Enoxaparin Ledraxen 8,000 IU (80 mg)/0.8 ml solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enoxaparina Ledraxen 8,000 IU (80 mg)/0.8 ml solution for injection in pre-filled syringe

enoxaparin sodium

This medicinal product is subject to additional monitoring, which will allow for rapid identification of new information on its safety. You can help by reporting any adverse reactions you may experience. Section 4 includes information on how to report adverse reactions.

Please read this entire leaflet carefully before you start using this medicine, 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 medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4. Contents of the leaflet

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

1. What Enoxaparin Ledraxen is and what it is used for

Enoxaparin Ledraxen contains an active substance called enoxaparin sodium, which is a low molecular weight heparin (LMWH).

Enoxaparin Ledraxen works in two ways:

1. By preventing existing blood clots from getting larger. This helps your body to break them down and prevents further harm.
2. By inhibiting the formation of new blood clots.

Enoxaparin Ledraxen can be used to:

• treat blood clots that are already present
• prevent the formation of blood clots in the following situations:
• before and after surgical procedures
• when you have a short-term illness and are unable to move around for some time
• if you have had a blood clot due to cancer, to prevent further clots from forming
• to prevent blood clots in patients with unstable angina (a condition in which insufficient blood reaches the heart) or after a heart attack
• to prevent blood clots in the tubing of dialysis equipment (used in people with serious kidney problems)

2. What you need to know before starting to use Enoxaparin Ledraxen

Do not use Enoxaparin Ledraxen

• if you are allergic to:
  • enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6)
  • 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, mouth, throat or eyes.

• if you have had a reaction to heparin causing a severe drop in the number of blood cells involved in clotting (platelets) within the last 100 days
• if you have antibodies in your blood against enoxaparin
• if you are experiencing severe bleeding or have conditions with a high risk of bleeding such as:
  • stomach ulcer, recent brain or eye surgery, or cerebral hemorrhage.
• if you are using Enoxaparin Ledraxen to treat blood clots and are scheduled to undergo within 24 hours:
  • a lumbar or spinal puncture
  • surgery with spinal or epidural anesthesia.

Warnings and precautions

Enoxaparin Ledraxen must not be exchanged 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 or the same instructions for use.

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

• you have ever had a reaction to heparin that caused a severe decrease in the number of cells involved in blood clotting (platelets)
• you have had a heart valve implanted
• you have endocarditis (an infection of the inner lining of the heart)
• you have a history of gastric ulcer
• you have recently had a stroke (cerebrovascular accident)
• you have high blood pressure
• you have diabetes or diabetes-related eye vessel problems (called

diabetic retinopathy )

• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), and especially if you are over 75 years old
• you have kidney problems
• you have liver problems
• you have very low body weight or are overweight
• you have high levels of potassium in your blood (which could be checked with a blood test)
• you are currently taking medicines that affect bleeding (see below - Use of Enoxaparin Ledraxen with other medicines)
• you have any spinal problems or have undergone spinal surgery.

If any of the conditions mentioned above apply to you (or if you are unsure), consult your doctor or pharmacist before using Enoxaparin Ledraxen.

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

Laboratory tests and monitoring

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 levels of cells involved in blood clotting (platelets) and the levels of potassium in your blood.

Children and adolescents

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

Other medicines and Enoxaparin Ledraxen

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

• Warfarin – used to reduce blood clotting
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel, or other medicines used to prevent blood clots (see also section 3, “Switching anticoagulant treatment”)
• Dextran injection – used as a blood substitute
• Ibuprofen, diclofenac, ketorolac, and other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation in arthritis and other conditions
• Prednisolone, dexamethasone, and other medicines used to treat asthma, rheumatoid arthritis, and other diseases
• Medicines that increase potassium levels in blood, such as potassium salts, diuretics (medicines to remove fluid), and some medicines used to treat heart problems

Surgical operations and anesthesia

If you are scheduled for a lumbar puncture or undergoing a surgical procedure involving spinal or epidural anesthesia, inform your doctor that you are using Enoxaparin Ledraxen.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

If you are breastfeeding or planning to breastfeed, you should consult your doctor before using this medicine.

Driving and using machines

Enoxaparin Ledraxen does not affect the ability to drive or operate machinery.

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

3. How to use Enoxaparin Ledraxen

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use of the medicine

• Your doctor or nurse will normally administer Enoxaparin Ledraxen. This is because it must be given by injection.

• Enoxaparin Ledraxen is usually administered by subcutaneous injection (under the skin).

• Enoxaparin Ledraxen may be given by intravenous injection (into the vein) after certain types of heart attacks and surgical procedures.

• Enoxaparin Ledraxen can be added to the tube draining from the body (arterial line) at the start of a dialysis session.

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

What dose will be given to you

• Your doctor will decide the dose of Enoxaparin Ledraxen you will receive. The dose depends on the reason for which it is being used.
• If you have any kidney problems, you may be given a lower dose of Enoxaparin Ledraxen.

1. Treatment of blood clot formation:

   • The usual dose is 150 IU (1.5 mg) per kilogram of body weight once daily or 100 IU (1 mg) per kilogram of body weight twice daily.
   • Your doctor will decide how long you will receive Enoxaparin Ledraxen.

2. Prevention of blood clot formation during surgery or periods of limited mobility due to illness:

   • The dose will depend on your risk of developing a blood clot. You will be given
     

   2,000 IU (20 mg) or 4,000 IU (40 mg) of Enoxaparin Ledraxen daily.
   

   • If you are undergoing surgery, the first injection is usually given 2 or 12 hours before the procedure.
     
   • If you have reduced mobility due to illness, you will usually be given 4,000 IU (40 mg) of
     

   Enoxaparin Ledraxen daily.
   

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

3. Prevention of blood clot formation in unstable angina or after a heart attack:
   Enoxaparin Ledraxen can be used in two different types of heart attacks. The dose of Enoxaparin Ledraxen you receive will depend on your age and the type of heart attack you have had.

   Heart attack type NSTEMI (non-ST-segment elevation myocardial infarction):
   

   • The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
     
   • Your doctor will usually also recommend that you take aspirin (acetylsalicylic acid).
     
   • Your doctor will decide how long you will receive Enoxaparin Ledraxen.

   Heart attack type STEMI (ST-segment elevation myocardial infarction) if you are under 75 years of age:
   

   • You will receive an initial intravenous injection of 3,000 IU (30 mg) of Enoxaparin Ledraxen.
     
   • At the same time, you will receive a subcutaneous (under the skin) injection of Enoxaparin Ledraxen. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
     
   • Your doctor will usually also recommend that you take aspirin (acetylsalicylic acid).
     
   • Your doctor will decide how long you will receive Enoxaparin Ledraxen.

   Heart attack type STEMI if you are 75 years of age or older:
   

   • The usual dose is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
     
   • The maximum total dose of Enoxaparin Ledraxen in the first two injections is
     

   7,500 IU (75 mg).
   

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

   For patients undergoing percutaneous coronary intervention (PCI):
   Depending on when you received your last injection of Enoxaparin Ledraxen, your doctor may decide to administer an additional dose of Enoxaparin Ledraxen before a PCI procedure. This would be given as an intravenous injection.

4. Prevention of blood clot formation in dialysis equipment tubing:
   

   • The usual dose is 100 IU (1 mg) per kilogram of body weight.
     
   • Enoxaparin Ledraxen is added to the tube carrying blood from the body (arterial line) at the beginning of the dialysis session. This dose is usually sufficient for a 4-hour session. However, your doctor may administer an additional injection of 50 IU to 100 IU/kg (0.5 to 1 mg/kg) per kilogram of body weight if needed.

If You Are Going to Self-Administer Enoxaparin Ledraxen

If you are able to self-administer Enoxaparin Ledraxen, your doctor or nurse will show you how to do it. Do not attempt to inject yourself unless you have been properly trained. If you are unsure what to do, consult your doctor or nurse immediately. When the injection is correctly administered under the skin (known as a "subcutaneous injection"), it helps reduce pain and bruising at the injection site.

Before self-injecting Enoxaparin Ledraxen

• Prepare the items you will need: syringe, alcohol swab or soap and water, and a sharps container
• Check the medicine's expiration date. If it has expired, do not use it
• Check that the syringe is not damaged and that the medicine solution is clear and transparent. If not, use another syringe
• Make sure you know the amount to be injected
• Examine the area of your stomach to see if the last injection caused redness, skin discoloration, swelling, discharge, or persistent pain. If this occurs, consult your doctor or nurse

Instructions for using the syringe

To reduce pain and the occurrence of bruising at the injection site, it is necessary to use the syringes appropriately. Follow the instructions carefully.

Instructions for syringe without safety system

• Preparation of the injection site:

Before administering the injection, wash and dry your hands. Using a cotton ball, clean (without rubbing) the area you have selected for the injection.

Choose a different area of the abdomen for each injection.

• Remove the protective cap covering the needle.

A drop may appear at the tip of the needle. If this occurs, remove the drop before injecting by gently tapping the body of the syringe (with the needle pointing downward).

• Administering the injection:

The pre-filled syringe is ready for immediate use. Select an area on the left or right side of your abdomen. It should be at least 5 cm away from your navel and toward the sides. Hold the syringe so that the needle points downward (vertically at a 90º angle), within the thickness of a skin fold pinched by the operator with the thumb and index finger. The skin fold should be kept pinched throughout the entire injection.

• Immediately dispose of the syringe in the appropriate container.

Any unused medicine and all materials that have come into contact with it must be disposed of in accordance with local regulations.

Instructions for Syringe with Safety System

• Preparation of the injection site:

Before administering the injection, wash and dry your hands. Using a cotton ball, clean (without rubbing) the area you have selected for the injection.

Choose a different area of the abdomen for each injection.

• First, tilt the safety shield sideways approximately 90 degrees. Important: Do not remove the cap before tilting the shield!

• Remove the protective cap covering the needle.

A drop may appear at the tip of the needle. If this occurs, remove the drop before injecting by gently tapping the body of the syringe (with the needle pointing downward).

• Administering the injection:

The pre-filled syringe is ready for immediate use. Select an area on the right or left side of your abdomen, at least 5 cm away from your navel and toward the sides. Hold the syringe so that the needle points downward (vertically at a 90º angle), within a skin fold that is pinched between your thumb and index finger. Maintain the skin fold pinched throughout the entire injection.

• Secure the needle:

Anchor the needle by placing the shield against a firm, stable surface using one hand. Then press the shield downward. Important: Do not use your finger to secure the needle to the shield! Continue pressing until the needle is fully enclosed within the plastic piece, indicated by an audible click.

When finished

1. To help prevent bruising, do not rub the injection site after the injection.
2. Dispose of the used syringe in a sharps container. Close the container tightly and store it out of the reach of children. When the container is full, dispose of it as instructed by your doctor or pharmacist.

Any unused medicine and all materials that have come into contact with it must be disposed of in accordance with local regulations.

Switching anticoagulant treatment

• Switching from Enoxaparin Ledraxen to vitamin K antagonist anticoagulant medicines (e.g., warfarin)

Your doctor will order a blood test to determine the INR value and will advise you when to stop treatment with Enoxaparin Ledraxen.

• Switching from vitamin K antagonist anticoagulant medicines (e.g., warfarin) to Enoxaparin Ledraxen

Discontinue the vitamin K antagonist. Your doctor will order a blood test to determine the INR value and will advise you when to start treatment with Enoxaparin Ledraxen.

• Switching from Enoxaparin Ledraxen to direct oral anticoagulant treatment

Discontinue Enoxaparin Ledraxen. Start taking the direct oral anticoagulant 0–2 hours before the time of your next scheduled injection, then continue as usual.

• Switching from direct oral anticoagulant treatment to Enoxaparin Ledraxen

Stop taking the direct oral anticoagulant. Do not start treatment with Enoxaparin Ledraxen until 12 hours after the last dose of the direct oral anticoagulant.

If you use more enoxaparin ledraxen than you should

If you think you have used too much or too little Enoxaparin Ledraxen, inform your doctor, nurse, or pharmacist immediately, even if you do not notice any signs of problems. If a child accidentally injects or swallows Enoxaparin Ledraxen, take them immediately to the hospital emergency department.

If you forget to use Enoxaparin Ledraxen

If you forget to take a dose, take it as soon as you remember. Do not use a double dose on the same day to make up for missed doses. To help ensure you do not miss any doses, it may be helpful to use a diary.

If treatment with Enoxaparina Ledraxen is interrupted

It is important that you continue receiving Enoxaparina Ledraxen until your doctor decides to stop the treatment. If you stop using it, a blood clot could form, which may be very dangerous.

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

4. Possible adverse effects

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

Serious adverse effects

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

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

• widespread red, scaly rash with lumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).

Like other similar medicines used to reduce blood clots, Enoxaparin Ledraxen may cause bleeding. This could be life-threatening. In some cases, bleeding may not be obvious.

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 strict observation or change your medication.

You must inform your doctor immediately:

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

• cramp-like pain, redness, warmth, or swelling in one of your legs – symptoms of deep vein thrombosis

• difficulty breathing, chest pain, fainting, or coughing up blood – symptoms of pulmonary embolism

• if you develop a painful skin rash with dark red spots under the skin that do not fade when pressed.

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

Other adverse effects:

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

• Bleeding.
• Increased liver enzymes.

Common (may affect up to 1 in 10 people)

• Bruising more easily than usual. This could be due to a blood disorder caused by a low platelet count.
• Pinkish skin patches. These occur more frequently at the site where Enoxaparin Ledraxen was injected.
• Skin rash (hives, urticaria).
• Redness and itching of the skin.
• Bruising or pain at the injection site.
• Decrease in the number of red blood cells in the blood.
• Increase in the number of platelets 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.
• Tenderness and swelling in the stomach area. This could indicate gastrointestinal bleeding.
• Large, irregular red lesions on the skin, with or without blisters.
• Skin irritation (local irritation).
• You may notice yellowing of the skin or eyes, and darkening of the urine. This could be due to a liver problem.

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

• Severe allergic reaction. Signs of this reaction may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Increased potassium levels in the blood. This is more likely to occur in people with kidney problems or diabetes. Your doctor can check this with a blood test.
• Increased number of eosinophils in the blood. Your doctor can check this with a blood test.
• Hair loss.
• Osteoporosis (a condition in which bones become more likely to fracture) after prolonged use.
• Tingling, numbness, and muscle weakness (especially in the lower part of the body) when a lumbar puncture or spinal anesthesia has been performed.
• Loss of bladder or bowel control (inability to control urination or defecation).
• Hardening or nodule at the injection site.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enoxaparin Ledraxen

Store below 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Enoxaparin Ledraxen

• The active substance is enoxaparin sodium.

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

• The other component is water for injections.

Appearance of the product and contents of the pack

The liquid is clear, colourless or pale yellow.

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

Packs containing 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 certain pack sizes may be marketed.

Marketing Authorisation Holder

Venipharm

4, Bureaux de la Colline

92210 Saint-Cloud

FRANCE

+33 1 47 71 16 98

[email protected]

Manufacturer

Centre Spécialités Pharmaceutiques (France)

ZAC des Suzots

35 rue de la Chapelle F-63450

Saint-Amant Tallende,

FRANCE

This medicinal product is authorised in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Germany: Enoxaparin Ledraxen

United Kingdom: Ledraxen

Sweden: Enoxaparin Ledraxen

Spain: Enoxaparina Ledraxen

France: Enoxaparine Arrow

Latvia: Enoxaparin sodium Ledraxen

Lettonia: 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

Norway: Enoxaparin Ledraxen

Poland: Enoxaparin sodium Ledraxen

Portugal: Enoxaparin Ledraxen

Slovakia: Ledraxen

Slovenia: Enoksaparin Ledraxen

Date of the most recent revision of this leaflet: June 2023

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)