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Heparin Sodium 100 Iu/Ml. I.V Flush Solution

RJAP108FUA    PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin sodium 100 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 it again.

•    Ifyou have anyfurtherquestions,askyourdoctororpharmacist.

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

•    In this leaflet Heparin sodium 100 IU/ml I.V.flush solution will becalled 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.    Furtherinformation

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

Heparin flush belongs to a group of medicines called anticoagulants. It helps to stopthe 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. Itis notrecommended fortreatment of harmful blood clots in your body.

2.    BEFORE YOU HAVE HEPARIN FLUSH Do not have Heparin flush

•Ifyou are allergic (hypersensitive) to heparin orany of the other ingredients in your medicine. You can find a list ofthese 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).

Do notgive this medicine to a premature baby,a newborn baby,ora babyuptoa month old.

Take special care with Heparin flush

Before you have Heparin flush, tell your doctor:

•Ifyou are pregnantorthinkyou are pregnant.

Read thesection "Pregnancyand breast-feeding". •Ifyou are allergic (hypersensitive) to low molecular weightheparins,such astinzaparin,enoxaparin or dalteparin.

•Ifthis medicine isforachildwho is between one month and threeyearsold.

•Ifyou know thatyou are sensitive to methylparahydroxybenzoate or propylparahydroxybenzoate. Read the information in the section "Importantinformation aboutsome of the ingredients of Heparin flush".

Ifyou have Heparin flush regularlyformore than five days,yourdoctor maytake regularblood tests. This is to check the level of platelets (a type of cell) inyour blood while you have your medicine. Depending on the resultthedoctor maytell you to stop having this medicine straight away.

Taking other medicines

Please tell your doctoror pharmacist ifyou are taking, or have recently taken any other medicines. This includesany medicineswhich you have bought without a prescription.

Pregnancy and breast-feeding Unless your doctor has told you it is essential, you must not have Heparin flush if you are pregnant, or think you are pregnant. Read the information about benzyl alcohol in the section "Important information about some of the ingredients of Heparin flush". If you are pregnantormightbe pregnant,tell your doctor beforeyou are given Heparin flush. Ifyou become pregnantwhile having this medicine,tell yourdoctor. Ifyou are breast-feeding,askyour doctor for advice before having Heparin infusion. Driving and using machines Usuallyyour medicine mayhave littleeffectonyour ability to drive or use machines. However,you should checkwith yourdoctor ifyou feel anyside effectthat maystopyou from driving or using machines.

Important information about some of the ingredients of Heparin flush

This medicine contains:

• Benzyl alcohol. This is a preservative. It may harm a newborn baby. It must not be used in premature babies or babies under one month old. •Methylparahydroxybenzoate and propylparahydroxybenzoate. These are preservatives. They may give you an allergic reaction. This may happen at any time alter you have your medicine. Please read section 4 so you can spotany signs this may be happening toyou. •Sodium.This medicine is nearly "sodium free". Your medicine contains lessthan 23 milligrams (mg) ofsodium in each 100 International Units(IU)dose. Please askyour doctor ifyou are worried about any of the ingredients in this medicine.

3.    HOW TO USE HEPARIN FLUSH

Heparin flush will begiventoyou byadoctoror nurse. Heparin flush should not be mixed with any other injection.

How much Heparin flush to have

Yourdoctorwill prescribe the rightdose foryou.

If you have more Heparin flush than you should You maystartto haemorrhage (bleed severely).

Please read section 4so you can spot any signs this may be happening toyou.

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

Ifyou haveanyfurtherquestionsabouttaking this medicine, please askyour doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

When used as recommended the lowdose ofheparin reaching the blood is unlikely to haveanyeffectson the body. However,information isgiven hereon 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

•    Bleedng 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) inyour blood maygiveyou these symptoms. Your doctor can explain this more. Reporting of side effects

Ifyou get any side effects, talk to yourdoctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theyellow card schemeat 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 ofthe reach and the sight of children.

•Do notuse Heparinflush aftertheexpirydate on the label. The expirydate is the last day of that month.

•Store below250C.

Medicines should not be thrown away in waste waterorin householdwaste. Pleaseaskyour pharmacist how to throw away any medicine you do not need anymore. Ifyou do thisyou will help protect the environment.

6.    FURTHER INFORMATION What Heparin flush contains

•The active ingredient is heparin sodium.

This productcontains 100IU ofheparinsodium in each millilitre (ml).

•The otheringredientsare benzyl alcohol, methylparahydroxybenzoate, propylparahydroxybenzoate, sodium chloride, sodium citrate and water for injections.

You can find importantinformation 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 2 ml. Thereare 10ampoules in a carton. Marketing Authorisation Holder and Manufacturer responsible for batch release:

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

NN8 6GT, UK.

This leafletwas lastrevised in July2014.

RJAP108FUA

Customer

Fannin UK

Originated by

Athlone Laboratories TC

Product

Heparin Sodium 100iu/ml I.V. Flush Solution 200 units in 2ml

Dimensions

PIL 250mm x 150mm

Artwork Code

RJAP108FUA

Date

21/07/2014

Proof Number

2