INNOHEP 20 000 IU/ML SYRINGES

Active substance: TINZAPARIN SODIUM

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Patient Information leaflet
®

innohep 20,000 IU/ml syringes
(tinzaparin sodium)
Please read all of this leaflet carefully before you start having
this medicine.
This product is available in other strengths and formats.






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 syringes 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.

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: 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 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 potassiumsparing 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. 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
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 metabisulphate. 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®
innohep® is usually given to you by a doctor or nurse.
innohep® should not be mixed with any other injection.
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.
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.
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.
Your doctor will tell you the right dose to use and how to
measure it. Do not change this dose yourself.
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. Only use one syringe for each injection. Never keep an
opened one for later.
9. 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.
10. a) If your dose is less than the whole syringe: You must now
get rid of any extra liquid. Hold the syringe upright, with the
needle pointing upwards. Gently press in the plunger so any
extra liquid is pushed out.
b) If your dose uses the whole syringe:
You may notice a small air bubble in the syringe. You do not
need to remove this. The syringe is ready to use.
11. Hold the syringe in your writing hand like a pen.
12. 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.
13. 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.
14. Press the plunger
slowly down over 1015 seconds. All the
liquid should come out
of the syringe.
15. Pull the needle right
out of your skin. Then
let go of the skin fold.
The injection is
complete.
16. Do not rub or massage the place where you have just put
the injection. If you do this you may get a bruise.
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 forget to have 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.

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
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any 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 INNOHEP®
Keep out of the sight and reach 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.
If your medicine becomes discoloured or shows any other signs of
deterioration, please seek the advice of your pharmacist who will
advise you what to do.

6. FURTHER INFORMATION What innohep® contains
The active ingredient is tinzaparin sodium. innohep® 20,000 IU/ml
syringes contains 20,000 IU of tinzaparin in each millilitre (ml).
The other ingredients are sodium metabisulphite, sodium
hydroxide, benzyl alcohol 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
Prefilled syringes with green plunger and grey safety cap, encased
in a clear plastic casing with tamper evident seal (colour of tamper
evident seal varies with quantity of solution 0.5ml = red,
0.7ml = yellow and 0.9ml = blue).
There are 6 variable dose syringes in a carton.
Manufacturer: Leo Pharma AB, Box 404, 201 24 Malmo,
Sweden.
Procured from within the EU
Product Licence holder: Ecosse Pharmaceuticals Limited
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited
3 Young Place, East Kilbride, G75 0TD.
PL 19065/0414
This leaflet was revised 23/05/2014
E0414/1
Innohep® is a registered trade mark of LEO Pharma A/S

POM

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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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