CLEXANE FORTE 15 000IU (150 MG)/1 ML SYRINGES - Patient leaflet, side effects, dosage

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clexane® Forte 12,000IU (120 mg)/0.8 ml Syringes

(enoxaparin sodium)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is available using any one of the above names but will be referred to as Clexane Forte throughout the remainder of this leaflet.

What is in this leaflet

• 1. What Clexane Forte are and what they are used for

• 2. What you need to know before you use Clexane Forte

• 3. How to use Clexane Forte

• 4. Possible side effects

• 5. How to store Clexane Forte

• 6. Contents of the pack and other information

• 1. What Clexane Forte are and what they are used for

Clexane Forte contain the active substance called enoxaparin sodium. This belongs to a group of medicines called ‘low molecular weight heparin’ or LMWH.

How Clexane Forte work

Clexane Forte work in two ways:

• 1 ) Stopping existing blood clots from getting any bigger. This helps your body to break them down and stops them from causing you harm.

• 2 ) Stopping new blood clots from forming in your blood.

What Clexane Forte are used for

Clexane Forte can be used to:

• Treat blood clots that are in your blood
• Stop blood clots from forming in your blood in the following situations:

o before and after an operation

o when you have a short-term illness and will not be able to move around for some time.

• Stop blood clots from forming when you have unstable angina (where not enough blood gets to your heart) or after a heart attack
• Stop blood clots from forming in the tubes of your dialysis machine (used for people with severe kidney problems).

2. what you need to know before you use clexane forte do not use clexane forte if:

• you are allergic to:

o enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6)

o heparin or other ‘low molecular weight heparins’ such as nadroparin, tinzaparin or dalteparin.

Signs of an allergic reaction include: rash, difficulty breathing or swallowing, swelling of the face, lips, mouth, throat or eyes.

• you have had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) within the last 100 days
• you have antibodies against enoxaparin in your blood
• you are bleeding heavily or have a condition with a high risk of bleeding, such as:

o stomach ulcer, recent surgery of the brain or eyes, or recent bleeding stroke.

• you are using Clexane Forte to treat blood clots and are going to have within 24 hours:

o a spinal or lumbar puncture

o an operation with epidural or spinal anaesthesia.

Do not use Clexane Forte if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Clexane Forte.

Warnings and precautions

Clexane Forte should not be interchanged with other ‘low molecular weight heparins’ such as nadroparin, tinzaparin or dalteparin. This is because they are not exactly the same and do not have the same activity and instructions for use.

Talkto your doctor or pharmacist before using Clexane Forte if:

• you have ever had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets)
• you have had a heart valve fitted
• you have endocarditis (an infection of the inner lining of the heart)
• you have a history of gastric ulcer
• you have had a recent stroke
• you have high blood pressure
• you have diabetes or problems with blood vessels in the eye caused by diabetes (called diabetic retinopathy)
• you have had an operation recently on your eyes or brain
• you are elderly (over 65 years old) and especially if you are over 75 years old
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (this may be checked with a blood test)
• you are currently using medicines which affect bleeding (see section 2, ‘Other medicines and Clexane Forte’)
• you have any problem with your spine or you have had spinal surgery.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Clexane Forte.

Tests and checks

You may have a blood test before you start using this medicine and at intervals while you are using it; this is to check the level of the clotting cells (platelets) and potassium in your blood.

Use in children and adolescents

The safety and efficacy of Clexane Forte has not been evaluated in children or adolescents.

Other medicines and Clexane Forte

Tell your doctor or pharmacist if you are taking or might take any other medicines.

• warfarin – used for thinning the blood
• aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming (see section 3, ‘Changing anticoagulant medicine’)
• dextran injection – used as a blood replacer
• ibuprofen, diclofenac, ketorolac or other medicines known as nonsteroidal anti-inflammatory medicines which are used to treat pain and swelling in arthritis and other conditions
• prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
• medicines which increase potassium levels in your blood such as potassium salts, water pills, and some medicines for heart problems.

Operations and anaesthetics

If you are going to have a spinal or lumbar puncture, or an operation where an epidural or spinal anaesthetic is used, tell your doctorthat you are using Clexane Forte.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots. Your doctor should discuss this with you.

If you are breast-feeding or plan to breast-feed, you should ask your doctor for advice before taking this medicine.

Driving and using machines

Clexane Forte does not affect the ability to drive and operate machinery.

It is advised that the trade name and batch number of the product you are using are recorded by your healthcare professional.

3. how to use clexane forte

Always use the medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Having this medicine

• Your doctor or nurse will normally give you Clexane Forte. This is because they need to be given as an injection.
• Clexane Forte are usually given by injection underneath the skin (subcutaneous).
• Clexane Forte can be given by injection into your vein (intravenous) after certain types of heart attack or operations.
• Clexane Forte can be added to the tube leaving the body (arterial line) at the start of a dialysis session.
• Do not inject Clexane Forte into a muscle.
• Your doctor will decide how much Clexane Forte to give you. The amount 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.

• 1) Treating blood clots that are in your blood

• The usual dose is 150 lU (1.5 mg) for every kilogram of your bodyweight once a day or 100 IU (1 mg) for every kilogram of your bodyweight twice a day.
• Your doctor will decide how long you should receive Clexane Forte.

• 2) Stopping blood clots from forming in your blood during operations or periods of limited mobility due to an illness

• The dose will depend on how likely you are to develop a clot. You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Clexane Forte each day.
• If you are going to have an operation your first injection will be usually given 2 hours or 12 hours before your operation.
• If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg) of Clexane Forte each day.
• Your doctor will decide how long you should receive Clexane Forte.

• 3) Stopping blood clots when you have unstable angina or after you have had a heart attack

• Clexane Forte can be used for two different types of heart attack.
• The amount of Clexane given to you will depend on your age and the kind of heart attack you have had.

NSTEMI (Non-ST segment Elevation Myocardial Infarction) type of heart attack:

• The usual dose is 100 IU (1 mg) for every kilogram of your bodyweight every 12 hours.
• Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
• Your doctor will decide how long you should receive Clexane Forte.

STEMI (ST segment Elevation Myocardial Infarction) type of heart attack if you are under 75 years old:

• An initial dose of 3,000 IU (30 mg) of Clexane Forte will be given as an injection into your vein.
• At the same time you will also be given Clexane Forte as an injection underneath your skin (subcutaneous injection). The usual dose is 100 IU (1 mg) for every kilogram of your bodyweight, every 12 hours.
• Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
• Your doctor will decide how long you should receive Clexane Forte.

STEMI type of heart attack if you are 75 years old or older:

• The usual dose is 75 IU (0.75 mg) for every kilogram of your bodyweight, every 12 hours.
• The maximum amount of Clexane Forte given for the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you should receive Clexane Forte.

For patients that have 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.

• 4) Stopping blood clots from forming in the tubes of your dialysis machine

• The usual dose is 100 IU (1 mg) for every kilogram of your bodyweight.
• Clexane Forte is added to the tube leaving the body (arterial line) at the start of a dialysis session.

This amount is usually enough for a 4-hour session. However, your doctor may give you a further dose of 50 IU to 100 IU (0.5 to 1 mg) for every kilogram of your bodyweight, if necessary.

Giving 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. Performing the injection properly under the skin (called “subcutaneous injection”) will help reduce pain and bruising at the injection site.

Before injecting yourself with Clexane Forte

• Collect together the items that you need: syringe, alcohol swab or soap and water, and sharps container
• 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 stomach 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

Instructions on injecting yourself with Clexane Forte:

Preparing the injection site

1) 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.

• 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 last injected.

• 2) Wash your hands. Cleanse (do not rub) the area that you will inject with an alcohol swab or soap and water.

• 3) 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.

Selecting your dose

• 1) Carefully pull off the needle cap from the syringe. Throw away the cap.

• 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).

• 2) When the amount of medication in the syringe already matches your prescribed dose, there is no need to adjust the dose. You are now ready to inject.

• 3) When the dose depends on your body weight, you may need to adjust the dose in the syringe to match the prescribed dose. In that case, you can get rid of any extra medicine by holding the syringe pointing down (to keep the air bubble in the syringe) and ejecting the extra amount into a container.

• 4) A drop may appear at the tip of the needle. If this occurs, remove the drop before injecting by tapping on the syringe with the needle pointing down. You are now ready to inject.

Injecting

• 1) Hold the syringe in the hand you write with (like a pencil). With your other hand, gently pinch the cleaned area of your stomach between your forefinger and thumb to make a fold in the skin.

• Make sure you hold the skin fold throughout the injection.

• 2) Hold the syringe so that the needle is pointing straight down (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

• 3) Press down on the plunger with your thumb. This will send the medication into the fatty tissue of the stomach. Complete the injection using all of the medicine in the syringe.

• 4) Remove the needle from the injection site by pulling it straight out. You can now let go of the skin fold.

When you have finished

• 1) To avoid bruising, do not rub the injection site after you have injected yourself.

• 2) Drop the used syringe into a sharps container. Close the container lid tightly and place the container out of reach of children. When the container is full, dispose of it as your doctor or pharmacist has instructed.

Any unused medicine or waste material should be disposed of in accordance with local requirements.

Changing anticoagulant medicine

• Changing from Clexane Forte to blood thinners called vitamin-K antagonists (such as warfarin)

Your doctor will ask you to have blood tests called INR and tell you when to stop Clexane Forte.

• Changing from blood thinners called vitamin-K antagonists (such as warfarin) to Clexane Forte.

Stop taking the vitamin-K antagonist.

Your doctor will ask you to have blood tests called INR and tell you when to start Clexane Forte.

• Changing from Clexane Forte to treatment with direct oral anticoagulants

Stop taking Clexane Forte.

Start taking the direct oral anticoagulant 0 to 2 hours before the time you would have had the next injection, then continue as normal.

• Changing from treatments with direct oral anticoagulants to Clexane Forte

Stop taking the direct oral anticoagulant. Do not start treatment with Clexane Forte until 12 hours after the final dose of the direct oral anticoagulant.

If you use more Clexane Forte than you should

If you think that you have used too much or too little Clexane Forte, tell your doctor or pharmacist or nurse 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop using Clexane Forte and talk to a doctor or nurse straight away if you get any signs of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, mouth, throat or eyes).

Like other similar medicines to reduce blood clotting, Clexane Forte may cause bleeding. This may be life-threatening. In some cases the bleeding may not be obvious.

Talk to your doctor straight away if:

• you have any bleeding that does not stop by itself
• you have signs of too much bleeding such as being very weak, tired, pale, or dizzy with headache or unexplained swelling.

Your doctor may decide to keep you under closer observation or change your medicine.

You should tell your doctor straight away:

• if you have any sign of blockage of a blood vessel by a blood clot such as:

o cramping pain, redness, warmth, or swelling in one of your legs – these are symptoms of deep vein thrombosis

o breathlessness, chest pain, fainting or coughing up blood -these are symptoms of a pulmonary embolism

• if you have a painful rash of dark red spots under the skin which do not go away when you put pressure on them.

Your doctor may request you perform a blood test to check your platelet count.

Other side effects

Very common (may affect more than 1 in 10 people):

• Bleeding.
• Increases in liver enzymes.

Common (may affect up to 1 in 10 people):

• you bruise more easily than usual

-this could be because of a blood problem with low platelet counts

• pink patches on your skin – these are more likely to appear in the area you have been injected with Clexane Forte
• skin rash (hives, urticaria)
• itchy red skin
• bruising or pain at the injection site
• decreased red blood cell count
• high platelet counts in the blood
• headache.

Uncommon (may affect up to 1 in 100 people):

• 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 in your stomach
• large red irregularly shaped skin lesions with or without blisters
• skin irritation (local irritation)
• yellowing of your skin or eyes and your urine becomes darker in colour

– this could be a liver problem.

Rare (may affect up to 1 in 1,000 people):

• severe allergic reaction – the signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• increased potassium 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

• an increase in the number of eosinophils in your blood – your doctor will be able to check this by carrying out a blood test
• hair loss
• osteoporosis (a condition where your bones are more likely to break) after long term use
• tingling, numbness and muscular weakness (particularly in the lower part of your body) when you have had a spinal puncture or a spinal anaesthetic
• loss of control over your bladder or bowel (so you cannot control when you go to the toilet)
• hard mass or lump at the injection site.

5. how to store clexane forte

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not refrigerate or freeze.

Store in the original package in order to protect from light.

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 use this medicine if you notice a breach in the syringe, particulate matter in the solution, or an abnormal colour of the solution (see “What Clexane Forte looks like and the contents of the pack”). If your medicine shows any signs of discolouration or deterioration consult your pharmacist for advice.

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.

6. contents of the pack and other informationwhat clexane forte containsthe active substance is enoxaparin sodium.

Each ml contains 150 mg enoxaparin sodium, equivalent to 15,000 lU of anti-Xa activity.

Each pre-filled syringe (0.8 ml) contains 12,000 IU (120 mg) of enoxaparin sodium.

Each pre-filled syringe (1 ml) contains 15,000 IU (150 mg) of enoxaparin sodium.

Also contains water for injection.

What Clexane Forte looks like and the contents of the pack

The 12000 IU (120mg)/0.8ml syringe.

Clear, colourless to pale yellow solution for injection in a Type 1 glass, pre-filled syringe fitted with an injection needle and needle cap with a plunger that is purple in colour.

The 15000 IU (150mg)/1ml syringe.

Clear, colourless to pale yellow solution for injection in a Type 1 glass, pre-filled syringe fitted with an injection needle and needle cap with a plunger that is blue in colour

Clexane Forte Syringes come individually packed in a pack size of 10 pre-filled syringes.

This medicine is manufactured by: Sanofi Winthrop Industrie (Fab. Maisons Alfort), 180 Rue Jean Jaures, 94702 Maisons Alfort, France. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, LynstockWay, Lostock, Bolton, BL6 4SA. Repackaged by: Maxearn Ltd, Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester, M28 3PT.

Clexane Forte 12.000IU (120 mg)/0.8 ml Syringes PL 20774/1562

Clexane Forte 15.000IU (150 mg)/1 ml Syringes

PL 20774/1563

Clexane is registered trademark.

Date of preparation 6th December 2018

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Contact Quadrant Pharmaceuticals Ltd, Tel: 01204 471 269

L-01–1562/3–04