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CLEXANE FORTE 150MG/ML SYRINGES

Active substance(s): ENOXAPARIN SODIUM / ENOXAPARIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clexane® Forte 120mg/0.8ml Syringes
Clexane® Forte 150mg/ml Syringes
enoxaparin sodium
Read all of this leaflet carefully before you start using this
medicine
• 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. 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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor,
pharmacist or nurse.
In this leaflet:
1. What Clexane Forte is and what it is used for
2. Before you use Clexane Forte
3. How to use Clexane Forte
4. Possible side-effects
5. How to store and dispose of Clexane Forte
6. Further information
1. What Clexane Forte is and what it is used for
The name of your medicine is Clexane Forte 120mg/0.8ml
Syringes or Clexane Forte 150mg/ml Syringes (called Clexane
Forte in this leaflet). Clexane Forte contains a medicine called
enoxaparin sodium. This belongs to a group of medicines
called Low Molecular Weight Heparins.
Clexane Forte works in two ways:
1) Stopping existing blood clots from getting any bigger. This
helps your body to break them down and stop them causing
you harm.
2) Stopping blood clots forming in your blood.
Clexane Forte can be used to:
• Treat blood clots that are in your blood
• Stop blood clots forming in your blood in the following
situations:
• Unstable angina (where not enough blood gets to your
heart)
• After an operation or long periods of bed rest due to illness
• After you have had a heart attack
• Stop blood clots forming in the tubes of your dialysis machine
(used for people with kidney problems)
2. Before you use Clexane Forte
Do not have this medicine and tell your doctor if:
• You are allergic (hypersensitive) to enoxaparin sodium.
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue
• You are allergic to heparin or other Low Molecular Weight
Heparins such as tinzaparin or dalteparin
• You have a problem with bruising or bleeding too easily
• You are bleeding heavily
• You have an ulcer in your stomach or gut (intestine)
• You have had a stroke caused by bleeding in the brain
• You have an infection in your heart
• You are using the medicine called heparin to treat blood
clots
Do not take this medicine if any of the above apply to you. If
you are not sure, talk to your doctor, pharmacist or nurse
before having Clexane Forte.
Take special care with Clexane Forte
Check with your doctor or pharmacist before having this
medicine if:
• You have high blood pressure which is not controlled by
medication
• You have kidney problems
• You have had a heart valve fitted
• You have ever had bruising and bleeding caused by the
medicine heparin
• You have ever had a stroke
• You have ever had a stomach ulcer
• You have recently had an operation on your eyes or brain
• You are a diabetic or have an illness known as ‘diabetic
retinopathy’ (problems with the blood vessels in the eye
caused by diabetes)
• You have any problems with your blood
• You are underweight or overweight
• You are elderly (over 65 years old) and especially if you are
aged over 75 years old
If you are not sure if any of the above applies to you, talk to
your doctor, pharmacist or nurse before having Clexane Forte.
Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are taking or
have recently taken any other medicines. This includes
medicines you buy without a prescription, including herbal
medicines. This is because Clexane Forte can affect the way
some other medicines work. Also some medicines can affect
the way Clexane Forte works.

• Ibuprofen, diclofenac, ketorolac or other medicines used to
treat pain and swelling in arthritis and other illnesses
• Prednisolone, dexamethasone or other steroid medicines used to treat asthma, rheumatoid arthritis and other
conditions
• Water tablets (diuretics) such as spironolactone,
triamterene or amiloride. These may increase the levels of
potassium in your blood when taken with Clexane Forte
Your doctor may change one of your medicines or take regular
blood tests to check that taking these medicines with Clexane
Forte is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an operation
where an epidural or spinal anaesthetic is used, tell your doctor
that you are using Clexane Forte. Tell also your doctor if you
have any problem with your spine or if you have ever had
spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you are given this medicine if you
are pregnant, might become pregnant or think you may be
pregnant.
You should not use this medicine if you are pregnant and have
a mechanical heart valve as you may be at increased risk of
developing blood clots. Your doctor should discuss this with
you.
You should not breast-feed whilst using Clexane Forte. If you
are planning to breast-feed, talk to your doctor, pharmacist or
nurse.
Ask your doctor, pharmacist or nurse for advice before taking
any medicine if you are pregnant or breast-feeding.
3. How to use Clexane Forte
Having this medicine
• Before you have Clexane Forte your doctor or nurse may
carry out a blood test
• While you are in hospital your doctor or nurse will normally
give you Clexane Forte. This is because it needs to be
given as an injection
• When you go home you may need to continue to use
Clexane Forte and give it to yourself (see below
instructions on how to do this)
• Clexane Forte is usually given by injection underneath the
skin (subcutaneous)
• Do not inject Clexane Forte into a muscle (intramuscular)
If you are not sure why you are receiving Clexane Forte or
have any questions about how much Clexane Forte is being
given to you, speak to your doctor, pharmacist or nurse.
How much will be given to you in hospital
• Your doctor will decide how much to give you. The amount
of Clexane Forte given to you will depend on the reason it
is being used
• If you have problems with your kidneys, you may be given
a smaller amount of Clexane Forte
Adults including the elderly
1) Treating blood clots that are in your blood
• The usual dose is 1.5mg for every kilogram of your weight,
each day
• Clexane Forte will usually be given for at least 5 days
2) Stopping blood clots forming in your blood in the
following situations:
a) Unstable angina
• The usual dose is 1mg for every kilogram of your weight,
every 12 hours
• Clexane Forte will usually be given for 2 to 8 days. Your
doctor will normally ask you to take aspirin as well
b) After an operation or long periods of bed rest due to
illness
The usual dose is 20mg or 40mg each day. The dose will
depend on how likely you are to develop a clot.
• If you have a low to medium risk of getting a clot, you will
be given 20mg of Clexane Forte each day for 7 to 10 days.
If you are going to have an operation, your first injection will
usually be given 2 hours before your operation
• If you have a higher risk of getting a clot, you will be given
40mg each day for 7 to 28 days. If you are going to have an
operation, your first injection will usually be given 12 hours
before your operation
• If you are bedridden due to illness, you will be normally be
given 40mg of Clexane Forte each day for 6 to 14 days
c) After you have had a heart attack
Clexane can be used for two different types of heart attack
called NSTEMI or STEMI. The amount of Clexane given to you
will depend on your age and the kind of heart attack you have
had.
i) NSTEMI type of heart attack
• The usual amount is 1mg for every kilogram of weight,
every 12 hours
• Clexane will usually be given for 2 to 8 days. Your doctor
will normally ask you to take aspirin as well.

In particular, do not take this medicine and tell your doctor if:
• You are using the medicine called heparin to treat blood clots
Tell your doctor if you are taking any of the following
medicines:
• Warfarin - used for thinning the blood
• Aspirin - used to stop blood clots from forming. Aspirin may also
be used for pain relief and in medicines for colds and flu
• Dipyridamole, clopidogrel, or other medicines – used to stop
blood clots forming
• Streptokinase, alteplase and reteplase – used to dissolve blood
clots after a heart attack
• Dextran injection - used to replace blood volume



ii) STEMI type of heart attack
If you are under 75 years old
• 30mg of Clexane will be given as an injection into your
vein (intravenous injection using Clexane Multidose Vial
or 60, 80 or 100mg Pre-filled syringes)
• At the same time, you will also be given Clexane as an
injection under your skin (subcutaneous injection). The
usual dose is 1mg for every kilogram of your weight.
• Then you will be given 1mg for every kilogram of your
weight every 12 hours
• The maximum amount of Clexane given for the first two
injections is 100mg
The injections will normally be given for up to 8 days

If you are aged 75 years or older
• Your doctor or nurse will give you injections of Clexane
Forte under your skin (subcutaneous injection)
• The usual dose is 0.75mg for every kilogram of your
weight, every 12 hours
• The maximum amount of Clexane given for the first two
injections is 75mg
For patients having an operation called Percutaneous
Coronary Intervention (PCI)
• Depending on when you were last given Clexane Forte,
your doctor may decide to give an additional dose of
Clexane before a PCI operation. This is by injection into
your vein (intravenous using Clexane Multidose Vial or
60, 80 or 100mg Pre-filled Syringes).
3) Stopping blood clots forming in the tubes of your
dialysis machine
• The usual dose is 1mg for every kilogram of your weight
• Clexane Forte is added to the tube leaving the body
(arterial line) at the start of the dialysis session
• This amount is usually enough for a 4 hour session.
However, your doctor may give you a further dose of 0.5 to
1mg for every kilogram of your weight if necessary
Children
This medicine should not be given to children.
How to give yourself an injection of Clexane Forte
If you are able to give Clexane Forte to yourself, your doctor or
nurse will show you how to do this. Do not try to inject yourself
if you have not been trained how to do so. If you are not sure
what to do, talk to your doctor or nurse immediately.
Before injecting yourself with Clexane Forte
• Check the expiry date on the medicine. Do not use if the
date has passed
• Check the syringe is not damaged and the medicine in it is
a clear solution. If not, use another syringe
• Make sure you know how much you are going to inject
• Check your abdomen to see if the last injection caused any
redness, change in skin colour, swelling, oozing or is still
painful. If so talk to your doctor or nurse
• Decide where you are going to inject the medicine. Change
the place where you inject each time from the right to the
left side of your stomach. Clexane Forte should be injected
just under the skin on your stomach, but not too near the
belly button or any scar tissue (at least 5cm away from
these)
Instructions on injecting yourself with Clexane Forte:
1) Wash your hands and the area
that you will inject with soap and
water. Dry them.
2) Sit or lie in a comfortable
position so you are relaxed. Make
sure you can see the place you
are going to inject. A lounge chair,
recliner, or bed propped up with
pillows is ideal.
3) Choose an area on the right or left
side of your stomach. This should be at
least 5 centimetres away from your belly
button and out towards your sides.
Remember: Do not inject yourself within 5cm of
your belly button or around existing scars or bruises. Change
the place where you inject between the left and right sides of
your stomach, depending on the area you were last injected.
4) Carefully pull off the needle cap
from the Clexane Forte syringe.
Throw away the cap. The syringe
is pre-filled and ready to use.
Do not press on the plunger before
injecting yourself to get rid of air
bubbles. This can lead to a loss of the medicine. Once you
have removed the cap, do not allow the needle to touch
anything. This is to make sure the needle stays clean (sterile).
5) Hold the syringe in the hand you write
with (like a pencil) and with your other
hand, gently pinch the cleaned area of
your abdomen between your forefinger
and thumb to make a fold in the skin.
Make sure you hold the skin fold
throughout the injection.
6) Hold the syringe so that the needle is
pointing downwards (vertically at a 90º
angle). Insert the full length of the needle
into the skin fold.
7) Press down on the plunger with your
thumb. This will send the medication into the
fatty tissue of the stomach. Make sure you
hold the skin fold throughout the injection.
8) Remove the needle by pulling it straight
out. A protective sleeve will automatically
cover the needle. You can now let go of the
skin fold.
Note: the safety system allowing release of the protective
sleeve can only be activated when the syringe has been
emptied by pressing the plunger all the way down.
To avoid bruising, do not rub the injection site after you
have injected yourself.
9) Drop the used syringe with its protective sleeve into the
sharps bin provided. Close the container lid tightly and place
the container out of reach of children.

When the container is full, give it to your doctor or home
care nurse for disposal. Do not put it in the household
rubbish.

5. How to store and dispose of Clexane Forte
Keep this medicine out of the sight and reach of children.

If you have too much or too little Clexane Forte
If you think that you have used too much or too little Clexane
Forte, tell your doctor, nurse or pharmacist immediately, even if
you have no signs of a problem. If a child accidentally injects or
swallows Clexane Forte, take them to a hospital casualty
department straight away.

Do not use this medicine after the expiry date which is stated on
the carton or syringe blister container after EXP. The expiry date
refers to the last day of that month.

If you forget to use Clexane Forte
If you forget to give yourself a dose, have it as soon as you
remember. Do not give yourself a double dose on the same
day to make up for a forgotten dose. Keeping a diary will help
to make sure you do not miss a dose.
If you stop using Clexane Forte
It is important for you to keep having Clexane Forte injections
until your doctor decides to stop them. If you stop, you could
get a blood clot which can be very dangerous.

Do not use this medicine if you notice visible signs of
deterioration.

Blood Tests
Using Clexane Forte may affect the results of some blood
tests. If you are going to have a blood test, it is important to tell
your doctor you are having Clexane Forte.
4. Possible side effects
Like all medicines, Clexane Forte can cause side-effects,
although not everybody gets them.
Tell a nurse or doctor or go to hospital straight away if you
notice any of the following side-effects:
Very common (affects more than 1 in 10 people)
• Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
• A painful rash of dark red spots under the skin which do not
go away when you put pressure on them. You may also
notice pink patches on your skin. These are more likely to
appear in the area you have been injected with Clexane
Forte.
Uncommon (affects 1 to 10 people in a 1,000)
• Sudden severe headache. This could be a sign of bleeding
in the brain.
• A feeling of tenderness and swelling in your stomach. You
may have bleeding inside your stomach.
Rare (affects less than 1 in a 1000 people)
• If you have an allergic reaction. The signs may include: a
rash, swallowing or breathing problems, swelling of your
lips, face, throat or tongue.

Do not store above 25°C.
Do not refrigerate or freeze.

Medicines should not be disposed of via wastewater or
household waste. If you are using this medicine at home you will
be given a container (a sharps bin) to use for disposal. Return
the sharps bin or any used or unused syringes to your doctor or
nurse or pharmacist for disposal. These measures will help to
protect the environment.
6. Further information
What Clexane Forte contains:
Each 120mg pre-filled syringe contains 120mg of enoxaparin
sodium (equivalent to 12,000 IU anti-Xa activity) in 0.8ml.
Each 150mg pre-filled syringe contains 150mg of enoxaparin
sodium (equivalent to15,000 IU anti-Xa activity) in 1ml.
The other ingredient is water for injections.
What Clexane Forte looks like and contents of the pack
Clexane Forte is a clear, colourless to pale yellow solution for
injection in a Type 1 glass pre-filled syringe fitted with an
injection needle, needle cap and an automatic safety device.
Clexane Forte comes in packs of 10 syringes.
Manufacturer:
• Sanofi Winthrop Industrie, 180 rue Jean Jaures, 94702
Maison Alfort, France
Procured from within the EU and repackaged by the
Product Licence Holder:
Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe Business
Park, Ashby de la Zouch, Leicestershire LE65 2UY, United
Kingdom.
PL 33652/0076
Clexane® Forte 120mg/0.8ml Syringes
Clexane® Forte 150mg/1ml Syringes

POM

Clexane® is a registered trademark of Aventis Pharma SA.
Leaflet edit date: 04/10/2016

Frequency unknown
• If you have had a spinal puncture or a spinal anaesthetic
and notice tingling, numbness and muscular weakness,
particularly in the lower part of your body. Also if you lose
control over your bladder or bowel (so you cannot control
when you go to the toilet).
Tell a nurse or doctor as soon as possible if you notice
any of the following side effects:
Common (affects 1 to 10 people in a 100)
• You bruise more easily than usual. This could be because
of a blood problem (thrombocytopenia).
• You have pain, swelling or irritation in the area you have
been injected with Clexane Forte. This normally gets better
after a few days.
Rare (affects less than 1 in a 1000 people)
• If you have a mechanical heart valve, treatment with
Clexane Forte might not be sufficient to prevent blood clots.
You may notice that you have difficulty breathing, tiredness
or difficulty exercising, chest pain, numbness, feeling sick
or loss of consciousness. This could be due to a blood clot
on the heart valve
Frequency unknown
• Feeling tired, faint, dizzy, having pale skin. These could be
symptoms of anaemia.
• You notice yellowing of your skin or eyes and your urine
becomes darker in colour. This could be a liver problem.’
Other side effects that you should discuss with your nurse
or doctor if you are concerned about them:
Very common (affects more than 1 in 10 people)
• Changes in the results of blood tests done to check how
your liver is working. These usually go back to normal after
you stop having Clexane Forte.
Rare (affects less than 1 in a 1000 people)
• Changes in the potassium levels in your blood. This is more
likely to happen in people with kidney problems or diabetes.
Your doctor will be able to check this by carrying out a
blood test.
Frequency unknown
• If Clexane Forte is used for a long period of time (more
than 3 months), it may increase the risk of you getting a
condition called ‘osteoporosis’. This is when your bones are
more likely to break.
• Headache
• Hair loss
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.

P-PILCLEXFORT (SK) V1

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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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