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CLEXANE FORTE 120MG/0.8ML SYRINGE

Active substance(s): ENOXAPARIN SODIUM

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PATIENT INFORMATION LEAFLET

2445
01.03.16[P-12]

Clexane Forte® 120 mg/0.8 ml Syringe
Clexane Forte® 150 mg/1 ml Syringe
(enoxaparin sodium)
Your medicine is available using any one of the above names but will be
referred to as Clexane Forte throughout the following leaflet.
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
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.
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
 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)

 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 5
cm 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.

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 Forte can be used for two different types of heart attack called
NSTEMI or STEMI. The amount of Clexane Forte 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 Forte will usually be given for 2 to 8 days. Your doctor will
normally ask you to take aspirin as well.
ii) STEMI type of heart attack
If you are under 75 years old
 30mg of Clexane Forte will be given as an injection into your vein
(intravenous injection using Clexane Forte Multidose Vial or 60, 80 or
100mg Pre-filled syringes)
 At the same time, you will also be given Clexane Forte 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 Forte 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 Forte 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 Forte before a PCI
operation. This is by injection into your vein (intravenous using Clexane
Forte 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 1 mg 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

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 – needle first - 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.
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.
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.
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.
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.
5. How to store Clexane Forte
Keep them out of the sight and reach of children.
Do not use Clexane Forte after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not store in refrigerator or freezer.
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.
If your prefilled syringe become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Clexane Forte contains
 The active ingredient in Clexane Forte is enoxaparin sodium.
Each 120mg pre-filled syringe contains 120 mg enoxaparin sodium
(equivalent to 12,000 IU anti-Xa activity) in 0.8 ml water for injection.
Each 150mg pre-filled syringe contains 150 mg enoxaparin sodium
(equivalent to 15,000 IU anti-Xa activity) in 1 ml water for injection.
The only other ingredient is water for Injections.
What Clexane Forte looks like and contents of the pack
Clexane Forte is available as a clear, colourless solution in a pre-filled
glass syringes fitted with an injection needle, needle cap and an
automatic safety device.
The 120 mg/0.8 ml syringe has a purple plunger.
The 150 mg/1 ml syringe has a dark blue plunger.
Clexane Forte Syringes comes in packs of 10 pre-filled syringes.
Manufacturer and Product Licence Holder
Manufactured by Sanofi Winthrop Industrie., 180 rue Jean Jaures, 94702
Maisons-Alfort, France. Procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2445

Leaflet revision and issue date (Ref) 01.03.16[P-12]
Clexane Forte is a trademark of May & Baker Limited.

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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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