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CLEXANE 40MG/0.4 ML PRE-FILLED SYRINGES

Active substance(s): ENOXAPARIN SODIUM

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Package leaflet: Information for the user

Clexane® 40 mg/0.4 ml Pre-filled Syringes
Clexane® 100 mg/1 ml Pre-filled 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 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 get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist
Your medicine is called Clexane® 40 mg/0.4 ml Pre-filled syringes/
Clexane® 100 mg/1 ml Pre-filled syringes but throughout this leaflet
will be referred to as Clexane.
Other strengths of this product are also available.
In this leaflet:
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side-effects
5. How to store Clexane
6. Further information

1. What Clexane is and what it is used for
The name of your medicine is stated above but will be referred to as
Clexane in this leaflet.
Clexane contains a medicine called enoxaparin sodium. This
belongs to a group of medicines called Low Molecular Weight
Heparins.
Clexane 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 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
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Do not have this medicine and tell your doctor, pharmacist
or nurse if:
You are allergic (hypersensitive) to enoxaparin sodium or any of
the other ingredients of Clexane (listed in Section 6: Further
information) 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 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 have 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.
Take special care with Clexane
Check with your doctor or pharmacist or nurse before using
this medicine if:
▲ You have high blood pressure
▲ 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 or pharmacist or nurse before using Clexane.
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 can affect the way some other medicines work.
Also some medicines can affect the way Clexane works.
In particular, do not have this medicine and tell your doctor if:
x 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, dipyridamole, clopidogrel or other medicines - used to
stop blood clots forming
• Dextran injection - used as a blood replacer
• Ibuprofen, diclofenac, ketorolac or other medicines - used to
treat pain and swelling in arthritis and other illnesses
• Prednisolone, dexamethasone or other 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
Your doctor may change one of your medicines or take regular
blood tests to check that taking these medicines with Clexane 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. 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 use 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. If you are planning
to breast-feed, talk to your doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before taking any medicine
if you are pregnant or breast-feeding.
3. How to use Clexane
Having this medicine
• Before you use Clexane your doctor or nurse may carry out a
blood test
• While you are in hospital your doctor or nurse will normally give
you Clexane. This is because it needs to be given as an
injection
• When you go home you may need to continue to use Clexane
and give it to yourself (see below instructions on how to do this)
• Clexane is usually given by injection underneath the skin
(subcutaneous)
• Do not inject Clexane into a muscle (intramuscular)
If you are not sure why you are receiving Clexane or have any
questions about how much Clexane is being given to you, speak to
your doctor, pharmacist or nurse.
How much will be given to you
• Your doctor will decide how much to give you. The amount of
Clexane 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
1) Treating blood clots that are in your blood
• The usual dose is 1.5mg for every kilogram of your weight, each
day
• Clexane 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 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
b) After an operation or long periods of bedrest 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 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 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

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 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, 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 1 mg for every kilogram of your weight
• Clexane 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
How to give yourself an injection of Clexane
If you are able to give Clexane 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
 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 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:
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 5 centimetres 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 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

4. Possible side-effects
Like all medicines, Clexane 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.
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. 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
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.
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 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.
United Kingdom
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 and dispose of Clexane

8) Remove the needle by pulling it straight out. You can now let go
of the skin fold.
To avoid bruising, do not rub the injection site after you have
injected yourself.
9) Drop the used syringe 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
If you think that you have used too much or too little Clexane, tell
your doctor, nurse or pharmacist immediately, even if you have no
signs of a problem. If a child accidentally injects or swallows
Clexane, take them to a hospital casualty department straight away.
If you forget to use Clexane
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
It is important for you to keep having Clexane 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 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.

Keep out of the sight and reach of children.
Do not use Clexane 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 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.
If your medicine shows any signs of deterioration or discolouration,
please seek the advice of your pharmacist who will advise you.
6. Further information
What Clexane contains
• Each pre-filled syringe contains 40 mg Enoxaparin sodium
(4000 IU anti-Xa activity) in 0.4 ml water for injections.
• Each pre-filled syringe contains 100 mg Enoxaparin sodium
(10,000 IU anti-Xa activity) in 1 ml water for injections.
What Clexane Pre-filled Syringes looks like and contents of the
pack
Clear colourless to pale yellow solution for injection in Type I glass
pre-filled syringes fitted with injection needle including a needle cap
in packs of 10.
Manufacturer
sanofi-aventis AB, Box 14142, 167 14 Bromma, Sweden.
Procured within the EU
Product Licence holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD.
PL 19065/0400 Clexane® 40 mg/0.4 ml Pre-filled syringes/
Clexane® 100 mg/1 ml Pre-filled syringes
POM
This leaflet was last revised: 20/10/2015
E0400/4
Clexane® is a registered trade mark of Sanofi-aventis

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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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