INNOHEP 20 000 IU/ML

Active substance: TINZAPARIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

20,000 IU/ml
tinzaparin 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 innohep® 20,000 IU/ml will be called innohep®.
In this leaflet:
1. What innohep® is and what it is used for
2. Before you have innohep®
3. How to use innohep®
4. Possible side effects
5. How to store innohep®
6. Further information

1. WHAT INNOHEP® IS AND WHAT IT IS
USED FOR
innohep® belongs to a group of medicines called
anticoagulants. It is a type of heparin called a
low molecular weight heparin.
innohep® 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.
innohep® is used to treat:
• Harmful blood clots that have formed in a
vein deep inside part of your body. This is
usually in your leg (deep vein thrombosis
or DVT for short).
• Harmful blood clots that have formed in a
vein in your body. The clots may travel in
your bloodstream and then get stuck in
another blood vessel (thromboembolism).
A clot may block the blood supply to your
lungs (pulmonary embolism). It can cause
breathing difficulties.

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2. BEFORE YOU HAVE INNOHEP®
Do not have innohep®
• If you are allergic (hypersensitive) to
tinzaparin 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: You must not have an epidural or
spinal anaesthetic if you are having innohep®
treatment.
Take special care with innohep®
Before you have innohep® tell your doctor:
• If you are pregnant or think you may be
pregnant. See the section "Pregnancy and
breast-feeding".
• 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
heparin.
• If you are allergic to other low molecular
weight heparins, such as enoxaparin or
dalteparin.

• If you have kidney problems.
• If you have asthma.
• 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 have an artificial heart valve.
Your doctor may take a blood test before you
start having this medicine, and while you are
having it. This is to check the level of the clotting
cells (platelets) and potassium in your blood. If
you are elderly your doctor may also check how
well your kidneys are working and take blood
tests to monitor the activity of innohep®.
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:
• 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.
• 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.
Pregnancy and breast-feeding
The use of innohep® vials should be avoided if
you are pregnant or think you are pregnant.
Please ask your doctor or pharmacist for advice
before having innohep®:
• If you are pregnant, or think you are
pregnant.
• If you are breast-feeding.
Tell your doctor if you become pregnant while
having this medicine.
You must not have an epidural anaesthetic to
help with your labour if you are having innohep®.

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 innohep®
innohep® vials contain:
• 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.
• Sodium metabisulphite. This is a
preservative. It may give you an allergic
reaction. It may give you breathing
difficulties. Please read section 4 so you
can spot any signs that this may be
happening to you.
• Sodium. This medicine is nearly "sodium
free". Your medicine contains less than
23 milligrams (mg) of sodium per dose.
Please ask your doctor if you are worried about
any of the ingredients in this medicine.

3. HOW TO USE INNOHEP®
Your doctor or your nurse will give you innohep®
as an injection. innohep® should not be mixed
with any other injection.
How much innohep® to have
Your doctor will prescribe the right dose for you.
Adults, including the elderly:
The dose depends on your weight (called
bodyweight). You will have one dose of innohep®
each day for at least 6 days.
If you have more innohep® 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 missed a dose of innohep®
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.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, innohep® 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
getting an allergic reaction:
• You have difficulty breathing
• Your face or throat swell
• Your skin develops a severe rash
• Your skin develops blisters at the site of
your injection
• Your skin peels.
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:
• 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, or mouth or
any operation wound that will not stop.
Other possible side effects
The side effects most often reported are blood
problems and skin reactions, especially where
your injection has been given.
Very Common side effects (probably affect more
than 1 in 10 people)
• Bleeding (haemorrhage). This may be more
likely if you are having a high dose of
innohep®.

Common side effects (probably affect less than 1
in 10 people)
• Bruising, pain or irritation at the site of the
injection.
Uncommon side effects (probably affect less
than 1 in 100 people)
• Rash
• Itchy skin
• Hives
• Headache
• Blood tests results may show changes in the
way your liver is working.
Side effects where the number of people
affected is not known
• Changes in your blood test results. This may
lead to bruising or bleeding more easily,
because of a reaction in your blood. Your blood
may form more harmful clots. A drop in the
number of 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.
• Problems with your heart if you have an
artificial heart valve. This may be because you
are not having the dose of innohep® that is
right for you.
• Your bones may weaken and break more
easily. This is known as osteoporosis and has
been seen in patients taking heparin for a long
time.
• 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 INNOHEP®
• Keep out of the reach and the sight of
children.
• Do not use after the expiry date on the
label. The expiry date is the last day of
that month. Any contents remaining in
the vial 14 days after first opening should
be discarded.
• Do not store above 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 innohep® contains
• The active ingredient is tinzaparin sodium.
Each vial contains 40,000 IU of tinzaparin
sodium in 2 millilitres (ml) of solution.
• The other ingredients are benzyl alcohol,
sodium metabisulphite, sodium
hydroxide 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 innohep® looks like and contents of the
pack
innohep® is a straw coloured liquid.
innohep® comes in a glass vial containing 2 ml.
There is 1 vial in a carton.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
LEO Laboratories Limited,
Hurley, Berkshire SL6 6RJ, UK.
Manufacturer:
LEO Pharma A/S,
55 Industriparken, DK 2750 Ballerup, Denmark.
This leaflet was last revised in October 2013.
® Registered Trade Mark

LEO

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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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