Anhydrol Forte 20% w/v Cutaneous Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Aluminium chloride hexahydrate
Available from:
Dermal Laboratories (Ireland) Limited
ATC code:
D11AA
INN (International Name):
Aluminium chloride hexahydrate
Dosage:
20 percent weight/volume
Pharmaceutical form:
Cutaneous solution
Therapeutic area:
Antihidrotics
Authorization status:
Marketed
Authorization number:
PA23128/004/001
Authorization date:
1982-03-15

Read the complete document

Package leaflet: Information for the user

Anhydrol

TM

Forte 20% w/v cutaneous solution

aluminium chloride hexahydrate

Read all of this leaflet carefully before you start using this product.

Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need

more information or advice.

In this leaflet:

1. What Anhydrol Forte is and what it is used for

2. Before you use Anhydrol Forte

3. How to use Anhydrol Forte

4. Possible side effects

5. How to store Anhydrol Forte

6. Further information

1. WHAT ANHYDROL FORTE IS AND WHAT IT IS USED FOR

Anhydrol Forte is a treatment for excessive sweating (hyperhidrosis) of the armpits, hands or feet.

Anhydrol Forte is suitable for use by adults, children and the elderly.

The active ingredient in this product is aluminium chloride hexahydrate. It helps the product to:

– reduce sweating by blocking sweat ducts in the skin, and

– provide a deodorant action by killing the bacteria that cause body odour.

2. BEFORE YOU USE ANHYDROL FORTE

Do not use

Anhydrol Forte if you are allergic (hypersensitive) to aluminium chloride hexahydrate or

the other ingredient of Anhydrol Forte, industrial methylated spirit.

Take special care

when using this product:

Only use it on the armpits, hands or feet.

Make sure that the treated areas are

completely dry

before applying the product (see Section 3 for

advice on this).

Do not use on broken or irritated skin:

– when treating the armpits, do not shave or use hair-removing products within 12 hours before or

after applying Anhydrol Forte.

Keep it away from the eyes, nose and mouth.

Avoid spillage

as this may cause damage to you, your clothing and your possessions (see Section

– do not shake the bottle.

– do not attempt to remove the roller ball head.

– keep the cap tightly closed when not in use.

The product is highly flammable. Do not use it near flames or ignition sources.

Under arm shaving/hair removal

Do not shave or use hair removing products in the 12 hours before and after using Anhydrol Forte

Using other medicines

Anhydrol Forte is not known to affect or be affected by any other medicines.

Pregnancy and breast feeding

This product can be used during pregnancy and while breast feeding. The ingredients have been in

widespread use in this and similar preparations for many years, without reports of problems.

However, safety trials have not been conducted.

Driving and using machinery

Using this product is not known to affect your ability to drive or use machinery.

3. HOW TO USE ANHYDROL FORTE

For adults, children and the elderly:

Use only on the armpits, hands or feet.

Ensure that the treated areas are

completely dry

before applying the product. To achieve this:

– do not bathe or shower immediately before applying the product,

apply it last thing at night,

just before going to bed (this is because your sweat glands tend to

be least active while you are asleep).

Before applying the product, ensure the cap is screwed on tightly, then tip the bottle up to wet the

roller-ball.

Do not shake the bottle.

Unscrew the cap and apply the product to the affected areas, as required.

Allow the product to dry naturally (this should only take a couple of minutes), then wash the

hands (unless treating them).

Leave the product on overnight, then wash it off thoroughly in the morning.

Initially, apply Anhydrol Forte overnight in this way for two nights in a row, then do not use the

product for the next two nights.

Repeat this two-nightly treatment cycle for as long as necessary.

Increase or decrease the frequency of application to suit your own requirements (but bear in mind

that if you experience side effects this probably means that you are applying it too often - see

Section 4).

Using other antiperspirants or deodorants:

The use of ordinary antiperspirants or deodorants is

not

necessary when using Anhydrol Forte. If you

still wish to use these types of products, you should either:

apply them only on the days in between, when you are not using Anhydrol Forte, or;

apply them after washing off Anhydrol Forte the next morning, making sure that all

antiperspirants and deodorants are washed off and the skin is

completely

dry before re-applying

Anhydrol Forte.

If the product gets into the eyes or mouth

The product may cause damage if it gets into the eyes or mouth. Rinse the eyes or mouth with plenty

of water. If rinsing one eye, take care to avoid washing product into the other eye. Then seek urgent

hospital attention.

If you use this product too often

Excessive use may lead to irritation of the treated skin. If irritation occurs, apply the product less

frequently and treat the symptoms as described in Section 4.

If you forget to use this product

Do not worry if you occasionally forget to use this product, just carry on using it when you remember.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Anhydrol Forte can cause side effects, although not everybody gets them. A

common reaction to this type of treatment is

skin irritation and redness

at the site of application.

This is normally mild and temporary. If it becomes troublesome, try applying the product less often,

or you may wish to apply a mild hydrocortisone cream to help to relieve the irritation.

If you spill the product

on your clothes, fabrics, jewellery or metal and polished surfaces it may

damage them permanently.

Stop using

this product and

tell

your doctor or pharmacist if any of the side effects get serious, or you

notice any other side effects not mentioned in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly (see details below).

By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1

6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

5. HOW TO STORE ANHYDROL FORTE

Keep it out of the reach and sight of children.

Always replace the cap tightly after use.

Store the bottle upright to avoid spillage.

Do not store the product above 25°C.

The product is

highly flammable

. Store it away from flames or ignition sources.

Do not use after the expiry date shown on the container. The expiry date refers to the last day of

that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist

how to dispose of medicines no longer required. These measures will help to protect the

environment.

6. FURTHER INFORMATION ABOUT ANHYDROL FORTE

What Anhydrol Forte contains:

active ingredient

aluminium chloride hexahydrate

(20% w/v).

other ingredient

is industrial methylated spirit.

What Anhydrol Forte looks like and contents of the pack

This bottle contains 60 ml cutaneous solution of Anhydrol Forte.

The bottle is fitted with a roll-on applicator and screw-cap.

The product is a clear, colourless liquid that contains no fragrance.

Marketing Authorisation holder

UK: Dermal Laboratories, Hitchin, Herts, SG4 7QR, UK.

Ireland: Dermal Laboratories (Ireland) Limited, 38 Main Street, Swords, County Dublin, K67E0A2,

Ireland.

Manufacturer

Aeropak, Viking Road, Great Yarmouth, Norfolk, NR31 0NU, UK.

This leaflet was last revised in

November 2020.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge:

0800 198 5000

(UK only). Please be ready to give the following information: Anhydrol Forte,

00173/0030. This is a service provided by the Royal National Institute of Blind People (RNIB).

Read the complete document

Health Products Regulatory Authority

11 December 2020

CRN00C165

Page 1 of 3

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 20.0 % w/v.

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cutaneous solution

Clear, colourless, evaporative solution.

4 CLINICAL PARTICULARS

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, polished surfaces, jewellery or metal.

Replace cap tightly after use.

For external use only.

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.

Health Products Regulatory Authority

11 December 2020

CRN00C165

Page 2 of 3

4.6 Fertility, 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

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 Preclinical safety data

No special information.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Industrial Methylated Spirit

6.2 Incompatibilities

Not applicable.

Health Products Regulatory Authority

11 December 2020

CRN00C165

Page 3 of 3

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 capacity) with polypropylene roll on applicators and urea formaldehyde screwcaps,

containing 10 or 60ml of solution.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal

product and other handling of the product

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Dermal Laboratories (Ireland) Limited

38 Main Street

Swords

Co Dublin

K67 E0A2

Ireland

8 MARKETING AUTHORISATION NUMBER

PA23128/004/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

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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