Enoxaparin Ledraxen

Package leaflet: Information for the patient

Enoxaparin Ledraxen 2000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe, 4000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe, 6000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringe, 8000 IU (80 mg)/0.8 mL solution for injection in pre-filled syringe, 10000 IU (100 mg)/1 mL solution for injection in pre-filled syringe

Enoxaparin sodium
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Enoxaparina Ledraxen contains an active substance called enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Enoxaparina Ledraxen works in two ways.

1. It prevents the growth of existing blood clots. This helps the body to break them down and prevents them from causing harm.
2. It prevents the formation of new blood clots.
   Enoxaparina Ledraxen can be used for:

• Treating blood clots that are already present
• Preventing the formation of blood clots in your blood in the following situations:
  • Before and after surgery
  • In case of a short-term illness involving a limited period of reduced mobility
  • if you have had a blood clot due to cancer, to prevent further clots from forming
• Preventing the formation of blood clots in unstable angina (when insufficient blood reaches the heart) or after a heart attack
• Preventing the formation of blood clots in the tubes of a dialysis machine (used by people with severe kidney problems).

2. What you need to know before using Enoxaparina Ledraxen

Do not use Enoxaparina Ledraxen if:

• you are allergic to: either enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6), or heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin. Signs of an allergic reaction include: skin rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat or eyes.
• you have previously had a reaction to heparin that caused a severe decrease in the number of blood clotting cells (platelets) within the last 100 days
• you have antibodies against enoxaparin in your blood
• you are actively bleeding or have a disease with a high risk of bleeding such as: stomach ulcer, recent brain or eye surgery, or recent haemorrhagic stroke.
• you are using Enoxaparina Ledraxen to treat blood clots and will undergo within the next 24 hours: a lumbar or spinal puncture or surgery with spinal or epidural anaesthesia.

Do not use Enoxaparina Ledraxen if you are in any of the above conditions. If you have any doubts, contact your doctor or pharmacist before using Enoxaparina Ledraxen.

Warnings and precautions
Enoxaparina Ledraxen must not be substituted with other medicines belonging to the group of
low molecular weight heparins. These medicines are not identical to each other and do not have
the same activity or the same instructions for use.
Consult your doctor or pharmacist before using Enoxaparina Ledraxen if:

• you have ever had a reaction to heparin that caused a significant reduction in the number of blood clotting cells (platelets)
• you have had a heart valve implanted
• you suffer from endocarditis (an infection of the inner lining of the heart)
• you suffer from a stomach ulcer
• you have recently had a stroke
• you have high blood pressure
• you have diabetes or eye blood vessel problems caused by diabetes (so-called diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), especially if you are over 75
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (levels can be checked with a blood test)
• you are currently taking medicines that affect bleeding (see section 2, “Other medicines and Enoxaparina Ledraxen”)
• you have any spinal problems or have undergone spinal surgery.

If you are in any of the above conditions (or are unsure), contact your doctor or pharmacist
before using Enoxaparina Ledraxen.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
Tests and monitoring
You may need to have a blood test before starting this medicine and at regular intervals during treatment,
to monitor the levels of blood clotting cells (platelets) and the level of potassium in your blood.
Other medicines and Enoxaparina Ledraxen
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• warfarin – used to thin the blood
• aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to prevent blood clots (see section 3, “Changing from another anticoagulant medicine”)
• dextran injection – used as a blood substitute
• ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), 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 that increase potassium levels in the blood such as potassium salts, diuretics and certain medicines for heart problems

Surgery and anaesthesia
If you are scheduled for a spinal or lumbar puncture or surgery requiring epidural or spinal anaesthesia,
inform your doctor that you are using Enoxaparina Ledraxen.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
If you are pregnant and have a mechanical heart valve, you may be at increased risk of developing blood clots. Your doctor will discuss this with you.
If you are breastfeeding or planning to breastfeed, ask your doctor for advice before taking this medicine.
Use in children and adolescents
The safety and efficacy of Enoxaparina Ledraxen has not been established in children or adolescents.
Driving and using machines
Enoxaparina Ledraxen does not affect the ability to drive or operate machinery.
It is recommended that the healthcare provider records the brand name and batch number of the product you are using.

3. How to use Enoxaparin Ledraxen

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Administration of the medicine

• Enoxaparin Ledraxen is normally administered by a doctor or nurse, as 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 a vein) after certain types of heart attack or surgical procedures.
• Enoxaparin Ledraxen may be added to the tubing draining blood from the body (arterial line) at the beginning of a dialysis session.
• Do not inject Enoxaparin Ledraxen into a muscle.

How much medicine will be administered to you

• Your doctor will decide how much Enoxaparin Ledraxen you will receive. The dose depends on the reason for its use.
• If you have kidney problems, you may need to receive a lower dose of Enoxaparin Ledraxen.

1. Treatment of blood clots present in the blood

• 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 should receive Enoxaparin Ledraxen.

2. Prevention of blood clot formation during surgical procedures or periods of reduced mobility due to illness

• The dose depends on how likely a clot is to develop. You may receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of Enoxaparin Ledraxen per day.
• If surgery is planned, the first injection is usually given 2 or 12 hours before the operation.
• In case of reduced mobility due to illness, 4,000 IU (40 mg) of Enoxaparin Ledraxen is usually administered daily.
• Your doctor will decide how long you should receive Enoxaparin Ledraxen.

3. Prevention of blood clots in the case of unstable angina or after a heart attack

Enoxaparin Ledraxen can be used for two different types of heart attack. The amount of Enoxaparin Ledraxen administered depends on your age and the type of heart attack you have had.

Heart attack of the NSTEMI type (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 ask you to take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should receive Enoxaparin Ledraxen.

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

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

Heart attack of the STEMI type 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 amount of Enoxaparin Ledraxen administered for the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you should receive Enoxaparin Ledraxen.

For patients undergoing a procedure called percutaneous coronary intervention:
Depending on when Enoxaparin Ledraxen was last administered, your doctor may decide to administer an additional dose of Enoxaparin Ledraxen before a percutaneous coronary intervention. The medicine will be injected into a vein.

4. Prevention of blood clot formation in the dialysis machine tubing

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

How to self-inject Enoxaparina Ledraxen
If you are able to self-administer Enoxaparina Ledraxen, your doctor or nurse will show you how to do it. Do not attempt to give the injection yourself unless you have been properly trained.
If you are unsure about what to do, consult your doctor or nurse immediately. Correct administration of the injection under the skin (called a "subcutaneous injection") will help reduce pain and bruising at the injection site.
Before self-injecting Enoxaparina Ledraxen:

• Gather the necessary supplies: syringe, alcohol swab or soap and water, and a sharps container
• Check the medicine’s expiry date. Do not use it if the date has passed
• Check that the syringe is undamaged and that the medicine inside is a clear solution. If not, use another syringe
• Make sure you know how much medicine you need to inject
• Examine the abdominal area to see if the previous injection caused redness, skin discoloration, swelling, oozing, or is still painful. If so, contact your doctor or nurse.

Instructions for using the syringe
Proper use of syringes is necessary to reduce the risk of pain and bruising at the injection site. Follow these instructions carefully.
Instructions for pre-filled syringes without a safety system

• Preparing the injection site: Before injecting, wash and dry your hands. Use a cotton swab to clean (without rubbing) the area selected for injection. Choose a different area of the abdomen for each injection.
• Remove the protective needle cap: A drop may appear at the tip of the needle. If so, remove the drop before injecting by gently tapping the syringe body (with the needle pointing downward).

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

• Immediately dispose of the syringe in the appropriate sharps container.

Any unused medicine or waste material derived from this medicine must be disposed of in accordance with local regulations.
Instructions for pre-filled syringes with a safety system

• Preparing the injection site: Before injecting, wash and dry your hands. Use a cotton swab to clean (without rubbing) the area selected for injection. Choose a different area of the abdomen for each injection.
• First, bend the safety lock device sideways by about 90 degrees. Important: do not remove the cap before bending the safety lock device.

• Remove the protective needle cap. A drop may appear at the tip of the needle. If so, remove the drop before injecting by gently tapping the syringe body (with the needle pointing downward).

• Administer the injection: The pre-filled syringe is ready for immediate use. Choose an area on the right or left side of the abdomen, at least 5 cm away from the navel and toward the sides.

Hold the syringe so that the needle points downward (vertically at a 90º angle), into a skin fold pinched between the thumb and index finger of the operator. Maintain the skin fold throughout the entire injection.

• Engage the needle safety device: Place the safety device against a hard, stable surface using one hand. Important: do not use your fingers to secure the needle into the safety device. Then press down on the safety device. Bend the safety device until the needle clicks audibly into the plastic part.

When you have finished

1. To avoid bruising, do not rub the site where you just injected.
2. Dispose of the used syringe in the appropriate sharps container. Close the container lid tightly and keep the container out of the reach of children. When the container is full, dispose of it according to your doctor’s or pharmacist’s instructions.
   Any unused medicine or waste material derived from this medicine must be disposed of in accordance with local regulations.
   Switching from another anticoagulant medicine

• Switching from Enoxaparina Ledraxen to vitamin K antagonists (such as warfarin)
  Your doctor will ask you to have a blood test called INR and, based on the result, will tell you when to stop treatment with Enoxaparina Ledraxen.
• Switching from vitamin K antagonists (such as warfarin) to Enoxaparina Ledraxen
  Stop taking the vitamin K antagonist. Your doctor will ask you to have a blood test called INR and, based on the result, will tell you when to start treatment with Enoxaparina Ledraxen.
• Switching from Enoxaparina Ledraxen to direct oral anticoagulants
  Stop administering Enoxaparina 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 anticoagulants to Enoxaparina Ledraxen
  Stop taking the direct oral anticoagulant. Start treatment with Enoxaparina Ledraxen only 12 hours after the last dose of the direct oral anticoagulant.

If you use more Enoxaparina Ledraxen than you should
If you think you have used too much or too little Enoxaparina Ledraxen, inform your doctor, nurse, or pharmacist immediately, even if you do not have any symptoms. If a child accidentally injects or swallows Enoxaparina Ledraxen, take them immediately to the emergency room.
If you forget to use Enoxaparina Ledraxen
If you forget to administer a dose, take it as soon as you remember. Do not administer a double dose on the same day to make up for the missed dose. Keeping a diary will help ensure you do not miss a dose.
If you stop using Enoxaparina Ledraxen
It is important that you continue your Enoxaparina Ledraxen injections until your doctor decides to stop them. If you stop, a blood clot may form, which could be very dangerous.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Serious side effects

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

Stop using enoxaparin and consult a doctor immediately if you notice any of the following symptoms:

• A widespread red, scaly rash with lumps under the skin and blisters accompanied by fever. Symptoms usually occur early in treatment (generalized pustular exanthema).

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

Seek immediate medical attention:

• if you experience any type of bleeding that does not stop on its own
• if you experience signs of excessive bleeding such as extreme weakness, fatigue, paleness, dizziness, headache or unexplained swelling. Your doctor may decide to monitor you closely or switch your medication.

You must inform your doctor immediately:

• If you experience signs of a blood vessel blockage caused by a clot, such as:
  • painful cramps, redness, warmth or swelling in one of the legs – symptoms of deep vein thrombosis
  • shortness of breath, chest pain, fainting or coughing up blood – symptoms of pulmonary embolism
• If you develop a painful rash with dark red spots under the skin that do not fade when pressed. Your doctor may ask you to have a blood test to check your platelet count.

Complete list of possible 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)

• Bruising more easily than usual. This may be due to a blood disorder with low platelet count.
• Pink spots on the skin. These are more likely to appear at the site where Enoxaparin Ledraxen was injected.
• Skin rash (bumps, hives)
• Red, itchy skin
• Bruising or pain at the injection site
• Decrease in red blood cells
• High number of platelets in the blood
• Headache

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache which may be a sign of bleeding in the brain
• Stomach pain and swelling. This may be a symptom of bleeding in the stomach
• Large, irregularly shaped red skin lesions with or without blisters
• Skin irritation (local irritation)
• Yellowing of the skin or eyes and darker urine. This may indicate a liver problem

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

• Severe allergic reaction. Signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• Increased potassium levels in the blood. This is more likely in people with kidney problems or diabetes. Your doctor may monitor this with a blood test.
• Increased number of eosinophils in the blood. Your doctor may monitor this with a blood test.
• Hair loss
• Osteoporosis (a condition that makes bones more fragile) after prolonged use
• Tingling, numbness, and muscle weakness (particularly in the lower part of the body) after having had a spinal puncture or spinal anaesthetic
• Loss of bladder or bowel control (inability to control when to go to the toilet)
• Hard mass or nodule at the injection site

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enoxaparin 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 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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Enoxaparina Ledraxen contains
2,000 IU (20 mg)/0.2 mL solution for injection

• The active substance is enoxaparin sodium.
• Each mL contains 100 mg of enoxaparin sodium.
• Each 0.2 mL pre-filled syringe contains 2,000 IU anti-Xa activity (equivalent to 20 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

4,000 IU (40 mg)/0.4 mL solution for injection

• The active substance is enoxaparin sodium.
• Each mL contains 100 mg of enoxaparin sodium.
• Each 0.4 mL pre-filled syringe contains 4,000 IU anti-Xa activity (equivalent to 40 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

6,000 IU (60 mg)/0.6 mL solution for injection

• The active substance is enoxaparin sodium.
• Each mL contains 100 mg of enoxaparin sodium.
• Each 0.6 mL pre-filled syringe contains 6,000 IU anti-Xa activity (equivalent to 60 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

8,000 IU (80 mg)/0.8 mL solution for injection

• The active substance is enoxaparin sodium.
• Each mL contains 100 mg of enoxaparin sodium.
• Each 0.8 mL pre-filled syringe contains 8,000 IU anti-Xa activity (equivalent to 80 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

10,000 IU (100 mg)/1 mL solution for injection

• The active substance is enoxaparin sodium.
• Each mL contains 100 mg of enoxaparin sodium.
• Each 1 mL pre-filled syringe contains 10,000 IU anti-Xa activity (equivalent to 100 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

Description of the appearance of Enoxaparina Ledraxen and contents of the pack
2,000 IU (20 mg)/0.2 mL solution for injection
Clear, colourless or pale yellow solution.
0.2 mL solution in a colourless Type I glass syringe with a fixed needle and needle cap sealed with a chlorobutyl rubber stopper and a purple polypropylene plunger (with or without safety system).
Pack sizes of 1, 2, 6, 10, 20 and 50 pre-filled syringes.

4,000 IU (40 mg)/0.4 mL solution for injection
Clear, colourless or pale yellow solution.
0.4 mL solution in a colourless Type I glass syringe with a fixed needle and needle cap sealed with a chlorobutyl rubber stopper and a yellow polypropylene plunger (with or without safety system).
Pack sizes of 1, 2, 6, 10, 20, 30 and 50 pre-filled syringes.

6,000 IU (60 mg)/0.6 mL solution for injection
Clear, colourless or pale yellow solution.
0.6 mL solution in a graduated colourless Type I glass syringe with a fixed needle and needle cap sealed with a chlorobutyl rubber stopper and an orange polypropylene plunger (with or without safety system).
Pack sizes of 1, 2, 6, 10, 12, 20, 24, 30 and 50 pre-filled syringes.

8,000 IU (80 mg)/0.8 mL solution for injection
Clear, colourless or pale yellow solution.
0.8 mL solution in a graduated colourless Type I glass syringe with a fixed needle and needle cap sealed with a chlorobutyl rubber stopper and a brown polypropylene plunger (with or without safety system).
Pack sizes of 1, 2, 6, 10, 12, 20, 24, 30 and 50 pre-filled syringes.

10,000 IU (100 mg)/1 mL solution for injection
Clear, colourless to pale yellow solution.
1 mL solution in a graduated colourless Type I glass syringe with a fixed needle and needle cap sealed with a chlorobutyl rubber stopper and a grey polypropylene plunger (with or without safety system).
Pack sizes of 1, 2, 6, 10, 12, 20, 24 and 30 pre-filled syringes.

The 0.2 mL and 0.4 mL syringes are not graduated.
The 0.6 mL, 0.8 mL and 1 mL syringes are graduated.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Venipharm
4, Bureaux de la Colline
Saint-Cloud
FRANCE
+33 1 47 11 04 47
[email protected]

Manufacturer
Centre Spécialités Pharmaceutiques
ZAC des Suzots
35 rue de la Chapelle
F-63450
Saint-Amant Tallende
FRANCE

This medicinal product is authorized in the European Economic Area and 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
Letonia: 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
Hungary: Enoxaparin Ledraxen
Iceland: Enoxaparin Ledraxen
Italy: Enoxaparina Ledraxen

Other sources of information
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency: http://www.agenziafarmaco.gov.it/it .