SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Anhydrol Forte 20% w/v Cutaneous Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Aluminium Chloride Hexahydrate EP 20.0% w/v.

3    PHARMACEUTICAL FORM

Cutaneous Solution,

Clear, colourless, evaporative cutaneous solution.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

For the topical treatment of hyperhidrosis specifically involving axillac, 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. Contra-Indications

Not to be used in cases of sensitivity to any of the ingredients.

4.4. Special Warnings and Special Precautions for Use

Care should be taken to restrict the application to the affected sites only.

Keep away from the eyes.

Care should be taken to avoid Anhydrol Forte coming into direct contact with clothing, polished surfaces, jewellery or metal.

Replace cap tightly after use.

4.5. Interaction with other Medicinal Products and other Forms of Interactions

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 after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9. Overdose

See section 4.8 above (undesirable effects).

5. PHARMACOLOGICAL PROPERTIES

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 action of the aluminium ion also precludes the development of miliaria. Accordingly, there is no secondary inflammation. The intraluminal pressure rises to the point where it acts as a feedback system, shutting off acinar secretion.

The formulation of Anhydrol Forte has been tested in widespread clinical practice, and has been shown to be effective when used in accordance with the recommended instructions.

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 then evaporates off leaving the salt deposited in close contact with the lining of the duct. The use of the preparation is restricted to small areas of skin, namely the axillae, hands or feet, to ensure that there are no detrimental effects from widespread obstruction of sweating.

5.3. Pre-clinical Safety data

None stated.

6. PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

Industrial Methylated Spirit BP

6.2.    Incompatibilities

None known.

6.3.    Shelf-Life

36 months in unopened container

6.4.    Special Precautions for Storage

Highly flammable.

Store at room temperature, not exceeding 25⁰C. Store upright and away from flames.

6.5. Nature and Contents of Container

(According to CPMP List of Allowed Terms (III/3593/91).

10ml glass BOTTLE with roll on APPLICATOR and SCREWCAP. 56ml glass BOTTLE with roll on APPLICATOR and SCREWCAP. 60ml glass BOTTLE with roll on APPLICATOR and SCREWCAP. 60ml HDPE BOTTLE with roll on APPLICATOR and SCREWCAP. These are supplied as original packs (OP).

6.6 Instructions for Use/Handling

Not applicable.

7. MARKETING AUTHORIZATION HOLDER

Diomed Developments Limited T/A Dermal Laboratories Tatmore Place, Gosmore Hitchin,

Herts,

SG4 7QR, UK.

8. MARKETING AUTHORIZATION NUMBER

PL 00173/0030

9. DATE OF FIRST AUTHORIZATION / RENEWAL OF AUTHORIZATION

11 September 1979 / 8 February 1995.

10 DATE OF REVISION OF THE TEXT

06/07/2015