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HEPARIN MUCOUS INJECTION BP

Active substance: HEPARIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin (mucous) Injection BP
1,000 and 5,000 Units/ml
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.
• 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, or you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
• In this leaflet Heparin (mucous) Injection will be called heparin.
In this leaflet:
1. What heparin is and what it is used for
2. Before you have heparin
3. How to use heparin
4. Possible side effects
5. How to store heparin
6. Further information

1. WHAT HEPARIN IS AND WHAT IT IS USED
FOR

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Heparin 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 is used:
• to help stop harmful blood clots in your veins
growing bigger (treatment).
• to help stop harmful blood clots forming in your
veins (prevention).
• 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. BEFORE YOU HAVE HEPARIN
Do not have heparin
• 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.
Do not give this medicine to a premature baby, a
newborn baby, or a baby up to a month old.
Important: If you are having an epidural or spinal
anaesthetic
You must remind your doctor that you are having
heparin before you receive any anaesthetic.
If you are pregnant please also read the section of
this leaflet “Pregnancy and breast-feeding”.
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
Before you have heparin, tell your doctor:
• If you have any condition which makes you more
likely to bleed more easily.
Ask your doctor if you are unsure.
• 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. These are commonly called water
tablets.
• If this medicine is for a child who is between one
month and three years old.
• If you are taking another medicine that may affect
your blood clotting. For a list of these medicines
see the section “Taking other medicines”.
• If you know that you are sensitive to
methylparahydroxybenzoate or propylparahydroxybenzoate. Read the information
in the section “Important information
about some of the ingredients of heparin”.
• 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”.
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.
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.
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

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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.
• 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.
Pregnancy and breast-feeding
Unless your doctor has told you it is essential, you
must not have heparin 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”.
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.
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
This medicine contains:
• Benzyl alcohol. This is a preservative. It may harm
a newborn baby. It must not be given to premature
babies or babies under one month old.
Your doctor will decide if you can have heparin
if you are pregnant. It may be possible for your
doctor to use another type of heparin that does
not contain this ingredient.
• Methylparahydroxybenzoate and propylparahydroxybenzoate. These are preservatives.
They may give you an allergic reaction. This may
happen at any time after you have your medicine.
Please read section 4 so you can spot any signs
this may be happening to you.
• Sodium. This medicine is nearly “sodium free”.
Your medicine contains less than 23 milligrams
(mg) of sodium in each 25,000 International
Units (IU) dose.
Please ask your doctor if you are worried about any
of the ingredients in this medicine.

spinal anaesthetic. You may be developing
paralysis:
• Tingling, weakness or numbness in your legs or
lower body
• Back pain
• Problems in going to the toilet.
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 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.
• 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.

5. HOW TO STORE HEPARIN

• Keep out of the reach and the sight of children.
• Do not use the injection after the expiry date on
the vial. The expiry date is the last day of that
month.
3. HOW TO USE HEPARIN
• Store below 25°C.
Heparin will be given to you by a doctor or nurse.
Heparin should not be mixed with any other injection. Medicines should not be thrown away in waste
It may be given under your skin or into your vein.
water or in household waste. Please ask your
pharmacist how to throw away any medicine you
How much heparin to have
do not need anymore. If you do this you will help
Your doctor will prescribe the right dose for you.
protect the environment.
If you have more heparin than you should
6. FURTHER INFORMATION
Your doctor or nurse will give you this medicine. If
What heparin contains
you think you may have been given too much, tell
• The active ingredient is heparin sodium.
your doctor or nurse straight away.
There are two strengths of this product containing
You may start to haemorrhage (bleed severely).
either 1,000 or 5,000 IU of heparin sodium in each
Please read section 4 so you can spot any signs this millilitre (ml).
may be happening to you.
• The other ingredients are benzyl alcohol,
You may be given another injection of a medicine
methylparahydroxybenzoate, propylparahydroxycalled protamine sulphate.
benzoate, sodium citrate dihydrate, sodium
chloride and water for injections.
If you have missed a dose of heparin
Your doctor or nurse will give you this medicine. If
You can find important information about some of
you think that you have missed a dose then tell your
the ingredients near the end of section 2, just
doctor or nurse.
before section 3.
If you have any further questions about taking this What heparin looks like and contents of the pack
medicine, please ask your doctor or pharmacist.
Heparin is a clear, colourless or pale yellow liquid.
This medicine comes in glass vials containing 5 ml.
4. POSSIBLE SIDE EFFECTS
Like all medicines, heparin can cause side effects, There are 10 vials of heparin 1,000 and 5,000 IU/ml in
a carton.
although not everybody gets them.
Marketing Authorisation Holder / Manufacturer
Important side effects to look out for
Marketing Authorisation Holder:
You must get urgent medical help if you have any of LEO Laboratories Limited, Hurley, Berkshire
the following symptoms. You may be having an
SL6 6RJ, UK.
allergic reaction:
Manufacturer: LEO Pharma A/S, DK 2750 Ballerup,
• You have difficulty breathing
Denmark.
• Your face or throat swell
This leaflet was last revised in October 2013.
• Your skin develops a severe rash
• Your skin develops blisters at the site of your
injection.
You must get urgent medical help if you have any of
LEO
the following symptoms after having an epidural or

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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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