INNOHEP SYRINGE 10 000 IU/ML

Active substance: TINZAPARIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

025876-01

syringe 10,000 IU/ml
tinzaparin sodium

02587601

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® syringe 10,000 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 help stop:
• Harmful blood clots forming in your veins following an
operation. An example is a clot in a vein deep inside your body. This is
usually in your leg (deep vein thrombosis or DVT for short).
• Harmful blood clots forming in the tubing of an artificial kidney
machine during kidney dialysis (haemodialysis).

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.
Important: If you are having an epidural or spinal anaesthetic
You must remind your doctor that you are having innohep® 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 innohep®
Before you have innohep® 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 heparin.
• If you are allergic to other low molecular weight heparins, such as
enoxaparin or dalteparin.
• If you have kidney problems. Your doctor may need to adjust your
dose.
• 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 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.
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
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® contains:
• 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®
innohep® is usually given to you by a doctor or nurse. innohep® should not
be mixed with any other injection.
How much innohep® to have
Your doctor will prescribe the right dose for you.
To prevent harmful blood clots forming in the tubing of an artificial kidney
machine during kidney dialysis (haemodialysis)
innohep® will be given either into the artificial kidney machine or into your
vein.
The usual dose depends on the length of dialysis.
To prevent harmful blood clots forming in your veins after an operation
Your doctor may decide that you or a carer may inject this medicine. Your
doctor or nurse will show you how to inject yourself with the syringe. Only
inject yourself if you have been instructed how.
The usual dose depends on the type of operation you are having.
You will have one dose of innohep® before your operation. Then usually
you will have one dose of innohep® once a day for 7 to 10 days afterwards.
Your doctor will decide how long you should have innohep®.
How to inject innohep®
This section explains how to inject yourself with the innohep® syringe.
Warning: Only give this injection to yourself after you have received
instructions from your doctor or nurse.
Always use innohep® exactly as your doctor has told you. You should
check with your doctor or nurse if you are not sure about anything.

Where to inject
This injection goes under your skin. This
may be called SC (subcutaneous). The
usual place to inject yourself is on the left
or right side of your tummy. Choose a
place at least 5 cm (2 inches) from the belly
button. Avoid the shaded area shown in
the picture.
Choose a place away from any scars or
bruises.
You should change the side you inject on
each day. Pick a place on the opposite side
from where your last injection went.
How to give the injection
1. Wash your hands thoroughly. Dry your hands well.
2. Decide where you are going to inject.
3. Put all the equipment you will need somewhere convenient to reach on
a clean surface.
4. Check the expiry date on the syringe label. Do not use the injection after
the expiry date. The expiry date is the last day of that month.
5. Look at the liquid inside the syringe. If you can see the liquid is cloudy or
that it has any particles you must not use it.
6. Sit or lie in a comfortable position so you can see your skin where the
injection will go. You may find using pillows or cushions will help.
7. Clean and dry the area of the skin as you have been told to do.
8. Bend the coloured lid on the plastic container all the way back. This will
let you pull the syringe out. Only use one syringe for each injection.
Never keep an opened one for later.
9. Bend the orange coloured safety device
down away from the cap on the
needle.
10. Only pull the cap off the needle when you
are ready to use the syringe. It is important
to keep the needle clean. Do not let it touch
anything.
11. You may notice a small air bubble in the
syringe. You do not need to remove this.
The syringe is ready to use.
12. Hold the syringe in your writing hand like a pen.
13. Use your other hand to make a skin fold. Pinch your skin tight using
your thumb and first finger. When you have made the skin fold keep
holding on to it firmly.
14. It is important to hold your skin firmly until all the medicine has been
injected. Hold the syringe upright with the needle pointing down. Push
the needle down into the skin fold.
15. Press the plunger slowly down over 10-15
seconds. All the liquid should come out
of the syringe.
16. Pull the needle right out of your skin.
Then let go of the skin fold. The injection
is complete.
17. Do not rub or massage the place where
you have just put the injection. If you do
this you may get a bruise.
18. Bend the orange safety device back to its
original position so it is now underneath
the needle. Then with the safety device
flat against a hard surface such as a table,
push downwards until the needle clicks
into the device. Now bend the safety
device so that the needle and device are
at a 45 degree angle to the syringe.
How to get rid of syringes safely
You should have a sharps bin. Put the used syringe carefully into your
sharps bin as you have been told to do. Put the needle end in first. Keep it
out of the reach and sight of children. When the bin is full give it to your
nurse or pharmacist.
Never throw syringes into the household waste.
If you have more innohep® than you should
Your doctor or nurse will usually give you this medicine, if you think you
may have injected yourself with too much, or 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 innohep®
Your doctor or nurse will usually give you this medicine. If you forget to
inject yourself, or 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 pharmacist.

• 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 taking 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 syringe. The expiry date is the
last day of that month.
• 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.
innohep® syringe 10,000 IU/ml contains 10,000 IU of tinzaparin sodium
in each millilitre (ml).
• The other ingredients are sodium acetate, 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 glass syringe containing 0.25 ml, 0.35 ml or 0.45 ml.
There are 10 syringes in a carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LEO Laboratories Limited, Hurley, Berkshire SL6 6RJ, UK.
Manufacturer:
Laboratoires LEO, 28500 Vernouillet, France.
This leaflet was last revised in October 2013
® Registered Trade Mark

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:

LEO
025876-01

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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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