Skip to Content

TINZAPARIN SODIUM 10 000 IU/ML SYRINGE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

INNOHEP 10,000 IU/ml SYRINGE
(tinzaparin sodium)
The name of your medicine is Innohep 10,000 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 help stop:
• Harmful blood clots forming in your veins following an
operation. An example is a clot in a vein deep inside
your body. This is usually in your leg (deep vein
thrombosis or DVT for short).
• Harmful blood clots forming in the tubing of an artificial
kidney machine during kidney dialysis (haemodialysis).

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: If you are having an epidural or spinal
anaesthetic
You must remind your doctor that you are having
Innohep before you receive any anaesthetic.
If you are pregnant please also read the section of this
leaflet "Pregnancy and breast-feeding".
After you have the anaesthetic your doctor or nurse will
make regular checks. This is to check if you are getting
any major bleeding or bruising around your spine. This
may cause paralysis that could be permanent.
Any signs this may be happening to you include tingling,
weakness or numbness in your lower legs or body, back
pain or problems in going to the toilet. This happens
very rarely.
After you have the anaesthetic your doctor will tell you
when you can take your medicine again.
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. Your doctor may need to
adjust your dose.

• 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.
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.
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. 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 w orried about any
of the ingredients in this medicine.

3. How to use Innohep
Innohep is usually given to you by a doctor or nurse.
Innohep should not be mixed with any other injection.
How much Innohep to have
Your doctor will prescribe the right dose for you.
To prevent harmful blood clots forming in the tubing
of an artificial kidney machine during kidney
dialysis (haemodialysis)
Innohep w ill be given either into the artificial kidney
machine or into your vein.
The usual dose depends on the length of dialysis.
To prevent harmful blood clots forming in your
veins after an operation
Your doctor may decide that you or a carer may
inject this medicine.
Your doctor or nurse w ill show you how to inject
yourself w ith the syringe. Only inject yourself if you
have been instructed how .
The usual dose depends on the type of operation you
are having.
You w ill have one dose of Innohep before your
operation. Then usually you w ill have one dose of
Innohep once a day for 7 to 10 days afterw ards. Your
doctor w ill decide how long you should have
Innohep.
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.
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.

9. Bend the orange
coloured safety
device dow n
aw ay from the
cap on the
needle.
10. Only pull the cap
off the needle w hen you are ready to use the
syringe. It is important to keep the needle clean.
Do not let it touch anything.
11. 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.
You may be given another injection of a medicine called
protamine sulphate.
If you have missed a dose of 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.

4. Possible side effects
Like all medicines, Innohep can cause side effects,
although not everybody gets them.
Important side effects to look out for
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.

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
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 w ith 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 w eaken and break more easily.
This is know n 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.
Innohep should not be used after the expiry date which
is stamped on the pack. The expiry date refers to the
last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
If the medicine becomes discoloured or shows any other
signs of deterioration, you should seek the advice of
your pharmacist who will tell you what to do.

6. Further Information
What Innohep contains
• The active ingredient is tinzaparin sodium. Each
syringe contains 3,500 IU of tinzaparin sodium in
0.35ml.
• The other ingredients are sodium acetate, sodium
hydroxide solution 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
Straw coloured solution supplied in a glass prefilled unit
dose syringe with a needle safety device within a plastic
protective tube.
There are 10 syringes in a carton.
Manufacturer
Manufactured by Laboratoires LEO S.A., 39 Route de
Chartres, F-28500 Vernouillet, Cedex, France.
Procured from within the EU and repackaged in the UK
by the Product Licence holder: CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Hertfordshire
WD6 1EE.
PL 20492/0456

Innohep 10,000 IU/ml Syringe

POM
Innohep is a trademark of Leo Pharma A/S.
Date of Preparation: 23rd May 2013

PACKAGE LEAFLET: INFORMATION FOR THE USER

TINZAPARIN SODIUM 10,000 IU/ml
SYRINGE
The name of your medicine is Tinzaparin sodium 10,000
IU/ml Syringe but will be referred to as Tinzaparin
sodium 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 Tinzaparin sodium is and what it is used for
2. Before you have Tinzaparin sodium
3. How to use Tinzaparin sodium
4. Possible side effects
5. How to store Tinzaparin sodium
6. Further information

1. What Tinzaparin sodium is and
what it is used for
Tinzaparin sodium belongs to a group of medicines
called anticoagulants. It is a type of heparin called a low
molecular weight heparin.
Tinzaparin sodium 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.
Tinzaparin sodium is used to help stop:
• Harmful blood clots forming in your veins following an
operation. An example is a clot in a vein deep inside
your body. This is usually in your leg (deep vein
thrombosis or DVT for short).
• Harmful blood clots forming in the tubing of an artificial
kidney machine during kidney dialysis (haemodialysis).

2. Before you have Tinzaparin sodium
Do not have Tinzaparin sodium
• 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: If you are having an epidural or spinal
anaesthetic
You must remind your doctor that you are having
Tinzaparin sodium before you receive any anaesthetic.
If you are pregnant please also read the section of this
leaflet "Pregnancy and breast-feeding".
After you have the anaesthetic your doctor or nurse will
make regular checks. This is to check if you are getting
any major bleeding or bruising around your spine. This
may cause paralysis that could be permanent.
Any signs this may be happening to you include tingling,
weakness or numbness in your lower legs or body, back
pain or problems in going to the toilet. This happens
very rarely.
After you have the anaesthetic your doctor will tell you
when you can take your medicine again.
Take special care with Tinzaparin sodium
Before you have Tinzaparin sodium 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. Your doctor may need to
adjust your dose.

• 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.
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.
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 Tinzaparin sodium:
• 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 Tinzaparin sodium

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 Tinzaparin sodium
Tinzaparin sodium contains:
• 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 w orried about any
of the ingredients in this medicine.

3. How to use Tinzaparin sodium
Tinzaparin sodium is usually given to you by a doctor or
nurse.
Tinzaparin sodium should not be mixed with any other
injection.
How much Tinzaparin sodium to have
Your doctor will prescribe the right dose for you.
To prevent harmful blood clots forming in the tubing
of an artificial kidney machine during kidney
dialysis (haemodialysis)
Tinzaparin sodium w ill be given either into the
artificial kidney machine or into your vein.
The usual dose depends on the length of dialysis.
To prevent harmful blood clots forming in your
veins after an operation
Your doctor may decide that you or a carer may
inject this medicine.
Your doctor or nurse w ill show you how to inject
yourself w ith the syringe. Only inject yourself if you
have been instructed how .
The usual dose depends on the type of operation you
are having.
You w ill have one dose of Tinzaparin sodium before
your operation. Then usually you w ill have one dose
of Tinzaparin sodium once a day for 7 to 10 days
afterw ards. Your doctor w ill decide how long you
should have Tinzaparin sodium.
How to inject Tinzaparin sodium
This section explains how to inject yourself with the
Tinzaparin sodium syringe.
Warning: Only give this injection to yourself after
you have received instructions from your doctor or
nurse.
Always use Tinzaparin sodium 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.

9. Bend the orange
coloured safety
device dow n
aw ay from the
cap on the
needle.
10. Only pull the cap
off the needle w hen you are ready to use the
syringe. It is important to keep the needle clean.
Do not let it touch anything.
11. 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 Tinzaparin sodium 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.
You may be given another injection of a medicine called
protamine sulphate.
If you have missed a dose of Tinzaparin sodium
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.

4. Possible side effects
Like all medicines, Tinzaparin sodium can cause side
effects, although not everybody gets them.
Important side effects to look out for
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.

having the dose of Tinzaparin sodium that is right
for you.
• Your bones may w eaken and break more easily.
This is know n as osteoporosis and has been seen in
patients taking heparin for a long time.
• Prolonged, painful erections in men.

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.

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.

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.

Tinzaparin sodium should not be used after the expiry
date which is stamped on the pack. The expiry date
refers to the last day of that month.

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 Tinzaparin sodium.
Common side effects (probably affect less than 1 in 10
people)
• Bruising, pain or irritation at the site of the injection
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 w ith your heart if you have an artificial
heart valve. This may be because you are not

5. How to store Tinzaparin sodium
Keep out of the sight and reach of children.

Do not store above 25°C.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
If the medicine becomes discoloured or shows any other
signs of deterioration, you should seek the advice of
your pharmacist who will tell you what to do.

6. Further Information
What Tinzaparin sodium contains
• The active ingredient is tinzaparin sodium. Each
syringe contains 3,500 IU of tinzaparin sodium in
0.35ml.
• The other ingredients are sodium acetate, sodium
hydroxide solution 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 Tinzaparin sodium looks like and contents of
the pack
Straw coloured solution supplied in a glass prefilled unit
dose syringe with a needle safety device within a plastic
protective tube.
There are 10 syringes in a carton.
Manufacturer
Manufactured by Laboratoires LEO S.A., 39 Route de
Chartres, F-28500 Vernouillet, Cedex, France.
Procured from within the EU and repackaged in the UK
by the Product Licence holder: CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Hertfordshire
WD6 1EE.
PL 20492/0456

Tinzaparin sodium 10,000 IU/ml
Syringe

POM
Date of Preparation: 23rd May 2013

Expand Transcript

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.

Hide