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 quick identification of new safety information. You can help by reporting any side effects you may get. To find out more, 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 doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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, making them harmless.
• 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 cases: before and after surgery, during acute illness when the patient has limited 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 in which the heart receives insufficient blood), and after a heart attack.
• Preventing the formation of clots in dialysis 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 within 24 hours.

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 have different instructions for use.
Before starting to use Losmina, you should discuss it with your doctor or pharmacist if:

• the patient has ever had a reaction to heparin that caused a significant decrease in the number of platelets
• the patient is scheduled for spinal or epidural anesthesia or lumbar puncture (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 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 old), 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 the section 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 in the blood and the level of potassium.

Children and adolescents:

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

Losmina and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you 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 medicine")
• 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 epidural or spinal anesthesia, they should inform their doctor that they are using Losmina. See the 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 child, they should consult their doctor or pharmacist before using this medicine.
Women with pregnancy and mechanical heart valve may have 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 to use 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 prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Administration of the medicine

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

The patient may need to continue using Losmina at home and administer it themselves.

• Losmina is usually administered subcutaneously.
• 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 start of the dialysis session. Losmina should not be administered intramuscularly.

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 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 Losmina.
• 2. Prevention of blood clot formation in the patient's blood in the following situations:
• Surgery or limited 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) per day.
• In the case of planned surgery, the first injection is usually given 2 hours or 12 hours before surgery.
• If the patient has limited mobility due to illness, they usually receive Losmina at a dose of 4000 IU (40 mg) per day.
• 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 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 take 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:

• The initial dose of Losmina is 3000 IU (30 mg) administered intravenously.
• Losmina 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 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.

Patient undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Losmina was administered, the doctor may decide to administer an additional dose of Losmina 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.
• Losmina is injected into the dialysis tube returning blood from the body (into the so-called arterial line) at the start 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

Self-administration of Losmina

If the patient is able to administer Losmina themselves, the doctor or nurse will show them how to do it. Do not attempt to administer the medicine yourself without instructions.
If the patient is unsure what to do, 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 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.
• Change the injection site between the left and right side of the abdomen, depending on the location 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 your 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 administering the injection 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. You can now administer the injection.
• 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, holding the syringe with the needle facing down (to maintain air bubbles in the syringe) and discarding the excess medicine into a container.
• 4) A drop may appear at the tip of the needle. In this case, remove the drop before administering the injection by tapping the syringe with the needle facing down. You can now administer the injection.

Administering the injection

• 1) Hold the syringe in the hand you write with (like a pencil). With your other hand, gently grasp the cleaned skin of the abdomen with your index finger and thumb, creating a skin fold between your fingers. Make sure to maintain the skin fold during the injection.
• 2) Hold the syringe with the needle facing down (perpendicular at a 90° 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. Administer the entire amount of medicine from the syringe.

After administering the injection

• 1) To avoid bruising, do not rub the injection site after administering the injection.
• 2) Dispose of the used syringe in a container for sharp objects. Close the container and store it in a place that is 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 should be disposed of in accordance with local regulations.
If you feel that the dose is too strong (e.g., unexpected bleeding occurs) or too weak (e.g., the dose probably does not work), you should consult your 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.
• Change the injection site between the left and right side of the abdomen, depending on the location 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 administering the injection 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.

Administering the injection

• 1) Hold the syringe in the hand you write with (like a pencil). With your other hand, gently grasp the cleaned skin of the abdomen with your index finger and thumb, creating a skin fold between your fingers. Make sure to maintain the skin fold during the injection.
• 2) Hold the syringe with the needle facing down (perpendicular at a 90° 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. Administer the entire amount of medicine from the syringe.
• 4) Remove the needle from the injection site, pulling it straight out, while still holding the plunger. Keep 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 clicking sound will be heard, confirming the activation of the protective cover. You can now release the skin fold.

Any unused medicines or waste should be disposed of in accordance with local regulations.
If you feel that the dose is too strong (e.g., unexpected bleeding occurs) or too weak (e.g., the dose probably does not work), you should consult your doctor or pharmacist.

Change of anticoagulant medicine

• 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 LosminaStop 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 anticoagulantsStop taking Losmina. Then, 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 LosminaStop 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 experience 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, it should be taken as soon as possible. Do 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 you have any further doubts about using this medicine, you should consult your doctor, pharmacist, or nurse.
It is important to continue administering Losmina injections until the doctor recommends stopping them. If treatment is stopped, a blood clot may form, which can be very dangerous.

4. Possible side effects

Like all medicines, this medicine 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 you experience 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), you should immediately consult your doctor. The doctor may decide to monitor the patient more closely or change the medicine.
If you experience any of the following symptoms, you should stop using enoxaparin and seek immediate medical attention:

• Any symptoms of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).
• 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).

You should immediately consult your doctor:

• If you experience any signs of a blood clot blocking a blood vessel, such as:
• cramping pain, redness, increased warmth, or swelling in one of the lower limbs - these are symptoms of deep vein thrombosis
• shortness of breath, chest pain, fainting, or coughing up blood - these are symptoms of pulmonary embolism
• If you experience 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)

• Greater than usual 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 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 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
By reporting side effects, you can help provide 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 in a place that is 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 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. Ask your 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 Losmina contains

• The active substance of Losmina 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 packaging

Losmina is a clear, colorless to pale yellow solution for injection in a pre-filled syringe made of 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. Packaging 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. Packaging 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. Packaging 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. Packaging 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. Packaging of 2, 6, 10, 12, 20, 24, 30, and 50 pre-filled syringes.
Not all pack sizes may be marketed.

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/