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HEPARIN MUCOUS INJECTION BP

Active substance(s): HEPARIN SODIUM

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Please return to:
LEO Pharma A/S
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Subject

Item No.

GB

Rev. No.

Sent by e-mail

XX

011697
Date

INS 120 x 320 mm

Date

Date

Sign.

Sign.

09/10/14

Colour

Sign.

EBD

Black

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Supplier / Place of production

Heparin (mucous) Injection BP

Denmark

Comments:

Page 1 of 2 Font size: Heading: 9 point, section: 9 point, linespacing: 3.35 mm Mock-up for registration purpose.

120 mm

Package Leaflet: Information for the user

Heparin (Mucous) Injection BP
1,000 and 5,000 Units/ml
heparin sodium

011697-XX

20 mm
(centred)

2. What you need to know before you have heparin
Do not have heparin
• If you are allergic (hypersensitive) to heparin
sodium or any of the other ingredients in this
medicine (listed in section 6).
• If you have ever had a reaction to heparin that
caused a severe drop in the number of your
clotting cells (platelets); a reaction called heparininduced thrombocytopenia.
• If you have a major bleed (for instance in the brain,
spine, eye, stomach, into a muscle or womb) or 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 have a condition called septic 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 before you receive any anaesthetic.
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 have your medicine again.
This medicine should not be given to a premature
baby, a newborn baby or a baby up to 1 month old as
it contains benzyl alcohol.
00621093

v1.0

5.

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189 mm

1. What heparin is and what it is used for
Heparin contains the active substance known as
heparin sodium. Heparin belongs to a group of
medicines called anticoagulants.
These medicines affect how the blood clots. Heparin
prevents clotting, allowing normal blood flow through
the arteries and veins.
Heparin is used to help:
• stop harmful blood clots in your veins growing
bigger (treatment).
• stop harmful blood clots forming in your veins
(prevention).
• stop harmful blood clots forming in the tubing of an
artificial kidney machine during kidney dialysis
(haemodialysis).
An example is a harmful blood clot that has been
formed in a deep vein (deep vein thrombosis, DVT).
This usually happens in a leg. Another example is a
clot that has travelled to the lung and caused a
blockage (pulmonary embolism, PE). This can cause
breathing difficulties and chest pain.
It is more likely these clots will form if you are either
overweight, pregnant, have certain blood disorders
or have already had a PE, DVT, heart attack or stroke.
They may 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.

If you are pregnant please also read the section of
this leaflet “Pregnancy and breast-feeding”.
Warnings and precautions
This medicine must not be injected into your muscles.
You should not receive any other injections into your
muscles while having heparin as this may lead to
bruising.
Talk to your doctor or nurse before having heparin:
• 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 are taking any medication that affects your
blood clotting process.
• If you have kidney problems.
• If you have liver problems.
• If you have problems with your blood pressure
(hypertension).
• If you have a medical condition (e.g. diabetes,
kidney failure or metabolic acidosis) which may
cause high levels of potassium in your blood
(hyperkalaemia). Ask your doctor if you are unsure.
• If you know you are sensitive to methyl or
propylhydroxybenzoate which are ingredients in
this medicine. Ask your doctor or nurse for advice as
these may cause allergic reactions and may also
very rarely lead to breathing difficulties.
• If you are on a controlled sodium diet. Ask your
doctor or nurse for more advice.
Your doctor may take a blood test before you start
having this medicine, and at intervals while you are
having it. This is so the doctor can check you are
receiving the right dose. This is also to check the
level of the clotting cells (platelets) and potassium in
your blood.
Children
• This medicine contains benzyl alcohol. If it is to be
given to children up to 3 years old, ask your doctor
or nurse for advice as this ingredient may cause
toxic or allergic reactions.
Other medicines and heparin
Tell your doctor or nurse if you are taking, have
recently taken or might take any other medicines.
This includes any medicines which you have bought
without a prescription.
You must tell your doctor or nurse if you are taking any
of the following medicines as they are likely to affect
your blood clotting process and make you bleed more
easily:
• 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.
• Aspirin either for reducing pain and inflammation
for thinning of the blood.
• Non-steroidal anti-inflammatory drugs such as
ibuprofen or diclofenac: for arthritis or aches or pains.
• Selective serotonin reuptake inhibitors (SSRIs) such
as citalopram, fluoxetine or sertraline: antidepressants used in the treatment of depression,
anxiety and some personality disorders.
• Thrombolytic agents such as streptokinase: for
dissolving blood clots.
• Vitamin K antagonists such as warfarin: for
stopping harmful blood clots.
• Glyceryl trinitrate infusion: for treating angina. This
may reduce the effect of heparin.
• Activated protein C: for getting rid of blood clots.
• Dextrans: for increasing your blood volume.
• Anticoagulants taken by mouth such as
rivaroxaban, dabigatran or apixaban, which may be
given to stop harmful blood clots.
Your doctor may carry out check-ups on you, including
blood tests, if you take or use any of these medicines
at the same time as heparin.

320 mm

What is in this leaflet
1. What heparin is and what it is used for
2. What you need to know before you have heparin
3. How to use heparin
4. Possible side effects
5. How to store heparin
6. Contents of the pack and other information

EBD

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 nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
• In this leaflet Heparin (Mucous) Injection BP will be called heparin.

Scale

Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Item No.

GB

Rev. No.

Date

Date

Date

Sign.

Sign.

09/10/14

Colour

Sign.

EBD

Black

Supplier / Place of production

Heparin (mucous) Injection BP

Denmark

Comments:

Page 2 of 2

011697-XX

189 mm

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor, nurse or midwife for advice before having this
medicine.
If you become pregnant while having this medicine,
tell your doctor.
Special precautions are required if you will have an
epidural anaesthetic to help with your labour when
you are having heparin (see section 2).
Driving and using machines
This medicine should not have any 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
Heparin contains
• Benzyl alcohol. This is a preservative. This must not
be given to premature babies or neonates as it may
cause toxic reactions and allergic reactions in
infants and children up to 3 years old and may harm a
newborn baby. Your doctor will decide if you can
have heparin while you are pregnant. It may be
possible for your doctor to use another type of
heparin that does not contain this ingredient.
• Methylhydroxybenzoate (E218) and
propylhydroxybenzoate (E216). These are
preservatives. These may cause allergic reactions
(possibly delayed) and may also rarely cause
breathing difficulties. 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.
• Heparin (Mucous) Injection BP – 1,000 IU/ml - Sodium.
This medicinal product contains 1.2 mmol (or 27 mg) of
sodium in each 10,000 International Units (IU) dose.
This should be taken into consideration if you are on a
controlled sodium diet.
• Heparin (Mucous) Injection BP – 5,000 IU/ml Sodium. This medicine is nearly “sodium free”. This
medicinal product contains less than 1 mmol sodium
(23 mg) in each 25,000 International Units (IU) dose.
Please ask your doctor or nurse if you are worried
about any of the ingredients in this medicine.
3. How to use heparin
This medicine will be given to you by a doctor or nurse.
Your doctor will prescribe the right dose of heparin for
you.
Heparin should not be mixed with any other injection.
It may be given subcutaneously (under your skin) or
intravenously (into your vein).
If you have more heparin 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 because you may
start to haemorrhage (bleed severely) and may need to
be given another injection of a medicine (called
protamine sulphate) to stop you bleeding.
If you have missed a dose of heparin
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 using this
medicine, please ask your doctor or nurse.

• Tingling, weakness or numbness in your legs or
lower body
• Back pain
• Problems in going to the toilet.
Other possible side effects
Common side effects (may affect up to 1 in 10 people)
• Bleeding (haemorrhage). This may be more likely if
you are having a high dose of heparin.
• Appearance of a large bruise like spot. This is caused
due to a localised collection of blood clot on skin or
eye area.
• Dark coloured urine.
• Reddening of the skin.
• Changes in your blood test results caused due to
increase in body enzymes. Your doctor can explain
this more.
Uncommon side effects (may affect up to 1 in 100
people)
• Changes in your blood test results. There may be a
drop in the platelet count (clotting cells) in your
blood. This may increase the risk of bleeding and
bruising. There may also be an increase in time it
takes for your blood cells to clot. Ask your doctor or
nurse for more advice.
• Allergic reactions.
• Increase in the amount of potassium in your blood.
• Rash.
• Itching.
• Itchy and swollen rash (hives).
• Blood spots near the injection site which could
develop in to a purple blister surrounded by red
inflamed skin.
• Osteoporosis. Your bones become less strong and
can break more easily. This has been seen in
patients taking heparin for a long time.
• Prolonged and painful erection in men.
• Local injection site allergic reactions such as
swelling, redness and/or pain may occur.
Reporting of side effects
If you get any side effects, talk to your doctor 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 heparin
• Keep this medicine out of the sight and reach of
children.
• Do not use the medicine after the expiry date on the
vial. The expiry date refers to the last day of that
month.
• Store below 25°C.
• Once opened, the product may be stored for a
maximum of 14 days below 25°C.
Do not throw away any medicines via waste water or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other information
What heparin contains
• The active substance is heparin sodium.
• There are two strengths of this product containing
either 1,000 or 5,000 IU of heparin sodium in each
millilitre (ml).
• The other ingredients are benzyl alcohol,
4. Possible side effects
methylhydroxybenzoate (E218),
Like all medicines, this medicine can cause side
propylhydroxybenzoate (E216), sodium citrate
effects, although not everybody gets them.
dihydrate, sodium chloride and water for injections.
Important side effects to look out for
You
can find important information about some of the
You should tell your doctor straight away if you spot
any of the following signs which mean you may be ingredients near the end of section 2, just before
section 3.
starting to bleed severely:
What heparin looks like and contents of the pack
• Red or brown urine
Heparin is a clear, colourless or pale yellow liquid.
• Black tarry stools
• Unusual bruising
This medicine comes in glass vials containing 5 ml.
• Bleeding from your nose or mouth or any operation
There are 5, 10 or 50 vials of heparin 1,000 and
wound that will not stop.
5,000 IU/ml in a carton.
Although severe bleeding is uncommon, permanent
disability and fatality has been reported in some cases. Not all pack sizes may be marketed.
You must get urgent medical help if you have any of the Marketing Authorisation Holder/Manufacturer
Marketing Authorisation Holder:
following symptoms. You may be having a serious
LEO Laboratories Limited, Honey Lane, Hurley,
allergic reaction:
Maidenhead, Berkshire SL6 6RJ, UK.
• You have difficulty breathing
Manufacturer: LEO Pharma A/S, DK 2750, Ballerup,
• Your face or throat swell
Denmark.
• Your skin develops a severe rash
This leaflet was last revised in April 2015.
• Your 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: LEO
00621093

v1.0

320 mm

120 mm

20 mm
(centred)

Sent by e-mail

XX

011697

INS 120 x 320 mm

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Expand view ⇕

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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