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Clexane 80mg/0.8ml Syringes

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PACKAGE LEAFLET: INFORMATION FOR THE USER CLEXANE® 80mg/0.8ml SYRINGES

(enoxaparin sodium)

Your medicine is called Clexane 80mg/0.8ml Syringes but will be referred to as Clexane throughout the remainder of this leaflet.

This product is also available in multiple strengths and other strengths will be referred to throughout the 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 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

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:

•    T reat 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

Do not have this medicine and tell your doctor, pharmacist or nurse if:

X 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 X You are allergic to heparin or other Low Molecular Weight Heparins such as tinzaparin or dalteparin

X You have a problem with bruising or bleeding too easily X You have an ulcer in your stomach or gut (intestine)

X You have had a stroke caused by bleeding in the brain X You have an infection in your heart

X 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 a 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:

• 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)

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. 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. 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 after that

•    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) Stop 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)