Losmina

Package Leaflet: Information for the Patient

Losmina, 12,000 IU (120 mg)/0.8 ml, solution for injection in a pre-filled syringe
Losmina, 15,000 IU (150 mg)/1 ml, solution for injection in a pre-filled syringe
Enoxaparin sodium
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. See section 4 for how to report side effects.

Read all of this leaflet carefully before using this medicine.

• You should keep this leaflet. You may need to read it again.
• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Losmina is and what it is 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 Losmina is and what it is 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 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.

Losmina can be used to:

• Treat blood clots that are already present in the patient's blood.
• Prevent 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 had blood clots due to cancer, to prevent further blood clot formation, in unstable angina (a condition where the heart does not receive enough blood), after a heart attack
• Prevent the formation of clots in the dialysis tubing (used in patients with severe kidney problems).

2. Important information before using Losmina

When not to use Losmina

• If the patient is 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 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 platelets in the blood (a condition known as heparin-induced thrombocytopenia) within the last 100 days or if the patient has antibodies against enoxaparin in their blood.
• If the patient has 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 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 identical, differ in activity, and have different instructions for use.
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 in the blood
• spinal or epidural anesthesia or lumbar puncture is planned (see "Surgical procedures and anesthetics"): an appropriate time interval between the use of Losmina and this procedure should be considered
• the patient has a heart valve replacement
• the patient has endocarditis (infection of the inner lining of the heart)
• the patient has had stomach ulcers
• the patient has recently had a stroke
• the patient has high blood pressure
• the patient has diabetes or has problems with blood vessels in the eyes due to diabetes (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 problems
• the patient has liver problems
• the patient is underweight or overweight
• the patient has high levels 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 and periodically during the use of this medicine, the patient may undergo blood tests to check the number of platelets in the blood and potassium levels.

Children and adolescents

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

Losmina and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might 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 therapy")
• 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, 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 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 ask their doctor or pharmacist for advice 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 instructed. 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 inject it themselves (see the instructions for administration below).
• Losmina is usually administered by subcutaneous injection.
• Losmina can be administered by intravenous injection in certain types of heart attack or after surgery.
• Losmina can be introduced into the dialysis tubing returning blood to the body (into the arterial line) at the start of the dialysis session. Losmina should 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 problems, 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 blood clot formation. 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 reduced mobility due to illness, they will 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 have 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 takes aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Losmina.

STEMI in patients under 75 years of age:

• The initial dose of Losmina is 3000 IU (30 mg) given as an intravenous injection.
• Losmina will also be given as a subcutaneous injection. 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.

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. This will be given as an intravenous injection.

• 3. Prevention of blood clot formation 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 is usually sufficient for a 4-hour dialysis session. However, the doctor may give an additional dose of 50 IU 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 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 until they have received instructions. If the patient is unsure, they should talk to their doctor or nurse. Proper administration of the injection (called a "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, 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, 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 device)

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.
• Alternate injection sites between the left and right sides of the abdomen, depending on the location of the previous injection.

• 2) Wash hands. Clean (do not rub) the injection site with an alcohol swab or soap and water.

• 3) Sit or lie down in a comfortable position, relaxed. Make sure the injection site is in view. 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 the needle. This will ensure the sterility of the needle.

• 2) If the amount of medicine in the syringe is the same as 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, holding the syringe with the needle pointing down (to maintain air bubbles in the syringe) and discarding excess medicine into a container.
• 4) A drop may appear at the end of the needle. In this case, remove the drop before injecting by tapping the syringe with the needle pointing down. The injection can now be administered.

Injecting

• 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 fold of skin between the fingers. Make sure to maintain the skin fold during the injection.
• 2) Hold the syringe with the needle pointing down (perpendicular at a 90° angle). Insert the entire length of the needle into the skin fold.

• 3) Press the plunger with the 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, pulling it straight out. Keep the needle away from yourself and others. Now the skin fold can be released.

After injecting

• 1) To avoid bruising, do not rub the injection site after administering the injection.
• 2) Dispose of the used syringe in a sharps container. 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 medicine or waste 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.
To avoid bruising, do not rub the injection site after administering the injection.

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 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.
• Alternate injection sites between the left and right sides 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 injecting to remove air bubbles. This may reduce the administered dose.
• 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 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 fold of skin between the fingers. Make sure to maintain the skin fold during the injection.
• 2) Hold the syringe with the needle pointing down (perpendicular at a 90° angle). Insert the entire length of the needle into the skin fold.

• 3) Press the plunger with the 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, pulling it straight out while still holding the plunger. The safety device is activated by firmly pressing the plunger. The protective shield will automatically cover the needle, and a clicking sound will be heard, confirming the activation of the protective shield. Now the skin fold can be released.

Any unused medicine or waste 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.
To avoid bruising, do not rub the injection site after administering the injection.

Change of anticoagulant therapy

• 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 a blood test 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, the patient should start taking the direct oral anticoagulant 0-2 hours before the scheduled time of the next Losmina injection; and then continue taking the medicine as usual.
• Change from direct oral anticoagulant to LosminaThe patient should stop taking the direct oral anticoagulant. Losmina treatment can be started 12 hours after 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. Do not take a double dose to make up for a missed dose. Keeping a diary helps ensure that no dose is missed.

Stopping Losmina treatment

In case of further doubts about the use of this medicine, consult a 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, 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, pallor, 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 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).

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 in the blood.
• Pink spots on the skin. These changes are more likely to occur at the injection sites of Losmina.
• Skin rash (hives).
• Itching, redness of the skin.
• Bruising or pain at the injection site.
• Decreased red blood cell count.
• Increased platelet count.
• Headaches.

Uncommon (may affect up to 1 in 100 people)

• Sudden severe headache. This may be a sign of bleeding in the brain.
• Tenderness and swelling in the stomach. This may be a sign of bleeding in the stomach.
• Large, red, irregularly shaped skin 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 in people with kidney problems or diabetes. The doctor can check this with a blood test.
• Increased eosinophil count in the blood. The doctor can 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 cannot 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, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 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 a pharmacist how to dispose of medicines that are no longer needed. This 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 12,000 IU of anti-Xa activity (which is equivalent to 120 mg) in 0.8 ml of water for injection.
Each pre-filled syringe contains enoxaparin sodium equivalent to 15,000 IU of anti-Xa activity (which is equivalent to 150 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 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 presentations:
Losmina 12,000 IU (120 mg)/0.8 ml solution for injection in a 1 ml pre-filled syringe.
Pack of 10, 30, and 50 pre-filled syringes.
Losmina 15,000 IU (150 mg)/1 ml solution for injection in a 1 ml pre-filled syringe.
Pack of 10, 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 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:

Germany: Enoxaparin Becat
Belgium: Enoxaparine Becat
Spain: Enoxaparina Rovi
Poland: Losmina
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/