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Heparin Sodium 10 Iu/Ml I.V. Flush Solution

RJAP107FUA PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin sodium 10 lU/ml I.V. flush solution

heparin sodium

Please read all of this leaflet carefully before you start having this medicine.

•    Keep this leaflet. You may need to read itagain.

•    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 become serious, oryou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

•    In this leaflet Heparin sodium 10 IU/ml I.V. flush solution will be called Heparin flush.


In this leaflet:

1.    What Heparin flush is and what it is used for

2.    Before you have Heparin flush

3.    How to use Heparin flush

4.    Possible side effects

5.    How to store Heparin flush

6.    Further information

1.    WHAT HEPARIN FLUSH IS AND WHAT IT IS USED FOR

Heparin flush belongs to a group of medicines called anticoagulants. It helps to stop the blood from clotting.

Heparin flush is given into an intravenous (I.V.) line. This means it is injected into the tube connected to a vein to keep it clear by preventing the blood from clotting in it. It is not recommended for treatment of harmful blood clots in your body.

2.    BEFORE YOU HAVE HEPARIN FLUSH

Do not have Heparin flush

•    Ifyou are allergic (hypersensitive) to heparin or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.

•    If you know that you have, or have ever had, a big drop in the clotting cells (platelets) in your blood, caused by having any type of heparin (reaction called heparin-induced thrombocytopenia).

Take special care with Heparin flush

Before you have Heparin flush, tell your doctor:

•    If you are allergic (hypersensitive) to low molecularweight heparins, such as tinzaparin, enoxaparin or dalteparin.

If you have Heparin flush regularly for more than five days, yourdoctormay take regular blood tests. This is to check the level of platelets (a type of cell) in your blood while you have your medicine. Depending on the result the doctor may tell you to stop having this medicine straight away.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

Pregnancy and breast-feeding

Ifyou are pregnantormight be pregnant, tell

your doctor before you are given Heparin flush.

If you become pregnant while having this medicine, tell your doctor.

Ifyou are breast-feeding, askyourdoctorfor advice before having Heparin flush.

Driving and using machines

Usually your medicine may have little effect on yourability to drive or use machines. However, you should check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of Heparin flush This medicine contains:

• Sodium. This medicine is nearly "sodium free". Your medicine contains less than 23 milligrams (mg) of sodium in each 10 International Units (IU) dose.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

3.    HOW TO USE HEPARIN FLUSH

Heparin flush will be given to you by a doctor or nurse. Heparin flush should not be mixed with any other injection.

How much Heparin flush to have

Your doctor will prescribe the right dose for you.

If you have more Heparin flush than you should

You may start to haemorrhage (bleed severely). Please read section 4 so you can spot any signs this may be happening to you.

You may be given another injection of a medicine called protamine sulphate.

If you have any further questions about taking this medicine, please askyourdoctoror pharmacist.

4.    POSSIBLE SIDE EFFECTS

When used as recommended the low dose of heparin reaching the blood is unlikely to have any effects on the body. However, information is given here on possible side effects.

Important side effects to look out for You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

•    You have difficulty breathing

•    Your face or throat swell

•    Your skin develops a severe rash

You should tell your doctor straight away if you spot any of the following signs which mean you may be starting to bleed severely:

•    Red or brown urine

•    Black tarry stools

•    Unusual bruising

•    Bleeding from your nose, mouth or any operation wound that will not stop.

Other possible side effects

•    Bruising or bleeding more easily. Your blood may also form harmful clots. A big drop in clotting cells (platelets) in your blood may give you these symptoms. Your doctor can explain this more.

Reporting of side effects

Ifyou getany side effects,talktoyourdoctoror pharmacist. 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 HEPARIN FLUSH

•    Keep out of the reach and the sight of children.

•    Do not use Heparin flush after the expiry date on the label. The expiry date is the last day of that month. Once opened, any of the solution not used at once should be discarded.

•    Store below 25°C.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6.    FURTHER INFORMATION What Heparin flush contains

•    The active ingredient is heparin sodium.

This product contains 10 IU of heparin sodium in each millilitre (ml).

•    The other ingredients are sodium chloride and water for injections

You can find important information about some of the ingredients near the end of section 2, just before section 3.

What Heparin flush looks like and contents of the pack

Heparin flush is a clear, colourless or pale yellow liquid. This medicine comes in glass ampoules containing 5 ml. There are 10 ampoules in a carton.

Marketing Authorisation Holder and Manufacturer responsible for batch release:

Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN86GT, UK.

This leaflet was last revised in July 2014.

RJAP107FUA

Customer

Fannin UK

Originated by

Athlone Laboratories TC

Product

Heparin Sodium 10iu/ml I.V. Flush Solution 50 units in 5ml

Dimensions

PIL 250mm x 150mm

Artwork Code

RJAP107FUA

Date

10/07/2014

Proof Number

2