STEREXIDINE 200 SOLUTION 0.5% w/v

Sterile Chlorhexidine Solution 0.5% w/v

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. it may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Sterexidine 200 Solution 0.5% w/v, which will be referred to as Sterexidine throughout this leaflet.

In this leaflet:

1.    What Sterexidine is and what it is used for

2.    Before you are given Sterexidine

3.    How you are given Sterexidine

4.    Possible side effects

5.    How to store Sterexidine

6.    Further information

1.    What Sterexidine is and what it is used for

Sterexidine is a sterile solution. Sterexidine contains the active ingredient chlorhexidine gluconate, which is an antiseptic. Your doctor has prescribed Sterexidine to clean skin wounds or for use in the care of a pregnant woman and her baby (obstetrics).

2.    Before you are given Sterexidine

Contra-indication

Do not take/use Sterexidine if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of Sterexidine (see section 6).

Special warnings and precautions

Sterexidine 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 Sterexidine and contact your doctor as soon as possible (see under section 4: “Possible side effects”). Use with care in newborn babies, especially those born prematurely. Sterexidine may cause chemical skin burns.

Take special care with Sterexidine

The solution should not be used if the container is damaged.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Please tell your doctor if you are pregnant, think you are pregnant or breast-feeding.

Driving and using machines

Sterexidine has no effect on driving or using machines.

3.    How you are given Sterexidine

Sterexidine is used on the skin as needed in adults, children and the elderly.

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

If too much Sterexidine is used

It is very unlikely, as your doctor will know the correct amount to use. However, tell your doctor if you have any concerns.

If accidental swallowing occurs

A stomach wash may be needed by using milk, egg white, gelatin or mild soap.

If accidentally injected

A blood transfusion may be necessary.

Important information about some of the ingredients of Sterexidine

Sterexidine contains carmoisine dye (E112), which may cause allergic reactions.

4.    Possible side effects

If you experience any of the following reactions stop using Sterexidine 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Sterexidine_

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Sterexidine. Sterexidine should be stored between 2°C and 25°C. Do not use after the expiry date. Keep out of the reach and sight of children.

6.    Further information

What Sterexidine contains:

The active ingredients is sterile chlorhexidine solution 0.5% w/v. The other ingredients are: Polysorbate 80 Ph Eur Carmoisine Dye (E122) Water for Injections BP

What Sterexidine looks like and contents of the pack.

Sterexidine comes in a rigid plastic pack. Pack sizes: 1000 ml, 500 ml and 150 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Terumo BCT Ltd.

Old Belfast Road Millbrook Larne

Northern Ireland BT40 2SH

United Kingdom

For any information about this medicinal product, please contact Marketing Authorisation Holder.

This leaflet was last amended in February 2015

TERUMOBCT

Terumo BCT Ltd.

Larne, BT40 2SH, U.K.