DRICLOR SOLUTION
Active substance: ALUMINIUM CHLORIDE HEXAHYDRATE
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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 6.1
3
PHARMACEUTICAL FORM
Solution for topical application
4
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Aluminium chloride hexahydrate acts locally, in the stratum comeum and in the terminal duct, to relieve hyperhidrosis.
5.2
Pharmacokinetic properties Not applicable
5.3
Preclinical safety data Not applicable
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients %w/w
Ethanol Purified water 6.2 Incompatibilities None
75.45 4.55
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 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 roller-ball with over-cap for selfassembly. 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
GlaxoSmithKline UK Limited 980 Great West Road Brentford Middlesex TW8 9GS
Trading as Stiefel Stockley Park West Uxbridge Middlesex UB11 1BT
8
MARKETING AUTHORISATION NUMBER(S)
PL 19494/0054
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31st August 1981
10
DATE OF REVISION OF THE TEXT
18/01/2011
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 6.1
3
PHARMACEUTICAL FORM
Solution for topical application
4
4.1
CLINICAL PARTICULARS
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
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Aluminium chloride hexahydrate acts locally, in the stratum comeum and in the terminal duct, to relieve hyperhidrosis.
5.2
Pharmacokinetic properties Not applicable
5.3
Preclinical safety data Not applicable
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients %w/w
Ethanol Purified water 6.2 Incompatibilities None
75.45 4.55
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 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 roller-ball with over-cap for selfassembly. 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
GlaxoSmithKline UK Limited 980 Great West Road Brentford Middlesex TW8 9GS
Trading as Stiefel Stockley Park West Uxbridge Middlesex UB11 1BT
8
MARKETING AUTHORISATION NUMBER(S)
PL 19494/0054
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31st August 1981
10
DATE OF REVISION OF THE TEXT
18/01/2011
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
