Skip to Content

UK Edition. Click here for US version.

CLEXANE 40MG/0.4ML PRE-FILLED SYRINGES

Active substance(s): SODIUM ENOXAPARIN

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
®

Clexane 20 mg/0.2 ml Pre-filled Syringes
Clexane® 40 mg/0.4 ml Pre-filled Syringes
Clexane® 80 mg/0.8 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
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

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.

Clexane contains a medicine called enoxaparin sodium. This belongs
to a group of medicines called Low Molecular Weight Heparins.

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

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.

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

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) 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

The name of your medicine is stated above but will be referred to as
Clexane in this leaflet.

2. Before you use Clexane
x
x

x
x
x
x
x
x

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.

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.

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).

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

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.

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

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. A protective sleeve
will automatically cover the needle. You can now let go of the skin
fold.

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
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.
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.

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:

What Clexane contains
Each 20mg pre-filled syringe contains 20mg (2,000 IU anti-Xa activity)
of the active substance, enoxaparin sodium in 0.2ml
Each 40mg pre-filled syringe contains 40mg (4,000 IU anti-Xa activity)
of the active substance, enoxaparin sodium in 0.4ml
Each 80mg pre-filled syringe contains 80mg (8,000 IU anti-Xa activity)
of the active substance, enoxaparin sodium in 0.8ml
Each 100mg pre-filled syringe contains 100mg (10,000 IU anti-Xa
activity) of the active substance, enoxaparin sodium in 1ml
The other ingredient is water for injections
What Clexane Pre-filled Syringes looks like and contents of the
pack
Clexane is a clear solution in a Type I glass pre-filled syringe fitted
with an injection needle and an automatic safety device. It is supplied
in packs of 10 syringes.
Manufacturers:
Sanofi Winthrop Industrie,
180 rue Jean Jaures, 94702 Maisons - Alfort, France
or
Sanofi Winthrop Industrie,
Boulevard Industrie, 76580 Le Trait, France
or
Chinoin Pharmaceutical and Chemical Works Private Co. Ltd
Csanyikvolgy Site, Miskolc, Csanyikvolgy, H-3510, Hungary
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 19065/0378
Clexane® 20 mg/0.2 ml Pre-filled Syringes, Clexane® 40 mg/0.4 ml
Pre-filled Syringes, Clexane® 80 mg/0.8 ml Pre-filled Syringes
Clexane® 100 mg/1 ml Pre-filled Syringes
This leaflet was last revised: 20/10/2015
E0378/5-P
Clexane® is a registered trade mark of Sanofi-aventis

Expand view ⇕

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