Enoxaparin sodium Lek-am

Leaflet attached to the packaging: patient information

Enoxaparin sodium LEK-AM, 2000 IU (20 mg)/0.2 ml, solution for injection
Enoxaparin sodium LEK-AM, 4000 IU (40 mg)/0.4 ml, solution for injection
Enoxaparin sodium LEK-AM, 6000 IU (60 mg)/0.6 ml, solution for injection
Enoxaparin sodium LEK-AM, 8000 IU (80 mg)/0.8 ml, solution for injection
Enoxaparin sodium LEK-AM, 10,000 IU (100 mg)/1 ml, solution for injection
Enoxaparin sodium
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also contribute to this by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

You should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicinal product has been prescribed specifically for you. Do not pass it on to others. The medicinal product may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Enoxaparin sodium LEK-AM and what is it used for
• 2. Important information before taking Enoxaparin sodium LEK-AM
• 3. How to take Enoxaparin sodium LEK-AM
• 4. Possible adverse reactions
• 5. How to store Enoxaparin sodium LEK-AM
• 6. Contents of the packaging and other information

1. What is Enoxaparin sodium LEK-AM and what is it used for

Enoxaparin sodium LEK-AM contains the active substance enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Enoxaparin sodium LEK-AM works in two ways:

• 1) It prevents the growth of existing blood clots. This helps the body to dissolve existing blood clots, making them harmless.
• 2) It prevents the formation of new blood clots in the patient's blood.

Enoxaparin sodium LEK-AM can be used for:

• Treating blood clots that are already present in the patient's blood.
• Preventing the formation of blood clots in the patient's blood in the following situations:
• Before and after surgery.
• In the course of an acute illness, when the patient has limited mobility.
• In unstable angina (a condition in which the heart does not receive enough blood).
• After a heart attack.
• Preventing the formation of blood clots in dialysis tubes (used in people with severe kidney function disorders).

2. Important information before taking Enoxaparin sodium LEK-AM

When not to take Enoxaparin sodium LEK-AM

• If the patient is allergic to enoxaparin sodium or any of the other ingredients of this medicinal product (listed in section 6). Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If the patient has been diagnosed with an allergy to heparin or other low molecular weight heparins, such as nadroparin, tinzaparin, or dalteparin.
• If the patient has been diagnosed with a reaction to heparin that caused a significant decrease in the number of blood cells responsible for blood clotting (platelets) - a reaction known as heparin-induced thrombocytopenia - within the last 100 days or if there are antibodies against enoxaparin in the patient's blood.
• If the patient has severe bleeding or a medical condition associated with an increased risk of bleeding (e.g., stomach ulcers, recent brain or eye surgery), including recent hemorrhagic stroke.
• If the patient is taking Enoxaparin sodium LEK-AM to treat blood clots and spinal or epidural anesthesia or lumbar puncture is planned within 24 hours.

Warnings and precautions

Enoxaparin sodium LEK-AM should not be used interchangeably with other low molecular weight heparins. This is because they are not exactly the same, differ in activity, and have different instructions for use.
Before starting treatment with Enoxaparin sodium LEK-AM, the patient should discuss the following with their doctor or pharmacist:

• if the patient has ever had a reaction to heparin that caused a significant decrease in the number of platelets;
• if the patient is scheduled for spinal or epidural anesthesia or lumbar puncture (see "Surgical procedures and anesthetics"): an appropriate time interval should be allowed between the administration of Enoxaparin sodium LEK-AM and this procedure;
• if the patient has a heart valve replacement;
• if the patient has endocarditis (infection of the membrane lining the heart);
• if the patient has had stomach ulcers;
• if the patient has recently had a stroke;
• if the patient has high blood pressure;
• if the patient has diabetes or has problems with blood vessels in the eyes due to diabetes (diabetic retinopathy);
• if the patient has recently had eye or brain surgery;
• if the patient is elderly (over 65 years), especially if they are over 75 years old;
• if the patient has kidney disease;
• if the patient has liver disease;
• if the patient is underweight or overweight;
• if the patient has an increased level of potassium in the blood (which can be checked with a blood test);
• if the patient is currently taking medications that may cause bleeding (see below "Enoxaparin sodium LEK-AM and other medications").

Before starting treatment with this medicinal product and periodically during treatment, the patient may undergo a blood test to check the number of platelets and potassium levels in the blood.

Enoxaparin sodium LEK-AM and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

• Warfarin - a medication used to thin the blood.
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel, or other medications used to prevent blood clots (see also section 3 "Change of anticoagulant medication").
• Dextran injections - used as a blood substitute.
• Ibuprofen, diclofenac, ketorolac, or other non-steroidal anti-inflammatory medications used to treat pain and swelling in arthritis and other conditions.
• Prednisolone, dexamethasone, or other medications used to treat asthma, rheumatoid arthritis, and other conditions.
• Medications that increase potassium levels in the blood, such as potassium salts, diuretics, or certain heart medications.

Surgical procedures and anesthetics

If the patient is scheduled for a lumbar puncture or surgery under spinal or epidural anesthesia, they should inform their doctor that they are taking Enoxaparin sodium LEK-AM. See "When not to take Enoxaparin sodium LEK-AM".
Additionally, the patient should inform their doctor if they have any spinal problems or if they have had spinal surgery.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicinal product.
In pregnant women with a mechanical heart valve, there may be an increased risk of blood clots. The doctor should discuss this with the patient.
Women who are breastfeeding or plan to breastfeed should consult their doctor before taking this medicinal product.

Driving and using machines

Enoxaparin sodium LEK-AM does not affect the ability to drive or use machines.

Enoxaparin sodium LEK-AM contains sodium

The medicinal product contains less than 1 mmol (23 mg) per dose, which means it is considered "sodium-free".
The doctor should document the trade name and batch number of the product used.

3. How to take Enoxaparin sodium LEK-AM

This medicinal product should always be taken according to the doctor's or pharmacist's instructions. If you have any doubts, you should consult a doctor or pharmacist.

Taking the medicinal product

• Enoxaparin sodium LEK-AM is usually administered to the patient by a doctor or nurse. This is because it requires injection.
• After returning home, the patient may need to continue taking Enoxaparin sodium LEK-AM and administer it themselves (see the administration instructions below).
• Enoxaparin sodium LEK-AM is usually administered subcutaneously.
• Enoxaparin sodium LEK-AM may be administered intravenously in certain types of heart attack or after surgery.
• Enoxaparin sodium LEK-AM may be introduced into the dialysis tube returning blood from the body (into the so-called arterial line) at the beginning of the dialysis session.
• Enoxaparin sodium LEK-AM should not be administered intramuscularly.

Dose of the medicinal product

• The doctor will decide what dose of Enoxaparin sodium LEK-AM the patient should take. This depends on the reason for taking the medicinal product.
• In patients with kidney disease, the dose of Enoxaparin sodium LEK-AM may be lower.
• 1. Treatment of blood clots in the patient's blood
• The usual dose is 150 IU (1.5 mg) per kilogram of body weight once a day or 100 IU (1 mg) per kilogram of body weight twice a day.
• The doctor will decide how long the patient should take Enoxaparin sodium LEK-AM.
• 2. Prevention of blood clot formation in the patient's blood in the following situations:

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Surgical procedure or period of limited mobility due to illness

• The dose depends on the patient's risk of blood clot formation. The patient will receive Enoxaparin sodium LEK-AM at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) per day.
• The first injection is usually administered 2 hours or 12 hours before surgery.
• If the patient has limited mobility due to illness, they usually receive Enoxaparin sodium LEK-AM at a dose of 4000 IU (40 mg) per day.
• The doctor will decide how long the patient should take Enoxaparin sodium LEK-AM.

❖
After a heart attack
Enoxaparin sodium LEK-AM can be used in two different types of heart attack: ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI).
The dose of Enoxaparin sodium LEK-AM will depend on the patient's age and the type of heart attack they had.
NSTEMI:

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also take aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should take Enoxaparin sodium LEK-AM.

STEMI in patients under 75 years of age:

• The initial dose of Enoxaparin sodium LEK-AM is 3000 IU (30 mg) administered intravenously.
• Enoxaparin sodium LEK-AM is also administered subcutaneously. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also take aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should take Enoxaparin sodium LEK-AM.

STEMI in patients 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 dose of Enoxaparin sodium LEK-AM in the first two doses is 7500 IU (75 mg).
• The doctor will decide how long the patient should take Enoxaparin sodium LEK-AM.

Patients undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Enoxaparin sodium LEK-AM was administered, the doctor may decide to administer an additional dose of Enoxaparin sodium LEK-AM before the PCI procedure. The medicinal product will be administered intravenously.

• 3. Prevention of blood clot formation in dialysis tubes
• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Enoxaparin sodium LEK-AM is administered into the dialysis tube returning blood from the body (into the so-called arterial line) at the beginning of the dialysis session. This dose is usually sufficient for a 4-hour dialysis session. However, if necessary, the doctor may administer an additional dose of 50 IU to 100 IU (0.5 to 1 mg) per kilogram of body weight.

Instructions for using the pre-filled syringe

How to administer Enoxaparin sodium LEK-AM injections yourself
If you can administer this medicinal product yourself, your doctor or nurse will show you how to do it.
Do not attempt to administer the injection yourself without prior training.
If you are unsure what to do, you should consult your doctor or nurse immediately.
Before administering Enoxaparin sodium LEK-AM yourself

• Check the expiration date of the medicinal product. Do not use it if the date has passed.
• Check if the pre-filled syringe is damaged and if the medicinal product is a clear solution. If not, use a different pre-filled syringe.
• Do not use this medicinal product if you notice any changes in its appearance.
• Make sure you know the planned dose of the medicinal product to be administered.
• Examine your abdomen to check if the last injection caused redness, discoloration, swelling, discharge, or persistent pain
• if so, consult your doctor or nurse.
• Decide where to administer the injection. The medicinal product should be administered alternately to the left and right side of the abdomen. The injection should be administered just under the skin on the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away).
• The pre-filled syringe is for single use only.

Instructions for self-administering Enoxaparin sodium LEK-AM

• 1)Wash your hands and the injection site with water and soap. Dry.
• 2)Sit or lie down in a comfortable, relaxed position. Make sure the planned injection site is visible. It is recommended to use a recliner, armchair, or bed with pillows.

• 3)Choose a site on the right or left side of the abdomen. It should be at least 5 cm away from the navel towards the side.

Important:Do not inject the medicinal product into areas that are less than 5 cm away from the navel or around scars or bruises. The medicinal product should be administered alternately to the left and right side of the abdomen, changing sides each time.

• 4)Carefully remove the needle cap. The pre-filled syringe is pre-filled with the medicinal product and ready for use.

Do notpress the plunger before injecting the medicinal product to remove air bubbles.
This may cause loss of some of the medicinal product. After removing the cap, do not allow the needle to come into contact with any object. This is to ensure the sterility of the needle.

• 5)Hold the pre-filled syringe (like a pencil) in the hand used for writing, and with the other hand gently pinch the cleaned area on the abdomen between the thumb and index finger, creating a skin fold.

Remember to hold the skin fold in this way throughout the injection.

• 6)Hold the pre-filled syringe so that the needle is pointing downwards (at a 90º angle). Insert the entire length of the needle into the skin fold.

• 7)Press the plunger with your finger. This will move the medicinal product into the fatty tissue on the abdomen. Remember to hold the skin fold throughout the injection.
• 8)Remove the needle, pulling it straight out.

To avoid bruising, do not rub the injection site after administration.

• 9)Dispose of the used pre-filled syringe.

Used pre-filled syringes should be disposed of in special containers at pharmacies or hospitals. Pre-filled syringes should not be disposed of in household waste containers.

Change of anticoagulant medication

• Change from Enoxaparin sodium LEK-AM to medications that thin the blood, known as vitamin K antagonists (e.g., warfarin)The doctor will recommend blood tests to determine the INR (International Normalized Ratio) and on this basis will inform the patient when to stop taking Enoxaparin sodium LEK-AM.
• Change from vitamin K antagonists (e.g., warfarin) to Enoxaparin sodium LEK-AMThe patient should stop taking the vitamin K antagonist. The doctor will recommend a blood test to determine the INR and on this basis will inform the patient when to start taking Enoxaparin sodium LEK-AM.
• Change from Enoxaparin sodium LEK-AM to direct oral anticoagulantsThe patient should stop taking Enoxaparin sodium LEK-AM. Then, they should start taking the direct oral anticoagulant 0-2 hours before the scheduled time of the next injection. Then, they should continue taking the oral anticoagulant as usual.
• Change from direct oral anticoagulant to Enoxaparin sodium LEK-AMThe patient should stop taking the direct oral anticoagulant. Treatment with Enoxaparin sodium LEK-AM can be started 12 hours after the last dose of the direct oral anticoagulant.

Use in children and adolescents

The safety and efficacy of Enoxaparin sodium LEK-AM in children and adolescents have not been established.

Overdose of Enoxaparin sodium LEK-AM

If the patient thinks they have taken too much or too little Enoxaparin sodium LEK-AM, they should immediately inform their doctor, nurse, or pharmacist, even if they do not notice any problems.
In case of accidental injection or ingestion of Enoxaparin sodium LEK-AM by a child, they should immediately go to the hospital emergency department.

Missing a dose of Enoxaparin sodium LEK-AM

If a dose is missed, it should be taken as soon as possible. A double dose should not be taken to make up for a missed dose. Keeping a diary can help ensure that no dose is missed.

Stopping treatment with Enoxaparin sodium LEK-AM

If the patient has any further doubts about taking this medicinal product, they should consult their doctor, pharmacist, or nurse.
It is important to continue administering Enoxaparin sodium LEK-AM injections until the doctor recommends stopping them. If treatment is stopped, a blood clot may form, which can be very dangerous.

4. Possible adverse reactions

Like other similar medications (used to reduce blood clotting), Enoxaparin sodium LEK-AM may cause bleeding, which can be life-threatening. In some cases, bleeding may not be immediately visible.
If the patient experiences any bleeding that does not stop on its own, as well as signs of excessive bleeding (severe weakness, fatigue, paleness, dizziness, headaches, or unexplained sweating), they should immediately consult their doctor.
The doctor may decide to monitor the patient more closely or change the medication.
The patient should stop taking Enoxaparin sodium LEK-AM and immediately consult their doctor or nurse if they experience symptoms of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).
If the patient experiences any of the following symptoms, they should stop taking Enoxaparin sodium LEK-AM and seek medical attention immediately:

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

The patient should immediately consult their doctor:

• If they experience any signs of a blood clot, such as:
• cramping pain, redness, increased warmth, or swelling in one of the legs - these are symptoms of deep vein thrombosis;
• shortness of breath, chest pain, fainting, or coughing up blood - these are symptoms of pulmonary embolism.
• If the patient experiences painful rash or dark red spots under the skin that do not disappear when pressed. The doctor may order blood tests to check the platelet count.

List of possible adverse reactions:

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

• Bleeding.
• Increased liver enzyme activity.

Common (may affect up to 1 in 10 people)

• Increased tendency to bruise. This may be due to a decrease in platelet count.
• Pink spots on the skin. These changes are more likely to occur at the injection site of Enoxaparin sodium LEK-AM.
• Hives.
• Itching, redness of the skin.
• Bruising or pain at the injection site.
• Decreased red blood cell count.
• Increased platelet count.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden severe headache. This may be a sign of bleeding in the brain.
• Tenderness and swelling in the stomach. This may be a sign of bleeding in the stomach.
• Large, red, irregularly shaped skin lesions with blisters or without blisters.
• Skin irritation (local irritation).
• The patient may notice yellowing of the skin or eyes and darker urine. This may indicate liver disease.

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

• Severe allergic reaction. Symptoms of such a reaction 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 to occur in people with kidney disease or diabetes. The doctor may check this with a blood test.
• Increased eosinophil count in the blood. The doctor may check this with a blood test.
• Hair loss.
• Osteoporosis (a condition in which bones are more prone to fractures) after long-term use of the medicinal product.
• Numbness, tingling, and muscle weakness (especially in the lower part of the body) after lumbar puncture or spinal or epidural anesthesia.
• Loss of control over the bladder or bowels (a condition in which the patient is unable to control when they need to go to the toilet).
• Hardening or a lump at the injection site.

Reporting adverse reactions

If adverse reactions occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions can help gather more information on the safety of the medicinal product.

5. How to store Enoxaparin sodium LEK-AM

Store at a temperature below 25°C. The medicinal product can also be stored in a refrigerator (2°C - 8°C) for no more than 1 month. Do not freeze.
The medicinal product should be stored out of sight and reach of children.
Do not use this medicinal product after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Do not use this medicinal product if you notice any visible signs of damage.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Enoxaparin sodium LEK-AM contains

• The active substance of the medicinal product is enoxaparin sodium.

Enoxaparin sodium LEK-AM 2000 IU (20 mg)/0.2 ml:One pre-filled syringe of 0.2 ml contains 2000 IU (20 mg) of enoxaparin sodium.
Enoxaparin sodium LEK-AM 4000 IU (40 mg)/0.4 ml:One pre-filled syringe of 0.4 ml contains 4000 IU (40 mg) of enoxaparin sodium.
Enoxaparin sodium LEK-AM 6000 IU (60 mg)/0.6 ml:One pre-filled syringe of 0.6 ml contains 6000 IU (60 mg) of enoxaparin sodium.
Enoxaparin sodium LEK-AM 8000 IU (80 mg)/0.8 ml:One pre-filled syringe of 0.8 ml contains 8000 IU (80 mg) of enoxaparin sodium.
Enoxaparin sodium LEK-AM 10,000 IU (100 mg)/1 ml:One pre-filled syringe of 1 ml contains 10,000 IU (100 mg) of enoxaparin sodium.

• The other ingredient is water for injections.

What Enoxaparin sodium LEK-AM looks like and contents of the packaging

Pre-filled syringes with a needle, in blisters, in a cardboard box.
2 or 10 pre-filled syringes with a needle, 0.2 ml
2 or 10 pre-filled syringes with a needle, 0.4 ml
2 or 10 pre-filled syringes with a needle, 0.6 ml
2 or 10 pre-filled syringes with a needle, 0.8 ml
2 or 10 pre-filled syringes with a needle, 1 ml
Not all pack sizes may be marketed.

Marketing authorization holder

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14a, 05-170 Zakroczym, Poland
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Importer

Health-Med Ltd.
Ul. Walewska 8 lok. 5
04-022 Warsaw

Date of last update of the leaflet:

Other sources of information

Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl/pl