PACKAGE LEAFLET Information for the user

Glutarol

cutaneous solution

glutaraldehyde 10% w/v

Please 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 Glutarol is and what it is used for

2.    Before you use Glutarol

3.    How to use Glutarol

4.    Possible side effects

5.    How to store Glutarol

6.    Further information

1.    WHAT GLUTAROL IS AND WHAT IT IS USED FOR

•    Glutarol is a paint for treating warts and verrucas.

-    Warts and verrucas are small excessive growths of skin caused by a type of virus. Warts often occur on the fingers, or on the back of the hands. You can recognise the common wart by the rough “cauliflower-like” appearance of the surface. Verrucas occur only on the sole of the foot. They can be painful, and often look like a small white ring of skin with a black dot in the centre. The virus is very infectious. This means that warts and verrucas can grow and spread, particularly if left untreated. The virus can also be transferred from one person to another.

•    Glutarol is suitable for use by adults, children and the elderly.

•    The active ingredient in this product is glutaraldehyde.

•    The active ingredient works by:

-    killing the virus that causes the wart or verruca;

-    drying the wart / verruca and surrounding skin, so helping to prevent the infection from spreading.

2.    BEFORE YOU USE GLUTAROL

Do not use Glutarol if you are allergic (hypersensitive) to glutaraldehyde or any of the other ingredients of Glutarol listed in Section 6.

•    Do not use this product anywhere on or near your face, bottom or genital (sex) area.

•    Do not use this product on moles, birthmarks, warts with hairs growing from them or any other spots.

Take special care when using this product:

•    If you are unsure whether you have a wart or verruca that is suitable for treatment with Glutarol, ask your doctor or pharmacist before starting treatment.

• Apply it carefully, to the wart or verruca only, by painting it on using the applicator attached to the inside of the cap:

-    Take care not to apply the product to surrounding healthy skin, especially on young children’s delicate skin, because this may cause irritation;

-    Do not apply excessive amounts.

•    Keep this product away from your eyes, nose, and mouth, and from broken skin, cuts and grazes.

•    Avoid spillage as this may cause damage to you, your clothing and your possessions (see Section 4).

•    The product is volatile and flammable. Do not use it near flames or ignition sources (e.g. burning cigarettes or anything else that might ignite it).

•    Avoid inhaling the vapour, as it can be harmful.

Using other medicines

This product is not known to affect, or to 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 GLUTAROL

Only use Glutarol on warts and verrucas for which your doctor or pharmacist has recommended it.

For adults, children and the elderly:

Repeat the following twice daily until the wart or verruca disappears:

A.    Soak the affected area in hot, soapy water for 2 to 3 minutes.

B.    Dry the area thoroughly with your own towel (this will help stop the infection from spreading to other people).

C.    Gently rub away any loose hard skin from the surface of the wart or verruca with an emery board or a piece of pumice stone;

-    do not let anyone else use the emery board or pumice stone as the infection may spread to them.

D.    Unscrew the cap of the bottle and, using the applicator attached to the inside of the cap, carefully apply two coats of the paint to the top of the wart or verruca only:

•    avoid spreading onto surrounding healthy skin;

•    allow the first coat to dry for a few minutes before applying the second coat.

continued...

E.    There is no need to cover the wart or verruca with a plaster.

F.    The length of treatment will vary depending on the size and resistance of the wart or verruca:

•    some may go in a relatively short time;

•    some warts and verrucas can require upto12 weeks treatment before they disappear;

•    it is important that you do not give up on the treatment until the wart, or verruca has disappeared (unless irritation occurs, see Section 4 below);

•    if you have any concerns about the wart or verruca during treatment seek advice from your doctor or pharmacist; if the wart or verruca has not disappeared after twelve weeks of treatment ask your doctor or pharmacist for further advice.

If the product accidentally gets onto normal skin, wipe it off straight away with a tissue, and, if necessary, wash the area.

If the product accidentally gets into the eyes, it may cause damage. Rinse the eyes with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. Then seek urgent hospital attention.

If the product accidentally gets swallowed, seek urgent hospital attention. A stomach washout is required immediately.

If you inhale a lot of the vapour from the product, get plenty of fresh air.

If you forget to use Glutarol

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Glutarol can cause side effects although not everybody gets them:

•    Very rarely a severe irritation reaction may occur particularly when the product is used on the hands or if it is used excessively and allowed to spread onto surrounding normal skin. If a severe reaction occurs, stop using this product and tell your doctor or pharmacist.

•    Very occasionally mild local skin rashes and skin irritation may occur. If this happens, apply a smaller amount, taking extra care to avoid spreading the product beyond the wart or verruca, and reapply less often.

•    Treated skin will be stained brown. This is normal and will disappear after you stop treating your wart or verruca.

•    If you spill this product on your clothes, fabrics, jewellery or metal and polished surfaces it may damage them permanently.

If any of the side effects get serious, or you notice any other side effect not mentioned in this leaflet, please tell your doctor or pharmacist.

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 GLUTAROL

•    Keep out of the reach and sight of children.

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

•    Do not store above 25°C.

•    Always replace the cap tightly after use.

•    Store the bottle upright to avoid spillage.

•    The product is highly flammable. Keep it away from flames or ignition sources.

•    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 GLUTAROL

What Glutarol contains:

The active ingredient is glutaraldehyde (10% w/v).

The other ingredients are purified water and industrial methylated spirit.

What Glutarol looks like and contents of the pack

The product is a clear colourless cutaneous solution. The product is available in amber glass bottles containing 10 ml of solution. The bottle cap incorporates a specially designed applicator spatula.

The Marketing Authorisation holder is Dermal Laboratories, Tatmore Place, Gosmore, Hitchin, Hertfordshire, SG4 7QR, UK.

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

This leaflet was last revised in February 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: Glutarol, 00173/0022.

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