DICLOR Solution for topical application (2018)

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Περιεχόμενα

1. Name of the medicinal product

Driclor/Driclor Solution.

2. Qualitative and quantitative composition

Aluminium Chloride Hexahydrate 20% w/w. For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for topical application.

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 ...

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 ...

4.5. Interaction with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

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 ...

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 ...

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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic Group: Dermatologicals, Other dermatological preparations, Antihidrotics. ATC Code: D11AA Aluminium chloride hexahydrate acts locally, in the stratum comeum and in the ...

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

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 0.1-0.3%, 1.5-2%, and approximately 0.01% respectively. ...

6.1. List of excipients

Ethanol 75.45 %w/w Purified water 4.55 %w/w

6.2. Incompatibilities

None.

6.3. Shelf life

For the product as packaged for sale: 3 years. After first opening the container: Comply with expiry date.

6.4. Special precautions for storage

Store in a cool place below 25°C. Keep away from naked flame. Store upright.

6.5. Nature and contents of container

High density polyethylene bottle with roll-on applicator. Pack size: 30ml, 40ml, 45ml, 50ml and 60ml High density polyethylene bottle with polypropylene cap. LDPE housing containing polypropylene ...

6.6. Special precautions for disposal and other handling

The pack should be assembled according to the instructions in the package leaflet.

7. Marketing authorization holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited trading as: Stiefel, 980 Great West Road, Brentford, Middlesex, TW8 9GS,United Kingdom

8. Marketing authorization number(s)

PL 44673/0036

9. Date of first authorization / renewal of the authorization

31 August 1981

10. Date of revision of the text

19 September 2018

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