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

How ENOXA works

ENOXA works 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 ENOXA is used for

ENOXA 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).

Do not use ENOXA 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, tongue, oral cavity, 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 ENOXA 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 ENOXA if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using ENOXA.

Warnings and precautions

ENOXA should not be interchangedwith other ‘low molecular weight heparins’ suchas nadroparin, tinzaparin or dalteparin. This isbecause they are not exactly the same and do nothave the same activity and instructions for use.

Talk to your doctor or pharmacist before using ENOXA if:

·        you have ever had a reaction to heparin thatcaused a severe drop in the number of yourclotting cells (platelets)

·        you have had a heart valve fitted

·        you have endocarditis (an infection of the innerlining 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 bloodvessels in the eye caused by diabetes (calleddiabetic retinopathy)

·        you have had an operation recently on your eyesor brain

·        you are elderly (over 65 years old) and especiallyif 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 affectbleeding (see section 2, ‘Other medicines andENOXA)

·        you have any problem with your spine or youhave had spinal surgery.

If any of the above apply to you (or you are notsure), talk to your doctor or pharmacist beforeusing ENOXA.

For patients receiving doses higher than 210 mg/day, this medicine contains more than 24 mg sodium (main component of cooking/table salt)in each dose. This is equivalent to 1.2% of therecommended maximum daily intake of sodiumfor an adult.

Tests and checks

You may have a blood test before you start usingthis medicine and at intervals while you are usingit; 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 enoxaparin has notbeen evaluated in children or adolescents.

Other medicines and ENOXA

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

·        warfarin – used for thinning the blood

·        aspirin (also known as acetylsalicylic acid orASA), clopidogrel or other medicines used tostop blood clots from forming (see section 3,‘Changing anticoagulant medicine’)

·        dextran injection – used as a blood replacer

·        ibuprofen, diclofenac, ketorolac or other medicinesknown as non-steroidal anti-inflammatorymedicines which are used to treat pain andswelling in arthritis and other conditions

·        prednisolone, dexamethasone or othermedicines used to treat asthma, rheumatoidarthritis and other conditions

·        medicines which increase potassium levels inyour 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 lumbarpuncture, or an operation where an epidural or

spinalanaesthetic is used, tell your doctor that youare using ENOXA.

Pregnancy and breast-feeding

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

If you are pregnant and have a mechanicalheart valve, you may be at an increased risk ofdeveloping blood clots. Your doctor should discussthis with you.

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

Driving and using machines

ENOXA does not affect the ability to driveand operate machinery.

It is advised that the trade name and batchnumber of the product you are using are recorded

by your healthcare professional.

Always use this medicine exactly as your doctor orpharmacist has told you. Check with your doctor orpharmacist if you are not sure.

Having this medicine

·        Your doctor or nurse will normally give you ENOXA. This is because it needs to be given as an injection.

·        ENOXA is usually given by injection underneath the skin (subcutaneous).

·        ENOXA can be given by injection into your vein (intravenous) after certain types of heart attack or operations.

·        ENOXA can be added to the tube leaving the body (arterial line) at the start of a dialysis session.

·        Do not inject ENOXA into a muscle.

How much will be given to you

·        Your doctor will decide how much ENOXA to give you. The amount will depend onthe reason it is being used.

·        If you have problems with your kidneys you maybe given a smaller amount of ENOXA.

1)     Treating blood clots that are in your blood

·        The usual dose is 150 IU (1.5 mg) for everykilogram of your bodyweight once a dayor 100 IU (1 mg) for every kilogram of yourbodyweight twice a day.

·        Your doctor will decide how long you shouldreceive ENOXA.

2)     Stopping blood clots from forming in yourblood during operations or periods oflimited mobility due to an illness

·        The dose will depend on how likely you areto develop a clot. You will be given 2,000 IU(20 mg) or 4,000 IU (40 mg) of ENOXAeach day.

·        If you are going to have an operation yourfirst injection will be usually given 2 hours or12 hours before your operation.

·        If you have restricted mobility due to illness,you will normally be given 4,000 IU (40 mg) ofENOXA each day.

·        Your doctor will decide how long you shouldreceive ENOXA.

3)     Stopping blood clots when you haveunstable angina or after you have had aheart attack

·        ENOXA can be used for two differenttypes of heart attack.

·        The amount of ENOXA given to youwill depend on your age and the kind of heartattack you have had.

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

o   The usual dose is 100 IU (1 mg) for everykilogram of your bodyweight every 12 hours.

o   Your doctor will normally ask you to takeaspirin (acetylsalicylic acid) as well.

o   Your doctor will decide how long you shouldreceive ENOXA.

STEMI (ST segment Elevation MyocardialInfarction) type of heart attack if you areunder 75 years old:

o   An initial dose of 3,000 IU (30 mg) of ENOXA will be given as an injection intoyour vein.

o   At the same time you will also begiven ENOXA as an injectionunderneath your skin (subcutaneousinjection). The usual dose is 100 IU (1 mg)for every kilogram of your bodyweight, every 12 hours.

o   Your doctor will normally ask you to takeaspirin (acetylsalicylic acid) as well.

o   Your doctor will decide how long youshould receive ENOXA.

STEMI type of heart attack if you are75 years old or older:

o   The usual dose is 75 IU (0.75 mg) for everykilogram of your bodyweight, every 12 hours.

o   The maximum amount of ENOXAgiven for the first two injections is 7,500 IU(75 mg).

o   Your doctor will decide how long you shouldreceive ENOXA.

For patients that have an operation calledpercutaneous coronary intervention (PCI):

o   Depending on when you were last givenENOXA, your doctor may decide togive an additional dose of ENOXAbefore a PCI operation. This is by injectioninto your vein

4)     Stopping blood clots from forming in thetubes of your dialysis machine

·        The usual dose is 100 IU (1 mg) for everykilogram of your bodyweight.

·        ENOXA is added to the tube leavingthe body (arterial line) at the start of a dialysissession. This amount is usually enough for a4-hour session. However, your doctor may giveyou a futher dose of 50 IU to 100 IU (0.5 to1 mg) for every kilogram of your bodyweight, ifnecessary.

Giving yourself an injection of ENOXA

If you are able to give ENOXA to yourself,your doctor or nurse will show you how to do this.

Do not try to inject yourself if you have not beentrained how to do so. If you are not sure whatto do, talk to your doctor or nurse immediately.

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

Before injecting yourself with ENOXA

·        Collect together the items that you need:syringe, alcohol swab or soap and water, andsharps 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 ENOXA:

Preparing the injection site

1)     Choose an area on the right or left side of yourstomach. This should be at least 5 centimetresaway from your belly button and out towardsyour sides.

·        Do not inject yourself within 5cm of your bellybutton or around existing scars or bruises.

·        Change the place where you inject betweenthe left and right sides of your stomach,depending on the area you last injected.

2)     Wash your hands. Cleanse (do not rub) the areathat you will inject with an alcohol swab or soapand water.

3)     Sit or lie in a comfortable position so you arerelaxed. Make sure you can see the place you aregoing to inject. A lounge chair, recliner, or bedpropped up with pillows is ideal.

Selecting your dose

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

·        Do not press on the plunger before injectingyourself to get rid of air bubbles. This can leadto a loss of the medicine.

·        Once you have removed the cap, do not allowthe needle to touch anything. This is to makesure the needle stays clean (sterile).

2)     When the amount of medication in the syringealready matches your prescribed dose, there isno need to adjust the dose. You are now readyto inject.

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

4)     A drop may appear at the tip of the needle. Ifthis occurs, remove the drop before injecting bytapping on the syringe with the needle pointingdown. You are now ready to inject.

Injecting

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

·        Make sure you hold the skin fold throughoutthe injection.

2)     Hold the syringe so that the needle is pointingstraight down (vertically at a 90° angle). Insertthe 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 tissueof the stomach. Complete the injection using allof the medicine in the syringe.

4)     Remove the needle from the injection site bypulling it straight out. A protective sleeve willautomatically cover the needle. You can nowlet go of the skin fold. The safety system onlyreleases the protective sleeve when the syringehas been emptied by pressing the plunger all theway down.

When you have finished

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

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

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

Changing anticoagulant medicine

·        Changing from ENOXA to bloodthinners called vitamin-K antagonists (such aswarfarin)

Your doctor will ask you to have blood testscalled INR and tell you when to stop ENOXA.

·        Changing from blood thinners calledvitamin-K antagonists (such as warfarin) toENOXA

Stop taking the vitamin-K antagonist. Yourdoctor will ask you to have blood tests called INRand tell you when to start ENOXA.

·        Changing from ENOXA to treatmentwith direct oral anticoagulants

Stop taking ENOXA. Start taking thedirect oral anticoagulant 0 to 2 hours before thetime you would have had the next injection,then continue as normal.

·        Changing from treatment with direct oralanticoagulants to ENOXA

Stop taking the direct oral anticoagulant. Donot start treatment with ENOXA until12 hours after the final dose of the direct oralanticoagulant.

If you use more ENOXA than you should

If you think that you have used too much ortoo little ENOXA, tell your doctor orpharmacist or nurse immediately, even if youhave no signs of a problem. If a child accidentallyinjects or swallows ENOXA, take them to ahospital emergency department straight away.

If you forget to use ENOXA

If you forget to give yourself a dose, have it as soonas you remember. Do not give yourself a doubledose on the same day to make up for a forgottendose. Keeping a diary will help to make sure youdo not miss a dose.

If you stop using ENOXA

It is important for you to keep having ENOXA injections until your doctor decides to stop

them. If you stop, you could get a blood clot whichcan be very dangerous.

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

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

Serious side effects

Stop using ENOXA 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, tongue, oral cavity, throat or eyes).

Like other similar medicines to reduce blood clotting, ENOXA 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 suchas being very weak, tired, pale, or dizzy withheadache 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 vesselby a blood clot such as:

o  cramping pain, redness, warmth, or swelling inone of your legs – these are symptoms of deepvein thrombosis

o  breathlessness, chest pain, fainting orcoughing up blood – these are symptoms of apulmonary embolism

·        if you have a painful rash of dark red spotsunder the skin which do not go away when youput pressure on them.

Your doctor may request you perform a blood testto 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 – thiscould be because of a blood problem withlow platelet counts

·        pink patches on your skin – these are morelikely to appear in the area you have beeninjected with ENOXA

·        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 asign of bleeding in the brain

·        a feeling of tenderness and swelling in yourstomach – you may have bleeding in yourstomach

·        large red irregularly shaped skin lesionswith or without blisters

·        skin irritation (local irritation)

·        yellowing of your skin or eyes and yoururine becomes darker in colour – thiscould be a liver problem.

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

·        severe allergic reaction – the signs mayinclude: a rash, swallowing or breathingproblems, swelling of your lips, face, throator tongue

·        increased potassium in your blood – thisis more likely to happen in people withkidney problems or diabetes. Your doctorwill be able to check this by carrying out ablood test

·        an increase in the number of eosinophilsin your blood – your doctor will be able tocheck this by carrying out a blood test

·        hair loss

·        osteoporosis (a condition where your bonesare more likely to break) after long termuse

·        tingling, numbness and muscular weakness(particularly in the lower part of your body)when you have had a spinal puncture or aspinal anaesthetic

·        loss of control over your bladder or bowel(so you cannot control when you go to thetoilet)

·        hard mass or lump at the injection site.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Saudi vigilance reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

a.      To report any side effect(s):

·        SaudiArabia:

Store below 30°C.

Keep this medicine out of the sight and reach ofchildren.

Do not use this medicine after the expiry date which is stated on the label. 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 matters in the solution, or an abnormal colour of the solution (see “What ENOXA looks like and contents of the pack”).

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how todispose of medicines no longer required. These measures will help protect the environment.