PACKAGE LEAFLET

Information for the user

Anhydrol Forte

20% w/v cutaneous solution

aluminium chloride hexahydrate

Read all of this leaflet carefully before 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 4):

-    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).

continued...

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:

The active ingredient is aluminium chloride hexahydrate (20% w/v). The 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.

The Marketing Authorisation holder is Dermal Laboratories, Hitchin, Herts, SG4 7QR, UK.

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

This leaflet was last revised in April 2015.

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).