Patient Information Leaflet for Hydroderm Plus 1% Cream What you should know about HYDRODERM PLUS 1% CREAM

Chlorhexidine Gluconate 1%w/w

The information in this leaflet applied only to your Hydroderm Plus 1% Cream, please read it carefully. It gives you important information but it can’t tell you everything.

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

What is your medicine?

Hydroderm Plus 1% Cream contains 1%w/w Chlorhexidine Gluconate.

The cream also contains a number of inactive ingredients which allow it to be made. These are cetostearyl alcohol, cetostearyl alcohol/ethylene oxide condensate, isopropyl alcohol, liquid paraffin, white soft paraffin and purified water.

Hydroderm Plus 1% Cream comes in bottles of 250 millilitres.

Hydroderm Plus 1% Cream belongs to a group of medicines called antiseptics. This means that it helps to prevent infection.

What is your medicine for?

Hydroderm Plus 1% Cream is used by the doctor or midwife to help prevent infection and act as a lubricant during childbirth and gynaecological examinations.

When should Hydroderm Plus 1% Cream not be used?

•    Hydroderm Plus 1 % Cream should not be used if you have ever had an allergic reaction to chlorhexidine or any of the ingredients.

•    Hydroderm Plus 1 % Cream should not be applied to any deep cuts on the head or spine.

Special Warnings and Precautions for Hydroderm Plus 1% Cream

•    Hydroderm Plus 1% 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 Hydroderm Plus 1% Cream and contact your doctor as soon as possible (see under section 4: possible side effects).

•    Hydroderm Plus 1 % Cream is for use on the skin and mucus membranes only.

•    Keep Hydroderm Plus 1 % Cream out of the eyes and ears. Should any cream get into the eyes, rinse thoroughly with water. If any cream gets into the ears remove by very careful swabbing.

•    If Hydroderm Plus 1 % Cream gets onto fabrics and hyperchlorite bleaches are used to try and remove it, brown stains may develop.

•    If Hydroderm Plus 1 % Cream is mixed with soaps or detergents its action may be reduced.

How should I use my Hydroderm Plus 1% Cream?

•    Hydroderm Plus 1 % Cream will be used by your doctor or midwife.

•    Your doctor or midwife will apply the cream to the skin around the birth canal and bottom. They may also apply it to their gloved hands.

What Side Effects may occur with Hydroderm Plus 1% Cream?

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following reactions stop using Hydroderm Plus 1% 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 Hydroderm Plus 1% Cream?

Do not store Hydroderm Plus 1 % Cream above 30°C and do not use the cream after the expiry date. Your doctor, midwife, nurse or pharmacist is responsible for the correct storage and disposal of Hydroderm Plus 1% Cream.

Product Licence Holder:

QP-Services UK Ltd

46 High Street, Yatton, Somerset, BS49 4HJ, UK.

Manufactured by: Bioglan AB S-202 13 Malmo Sweden

Date of preparation of leaflet: December 2015