Losmina

Leaflet accompanying the packaging: patient information

Losmina, 2000 IU (20 mg)/0.2 ml, solution for injection in a pre-filled syringe
Losmina, 4000 IU (40 mg)/0.4 ml, solution for injection in a pre-filled syringe
Losmina, 6000 IU (60 mg)/0.6 ml, solution for injection in a pre-filled syringe
Losmina, 8000 IU (80 mg)/0.8 ml, solution for injection in a pre-filled syringe
Losmina, 10,000 IU (100 mg)/1 ml, solution for injection in a pre-filled syringe
Sodium enoxaparin
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. You can help by reporting any side effects you may get. To find out how to report side effects, see section 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 for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

• 1. What is Losmina and what is it used for
• 2. Important information before using Losmina
• 3. How to use Losmina
• 4. Possible side effects
• 5. How to store Losmina
• 6. Contents of the pack and other information

1. What is Losmina and what is it used for

Losmina contains the active substance sodium enoxaparin, which is a low molecular weight heparin (LMWH).
Losmina works in two ways.

• 1) It prevents the growth of existing blood clots. This helps the body to dissolve existing blood clots, so they are no longer harmful.
• 2) It prevents the formation of new blood clots in the patient's blood.

Losmina 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, during acute illness when the patient has reduced mobility, in patients who have developed blood clots in the circulating blood due to cancer, to further prevent the formation of new blood clots, in unstable angina (a condition where the heart does not receive enough blood), after a heart attack
• Preventing the formation of clots in the dialyzer tubes (used in people with severe kidney function disorders).

2. Important information before using Losmina

When not to use Losmina

• If the patient is allergic to sodium enoxaparin or any of the other ingredients of this medicine (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 using Losmina to treat blood clots and spinal or epidural anesthesia or lumbar puncture is planned.

Warnings and precautions

Losmina should not be used interchangeably with other low molecular weight heparins.
This is because they are not exactly the same, differ in activity and administration instructions.
Before starting to use Losmina, the patient should discuss this 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
• spinal or epidural anesthesia or lumbar puncture is planned (see "Surgical procedures and anesthetics"): an appropriate time interval should be considered between the use of Losmina and this procedure
• the patient has a heart valve replacement
• the patient has endocarditis (infection of the membrane lining the heart)
• the patient has had stomach ulcers
• the patient has recently had a brain stroke
• the patient has high blood pressure
• the patient has diabetes or has problems with blood vessels in the eyes caused by diabetes (so-called diabetic retinopathy)
• the patient has recently had eye or brain surgery
• the patient is elderly (over 65 years), especially if they are over 75 years old
• the patient has kidney disease
• the patient has liver disease
• the patient is underweight or overweight
• the patient has an increased level of potassium in the blood (which can be checked with a blood test)
• the patient is currently taking medications that may cause bleeding (see below "Losmina and other medicines")

Before starting to use this medicine and periodically during its use, the patient may undergo a blood test to check the number of platelets and potassium in the blood.

Children and adolescents:

The safety and efficacy of enoxaparin have not been evaluated in children and adolescents.

Losmina 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 section 3 "Change of anticoagulant treatment")
• Dextrans - 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, and 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 using Losmina. See section "When not to use Losmina". 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 baby, 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 using this medicine.

Driving and using machines

Losmina does not affect the ability to drive or use machines.
The doctor should document the trade name and batch number of the product used.

Losmina contains sodium

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

3. How to use Losmina

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

Administration of the medicine

• Losmina will usually be 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 Losmina and administer it themselves (see the administration instructions below).

The patient should read the administration instructions carefully and follow them exactly.

• Losmina is usually administered by subcutaneous injection.
• Losmina may be administered intravenously after certain types of heart attack or after surgery.
• Losmina 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. Losmina must not be administered by intramuscular injection.

Dose

• The doctor will decide what dose of Losmina the patient should take. This depends on the reason for using the medicine.
• In patients with kidney disease, the patient may receive a lower dose of Losmina.
• 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 daily or 100 IU (1 mg) per kilogram of body weight twice daily.
• The doctor will decide how long the patient should receive Losmina.
• 2. Prevention of blood clot formation in the patient's blood in the following situations:
• Surgery or reduced mobility due to illness
• The dose depends on the patient's risk of developing a blood clot. The patient will receive Losmina at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) once daily.
• For planned surgery, the first injection is usually given 2 hours or 12 hours before surgery.
• If the patient has reduced mobility due to illness, they will usually receive Losmina at a dose of 4000 IU (40 mg) once daily.
• The doctor will decide how long the patient should receive Losmina.
• After a heart attackLosmina 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 Losmina will depend on the patient's age and the type of heart attack they have had.

Non-ST-segment elevation myocardial infarction (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 takes aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Losmina.

ST-segment elevation myocardial infarction (STEMI) in patients under 75 years of age:

• An initial dose of 3000 IU (30 mg) of Losmina will be given intravenously.
• Losmina will also be given 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 takes aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Losmina.

ST-segment elevation myocardial infarction (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 Losmina in the first two doses is 7500 IU (75 mg).
• The doctor will decide how long the patient should receive Losmina.

Patients undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Losmina was given, the doctor may decide to give an additional dose of Losmina before the PCI procedure. The medicine will be given intravenously.

• 3. Prevention of blood clot formation in dialyzer tubes
• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Losmina is injected into the dialysis 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 give the patient 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

Self-administration of Losmina

If the patient is able to self-administer Losmina, the doctor or nurse will show them how to do it. The patient should not attempt to self-administer the medicine without instruction.
If the patient is unsure, they should talk to their doctor or nurse immediately. Proper administration of the injection under the skin (so-called subcutaneous injection) will help reduce pain and bruising at the injection site.

Before self-administering Losmina

• The patient should prepare the necessary items: syringe, cotton ball or soap and water, and a container for sharp objects.
• Check the expiration date on the packaging. Do not use the medicine after the expiration date.
• Check if the syringe is damaged and if the liquid is clear. If not, use another syringe.
• Make sure what dose is to be administered.
• Examine the abdomen to check if the last injection has caused redness, skin discoloration, swelling, discharge, or if it is still painful. If so, consult a doctor or nurse.

Instructions for self-administering Losmina:

(Instructions for pre-filled syringes without a safety system)

Preparing the injection site

• 1) Choose an injection site on the right or left side of the abdomen. The injection site should be at least 5 cm away from the navel towards the sides.
• Do not inject within 5 cm of the navel or around existing scars or bruises.
• The injection site should be changed between the left and right sides of the abdomen, depending on the site of the previous injection.

• 2) Wash your hands. Clean (do not rub) the injection site with a cotton ball soaked in alcohol or soap and water.
• 3) Sit or lie down in a comfortable position, so you are relaxed. Make sure the injection site is in sight. A chair, couch, or bed with pillows for support will be suitable.

Choosing the dose

• 1) Carefully remove the needle cap from the syringe. Discard the cap.
• Do not press the plunger before injecting to remove air bubbles. This may reduce the administered dose.
• After removing the cap, do not touch anything with the needle. This will ensure the sterility of the needle.

• 2) If the amount of medicine in the syringe is consistent with the prescribed dose, no dose adjustment is necessary. The injection can be administered.
• 3) If the dose depends on body weight, it may be necessary to adjust the dose in the syringe according to the prescribed dose. In this case, excess medicine should be discarded by holding the syringe upside down (to maintain air bubbles in the syringe) and discarding the excess medicine into a container.
• 4) A drop may appear at the end of the needle. In this case, the drop should be removed before injecting by tapping the syringe with the needle facing down. The injection can be administered.

Injecting the medicine

• 1) Hold the syringe in the hand used for writing (like a pencil). With the other hand, gently grasp the cleaned skin of the abdomen with the index finger and thumb, creating a skin fold between the fingers. Make sure to maintain the skin fold during the injection.
• 2) Hold the syringe with the needle facing down (perpendicular at a 90-degree angle). Insert the entire length of the needle into the skin fold.

• 3) Press the plunger with your thumb. This will introduce the medicine into the abdominal fat tissue. The entire amount of medicine in the syringe should be injected.
• 4) Remove the needle from the injection site by pulling it straight out. Hold the needle away from yourself and others. Now you can release the skin fold.

After injecting the medicine

• 1) To avoid bruising, do not rub the injection site after injecting.
• 2) Dispose of the used syringe in a container for sharp objects. Close the container and keep it out of sight and reach of children. If the container is full, dispose of it according to the doctor's or pharmacist's instructions.

Any unused medicines or waste materials should be disposed of in accordance with local regulations.
In case of feeling that the dose is too strong (e.g., unexpected bleeding) or too weak (e.g., the dose probably does not work), consult a doctor or pharmacist.

Instructions for pre-filled syringes with a safety system

Preparing the injection site

• 1) Choose an injection site on the right or left side of the abdomen. The injection site should be at least 5 cm away from the navel towards the sides.
• Do not inject within 5 cm of the navel or around existing scars or bruises.
• The injection site should be changed between the left and right sides of the abdomen, depending on the site of the previous injection.

Choosing the dose

• 1) Carefully remove the needle cap from the syringe. Discard the cap.
• Do not press the plunger before injecting to remove air bubbles. This may reduce the administered dose.
• After removing the cap, do not touch anything with the needle. This will ensure the sterility of the needle.

Injecting the medicine

• 1) Hold the syringe in the hand used for writing (like a pencil). With the other hand, gently grasp the cleaned skin of the abdomen with the index finger and thumb, creating a skin fold between the fingers. Make sure to maintain the skin fold during the injection.
• 2) Hold the syringe with the needle facing down (perpendicular at a 90-degree angle). Insert the entire length of the needle into the skin fold.

• 3) Press the plunger with your thumb. This will introduce the medicine into the abdominal fat tissue. The entire amount of medicine in the syringe should be injected.
• 4) Remove the needle from the injection site by pulling it straight out, while still holding the plunger. Hold the needle away from yourself and others. The safety system is activated by firmly pressing the plunger. The protective cover will automatically cover the needle, and a audible "click" will be heard, confirming the activation of the protective cover. Now you can release the skin fold.

Any unused medicines or waste materials should be disposed of in accordance with local regulations.
In case of feeling that the dose is too strong (e.g., unexpected bleeding) or too weak (e.g., the dose probably does not work), consult a doctor or pharmacist.

Change of anticoagulant treatment

• Change from Losmina 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 Losmina.
• Change from vitamin K antagonists (e.g., warfarin) to LosminaThe 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 Losmina.
• Change from Losmina to direct oral anticoagulantsThe patient should stop taking Losmina. Then, they should start taking the direct oral anticoagulant 0-2 hours before the scheduled time of the next injection; and then continue taking the medicine as usual.
• Change from direct oral anticoagulant to LosminaThe patient should stop taking the direct oral anticoagulant. Treatment with Losmina can be started only after 12 hours from the last dose of the direct oral anticoagulant.

Use of a higher than recommended dose of Losmina

If the patient thinks they have used too much or too little Losmina, 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 Losmina by a child, immediately go to the hospital emergency department.

Missing a dose of Losmina

If a dose is missed, the patient 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 the use of Losmina

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

4. Possible side effects

Like all medicines, Losmina can cause side effects, although not everybody gets them.
As with other similar medicines (used to reduce blood clotting), Losmina 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.
If the patient experiences any of the following symptoms, they should stop using enoxaparin and seek medical help immediately:

• Any symptoms of a severe allergic reaction (such as difficulty breathing, swelling of the lips, face, throat, or tongue).
• A red, scaly, widespread rash with bumps 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 blocking a blood vessel, 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.

Summary 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 the number of platelets.
• Pink spots on the skin. These changes are more likely to occur at the injection sites of Losmina.
• Skin rash (hives).
• Itchy, red skin.
• Bruising or pain at the injection site.
• Decreased number of red blood cells.
• Increased number of platelets.
• Headaches.

Uncommon (may affect up to 1 in 100 people)

• Sudden severe headache. This may be a sign of bleeding into the brain.
• Tenderness and swelling in the abdomen. This may be a sign of bleeding into the stomach.
• 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 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 number of eosinophils 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 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 side effects

If the patient experiences any side effects, including any 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 Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Losmina

Store in a temperature below 25°C. Do not freeze.
Losmina pre-filled syringes are single-dose containers - any unused product should be discarded.
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 month.
Do not use the medicine if the pre-filled syringe is damaged or if the product is not clear.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Losmina contains

• The active substance is sodium enoxaparin.

Each pre-filled syringe contains sodium enoxaparin in an amount equivalent to 2000 IU of anti-Xa activity (which corresponds to 20 mg) in 0.2 ml of water for injection.
Each pre-filled syringe contains sodium enoxaparin in an amount equivalent to 4000 IU of anti-Xa activity (which corresponds to 40 mg) in 0.4 ml of water for injection.
Each pre-filled syringe contains sodium enoxaparin in an amount equivalent to 6000 IU of anti-Xa activity (which corresponds to 60 mg) in 0.6 ml of water for injection.
Each pre-filled syringe contains sodium enoxaparin in an amount equivalent to 8000 IU of anti-Xa activity (which corresponds to 80 mg) in 0.8 ml of water for injection.
Each pre-filled syringe contains sodium enoxaparin in an amount equivalent to 10,000 IU of anti-Xa activity (which corresponds to 100 mg) in 1.0 ml of water for injection.

• The other ingredient is water for injection.

What Losmina looks like and contents of the pack

Losmina is a clear, colorless to pale yellow solution for injection in a pre-filled syringe made of colorless glass type I with a rubber stopper, plunger, and needle in a protective cover, with or without an automatic safety device. It is available in the following forms:
Losmina 2000 IU (20 mg)/0.2 ml solution for injection in a 0.5 ml pre-filled syringe without graduation. Pack of 2, 6, 10, 20, and 50 pre-filled syringes.
Losmina 4000 IU (40 mg)/0.4 ml solution for injection in a 0.5 ml pre-filled syringe without graduation. Pack of 2, 6, 10, 20, 30, and 50 pre-filled syringes.
Losmina 6000 IU (60 mg)/0.6 ml solution for injection in a 1 ml pre-filled syringe. Pack of 2, 6, 10, 12, 20, 24, 30, and 50 pre-filled syringes.
Losmina 8000 IU (80 mg)/0.8 ml solution for injection in a 1 ml pre-filled syringe. Pack of 2, 6, 10, 12, 20, 24, 30, and 50 pre-filled syringes.
Losmina 10,000 IU (100 mg)/1 ml solution for injection in a 1 ml pre-filled syringe. Pack of 2, 6, 10, 12, 20, 24, 30, and 50 pre-filled syringes.
Not all pack sizes may be marketed.
In some pack sizes, the pre-filled syringes may be connected to a safety system device.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spain
tel.: (+48) 699 711 147

Manufacturer:

ROVI Pharma Industrial Services, S.A.
Julián Camarillo, 35
28037 Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Denmark, Finland, Germany, Norway, Sweden: Enoxaparin Becat
Belgium, France, Luxembourg, Netherlands: Enoxaparine Becat
Spain, Portugal, Italy: Enoxaparina Rovi
Greece: Enoxaparin Rovi
Slovenia: Enoksaparin Rovi
Bulgaria, Czech Republic, Estonia, Croatia, Hungary, Latvia, Poland, Romania, Slovakia: Losmina
Ireland, United Kingdom (Northern Ireland): Arovi

Date of last revision of the leaflet: 01/2023

Other sources of information

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