Enoxaparin sodium Lek-am

Leaflet accompanying 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
Enoxaparinum natricum
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 may get. To learn how to report side effects, see point 4.

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See point 4.

Table of contents of the leaflet

• 1. What is Enoxaparin sodium LEK-AM and what is it used for
• 2. Important information before using Enoxaparin sodium LEK-AM
• 3. How to use Enoxaparin sodium LEK-AM
• 4. Possible side effects
• 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 less harmful.
• 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 acute illness, when the patient has limited mobility.
• In unstable angina (a condition where 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 problems).

2. Important information before using Enoxaparin sodium LEK-AM

When not to use Enoxaparin sodium LEK-AM

• If the patient is allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in point 6). Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the face, lips, 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 (such as stomach ulcers, recent brain or eye surgery), including recent hemorrhagic stroke.
• If the patient is using Enoxaparin sodium LEK-AM to treat blood clots and spinal or epidural anesthesia is planned.

Warnings and precautions

Enoxaparin sodium LEK-AM should not be used interchangeably with other low molecular weight heparins. This is because they are not identical, 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 (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 problems with blood vessels in the eyes caused by 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 problems;
• if the patient has liver problems;
• 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 medicines").

Before starting treatment with this medicine 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 medicines

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

• Warfarin - a medicine used to thin the blood.
• Aspirin (also known as acetylsalicylic acid or ASA), clopidogrel, or other medicines used to prevent blood clots (see also point 3 "Change of anticoagulant medicine").
• Dextran injections - used as a blood substitute.
• Ibuprofen, diclofenac, ketorolac, or other non-steroidal anti-inflammatory medicines 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, or certain heart medicines.

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 point "When not to use 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 using this medicine.
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 starting treatment with this medicine.

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 medicine 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 use Enoxaparin sodium LEK-AM

This medicine should always be used exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should ask their doctor or pharmacist.

Administration of the medicine

• 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 using 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 medicine

• The doctor will decide what dose of Enoxaparin sodium LEK-AM the patient should take. This depends on the reason for using the medicine.
• In patients with kidney problems, the patient may receive a smaller dose of Enoxaparin sodium LEK-AM.
• 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 receive Enoxaparin sodium LEK-AM.
• 2. Prevention of blood clot formation in the patient's blood in the following situations:

❖
Surgical procedure or 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 performed 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 receive 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 receive 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.
• At the same time, Enoxaparin sodium LEK-AM will also be 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 receive 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 receive 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 medicine 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 injected into the tube returning blood from the body (into the so-called arterial line) at the beginning of the dialysis session. This dose usually lasts 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 by the patient themselves
If the patient can administer the medicine themselves, the doctor or nurse will show them how to do it.
The patient should not attempt to administer the medicine themselves without prior training.
If the patient is unsure, they should consult their doctor or nurse immediately.
Before administering Enoxaparin sodium LEK-AM

• Check the expiration date of the medicine. Do not use it if the date has passed.
• Check if the pre-filled syringe is damaged and if the medicine is a clear solution. If not, use another pre-filled syringe.
• Do not use the medicine if the patient notices any changes in its appearance.
• Make sure the planned dose of the medicine is known.
• Examine the abdomen to check if the last injection caused redness, discoloration, swelling, discharge, or persistent pain
• if so, consult a doctor or nurse.
• Decide where to inject the medicine. The medicine should be administered alternately to the left and right side of the abdomen. The medicine should be injected 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 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 medicine into areas within 5 cm of the navel or around scars or bruises. The medicine should be injected 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 medicine and ready for use.

Do notpress the plunger before injecting the medicine to remove air bubbles.
This may cause loss of medicine. 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 writing hand, 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 medicine 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 medicine

• Change from Enoxaparin sodium LEK-AM to medicines 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, based on this, 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 blood tests to determine the INR and, based on this, 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. After that, they should continue taking the oral anticoagulant as usual.
• Change from direct oral anticoagulants 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 used 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.

Missed dose of Enoxaparin sodium LEK-AM

If the patient misses a dose, they should take it as soon as possible. They should not take a double dose to make up for the missed dose. Keeping a diary helps to ensure that no dose is missed.

Stopping treatment with Enoxaparin sodium LEK-AM

If the patient has any further questions about using this medicine, they should ask their doctor, pharmacist, or nurse.
It is important to continue injecting Enoxaparin sodium LEK-AM until the doctor recommends stopping it. If treatment is stopped, a blood clot may form, which can be very dangerous.

4. Possible side effects

Like other similar medicines (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 medicine.
The patient should stop using Enoxaparin sodium LEK-AM and immediately consult their doctor or nurse if they experience signs 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 using 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 leg - 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 side effects:

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.
• 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 abdomen. This may be a sign of bleeding in the abdomen.
• Large, red, irregularly shaped skin changes 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 problems.

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 problems 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 medicine.
• Numbness, tingling, and muscle weakness (especially in the lower part of the body) after lumbar puncture or spinal or epidural anesthesia.
• Loss of bladder or bowel control (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 side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides)
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Enoxaparin sodium LEK-AM

Store at a temperature below 25°C. The medicine can also be stored in the refrigerator (2°C - 8°C) for no longer than 1 month. Do not freeze.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Do not use this medicine if visible signs of damage are observed.
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 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 blister packs, in a cardboard box.
2 or 10 pre-filled syringes with a needle, 0.2 ml each
2 or 10 pre-filled syringes with a needle, 0.4 ml each
2 or 10 pre-filled syringes with a needle, 0.6 ml each
2 or 10 pre-filled syringes with a needle, 0.8 ml each
2 or 10 pre-filled syringes with a needle, 1 ml each
Not all pack sizes may be marketed.

Marketing authorization holder

Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14a, 05-170 Zakroczym, Poland
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Importer

Health-Med. spółka z ograniczoną odpowiedzialnością
Spółka komandytowa
Ul. Walewska 8 lok. 5
04-022 Warsaw

Date of last revision of the leaflet:

Other sources of information

Detailed information about this medicine is available on the website of the Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides) http://www.urpl.gov.pl/pl