Summary of Product Characteristics: Information for the User

Enoxaparin Ledraxen 2,000 IU (20 mg)/0.2 ml Injectable Solution in Pre-filled Syringe

Enoxaparin Sodium

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you get. The final part of section 4 includes information on how to report these side effects.

Read this leaflet carefully before you start using this medicinal product, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicinal product has been prescribed for you only; do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.See section 4.

6. Contents of the pack and additional information

Enoxaparina Ledraxen contains an active ingredient called enoxaparina sodium, which is a low molecular weight heparin (LMWH).

Enoxaparina Ledraxen acts in two ways.

1. Preventing existing blood clots from growing larger. This helps your body to break them down and prevent further damage.
2. Interfering with the formation of new blood clots in the blood.

Enoxaparina Ledraxen can be used for:

•Treating blood clots in the blood

•Preventing blood clots from forming in the following situations:

•Before and after a surgical operation

•When you have a short-term illness and are unable to move for some time

•If you have had a blood clot due to cancer, to prevent further blood clots from forming.

•Preventing blood clots from forming when you have unstable angina (a condition in which not enough blood reaches the heart) or after a heart attack.

• Preventing blood clots from forming in the tubes of the dialysis apparatus (used in people with severe kidney problems).

Do not use Enoxaparina Ledraxen

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

Warnings and precautions

Do not interchange Enoxaparina Ledraxen with other medicines that belong to the group of low molecular weight heparins. This is because they are not exactly the same and do not have the same activity or instructions for use.

Consult your doctor or pharmacist before starting to use Enoxaparina Ledraxen if:

diabetic retinopathy

If you are affected by any of these conditions (or are unsure), consult your doctor or pharmacist before using Enoxaparina Ledraxen.

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

Analyses and controls

You may need to have a blood test before starting to use this medicine, and while you are using it; this is to check the level of platelets (cells that help blood to clot) and the level of potassium in your blood.

Children and adolescents

The efficacy and safety of Enoxaparina Ledraxen have not been evaluated in children or adolescents.

Other medicines and Enoxaparina Ledraxen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Operations and anaesthesia

Inform your doctor that you are using Enoxaparina Ledraxen if you are going to have a spinal or epidural anaesthetic.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using this medicine if you are pregnant, think you may be pregnant or plan to become pregnant.

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

Consult your doctor before using this medicine if you are breastfeeding or plan to breastfeed.

Driving and operating machinery

Enoxaparina Ledraxen does not affect your ability to drive and use machines.

It is recommended that the healthcare professional notes the trade name and batch number of the product you are using.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use of the medication

• Normally, your doctor or nurse will administer Enoxaparin Ledraxen. This is because it has to be administered by injection.
• Enoxaparin Ledraxen is generally administered by injection under the skin (subcutaneously).
• Enoxaparin Ledraxen can be administered by injection into your veins (intravenously) after certain types of heart attacks and surgical operations.
• Enoxaparin Ledraxen can be added to the tube that comes out of the body (arterial line) at the beginning of dialysis.

dialysis session.

• Do not administer Enoxaparin Ledraxen into the muscle (intramuscularly).

How much will be administered

• Your doctor will decide how much Enoxaparin Ledraxen will be administered. The amount will depend on the reason for its use.
• If you have any kidney problems, you may be given a smaller amount of Enoxaparin Ledraxen.

1. Treatment of blood clot formation:
   • The usual dose is 150 UI (1.5 mg) per kilogram of body weight per day or 100 UI (1 mg) per kilogram of body weight twice a day.
   • Your doctor will decide how long you will receive Enoxaparin Ledraxen.

1. Prevention of blood clot formation during operations or periods of limited mobility due to illness:
   • The dose will depend on the likelihood that you will develop a clot. You will be given

2,000 UI (20 mg) or 4,000 UI (40 mg) of Enoxaparin Ledraxen per day.

Enoxaparin Ledraxen per day.

1. Prevention of blood clot formation when you have unstable angina or after a heart attack:

Enoxaparin Ledraxen can be used in two different types of heart attacks. The amount of Enoxaparin Ledraxen that will be administered will depend on your age and the type of heart attack you have had.

Heart attack type IAMSEST (myocardial infarction without ST segment elevation):

Heart attack type IAMCEST (myocardial infarction with ST segment elevation) if you are under 75 years:

Heart attack type IAMCEST if you are 75 years or older:

Your doctor will decide how long you will receive Enoxaparin Ledraxen.

For patients undergoing coronary angioplasty (ICP):

Depending on when you last received an injection of Enoxaparin Ledraxen, your doctor may decide to give you an additional dose of Enoxaparin Ledraxen before an ICP procedure.This will be by intravenous injection.

1. Prevention of blood clot formation in dialysis tubing:
   • The usual dose is 100 UI (1 mg) per kilogram of body weight.
   • Enoxaparin Ledraxen is added to the tube that comes out of the body (arterial line) at the beginning of dialysis. This amount is usually sufficient for a 4-hour dialysis session. However, your doctor may perform a new injection of 50 UI to 100 UI/kg (0.5 to 1 mg/kg) per kilogram of body weight, if necessary.

If you are to inject Enoxaparin Ledraxen yourself

If you can administer Enoxaparin Ledraxen yourself, your doctor or nurse will show you how to do it.Do not attempt to inject yourself if you have not been shown how to do it. If you are unsure what to do, consult your doctor or nurse immediately. If the injection is performed correctly under the skin (subcutaneously), this will help reduce pain and hematoma at the injection site.

Before injecting yourself with Enoxaparin Ledraxen

Instructions for using the syringe

To reduce pain and the appearance of hematomas at the injection site, the syringe must be used properly.Follow the instructions carefully.

Instructions for syringe without safety system

• Preparation of the injection site:

Before performing the injection, wash and dry your hands. With a cotton ball, clean (without rubbing) the area you have chosen for the injection.

Choose a different area of your stomach for each injection.

• Remove the cap that protects the needle.

You may see a drop at the end of the needle. If this occurs, remove the drop before performing the injection by gently tapping the syringe body (with the needle pointing downwards).

• Performing the injection:

The pre-loaded syringe is ready for immediate use.Choose an area on the right or left side of your stomach. It should be at least 5 cm away from your navel and towards the sides. Hold the syringe so that the needle points downwards (vertically at a 90° angle), inside the thick part of a fold of skin that the operator is pinching with their thumb and index finger. The fold should be kept pinched throughout the injection.

• Dispose of the syringe immediately in the appropriate container.

The disposal of unused medication and all materials that have come into contact with it will be done in accordance with local regulations.

Instructions for syringe with safety system

Before performing the injection, wash and dry your hands. With a cotton ball, clean (without rubbing) the area you have chosen for the injection.

Choose a different area of your stomach for each injection.

You may see a drop at the end of the needle. If this occurs, remove the drop before performing the injection by gently tapping the syringe body (with the needle pointing downwards).

The pre-loaded syringe is ready for immediate use.Choose an area on the right or left side of your stomach. It should be at least 5 cm away from your navel and towards the sides. Hold the syringe so that the needle points downwards (vertically at a 90° angle), inside the thick part of a fold of skin that the operator is pinching with their thumb and index finger. The fold should be kept pinched throughout the injection.

Secure the needle by placing the trap against a hard and stable surface using one hand. Then press the trap down. Important: Do not use your finger to secure the needle to the trap! Tilt the trap until the needle enters the plastic piece, making a clicking sound.

When you have finished

The disposal of unused medication and all materials that have come into contact with it will be done in accordance with local regulations.

Change of anticoagulant treatment

• Change from Enoxaparin Ledraxen to anticoagulant medications called vitamin K antagonists (e.g., warfarin)

Your doctor will request a blood test to determine a parameter called INR and will tell you when to stop using Enoxaparin Ledraxen.

• Change from anticoagulant medications called vitamin K antagonists (e.g., warfarin) to Enoxaparin Ledraxen

Stop using the vitamin K antagonist. Your doctor will request a blood test to determine a parameter called INR and will tell you when to start using Enoxaparin Ledraxen.

• Change from Enoxaparin Ledraxen to direct oral anticoagulants

Stop using Enoxaparin Ledraxen. Start taking the direct oral anticoagulant 0-2 hours before when you would have had the next injection, and then continue as usual.

• Change from direct oral anticoagulants to Enoxaparin Ledraxen

Stop taking the direct oral anticoagulant. Do not start using Enoxaparin Ledraxen until 12 hours have passed since the last dose of the direct oral anticoagulant.

If you use more Enoxaparin Ledraxen than you should

If you consider that you have used too much or too little Enoxaparin Ledraxen, inform your doctor, nurse, or pharmacist immediately, even if you do not show signs of having a problem. If a child accidentally injects or ingests Enoxaparin Ledraxen, take them immediately to the emergency department of a hospital.

You forgot to use Enoxaparin Ledraxen

If you forgot to administer a dose, do it as soon as you remember. Do not use a double dose on the same day to compensate for the missed doses. To ensure that you do not forget any doses, it may be helpful to use a calendar.

You interrupt the treatment with Enoxaparin Ledraxen

It is essential that you continue to receive Enoxaparin Ledraxen until your doctor decides to stop the treatment. If you stop using it, a blood clot may form, which can be very dangerous.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Severe side effects

Stop treatment with Enoxaparina Ledraxen and immediately inform your doctor or nurse if you experience any signs of severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat, or eyes).

Stop treatment with enoxaparina and immediately inform your doctor or nurse if you experience any of the following symptoms:

• a generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever.The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Like other medications similar to reduce blood clots, Enoxaparina Ledraxenmay cause bleeding. This could put your life at risk. In some cases, the bleeding may not be evident.

Inform your doctor immediately if:

• you have any bleeding that does not stop on its own
• you have signs of excessive bleeding (such as feeling very weak, fatigue, paleness, or dizziness with headache or unexplained swelling).

Your doctor may decide to keep you under close observation or change your medication.

You must inform your doctor immediately if:

• you experience any signs of a blood vessel blockage by a blood clot such as:

• cramp-like pain, redness, heat, or swelling in one of your legs – which are symptoms of deep vein thrombosis
• difficulty breathing, chest pain, fainting, or coughing up blood – which are symptoms of pulmonary embolism

• you have painful skin rash with dark red spots under the skin that do not disappear when pressed.

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

Orother side effects:

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

• Bleeding.
• Increased liver enzymes.

Common(may affect up to 1 in 10 people)

• If you experience frequent bruises. This could be due to a blood problem due to a low platelet count.
• Reddish patches on the skin. They appear more frequently in the area where Enoxaparina Ledraxen has been injected.
• Rash on the skin (hives, urticaria).
• Redness and itching on the skin.
• Ecchymosis or pain at the injection site.
• Decreased red blood cell count in the blood.
• Increased platelet count in the blood.
• Headache.

Uncommon(may affect up to 1 in 100 people)

• Severe headache. This could be a sign of brain hemorrhage.
• Sensation of sensitivity to palpation and swelling of the stomach. It could be indicative of gastric hemorrhage.
• Large, irregular red skin lesions, with or without blisters.
• Skin irritation (local irritation).
• You may notice yellowing of the skin or eyes, and darkening of the urine color. This could be due to liver problems.

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

• Severe allergic reaction. The signs of this reaction may include: rash, difficulty breathing or swallowing, swelling of the lips, face, throat, or tongue.
• Increased potassium in the blood. This is more likely to occur in people with kidney problems or diabetes. Your doctor will be able to check it by performing a blood test.
• Increased eosinophil count in the blood. Your doctor will be able to check it by performing a blood test.
• Hair loss.
• Osteoporosis (a disease in which the bones may be more likely to fracture)

after prolonged use.

• Numbness, tingling, and weakness in the muscles (especially in the lower part of the body) when you have had a lumbar puncture or spinal anesthesia.
• Loss of bladder or bowel control (so you cannot control your needs).
• Hardening or nodule at the injection site.

Communication of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Store below 25 °C.

Do not freeze.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe any visible change in the appearance of the solution.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medications you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Enoxaparin Ledraxen

• The active ingredient is enoxaparin sodium.

Each pre-filled syringe of 0.2 ml contains an anti-Xa activity of 2,000 UI (equivalent to 20 mg) of enoxaparin sodium.

• The other components are water for injection preparations.

Appearance of the product and contents of the package

The liquid is transparent, colorless, or light yellow.

0.2 ml of solution contained in a transparent glass syringe, colorless, neutral, and type I, with a fixed needle and a closed needle protector with a chlorobutyl rubber stopper and a black polypropylene plunger (without an automatic safety system).

Packaging of 1, 2, 6, 10, 20, or 50 pre-filled syringes.

For 0.2 ml and 0.4 ml syringes, the syringes are not graduated.

For 0.6 ml, 0.8 ml, and 1 ml syringes, the syringes are graduated.

Only some sizes of packaging may be marketed.

Marketing Authorization Holder

Venipharm

4, Bureaux de la Colline

92210 Saint-Cloud

FRANCE

+33 1 47 71 16 98

[email protected]

Responsible for manufacturing

Centre Spécialités Pharmaceutiques (France)

ZAC des Suzots

35 rue de la Chapelle F-63450

Saint-Amant Tallende,

FRANCE

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany Enoxaparin Ledraxen

United Kingdom Ledraxen

Sweden:Enoxaparin Ledraxen

Spain:Enoxaparina Ledraxen

France:Enoxaparine Arrow

Latvia:Enoxaparin sodium Ledraxen

Latvia Enoxaparin sodium Ledraxen

Austria:Enoxaparin Ledraxen

Cyprus:Ledraxen

Czech Republic:Enoxaparin sodium Ledraxen

Estonia:Enoxaparin sodium Ledraxen

Finland:Enoxaparin Ledraxen

Croatia:Enoksaparinnatrij Ledraxen

Ireland:Enoxaparin sodium Ledraxen

NorwayEnoxaparin Ledraxen

Poland:Enoxaparin sodium Ledraxen

Portugal:Enoxaparin Ledraxen

Slovakia:Ledraxen

Slovenia:Enoksaparin Ledraxen

Last review date of this leaflet:June 2023

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)