DICLOR Solution for topical application Ref.[27599] Active ingredients: Aluminium chloride

Aluminium chloride hexahydrate reacts with water to produce hydrochloric acid. Therefore the areas to be treated should be completely dry before application to avoid skin burning.

Application should be restricted to the affected area(s) only.

Driclor should not be applied to skin that has been shaved within 12 hours or which is broken or irritated.

Hair removal products should not be used on areas to be treated within 12 hours before or after applying Driclor.

Avoid contact with eyes, nostrils, mouth or other mucous membranes. In case of accidental contact with the eyes or other mucous membranes, rinse well with water.

Avoid direct contact with clothing, jewellery and polished metal surfaces.

None known.

Pregnancy

There are no data from the use of topical aluminium chloride hexahydrate in pregnant women.

Studies in animals have shown reproductive toxicity following oral and parenteral administration (see Non-Clinical Information).

Due to the nature of aluminium it is unlikely that it penetrates the skin, therefore no effects during pregnancy are anticipated with use of aluminium chloride hexahydrate solution.

Lactation

It is unknown whether topical aluminium chloride hexahydrate is excreted in human milk.

Due to the nature of aluminium, it is unlikely that it penetrates the skin, therefore no effects on the breast-fed newborn/infant are anticipated with use of aluminium chloride hexahydrate solution.

If aluminium chloride hexahydrate is used when breast-feeding, care should be taken not to get any solution on the breasts to ensure that the baby is not accidentally exposed to aluminium chloride hexahydrate. If any of the solution does get on the breasts, the patient should be instructed to wash-off all traces before beginning breast-feeding.

None.

Driclor may cause irritation which may be alleviated by use of a weak corticosteroid cream.

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).

Clinical Trial Data

Skin and Subcutaneous Tissue Disorders

Very common: Application site irritation

Post Marketing Data

Immune System Disorders

Not known: Application site hypersensitivity including application site dermatitis

Skin and Subcutaneous Tissue Disorders

Not known: Application site reactions including pain, pruritus, erythema, rash and skin burning sensation

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard.

None.