Patient Information Leaflet

What you should know about HIBITANE Antiseptic Cream.

Contains Chlorhexidine Gluconate 1.0% w/w (equivalent to 5% w/w Chlorhexidine Gluconate Solution Ph Eur)

CONTAINS PEANUT OIL

The information in this leaflet applied only to your Hibitane Antiseptic Cream. Please read it carefully.

It contains important information but cannot tell you everything.

If you have further questions, or are not sure about anything please ask your doctor or pharmacist.

What is your medicine?

Hibitane Antiseptic Cream belongs to a group of medicines called antiseptics. This means that it helps prevent infection.

It contains Chlorhexidine Gluconate 1.0% w/w (Equivalent to 5% v/w Chlorhexidine Gluconate Solution Ph Eur) which gives its antiseptic properties.

The cream also contains some inactive ingredients that allow it to be made. These include

Butylated Hydroxytoluene BP, Cetostearyl Alcohol Ph Eur, Cetostearyl Alcohol/Ethylene Oxide condensate, d-Gluconolactone, Liquid Paraffin Ph Eur, Silver Pine Perfume, Methyl Hydroxybenzoate Ph Eur, Propyl Hydroxybenzoate Ph Eur, Purified Water Ph Eur.

Hibitane Antiseptic Cream comes in a lacquered collapsible aluminium tube (50g). Who has made your medicine?

The product licence holder of Hibitane Antiseptic Cream is:

QP-Services UK Ltd, 46 High Street, Yatton, Somerset, BS49 4HJ, UK.

The manufacturer of Hibitane Antiseptic Cream is:

Adams Healthcare (a Division of Ecolab), Lotherton Way, Garforth, LS25 2JY, UK. What is your medicine for?

•    Hibitane Antiseptic Cream is for application to areas of broken skin to help prevent infection.

When should Hibitane Antiseptic Cream not be used?

•    Do not use Hibitane Antiseptic Cream if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of Hibitane Antiseptic Cream.

•    Hibitane Antiseptic Cream contains Arachis Oil (peanut oil). If you are allergic to peanut or Soya, do not use Hibitane Antiseptic Cream.

What precautions should be taken with Hibitane Antiseptic Cream

•    Hibitane Antiseptic Cream may in rare cases cause severe allergic reactions, leading to a drop in blood pressure and even to unconsciousness. Early symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these symptoms, stop using Hibitane Antiseptic Cream and contact your doctor as soon as possible.

•    It is for external use only.

•    If accidentally ingested milk, raw egg, gelatin or mild soap should be taken to try and counteract any possible effects.

•    Keep cream out of the eyes and ears and avoid contact with brain tissues and open head wounds. If cream should get into the eyes, rinse thoroughly with water. If any cream gets into the ears, remove by careful swabbing.

•    If the cream gets onto fabrics and hyperchlorite bleaches are used to try and remove it, brown stains may develop.

•    If the cream is mixed with soaps or detergents its action may be reduced.

How should I use my Hibitane Antiseptic Cream?

•    Your doctor will inform you how the cream is to be used.

•    It is usually applied liberally to the area of the broken skin.

What undesirable defects may be experienced with Hibitane Antiseptic Cream?

Like all medicines, Hibitane Antiseptic Cream can cause side effects, although not everybody gets them. If you experience any of the following reactions stop using Hibitane Antiseptic Cream and get immediate medical help:

Swelling of the face, lips, tongue or throat; a red itchy skin rash; wheezing or

difficulty breathing; feeling faint and dizzy; a strange metallic taste in the mouth;

collapse. You may be having an allergic reaction.

If you develop a rash or your skin becomes itchy, red, dry or inflamed where you have used the product as a skin wash, stop using it and talk to your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How should I store Hibitane Antiseptic Cream?

•    The cream should be stored below 30° and should not be used after the expiry date.

•    The product should be kept out of the sight and reach of children

Date of last revision December 2015