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HEPARIN SODIUM 1000IU/ML AMPOULE SOLUTION FOR INFUSION

Active substance(s): HEPARIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin sodium 1,000 IU/ml ampoule, solution for infusion
heparin sodium

Please read all of this leaflet carefully before you start having this medicine because it contains important information for you.

‡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 only. Do not pass it on to others. It may harm them, even if their symptoms are the

same as yours.
‡If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.
‡In this leaflet Heparin sodium 1,000 IU/ml ampoule, solution for infusion will be called Heparin infusion.
In this leaflet:
1. What Heparin infusion is and what it is used for
2. What you need to know before you use Heparin infusion
3. How to use Heparin infusion
4. Possible side effects
5. How to store Heparin infusion
6. Contents of the pack and other information

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

Heparin infusion belongs to a group of medicines called
anticoagulants.
Heparin changes the way your blood clots. This means your blood
keeps flowing smoothly inside your blood vessels. These are the
tubes that carry blood around your body and are called arteries and
veins.
Heparin infusion is used:
‡to help stop harmful blood clots in your veins growing bigger
(treatment).
‡to help stop harmful blood clots forming in the tubing of an
artificial kidney machine during kidney dialysis (haemodialysis).
An example is a harmful blood clot in a vein deep inside your body.
This is usually in your leg (deep vein thrombosis or DVT for short).
Another example is a clot which blocks the blood supply to your
lungs (pulmonary embolism).
It is more likely these clots will form if you are either overweight,
pregnant, have certain blood disorders or have already had a
pulmonary embolism, DVT, heart attack or stroke. It can also happen if
you do not move around for long periods of time. This could be
because you have had surgery or you have another illness.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
HEPARIN INFUSION
Do not use Heparin infusion
‡If you 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).
‡If you have any condition which makes you bleed severely,
such as haemophilia.
‡If you have very high blood pressure.
‡If you have severe liver problems.
‡If you have a stomach ulcer.
‡If you know that you have a condition called endocarditis (an
inflammation of the lining of the heart and heart valves).
‡If you have had a brain haemorrhage (bleeding inside your
brain).
‡If you have an injury to your spine, head, eyes or ears.
‡If you have recently had, or are about to have an operation
involving your spine, head, eyes or ears.
‡If you may be having a miscarriage.
Important: If you are having an epidural or spinal anaesthetic
You must remind your doctor that you are having Heparin infusion
before you receive any anaesthetic.
If you are pregnant please also read the section of this leaflet
“Pregnancy, breast-feeding and fertility”.
After you have the anaesthetic your doctor or nurse will make
regular checks. This is to check if you are getting any major
bleeding or bruising around your spine. This may cause paralysis
that could be permanent. Any signs this may be happening to you
include tingling, weakness or numbness in your lower legs or body,
back pain or problems in going to the toilet. This happens very
rarely.
After you have the anaesthetic your doctor will tell you when you
can take your medicine again.
Take special care with Heparin infusion
Before you have Heparin infusion, tell your doctor:
‡If you have any condition which makes you more likely to bleed
more easily. Ask your doctor if you are unsure.

Customer: Fannin PL 20417/0109
Change: QRD Updates
Colour: Pantone Black C
Size: 150 x 250mm Proof: 1
Date: 20 May 15

‡If you are allergic (hypersensitive) to low molecular weight

heparins, such as tinzaparin, enoxaparin or dalteparin.

‡If you have kidney problems.
‡If you have liver problems.
‡If you have problems with your blood pressure (hypertension).
‡If you know you have a condition called diabetes mellitus.
‡If you know you have a condition called metabolic acidosis.
‡If you know you have any medical condition which may

cause high levels of potassium in your blood (hyperkalaemia).
Ask your doctor if you are unsure.

‡If you are taking a medicine from the group called

potassium-sparing diuretics, such as amiloride or spironolactone.

‡If you are taking another medicine that may affect your blood

clotting. For a list of these medicines see the section “Taking
other medicines”.

Your doctor may take a blood test before you start having this
medicine, and while you are having it. This is so the doctor can
check you are having the right dose. This is also to check the level
of the clotting cells (platelets) and potassium in your blood.
This medicine may make you bleed more easily. The doctor or
nurse should take care when giving you any other injections or
procedures. This medicine must not be injected into your muscles.
Other medicines and Heparin
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.
You must tell your doctor or pharmacist if you are taking any of the
following medicines:
‡ACE inhibitors or angiotensin II antagonists, such as enalapril,
losartan or valsartan: for treating high blood pressure or heart
problems. You may get too much potassium in your blood.
‡Non-steroidal anti-inflammatory drugs, such as ibuprofen or
diclofenac: for arthritis or aches or pains. You may be likely to
bleed more easily.
‡Salicylates, such as aspirin: for reducing pain and inflammation,
or for stopping harmful blood clots forming. You may be likely
to bleed more easily.
‡Platelet aggregation inhibitors, such as clopidogrel: for
stopping harmful blood clots forming. You may be likely to
bleed more easily.
‡Thrombolytic agents, such as streptokinase: for dissolving
blood clots. You may be likely to bleed more easily.
‡Vitamin K antagonists, such as warfarin: for stopping harmful
blood clots. You may be likely to bleed more easily.
‡Glyceryl trinitrate infusion: for treating angina. This may
reduce the effect of Heparin infusion.
‡Activated protein C: for getting rid of blood clots. You may be

likely to bleed more easily.

‡Dextrans: for increasing your blood volume. You may be likely

to bleed more easily.
Your doctor may carry out check-ups on you, including blood tests,
if you take any of these medicines at the same time as Heparin
infusion.

Pregnancy, breast-feeding and fertility
If you are pregnant or might be pregnant, tell your doctor before
you are given Heparin infusion.
If you become pregnant while having this medicine, tell your
doctor.
If you are pregnant and are going to have an epidural anaesthetic,
you should stop having your medicine. Ask your doctor for advice.
If you are breast-feeding, ask your doctor for advice before having
Heparin infusion.
Driving and using machines
Usually your medicine may have little effect on your ability 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
infusion
This medicine contains:

‡Sodium. This medicine is nearly “sodium free”. Your medicine

contains less than 23 milligrams (mg) of sodium in each 1,000
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 INFUSION

Heparin infusion will be given to you by a doctor or nurse.
Heparin infusion should not be mixed with any other injection.
It may be given under your skin or into your vein.
How much Heparin infusion to have
Your doctor will prescribe the right dose for you.
If you have more Heparin infusion than you should
Your doctor or nurse will give you this medicine. If you think you
may have been given too much, tell your doctor or nurse straight
away.
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 missed a dose of Heparin infusion
Your doctor or nurse will give you this medicine. If you think that
you have missed a dose then tell your doctor or nurse.
If you have any further questions about taking this medicine,
please ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Heparin infusion can cause side effects,
although not everybody gets them.
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:
xYou have difficulty breathing
xYour face or throat swell
xYour skin develops a severe rash
xYour skin develops blisters at the site of your injection.
You must get urgent medical help if you have any of the following
symptoms after having an epidural or spinal anaesthetic. You
may be developing paralysis:
xTingling, weakness or numbness in your legs or lower body
xBack pain
xProblems in going to the toilet.

5. HOW TO STORE HEPARIN INFUSION

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The expiry date is the last day of that month.
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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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Heparin infusion contains
‡The active ingredient is heparin sodium.
‡This product contains 1,000 IU of heparin sodium in each
millilitre (ml).
‡The other ingredients are sodium chloride, sodium citrate 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 infusion looks like and contents of the pack
Heparin infusion is a clear, colourless or pale yellow liquid.
This medicine comes in glass ampoules containing 5, 10 or 20 ml.
There are 10 ampoules in a carton.
Marketing Authorisation Holder
Fannin (UK) Ltd., 42-46 Booth Drive, Park Farm South,
Wellingborough, Northamptonshire, NN8 6GT, UK
Manufacturer
Laboratorio Reig Jofre, SA, Gran Capita, 10,
08970 SANT JOAN DESPI, Barcelona, Spain.
This leaflet was last revised in May 2015.

You should tell your doctor straight away if you spot any of the
following signs which mean you may be starting to bleed severely:
xRed or brown urine
xBlack tarry stools
xUnusual bruising
xBleeding from your nose, mouth or any operation wound that
will not stop.
Other possible side effects
Common side effects (probably affect up to 1 in 10 people)
‡Bruising at the site of the injection.
‡Irritation at the site of the injection.
‡Bleeding (haemorrhage). This may be more likely if you are
taking a high dose of Heparin infusion.
‡Changes in your blood test results. Your doctor can explain
this more.
Uncommon side effects (probably affect less than 1 in 100 people)
‡Rash.
‡Itchy raised rash (hives).
‡Osteoporosis. Your bones become less strong and can break
more easily. This has been seen in patients taking heparin for
a long time.
Rare side effects (probably affect less than 1 in 1,000 people)
‡Bruising or bleeding more easily. Your blood may also form
more harmful clots. A big drop in clotting cells (platelets) in
your blood may give you these symptoms. Your doctor can
explain this more.
‡Changes in your blood test results. The amount of potassium
may be increased. This is more likely to happen if you have
severe kidney problems or diabetes. Your doctor can explain
this more.
Very rare side effects (probably affect less than 1 in 10,000 people)
‡Prolonged, painful erections in men.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, tell 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 United Kingdom 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.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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