (e.g. hypervitaminosis A) is highly unlikely.
The gel formulation contains more than 95% ethanol. Systemic absorption of this should be considered in the event of oral ingestion.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
For the product as packaged for sale: 3 years.
After first opening the container: 2 months.
Store below 25°C. Keep the tube tightly closed when not in use. Contents are flammable. Keep away from fire, flame or heat. Do not leave Isotrex gel in direct sunlight.
Aluminium tube of 5g, 15g, 25g, 30g, 50g, 60g fitted with a screw cap.
Not all pack sizes may be marketed.
There are no special instructions for use or handling of Isotrex Gel.
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