Driclor

1. Name Of The Medicinal Product

Driclor

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. Clinical Particulars

4.1 Therapeutic Indications

Driclor is indicated for the treatment of hyperhidrosis.

4.2 Posology And Method Of Administration

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.

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

Ensure that the affected areas to be treated are completely dry before application.

Do not apply Driclor to broken, irritated or recently shaven skin. Avoid contact with eyes.

Avoid direct contact with clothing and polished metal surfaces.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

There are no restrictions on the use of Driclor during pregnancy or lactation.

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.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Aluminium chloride hexahydrate acts locally, in the stratum corneum and in the terminal duct, to relieve hyperhidrosis.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

	% w/w
Ethanol	75.45
Purified water	4.55

6.2 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.

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 And Other Handling

The 75ml pack should be assembled according to the instructions in the package leaflet.

7. Marketing Authorisation Holder

Stiefel Laboratories (UK) Ltd

Eurasia Headquarters

Concorde Road

Maidenhead

SL6 4BY

UK

8. Marketing Authorisation Number(S)

PL 0174/0044

9. Date Of First Authorisation/Renewal Of The Authorisation

31^st August 1981/ 7^th January 2005

10. Date Of Revision Of The Text

August 2009