Pharmacotherapeutic group: Antithrombotic agent, heparin group, ATC code: B01AB05.

Farinox^®  contains the active substance called enoxaparin sodium that is a low molecular weight heparin (LMWH).

Farinox^® 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 blood clots from forming in your blood.

Farinox^® can be used to:

• Treat blood clots that are in your blood

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

- Before and after an operation

- When you have an acute illness and face period of limited mobility

- When you have unstable angina (a condition when not enough blood gets to your heart)

- After a heart attack

• Stop blood clots forming in the tubes of your dialysis machine (used for people with severe kidney problems).

Contraindications

Do not use Farinox^® :

• If you are allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

• If you are allergic to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.

• If you have had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) - this reaction is called heparin-induced thrombocytopenia - within the last 100 days or if you have antibodies against enoxaparin in your blood.

• If you are bleeding heavily or have a condition with a high risk of bleeding (such as stomach ulcer, recent surgery of the brain or eyes), including recent bleeding stroke.

• If you are using Farinox^® to treat blood clots in your blood and going to receive spinal or epidural anaesthesia or lumbar puncture within 24 hours.

Appropriate precautions for use; special warnings

Warnings and precautions:

Farinox^® should not be used interchangeably with other medicines belonging to the group of low molecular weight heparins. This is because they are not exactly the same and do not have the same activity and instructions for use.

Talk to your doctor or pharmacist before using Farinox^® if:

• you have ever had a reaction to heparin that caused a severe drop in the number of your platelets

you are going to receive spinal or epidural anesthesia or lumbar puncture (see Operations and Anaesthetics): a delay should be respected between Farinox^® use and this procedure.

• you have had a heart valve fitted

• you have endocarditis (an infection of the inner lining of the heart)

• you have 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 level of potassium in your blood (this may be checked with a blood test)

• you are currently using medicines which affect bleeding (see section below – Other medicines).

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.

Other medicines and Farinox^®

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 also in section 3, “Changing of anticoagulant medicine”)

• Dextran injection – used as a blood replacer

• Ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory agents 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 level in your blood such as potassium salts, water pills, some medicines for heart problems.

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 Farinox^® . See “Do not use Farinox^® ”. Also, tell your doctor if you have any problem with your spine or if you ever had spinal surgery.

Pregnancy and breastfeeding

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 or pharmacist for advice before taking this medicine.

Driving and using machines

Farinox^® 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.

Always use this 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 Farinox^® Syringes.

This is because it needs to be given as an injection.

When you go home, you may need to continue to use Farinox^® and give it yourself (see instructions below on how to do this).

• Farinox^® Syringes are usually given by injection underneath the skin (subcutaneous).

• Farinox^® Syringes can be given by injection into your vein (intravenous) after certain types of heart attack or Operation.

• Farinox^® Syringes can be added to the tube leaving the body (arterial line) at the start of a dialysis session.

• Do not inject Farinox^® Syringes into a muscle.

How much will be given to you

• Your doctor will decide how much Farinox^® Syringes 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 Farinox^® Syringes.

1. Treating blood clots that are in your blood

• The usual dose is 150 IU (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 Farinox^® Syringes.

2. Stopping blood clots from forming in your blood in the following situations:

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 Farinox^® Syringes 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 Farinox^® Syringes each day.

• Your doctor will decide how long you should receive Farinox^® Syringes

After you have had a heart attack

Farinox^®   can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non STEMI (NSTEMI). The amount of Farinox^®   given to you will depend on your age and the kind of heart attack you have had.

NSTEMI type of heart attack:

• The usual dose is 100 IU (1 mg) for every kilogram of weight 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 Farinox^® .

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

• An initial dose of 3 000 IU (30 mg) of Farinox^®   will be given as injection into your vein.

• At the same time you will also be given Farinox^® as an injection underneath your skin (subcutaneous injection). The usual dose is 100 IU (1 mg) for every kilogram of your weight, 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 Farinox^® .

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 weight, every 12 hours.

• The maximum amount of Farinox^®   given for the first two injections is 7500 IU (75 mg).

• Your doctor will decide how long you should receive Farinox^® .

For patients having an operation called percutaneous coronary intervention (PCI):

Depending on when you were last given Farinox^® , your doctor may decide to give an additional dose of Farinox^®   before a PCI operation. This is by injection into your vein.

3. 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 weight.

• Farinox^®   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 50 IU to 100 IU (0.5 to 1 mg) for every kilogram of your weight, if necessary.

Instructions for use of the syringe

Using the prefilled syringes with Subcutaneous injection technique:

Appropriate use of the syringes is necessary to reduce the risk of pain and the occurrence of bruising at the injection site. The instructions for use must be followed.

• Preparation of the injection site: Wash and dry hands before injecting. Clean, without rubbing, the injection site with a pad soaked in alcohol before performing the injection.

• Choose a different zone on the abdomen for each injection.

• Remove the needle shield.

A drop of medicine may appear at the end of the needle. In this case, before giving the injection, remove the drop of medicine by pointing the needle downwards and tapping on the syringe.

Proceed with the injection:

The prefilled syringe is ready for immediate use; do not purge the syringe before injecting. The patient should preferably lie down to receive the injection. The injection should be given in the fatty tissue under the skin of the front or back abdominal wall, on the left or right side (the subcutaneous tissue of the anterolateral or posterolateral abdominal wall). Alternate the injections between the right and left sides. Pinch a fold of skin between your thumb and index finger. Hold the needle vertically at a 90° angle and insert it into the skin fold. Do not insert the needle into the skin fold from the side. Make sure you hold the skin fold throughout the injection.

• Remove the syringe from the injection site keeping your finger on the plunger rod.

• Immediately dispose of the syringe in the appropriate container.

Changing anticoagulant medicine

• Changing from Farinox^® Syringes 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 Farinox^® Syringes accordingly

• Changing from blood thinners called vitamin-K antagonists (such as warfarin) to Farinox^® Syringes

Stop taking the vitamin-K antagonist. Your doctor will ask you to have blood tests called INR and tell you when to start Farinox^® Syringes accordingly

• Changing from Farinox^® Syringes to treatment with direct oral anticoagulants

Stop taking Farinox^® Syringes. 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 treatment with direct oral anticoagulants to Farinox^® Syringes

Stop taking the direct oral anticoagulant. Do not start treatment with Farinox^® Syringes until 12 hours after the final dose of the direct oral anticoagulant.

Use in children and adolescents

The saftety and efficacy of Enoxaparin sodium has not been evaluated in children or adolescents.

If you use more Farinox^® Syringes than you should

If you think that you have used too much or too little Farinox^® Syringes, tell your doctor or pharmacist or nurse immediately, even if you have no signs of a problem. If a child accidentally injects or swallows Farinox^® , take them to a hospital casualty department straight away.

If you forget to use Farinox^® Syringes

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 Farinox^® Syringes

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

It is important for you to keep having Farinox^® Syringes injections until your doctor decides to stop them. If you stop, you could get a blood clot which can be very dangerous.

Like other similar medicines (medicines to reduce blood clotting), Farinox^® may cause bleeding which may potentially be life-threatening. In some cases the bleeding may not be obvious.

If you experience any bleeding event that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, tiredness, paleness, dizziness, headache or unexplained swelling), consult your doctor immediately.

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

Stop using Farinox^® and talk to a doctor or nurse at once if you get any signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes).

You should tell your doctor straight away:

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

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

• 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.

Overall list of possible 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 Farinox^® .

• Skin rash (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).

• You notice 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 1000 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.

• Lost 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.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C. Do not refrigerate or freeze.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.