Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Aluminium chloride hexahydrate
Dermal Laboratories (Ireland) Limited
D11AA
Aluminium chloride hexahydrate
20 percent weight/volume
Cutaneous solution
Antihidrotics
Marketed
1982-03-15
PACKAGE LEAFLET: INFORMATION FOR THE USER ANHYDROL TM FORTE 20% W/V CUTANEOUS SOLUTION aluminium chloride hexahydrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS PRODUCT. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. ASK YOUR DOCTOR OR PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE. IN THIS LEAFLET: 1. What Anhydrol Forte is and what it is used for 2. Before you use Anhydrol Forte 3. How to use Anhydrol Forte 4. Possible side effects 5. How to store Anhydrol Forte 6. Further information 1. WHAT ANHYDROL FORTE IS AND WHAT IT IS USED FOR Anhydrol Forte is a treatment for excessive sweating (hyperhidrosis) of the armpits, hands or feet. Anhydrol Forte is suitable for use by adults, children and the elderly. The active ingredient in this product is aluminium chloride hexahydrate. It helps the product to: – reduce sweating by blocking sweat ducts in the skin, and – provide a deodorant action by killing the bacteria that cause body odour. 2. BEFORE YOU USE ANHYDROL FORTE DO NOT USE Anhydrol Forte if you are allergic (hypersensitive) to aluminium chloride hexahydrate or the other ingredient of Anhydrol Forte, industrial methylated spirit. TAKE SPECIAL CARE when using this product: Only use it on the armpits, hands or feet. Make sure that the treated areas are COMPLETELY DRY before applying the product (see Section 3 for advice on this). Do not use on broken or irritated skin: – when treating the armpits, do not shave or use hair-removing products within 12 hours before or after applying Anhydrol Forte. Keep it away from the eyes, nose and mouth. AVOID SPILLAGE as this may cause damage to you, your clothing and your possessions (see Section 4): – do not shake the bottle. – do not attempt to remove the roller ball head. – keep the cap tightly closed when not in use. The product is highly flammable. Do not use it near flames or ignition sources. UNDER ARM SHAVING/HAIR REMOVAL Do not shave or use hair removing products in the 12 hours before and after Läs hela dokumentet
Health Products Regulatory Authority 11 December 2020 CRN00C165 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anhydrol Forte 20% w/v Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aluminium Chloride Hexahydrate 20.0 % w/v. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution Clear, colourless, evaporative solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the topical treatment of hyperhidrosis specifically involving axillae, hands or feet. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adults, children and the elderly. Apply to the affected sites at night, as required, and allow to dry. Wash off in the morning. 4.3 CONTRAINDICATIONS Not to be used in cases of sensitivity to any of the ingredients. Not to be used in axillae within 12 hours of using depilatories or shaving. Not to be used immediately after bathing. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care should be taken to restrict the application to the affected sites only. Keep away from the eyes and mucous membranes. Care should be taken to avoid Anhydrol Forte coming into direct contact with clothing, polished surfaces, jewellery or metal. Replace cap tightly after use. For external use only. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS Do not bathe immediately before use and, if the axillae are treated, do not shave or use depilatories on this area within 12 hours before or after use. Health Products Regulatory Authority 11 December 2020 CRN00C165 Page 2 of 3 4.6 FERTILITY, PREGNANCY AND LACTATION No special precautions. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS If applied too frequently, Anhydrol Forte may cause irritation which should be treated with a mild topical hydrocortisone cream. 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 Läs hela dokumentet