INNOHEP 20 000 IU/ML SOLUTION FOR INJECTION

Active substance: TINZAPARIN SODIUM

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PACKAGE LEAFLET:
INFORMATION FOR THE USER



Innohep® 20,000 IU/ml
Solution for injection



(tinzaparin sodium)
This medicine is also available in other strength: 10,000 IU/ml.
In this leaflet Innohep 20,000 IU/ml Solution for injection will be
called Innohep.
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:
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.

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 potassiumsparing 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 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 contains:
 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:

5. HOW TO STORE INNOHEP

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 usually 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.



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



4. POSSIBLE SIDE EFFECTS
Like all medicines, Innohep can cause side effects, although not
everybody gets them.

Important side effects to look out for

Keep out of the reach and sight of children
Do not use the injection 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 25ºC. Store in the original package.

Each vial contains 40,000 IU of tinzaparin sodium in 2 millilitres of
solution.
The other ingredients are: sodium metabisulphite, benzyl alcohol,
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

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.

Innohep is a straw coloured liquid in a 2ml Glass vial with green plastic
flip-off cap.
There are 10 vials in a carton each containing 2 ml of liquid.

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.

Procured from within the EU and repackaged by: Amimed

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.

Leaflet Revision Date: 30/04/2013

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.

Manufacturer
LEO Pharmaceutical Products, Industriparken 55, DK-2750 Ballerup,
Denmark.
Direct Ltd, Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick
Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
POM

PL No: 33902/0283

Innohep® is a registered trademark of Leo Laboratories Ltd.

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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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