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INNOHEP 20 000 IU/ML SYRINGE

Active substance: TINZAPARIN SODIUM

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Innohep syringe 20,000 Iu/ml

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

06464/2981E

DATE OF PROOF:

20/06/13

DATE:

PROOF HISTORY:
v.2 - waymade - 20/06/13

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2012

Pg 1

Pg 4

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 sight and reach of children.
Do not use the injection after the expiry date on the syringe. The expiry date is the last day of that month.
Do not store above 25°C.
If solution is cloudy or show any signs of deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
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.
A pre-filled variable dose graduated syringe containing tinzaparin sodium 20,000 anti-Factor Xa IU in 1 ml.

Each pre-filled variable dose graduated syringe of 0.5 ml contains tinzaparin sodium 10,000
anti-Factor Xa IU.

Each pre-filled variable dose graduated syringe of 0.7 ml contains tinzaparin sodium 14,000
anti-Factor Xa IU.

Each pre-filled variable dose graduated syringe of 0.9 ml contains tinzaparin sodium 18,000
anti-Factor Xa IU.
The other ingredients are: sodium metabisulphite (E223), sodium hydroxide and water for injections.
What Innohep looks like and contents of the pack
Innohep is a clear to straw coloured solution.
Innohep comes in a pre-filled variable dose graduated syringe with green plunger and orange safety device, in
a plastic container with a red lid, containing 0.5 ml solution for injection.
Innohep comes in a pre-filled variable dose graduated glass syringe with green plunger and orange safety
device, in a plastic container with a yellow lid, containing 0.7 ml solution for injection.
Innohep comes in a pre-filled variable dose graduated glass syringe with green plunger and orange safety
device, in a plastic container with a dark blue lid, containing 0.9 ml solution for injection.
Available in packs of 2 and 6 pre-filled syringes in a carton.
POM

PL No: 06464/2981

These products are manufactured by Laboratoires LEO S.A., 39 Route de Chartres, F-28500 Vernouillet
Cedex, France and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date (Ref.) 20.6.2013
Innohep is a registered trademark LEO Pharma A/S.

INNOHEP®

20,000 IU/ml SYRINGE
(tinzaparin sodium)

Patient Information leaflet

The name of your medicine is Innohep 20,000 IU/ml Syringe but will be referred to as Innohep throughout this
leaflet.
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.
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 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. 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.
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT: Innohep syringe 20,000 Iu/ml

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE OF PROOF:

20/06/13

DATE:

PROOF HISTORY:
v.2 - waymade - 20/06/13

DATE:

CODE:

06464/2981E

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2012

Pg 2

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 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.

Pg 3

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. 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.
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.

3. How to use Innohep

You may be given another injection of a medicine called protamine sulphate.

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.

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 taking this medicine, please ask your doctor or pharmacist.

How much Innohep to have
Your doctor will prescribe the right dose for you.

4. Possible side effects

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.

Like all medicines, Innohep can cause side effects, although not everybody gets them.

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.

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.

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. 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.

Important side effects to look out for

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

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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