LEDRAXEN 10 000 IU (100 MG)/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

Patient leaflet - LEDRAXEN 10 000 IU (100 MG)/1 ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Ledraxen® is and what it is used for
2. What you need to know before you use Ledraxen®
3. How to use Ledraxen®
4. Possible side effects
5. How to store Ledraxen®
6. Contents of the pack and other information

1. what ledraxen® is and what it is used for

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

Ledraxen® 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.

Ledraxen® 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).

2. what you need to know before you use ledraxen® 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 Ledraxen® to treat blood clots in your body and going to receive spinal or epidural anaesthesia or lumbar puncture within 24 hours.

Warnings and precautions

Ledraxen® 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 Ledraxen® 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 Ledraxen® 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)
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 Ledraxen®

Tell your doctor or pharmacist if you are using any other medicines, have recently used or might use 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 Ledraxen®. See “Do not use Ledraxen®. Also, tell your doctor if you have any problem with your spine or if you ever had spinal surgery.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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.

Children and adolescents

The safety and efficacy of Ledraxen® has not been evaluated in children or adolescents

Driving and using machines

Ledraxen® 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 ledraxen®

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 Ledraxen®. This is because it needs to be given as an injection.
When you go home, you may need to continue to use Ledraxen® and give it yourself (see instructions below on how to do this).
Ledraxen® is usually given by injection underneath the skin (subcutaneous).
Ledraxen® can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
Ledraxen® can be added to the tube leaving the body (arterial line) at the start of the dialysis session.

Do not inject Ledraxen® into a muscle.

How much will be given to you

Your doctor will decide how much Ledraxen® 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 Ledraxen®.
1. Treating blood clots that are in your blood

The usual dose is 150 IU (1.5 mg) for every kilogram of your weight each day or 100 IU (1 mg) for every kilogram of your weight twice a day.

Your doctor will decide how long you should receive Ledraxen®.

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

Operation 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 Ledraxen® 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 Ledraxen® each day.
Your doctor will decide how long you should receive Ledraxen®.

After you have had a heart attack

Ledraxen® can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non STEMI (NSTEMI). The amount of Ledraxen® 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 Ledraxen®.

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

An initial dose of 3,000 IU (30 mg) of Ledraxen® will be given as injection into your vein.
At the same time you will also be given Ledraxen® 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 Ledraxen®.

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 Ledraxen® given for the first two injections is 7,500 IU (75 mg).
Your doctor will decide how long you should receive Ledraxen®.

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

Depending on when you were last given Ledraxen®, your doctor may decide to give an additional dose of Ledraxen® 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.
Ledraxen® 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.

Instruction for use of the syringe

Appropriate use of syringes is necessary to reduce the risk of pain and appearance of bruises at the injection site. Be careful to follow the instructions.

Instructions for syringes without safety system

Preparation of the injection site:

Before performing the injection, wash your hands and dry them. Use a cotton ball to clean (without rubbing) the area chosen for the injection.

Choose a different area of the stomach for each injection.

Remove the protective cap from the needle.

The appearance of a drop at the end of the needle is possible. In this case, remove the drop before injection by tapping on the body of the syringe (with the needle pointing downwards).

Perform the injection:

The pre-filled syringe is ready for immediate use. The injection should be performed, preferably with the patient lying down, under the skin of the waist, whether on the right or on the left. The needle should be introduced perpendicularly and not tangentially, into the thickness of a skin fold pinched between the thumb and index finger of the operator. The fold should be held throughout the entire injection.

Immediately throw away the syringe in the appropriate container.

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

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Instructions for syringes with safety system

Preparation of the injection site:

Before performing the injection, wash your hands and dry them. Use a cotton ball to clean (without rubbing) the area chosen for the injection.

Choose a different area of the stomach for each injection.

First, bend the trap toward the side by approximately 90 degrees. Important: do not remove the cap before bending the trap.
Remove the protective cap from the needle.

The appearance of a drop at the end of the needle is possible. In this case, remove the drop before injection by tapping on the body of the syringe (with the needle pointing down).

Perform the injection:

Secure the needle-trap:

Place the trap against a hard, stable surface, using one hand. Important: Do not use your finger to secure the needle in the trap. Then press down the trap. Bend the trap until the needle audibly clicks into the plastic part.

Dispose the syringe with the secured needle in the nearest sharps container.

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

Changing of anticoagulant treatment

- Changing from Ledraxen® to blood thinners called vitamin-K antagonists (e.g. warfarin)

Your doctor will request you perform blood tests called INR and tell you when to stop Ledraxen® accordingly.

- Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to Ledraxen®

Stop taking the vitamin-K antagonist. Your doctor will request you perform blood tests called INR and tell you when to start Ledraxen® accordingly.

- Changing from Ledraxen® to treatment with direct oral anticoagulant Stop taking Ledraxen®. Start taking the direct oral anticoagulant 0–2 hours before the time you would have had the next injection, then continue as normal.
- Changing from treatment with direct oral anticoagulant to Ledraxen® Stop taking direct oral anticoagulant. Do not start treatment with Ledraxen® until 12 hours after the final dose of direct oral anticoagulant.

If you use more Ledraxen® than you should

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

If you forget to use Ledraxen®

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 Ledraxen®

It is important for you to keep having Ledraxen® 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 other similar medicines (medicines to reduce blood clotting), Ledraxen® 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 Ledraxen® 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 Ledraxen®.
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).
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 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.
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.

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, Website:. uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store ledraxen®

Do not store above 25°C.

Do not freeze.

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 label. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible change in the appearance of the solution.

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