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INNOHEP 20 000 IU/ML

Active substance: TINZAPARIN SODIUM

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031280
Date

INS 120 x 320 mm

Date

Date

16/02/15

Colour

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

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Supplier / Place of production

innohep® 20,000 IU/ml vials

Denmark

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Innohep® Hætteglas
120 mm

Package leaflet: Information for the user

20,000 IU/ml
tinzaparin sodium
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.
• In this leaflet innohep 20,000 IU/ml will be called innohep.

031280-XX

20 mm
(centred)

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).
Do not give this medicine to a premature baby, a
newborn baby or a baby up to 1 month old as it
contains benzyl alcohol (see ‘Important information
about some of the ingredients of innohep’ below).
The use of innohep vials should be avoided if you
are pregnant or think you are pregnant due to the
presence of benzyl alcohol.
(see “Pregnancy and breast-feeding”)
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.
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.
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.

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 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.
The use of innohep vials should be avoided if you
are pregnant or think you are pregnant due to the
presence of benzyl alcohol. Your doctor will
prescribe a different formulation of innohep.
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.

Space for text: 2 x 47 5 x 300 mm or 1 x 100 x 300 mm

17/02/15

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.

JUG

189 mm

innohep is a type of heparin – a low molecular
weight heparin – and belongs to a group of
medicines called anticoagulants; these medicines
affect how your 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 your lung and caused
a blockage (pulmonary embolism, PE). This can
cause breathing difficulties and chest pain.

2.

1. What innohep® is and what it is used for

• 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 know 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).

320 mm

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

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Date

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Supplier / Place of production

innohep® 20,000 IU/ml vials

Denmark

Page 2 of 2

Innohep® Hætteglas

3. How to use innohep®

189 mm

innohep will be given to you by your doctor or nurse.
innohep should not be mixed with any other injection.
How much innohep to use
Adults, including the elderly:
The dose depends on your weight and this will be
worked out by your doctor who prescribes it for you.
You will have one dose of innohep each day for at
least 6 days.
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.
If you use more innohep than you should
If you feel unwell or think you may have been given
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 think that you have missed a dose, it is
important that you talk to your doctor or nurse as
soon as you remember and get advice on what to do.

031280-XX

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
and 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 after
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 this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date
which is stated on the label (EXP). 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 25°C.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What innohep contains
• The active substance is tinzaparin sodium.
• Each vial contains 40,000 IU of tinzaparin sodium
in 2 millilitres (ml) of solution.
• The other ingredients are benzyl alcohol, sodium
metabisulphite, 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
innohep is a straw coloured liquid.
innohep comes in a glass vial containing 2 ml.
There are 1 or 10 vials in a carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: LEO Laboratories
Limited, Hurley, Berkshire SL6 6RJ, UK.
Manufacturer: LEO Pharma A/S, 55 Industriparken,
DK 2750, Ballerup, Denmark.
This leaflet was last revised in February 2015.
® Registered Trade Mark

Space for text: 2 x 47 5 x 300 mm or 1 x 100 x 300 mm

LEO

320 mm

120 mm

Important information about some of the
ingredients of innohep
innohep vial contains:
• Benzyl alcohol. This is a preservative. It may
cause toxic and allergic reactions in infants up to
3 years old. It must not be used in premature
babies or babies up to 1 month old. It is
recommended to use the innohep formulation
without benzyl alcohol in pregnant women. Your
medicine contains 10 mg/ml of benzyl alcohol.
• 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.

Date

16/02/15

Comments:

20 mm
(centred)

Rev. No.

031280

INS 120 x 320 mm

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Sign.

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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