SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Driclor Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Aluminium Chloride Hexahydrate 20% w/w For a full list of excipients, see section PHARMACEUTICAL FORM Solution for topical application 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Driclor is indicated for the treatment of hyperhidrosis of the armpits (axillae), the hands and the feet. 4.2 Posology and method of administration Driclor is for application to the axillae, palms of the hands or soles of the feet. Before applying aluminium chloride hexahydrate, the affected area should be dried thoroughly to avoid burning of the skin (see Warnings and Precautions). Apply Driclor last thing at night after drying the affected areas carefully. Wash off in the morning. Do not re-apply the product during the day.

2 Initially the product may be applied each night until sweating stops during the day. The frequency of application may then be reduced to twice a week or less. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients. 4.4 Special warnings and precautions for use 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. 4.5 Interaction with other medicinal products and other forms of interaction None known 4.6 Fertility, pregnancy and lactation Pregnancy There are no data from the use of topical aluminium chloride hexahydrate in pregnant women.

3 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 breastfeeding. 4.7 Effects on ability to drive and use machines None 4.8 Undesirable effects 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

4 Skin and Subcutaneous Tissue Disorders Not known: Application site reactions including pain, pruritus, erythema, rash and skin burning sensation 4.9 Overdose Symptoms and signs Application more frequently than recommended may increase the severity of skin irritation. Ingestion can cause nausea, vomiting, diarrhoea and burning in the mouth and throat. The formulation contains a significant quantity of ethanol. Systemic absorption of this should be considered a possibility in the event of overdosage. Treatment In the event of accidental oral ingestion rinse the mouth with plenty of water. Further management should be as clinically indicated or as recommended by the national poisons centre, where available. 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Aluminium chloride hexahydrate acts locally, in the stratum comeum and in the terminal duct, to relieve hyperhidrosis. ATC Code D11AA Pharmacotherapeutic Group: Dermatologicals, Other dermatological preparations, Antihidrotics. Mechanism of Action Aluminium chloride hexahydrate is acidic and is thought to act by diffusing into the sweat ducts where on neutralisation it forms gelatinous hydroxides which obstruct the flow of sweat. The antiperspirant effect of aluminium chloride hexahydrate is partly explained by production of mechanical blockage in the eccrine sweat duct.

5 Following application, aluminium is found in the stratum corneum and intraluminally in the terminal duct. It has been suggested that the metal ions form precipitating complexes with the mucopolysaccharides and carboxyl groups of the stratum corneum. This causes damage to the luminal epithelial cells, generating an obstructive conglomerate which plugs the acrosyringium. Studies of long-term treatment with aluminium chloride have shown that prolonged application leads to functional and structural degeneration of the eccrine acini, accounting for the observed progressive decrease in severity of hyperhidrosis during treatment. 5.2 Pharmacokinetic properties Absorption Due to the effective absorption barriers of gut, lung and skin, the absorption rates of aluminium via the oral, inhalational and dermal routes are %, 1.5-2%, and approximately 0.01% respectively. Distribution About 90% of plasma aluminium is bound to transferrin, 7% occurs as citrate, and less than 1% as phosphate and hydroxide. Elimination More than 99% of orally ingested aluminium is eliminated via faeces. Of the small amounts of aluminium absorbed from the gastrointestinal tract, more than 95% is excreted in the urine. 5.3 Preclinical safety data Not applicable 6 PHARMACEUTICAL PARTICULARS

6 6.1 List of excipients %w/w Ethanol Purified water Incompatibilities None 6.3 Shelf life a) For the product as packaged for sale 3 years b) After first opening the container Comply with expiry date 6.4 Special precautions for storage Store in a cool place below 25 ºC. Keep away from naked flame. Store upright. 6.5 Nature and contents of container High density polyethylene bottle with roll-on applicator.

7 Pack size: 30ml, 40ml, 45ml, 50ml and 60ml High density polyethylene bottle with polypropylene cap. LDPE housing containing polypropylene roller-ball with over-cap for self-assembly. Pack Size: 75ml Not all pack sizes may be marketed. 6.6 Special precautions for disposal The 75ml pack should be assembled according to the instructions in the package leaflet. 7 MARKETING AUTHORISATION HOLDER Beecham Group plc, trading as Stiefel 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom 8 MARKETING AUTHORISATION NUMBER(S) PL 00079/ DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

8 31 st August DATE OF REVISION OF THE TEXT 20/02/ DOSIMETRY (IF APPLICABLE) 12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)