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INNOHEP 20 000IU/ML SYRINGE

Active substance(s): TINZAPARIN SODIUM

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Package leaflet: Information for the user
innohep® 20,000IU/ml Syringe
(tinzaparin sodium)
Please read all of this leaflet carefully before you start using
this medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist
or nurse
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
The name of your medicine is innohep® 20,000IU/ml Syringe, but
will be referred to as innohep® throughout the remainder of the
leaflet.
What is in this leaflet:
1. What innohep® is and what it is used for
2. What you need to know before you use innohep®
3. How to use innohep®
4. Possible side effects
5. How to store innohep®
6. Contents of the pack and other information
1. What innohep® is and what it is used for
innohep® is a type of heparin – a low molecular weight heparin –
and belongs to a group of medicines called anticoagulants; these
medicines affect how the blood clots. Innohep® prevents clotting,
allowing normal blood flow through the arteries and veins.
Innohep® is used in adults to treat:
• Harmful blood clots that have formed in a deep vein (deep vein
thrombosis or DVT). This usually occurs in a leg.
• Clots that may travel in your bloodstream and cause a blockage
(a thromboembolism).
• A clot that has travelled to the lung and caused a blockage
(pulmonary embolism, PE). This can cause breathing difficulties
and chest pain.
• Blood clots that have developed because of the presence of a
solid tumour (a particular type of cancer).
2. What you need to know before you use 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 have ever had a reaction to heparin that caused a severe
drop in the number of your clotting cells (platelets) – this
reaction is called heparin-induced thrombocytopenia (HIT).
• If you have ever had a major bleed (for instance: in the brain,
spine, eye or stomach, into a muscle or the womb, or any
conditions which make you bleed severely, such as
haemophilia).
• If you have a condition called septic endocarditis (an
inflammation of the lining of the heart and heart valves)
Important: You must not have an epidural or spinal anaesthetic
within 24 hours after your last injection of innohep®. You must
wait at least 4 to 6 hours after having a spinal anaesthetic, or after
the catheter has been removed, before you start using innohep®
again.
You may have a blood test before you start using this medicine
and at intervals while you are using it; this is to check the level of
the clotting cells (platelets) and potassium in your blood.
Warnings and precautions
Do not inject innohep into a muscle. See section 3, “How to use
innohep®.
This medicine may make you bleed more easily, so when you are
being given other injections or having any procedures carried out,
tell the doctor, nurse or dentist that you are using innohep.

If you have a brain tumour, you will be monitored closely because
medicines such as innohep that prevent blood from forming clots,
may cause bleeding into the skull.
Talk to your doctor, pharmacist or nurse before using
innohep

If you are pregnant or think you may be pregnant. See the
section “Pregnancy and breast-feeding”.

If you have a condition which makes you more likely to bleed.

If you are being treated with other injections into your
muscles.

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 a medical condition such as diabetes mellitus or
metabolic acidosis which may cause high levels of potassium
in your blood (hyperkalaemia).

If you have an artificial heart valve.

If you have kidney problems.

If you have asthma, as this medicine contains sodium
metabisulphite (see “Important information about some of the
ingredients of innohep” below).
innohep should not be interchanged with other low molecular
weight heparin products. This is because they are not exactly the
same and you could experience problems with your blood clotting.
Elderly people
Because kidney problems are more likely if you are elderly, you
may have a blood test to check how well your kidneys are working
and to monitor the activity of innohep.
Children and adolescents
innohep is not intended for use in children and adolescents under
the age of 18 years.
Other medicines and innohep
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes any
medicines bought without a prescription.
You must tell your doctor or pharmacist if you are taking any of
the following medicines as you may be likely to bleed more easily:








Non-steroidal anti-inflammatory drugs (such as ibuprofen or
diclofenac): for arthritis or aches or pains.
Aspirin: either for reducing pain and inflammation, or the
lower dose for thinning of the blood.
Platelet aggregation inhibitors (such as clopidogrel): for
stopping harmful blood clots forming.
Thrombolytic agents (such as streptokinase): for dissolving
blood clots.
Vitamin K antagonists (such as warfarin): for stopping
harmful blood clots.
Activated protein C: for getting rid of blood clots.
Anticoagulation, taken by mouth (such as rivaroxaban,
dabigatran or apixaban) for stopping harmful blood clots.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor, pharmacist or
midwife for advice before using this medicine.
You must not have an epidural anaesthetic to help with your
labour or surgery within 24 hours of your last injection of innohep.
You must wait at least 4 to 6 hours after having a spinal
anaesthetic, or after the catheter has been removed, before you
start using innohep again.
Driving and using machines
This medicine should not have any 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 syringe contains:

Sodium metabisulphite. This is a preservative and can cause
an allergic reaction which may result in breathing difficulties.
See section 4.

Sodium. This medicine is nearly “sodium free”. Your medicine
contains less than 23 milligrams (mg) of sodium per dose.
Please ask your doctor or pharmacist if you are worried about any
of the ingredients in this medicine.
3. How to use innohep®
Your doctor may decide that you or a carer may inject this
medicine. You will be shown how to do the injection and should
only do the injection when you have been instructed how to do so.
Always use this medicine exactly as your doctor, pharmacist or
nurse has told you.
Check with one of them if you are not sure that you understand
how to do the injection or if you are unsure about anything else to
do with the medicine.

4. Clean the chosen area
of the skin, as you have
been told to do by your
doctor or nurse, and
allow to dry before you
inject. Carefully take the
syringe out of its plastic
container by bending the
cap all the way
back and sliding the
syringe out. Bend the
orange safety device down away from the cap on the needle.
Remove the protective needle cap without bending the needle.
To keep the needle clean, make sure it does not touch anything.
The syringe is now ready for use. There is no need to remove the
air bubble if you need the total quantity in the syringe for your
dose.
5. IMPORTANT. If the dose you have been told to have is less
than the amount in the syringe, you will need to get rid of the extra
before your injection. To do this, hold the syringe vertically with
the needle pointing upwards and gently remove the excess by
pressing the plunger into the syringe.

How much innohep to use
Adults, including the elderly:
The dose depends on your weight and this will be worked out by
the doctor who prescribes it for you. You will be told how much
you need to inject. It is possible you may not need to inject the
entire contents of the syringe.
You will have one dose of innohep each day for at least 6 days.
The treatment may be continued for up to 6 months if you have a
solid tumour (a particular type of cancer).
Use in children and adolescents
There is limited experience of use in children and adolescents.
innohep is not intended for use in children and adolescents under
the age of 18 years.
How to inject yourself with innohep
You should inject yourself exactly as you have been shown and
only on the parts of your body that you have been told it is safe to
inject into. The type of injection you will be giving is known as a
subcutaneous injection. The injection goes into a pinched up fatty
layer on your abdomen or on the outer part of your thighs. Keep
away from your belly button. Do NOT inject into a muscle.
Ideally you should inject at the same time every day; this helps to
maintain a steady level of the medicine in your body.
When giving yourself an injection, make sure you:
1. Thoroughly wash and dry your hands.
2. Sit, stand or lie in a position so that you can see the skin where
you are going to inject yourself. This can comfortably be done
standing up or, if you prefer, in a lounge chair, recliner or bed
propped up with pillows.
3. Decide where to inject
yourself. This is usually on
the right or left side of the
abdomen, remembering
not to inject within 5 cm (2
inches) of your belly
button. You may also inject
into the sides of your thigh.
Do not inject near any
scars or bruises. Each
time you inject yourself, choose the opposite side from the site of
your previous injection.
So if you injected your right thigh last time, you would inject your
left thigh next time.
If you are injecting in your abdomen, you would do the left side
one day and right the next. You should also avoid injecting into
the exact site of a previous injection.

6. Hold the syringe in your writing-hand like you would hold a pen.
With your other hand, make a fold of your skin by gently pinching
the area where you are going to inject yourself with your thumb
and forefinger.
7. With the syringe at a
right angle to your body
(pointing straight, not at
an angle), insert the
needle fully into the skin
fold.
8. Continue to hold the
skin fold, press down on
the plunger slowly over
10-15 seconds. This
delivers the medicine into the fatty tissue.
9. Pull the needle completely out of the skin and then let go of the
skin fold. Do not rub or massage the place where you injected
yourself – this can lead to bruising.
10. Using a hard surface,
bend the orange safety
device so it is now
pointing in the same
direction as the needle
(back to its original
position). Then with the
safety device flat against a
hard surface such as a
table, gently push
downwards until the
needle clicks into the device. Then continue to push downwards
against the hard surface, so that the needle and device are at a
45 degree angle to the syringe.
11. The used syringe,
even when the orange
safety device is in place,
should be handled with
care and should be
disposed of in a “sharps”
container (i.e. a special
bin for needles)
immediately. If a “sharps”
container is not readily
available then please put the used syringe back into the plastic
container and close the lid by pressing down on the lid until it
clicks into the slot provided. Dispose of the syringe carefully, as
instructed by your healthcare professional.
Never put syringes or needles in the household rubbish.

For the attention of the healthcare professional:
Please dispose of the used syringe in accordance with your
institution/employer’s standard procedures for disposal of used
syringes.
If you use more innohep than you should
If you think you may have injected yourself with too much, tell
your doctor or nurse straight away because you may start to
haemorrhage (bleed severely) and need to be given another
injection of a medicine called protamine sulphate to stop you
bleeding.
If you have missed a dose of innohep
If you forget to have your injection, it is important that you talk to
your doctor or nurse as soon as you remember and get advice on
what to do.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
The side effects most often reported are blood problems and skin
reactions, especially where your injection has been given.
Important side effects to look out for:
You must get urgent medical help if you have any of the
following symptoms. You may be having a serious allergic
reaction. These are rare (may affect up to 1 in 1000 people)

You have difficulty breathing.

Your face or throat swell.

Your skin develops a severe rash.

You experience blistering of the skin, mouth, eyes or genitals
or your skin peels.

Blood spots near the injection site which could develop into a
purple blister surrounded by red inflamed skin.
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.

Rare side effects (may affect up to 1 in 1000 people)

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.

Hives.

Your bones may weaken and break more easily. This is
known as osteoporosis and has been seen in patients using
heparin for a long time.

Prolonged, painful erections in men.
Paediatric population
Limited information derived from one study and post marketing
data indicates that the pattern of adverse reactions in children and
adolescents is comparable to that in adults.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible 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 the 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.
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. Contents of the pack and other information
innohep® comes in a glass single pre-filled syringe containing
0.5ml (10,000 anti-Factor Xa IU) straw coloured liquid, fitted with
a needle with green plunger and a plastic needle safety device
contained in a plastic sealed casing, sealed with a red plastic
stopper.
The active ingredient is tinzaparin sodium. innohep® syringe
20,000 IU/ml also contains 20,000 IU of tinzaparin sodium in each
millilitre (ml).
The other ingredients are sodium metabisulphite (E223), 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.

Common side effects (may affect up to 1 in 10 people)
Bleeding (haemorrhage).
Anaemia. Reduction in red blood cells which can make the
skin pale and cause weakness and breathlessness.

A pooling of blood in tissues which may result in the skin
appearing dark in colour, similar to a large bruise.

Pain, itching, bruising or bleeding, redness, swelling, nodules
or hard lumps under your skin where the injection was given.

innohep® are available in pack size of 2 and 6 syringes in a
carton.

Uncommon side effects (may affect up to 1 in 100 people)

Changes in your blood test results. There may be a change
in the clotting cells (platelets) in your blood. These tests will
return to normal when innohep is stopped.

An allergic reaction. You may be sensitive to one of the
ingredients in this medicine.

Bruising, red or purple spots under your skin.

Some blood tests may also show a change in the way your
liver is working. These tests will return to normal when
innohep is stopped.

An itchy red rash with heat and swelling on your skin
(dermatitis).

Rash.

Itchy skin.

innohep® 20,000IU/ml Syringe




Manufactured by Laboratoires LEO S.A. 39 Route De Chartres F28500 Vernouillet, Cedex, France. Procured from within the EU.
Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock
House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by
Maxearn Ltd, Bolton BL6 4SA.
POM

PL 20774/1169

innohep® is a registered trademark of LEO Laboratories Limited
th
Date of preparation 24 July 2015

PP4/1169/V2

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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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