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INNOHEP 20 000 IU/ML SYRINGE

Active substance(s): TINZAPARIN SODIUM

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5. How to store Innohep®

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• Keep 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.
• 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.
• If the liquid become discoloured or shows
any other signs of deterioration, you
should seek the advice of your
pharmacist who will advise you what to
do.

Innohep® 20,000 IU/ml syringe
(tinzaparin sodium)

This medicine is available using the above
name but will be referred to as Innohep®
throughout the Patient Information Leaflet.

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

Patient Information Leaflet

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®.

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
syringe will be called Innohep.

6. Contents of pack and other
information
What Innohep® contains
• The active substance is tinzaparin
sodium.
• Contains:
- 10,000 anti-Factor Xa IU in each 0.5ml
variable dose syringe or
- 14,000 anti-Factor Xa IU in each 0.7ml
variable dose syringe or
- 18,000 anti-Factor Xa IU in each 0.9ml
variable dose syringe
• The other ingredients are sodium
metasbisulphite
(E223),
sodium
hydroxide and water for injections.

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

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 clear to straw-coloured liquid
contained within a prefilled variable dose
graduated glass syringe with a protective
cap, plunger and needle safety device.

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® comes in a glass syringe
containing:
0.5 ml (10,000 anti-Factor Xa IU), 0.7 ml
(14,000 anti-Factor Xa IU) and 0.9 ml
(18,000 anti-Factor Xa IU)

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).

There are 6 syringes in a carton.
Manufacturer and Product Licence
Holder
This
product
is
manufactured
by
Laboratoires LEO S.A., 39 Route de
Chartres, 28500 Vernouillet Cedex, France.
It is procured from within the EU by the
Product Licence Holder: Swinghope
Limited, Brandon House, Marlowe Way,
Croydon CR0 4XS UK.

POM

2. What you need to know before you
use Innohep®

PL No: 10380/1591

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).

Leaflet revision date: 25/02/2016
Innohep® is registered trademark of LEO
Pharma A/S, Denmark.

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.

Fold

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.

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®.

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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.

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.

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.

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.

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.
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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Fold

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.

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.

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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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