Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

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

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)

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.

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

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 90° 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.

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.

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.

What Clexane Forte contains

• Each 120mg pre-filled syringe contains 120mg (12,000 IU anti-Xa activity) of the active substance, enoxaparin sodium in 0.8ml
• Each 150mg pre-filled syringe contains 150mg (15,000 IU anti-Xa activity) of the active substance, enoxaparin sodium in 1.0ml
• 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 I glass prefilled syringe fitted with an injection needle, needle cap and an automatic safety device, it is supplied in packs of 2, 10 and 20 syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.