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
Enoxaparin sodium
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 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 enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Losmina works in two ways.

• 1) It prevents the growth of existing blood clots. This helps your body to dissolve existing blood clots, so they are no longer a problem.
• 2) It prevents the formation of new blood clots in your blood.

Losmina can be used to:

• Treat blood clots that are already in your blood.
• Prevent the formation of blood clots in your blood in the following situations: before and after surgery, when you are less able to move due to illness, in patients who have had blood clots due to cancer, to prevent further clots, in unstable angina (a condition where your heart does not get enough blood), after a heart attack
• Prevent the formation of clots in the dialysis tubing (used for people with severe kidney problems).

2. Important information before using Losmina

When not to use Losmina

• If you are allergic to enoxaparin sodium 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 face, lips, throat or tongue.
• If you have had an allergic reaction to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.
• If you have had a reaction to heparin that has caused a serious decrease in the number of platelets in your blood (a condition called heparin-induced thrombocytopenia) in the last 100 days or if you have antibodies against enoxaparin.
• If you have active bleeding or a medical condition that increases the risk of bleeding (such as stomach ulcers, recent brain or eye surgery), including recent hemorrhagic stroke.
• If you are using Losmina to treat blood clots and spinal or epidural anesthesia is planned.

Warnings and precautions

Losmina should not be used interchangeably with other low molecular weight heparins.
This is because they are not identical and have different potencies and instructions for use.
Before starting Losmina, you should discuss this with your doctor or pharmacist if:

• you have ever had a reaction to heparin that has caused a large decrease in the number of platelets in your blood
• you are going to have spinal or epidural anesthesia (see "Surgical procedures and anesthetics")
• you have a heart valve replacement
• you have endocarditis (an infection of the lining of the heart)
• you have had stomach ulcers
• you have recently had a stroke
• you have high blood pressure
• you have diabetes or have problems with the blood vessels in your eyes due to diabetes (diabetic retinopathy)
• you have recently had eye or brain surgery
• you are elderly (over 65 years), especially if you are over 75 years
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (which can be checked with a blood test)
• you are taking other medicines that may cause bleeding (see below "Losmina and other medicines")

Before starting and during treatment with this medicine, you may have blood tests to check the number of platelets in your blood and the level of potassium in your blood.

Children and adolescents:

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

Losmina and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, and 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 treatment")
• 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, and certain heart medicines.

Surgical procedures and anesthetics

If you are going to have a lumbar puncture or surgery with epidural or spinal anesthesia, tell your doctor that you are using Losmina. See "When not to use Losmina". Also, tell your doctor if you have any back problems or if you have ever had spinal surgery.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Women with pregnancy and mechanical heart valves may be at increased risk of blood clots. Your doctor should discuss this with you.
Women who are breastfeeding or plan to breastfeed should ask their doctor for advice before using this medicine.

Driving and using machines

Losmina does not affect the ability to drive or use machines.
It is recommended that the doctor documents 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 is essentially "sodium-free".

3. How to use Losmina

This medicine should always be used under the guidance of a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Administration of the medicine

• Losmina will usually be given to you by a doctor or nurse. This is because it needs to be given by injection.
• After you return home, you may need to continue using Losmina and give it to yourself (see the administration instructions below).

You will be shown how to do this by a doctor or nurse if you are able to give the injections to yourself.

• Losmina is usually given by subcutaneous injection.
• Losmina can be given by intravenous injection after certain types of heart attack or after surgery.
• Losmina can be introduced into the dialysis tubing returning blood to the body (the "arterial line") at the start of the dialysis session. Losmina must not be administered by intramuscular injection.

Dose

• Your doctor will decide what dose of Losmina you should have. The dose will depend on the reason for your treatment.
• If you have kidney problems, your doctor may give you a lower dose of Losmina.
• 1. Treatment of blood clots in your blood
• The usual dose is 150 IU (1.5 mg) per kilogram of body weight once daily or 100 IU (1 mg) per kilogram of body weight twice daily.
• Your doctor will decide how long you should receive Losmina.
• 2. Prevention of blood clots in your blood in the following situations:
• Surgery or reduced mobility due to illness
• The dose will depend on your risk of blood clots. You will usually receive Losmina at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) each day.
• For planned surgery, the first injection is usually given 2 hours or 12 hours before surgery.
• If you are less able to move due to illness, you will usually receive Losmina at a dose of 4000 IU (40 mg) each day.
• Your doctor will decide how long you 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 your age and the type of heart attack you 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.
• Your doctor will usually also recommend that you take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should receive Losmina.

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

• An initial dose of 3000 IU (30 mg) of Losmina will be given by intravenous injection.
• Losmina will also be given by subcutaneous injection. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually also recommend that you take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should receive Losmina.

ST segment elevation myocardial infarction (STEMI) in patients 75 years 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).
• Your doctor will decide how long you should receive Losmina.

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

• 3. Prevention of blood clots in the dialysis tubing
• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Losmina is injected into the arterial line at the start of the dialysis session. This dose usually lasts for a 4-hour dialysis session. However, your doctor may give you an additional dose of 50 to 100 IU (0.5 to 1 mg) per kilogram of body weight if necessary.

Instructions for using the pre-filled syringe

Self-administration of Losmina

If you are able to give yourself Losmina, your doctor or nurse will show you how to do it. Do not attempt to inject yourself until you have been trained. If you are unsure, talk to your doctor or nurse. Correct injection technique will help to reduce pain and bruising at the injection site.

Before self-administration of Losmina

• 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 that the syringe is not damaged and that the liquid is clear. If not, use another syringe.
• Make sure you know what dose you are going to inject.
• Look at your stomach to check if the last injection has caused any redness, discoloration, swelling, discharge, or if it is still painful. If so, talk to your doctor or nurse.

Instructions for self-administration of Losmina:

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

Preparing the injection site

• 1) Choose an injection site on the right or left side of your stomach. The injection site should be at least 5 cm away from your belly button.
• Do not inject within 5 cm of your belly button or around existing scars or bruises.
• Alternate injection sites between the left and right sides of your stomach, depending on the site of the previous injection.

• 2) Wash your hands. Clean (do not rub) the injection site with a cotton ball moistened with 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.

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

• 2) Hold the syringe in the hand you write with (like a pen). With your other hand, gently grasp the cleaned area of your stomach between your thumb and index finger to make a fold in the skin. Make sure you keep the fold in the skin while injecting.
• 3) Hold the syringe with the needle facing downwards (at a 90-degree angle). Insert the entire length of the needle into the fold of the skin.

After injecting

• 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.

Dispose of any unused medicine or waste in accordance with local regulations.
If you think the dose is too strong (for example, you have unexpected bleeding) or too weak (for example, the dose is probably not working), talk to your doctor or pharmacist.

Instructions for pre-filled syringes with a safety device

Preparing the injection site

• 1) Choose an injection site on the right or left side of your stomach. The injection site should be at least 5 cm away from your belly button.
• Do not inject within 5 cm of your belly button or around existing scars or bruises.
• Alternate injection sites between the left and right sides of your stomach, depending on the site of the previous injection.

Choosing the dose

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

Injecting

• 1) Hold the syringe in the hand you write with (like a pen). With your other hand, gently grasp the cleaned area of your stomach between your thumb and index finger to make a fold in the skin. Make sure you keep the fold in the skin while injecting.
• 2) Hold the syringe with the needle facing downwards (at a 90-degree angle). Insert the entire length of the needle into the fold of the skin.

• 3) Press the plunger with your thumb to inject the medicine into the fatty tissue of your stomach. Inject all of the medicine in the syringe.
• 4) Remove the needle from the injection site by pulling it straight out, while still holding the plunger. Keep the needle away from yourself and others. The safety device is activated by firmly pressing the plunger. The protective shield will automatically cover the needle and you will hear a "click" that confirms the activation of the shield. You can now release the fold in the skin.

Dispose of any unused medicine or waste in accordance with local regulations.
If you think the dose is too strong (for example, you have unexpected bleeding) or too weak (for example, the dose is probably not working), talk to your doctor or pharmacist.

Change of anticoagulant treatment

• Change from Losmina to medicines that thin the blood, known as vitamin K antagonists (e.g. warfarin)Your doctor will recommend that you have blood tests to measure your INR (a blood test that measures the time it takes for your blood to clot) and will tell you when to stop taking Losmina based on the results.
• Change from medicines that thin the blood, known as vitamin K antagonists (e.g. warfarin) to LosminaYou should stop taking the vitamin K antagonist. Your doctor will recommend that you have blood tests to measure your INR and will tell you when to start taking Losmina based on the results.
• Change from Losmina to direct oral anticoagulantsYou should stop taking Losmina. Then, you should start taking the direct oral anticoagulant 0-2 hours before the next scheduled injection; and then continue taking the medicine as usual.
• Change from direct oral anticoagulants to LosminaYou should stop taking the direct oral anticoagulant. You can start taking Losmina 12 hours after the last dose of the direct oral anticoagulant.

Overdose of Losmina

If you think you have used too much or too little Losmina, tell your doctor, nurse, or pharmacist immediately, even if you do not notice any problems. If a child has accidentally injected or swallowed Losmina, you should immediately take them to the hospital emergency department.

Missed dose of Losmina

If you miss a dose of Losmina, you should take it as soon as possible. Do not take a double dose to make up for a missed dose. Keeping a diary can help you remember to take your doses on time.

Stopping Losmina

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
It is important to continue injecting Losmina until your doctor tells you to stop. If you stop treatment, you may develop a blood clot, which can be very serious.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other medicines of this type (used to thin the blood), Losmina can cause bleeding, which can be life-threatening in some cases.
In some cases, bleeding may not be obvious.
If you experience any bleeding that does not stop by itself, as well as signs of excessive bleeding (severe weakness, tiredness, paleness, dizziness, headaches, or unexplained sweating), you should contact your doctor immediately. Your doctor may decide to monitor you more closely or change your medicine.
If you experience any of the following symptoms, stop taking enoxaparin and seek medical attention 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 under the skin and blisters, accompanied by fever. These symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

You should contact your doctor immediately:

• If you experience any signs of a blood clot, such as:
• cramping pain, redness, increased warmth, or swelling in one of your 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 you experience painful bruising or purple spots under the skin that do not fade on pressure. Your doctor may recommend a blood test to check your platelet count.

List of possible side effects:

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

• Bleeding.
• Increased liver enzymes.

Common (may affect up to 1 in 10 people)

• Increased tendency to bruise. This may be due to a decrease in the number of platelets in your blood.
• Pink spots on the skin. These changes are more likely to occur at the injection sites.
• Hives (nettle rash).
• Itching, redness of the skin.
• Bruising or pain at the injection site.
• Decrease in red blood cells.
• Increased platelet count.
• Headache.

Uncommon (may affect up to 1 in 100 people)

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

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

• Severe allergic reaction. Symptoms of this reaction may include rash, difficulty swallowing or breathing, swelling of the face, lips, throat, or tongue.
• High levels of potassium in the blood. This is more likely to occur in people with kidney problems or diabetes. Your doctor may check this with a blood test.
• Increased eosinophil count in the blood. Your doctor may check this with a blood test.
• Hair loss.
• Osteoporosis (a condition where bones are more likely to break) after long-term use of this medicine.
• Numbness, tingling, and muscle weakness (especially in the lower part of the body) after a lumbar puncture or spinal anesthesia.
• Loss of control over urination or bowel movements (a condition where you are unable to control when you go to the toilet).
• Hardening or a lump at the injection site.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 refrigerator (2°C - 8°C). Do not freeze.
Losmina pre-filled syringes are single-dose containers - any unused product should be discarded.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Losmina contains

• The active substance is enoxaparin sodium.

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

• The other ingredient is water for injections.

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 glass type I with a rubber stopper, plunger, and needle with a protective shield, with or without an automatic safety device. It is available in the following strengths:
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 fitted with a safety 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 Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych: http://www.urpl.gov.pl/