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INNOHEP 20 000 IU/ML SYRINGES

Active substance(s): TINZAPARIN SODIUM

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Patient Information leaflet
®

innohep 20,000 IU/ml syringes
(tinzaparin sodium)
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
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, 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 any of the side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
In this leaflet innohep 20,000 IU/ml syringes will be called
innohep.

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, 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 use innohep
• If you are allergic (hypersensitive) to tinzaparin or any of the
other ingredients of this medicine; you can find a list of
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).

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.

Important: You must not have an epidural/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.

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 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.

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).

Warnings and precautions
Do not inject innohep into a muscle. See section 3, “How to use
innohep®”.

Use in children and adolescents
There is a limited experience of use in children and adolescents.
innohep is not intended for use in children and adolescents under
the age of 18 years.

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.

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 that 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.

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.
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 throw syringes into 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.
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.
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
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 postmarketing
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 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 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.
What innohep® looks like and contents of the pack
Prefilled syringes with green plunger, an orange safety device 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

POM

This leaflet was revised 24/07/2015
E0414/3
innohep® is a registered trade mark of LEO Pharma A/S

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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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