ANHYDROL FORTE Cutaneous solution (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
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.
4.1. 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, ...
4.5. Interaction with other medicinal products and other forms of interaction
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.
4.6. 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 ...
4.9. Overdose
See section 4.8 above (undesirable effects).
5.1. Pharmacodynamic properties
Aluminium chloride is believed to denature the protein content of sweat issuing from eccrine glands, and to combine with the intraductal keratin fibrils, producing a functional closure. The antibacterial ...
5.2. Pharmacokinetic properties
As the active ingredient is applied in an alcoholic solution of low surface tension, it therefore penetrates into the terminal pores of the sweat ducts, when applied, as recommended, to dry skin. The alcohol ...
5.3. Preclinical safety data
No special information.
6.1. List of excipients
Industrial methylated spirit
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Highly flammable. Store upright and away from flames.
6.5. Nature and contents of container
HDPE bottles (nominal 10 or 60 ml capacity) with polypropylene roll on applicators and polystyrene or polypropylene screwcaps, containing 10 or 60 ml of solution. Type I glass bottles (nominal 10 or 60ml ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Dermal Laboratories (Ireland) Limited, 38 Main Street, Swords, Co Dublin, K67 E0A2, Ireland
8. Marketing authorization number(s)
PA23128/004/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 15th March 1982 Date of last renewal: 16th December 2006
10. Date of revision of the text
December 2020
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