Losmina

Package leaflet: Information for the patient

Losmina, 12,000 IU (120 mg)/0.8 ml, solution for injection in pre-filled syringe
Losmina, 15,000 IU (150 mg)/1 ml, solution for injection in pre-filled syringe
Enoxaparin sodium
This medicinal product will be subject to additional monitoring. This will allow rapid
identification of new safety information. You can also help by reporting any adverse reactions that occur after using the medicine. To find out how to report adverse reactions – see section 4.
Please read this leaflet carefully before using this medicine, as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 existing blood clots from growing larger. This helps the body dissolve existing clots so they are no longer harmful.
2. It prevents the formation of new blood clots in the patient's blood.

Losmina may be used for:

• Treating existing blood clots in the patient's blood.
• Preventing the formation of blood clots in the patient's blood in the following situations:
  • Before and after surgical procedures
  • During acute illness when the patient has limited mobility
  • In patients who have developed blood clots due to cancer, to further prevent formation of new clots
  • In unstable angina (a condition in which insufficient blood reaches the heart)
  • After myocardial infarction (heart attack)
• Preventing clot formation in the dialysis circuit (used in patients with severe kidney dysfunction).

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 lips, face, throat or tongue.
• If the patient has had an allergic reaction to heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.
• If the patient has previously experienced a reaction to heparin that caused a significant drop in platelets (blood cells responsible for blood clotting), known as heparin-induced thrombocytopenia, within the last 100 days, or if the patient has antibodies against enoxaparin in the blood.
• If the patient has active 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 being treated with Losmina for blood clots and spinal or epidural anaesthesia or lumbar puncture is planned within 24 hours.

Warnings and precautions
Losmina must not be used interchangeably with other medicines belonging to the group of low molecular weight heparins, as they are not exactly the same and differ in activity and dosing instructions.
Before starting treatment with Losmina, discuss with your doctor or pharmacist if:

• The patient has ever experienced a reaction to heparin causing a significant drop in platelet count.
• The patient is scheduled for spinal or epidural anaesthesia or lumbar puncture (see "Surgical procedures and anaesthetics"): appropriate timing between administration of Losmina and the procedure must be considered.
• The patient has had a heart valve replacement.
• The patient has endocarditis (infection of the inner lining of the heart).
• The patient has had or currently has stomach ulcers.
• The patient has recently had a stroke.
• The patient has high blood pressure.
• The patient has diabetes or diabetic eye complications affecting blood vessels (diabetic retinopathy).
• The patient has recently undergone eye or brain surgery.
• The patient is elderly (over 65 years), particularly over 75 years of age.
• The patient has kidney disease.
• The patient has liver disease.
• The patient is underweight or overweight.
• The patient has elevated potassium levels in the blood (this can be detected in a blood laboratory test).
• The patient is currently taking medications that may cause bleeding (see section below "Losmina with other medicines").

Before starting treatment with this medicine and periodically during treatment, blood tests may be performed to monitor platelet count and blood potassium levels.
Children and adolescents
The safety and efficacy of enoxaparin have not been established in children and adolescents.
Losmina with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans 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 "Changing anticoagulant therapy").
• Dextran injections – used as a blood volume expander.
• Ibuprofen, diclofenac, ketorolac, or other non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and swelling in arthritis and other conditions.
• Prednisolone, dexamethasone, or other medicines used to treat asthma, rheumatoid arthritis, and other disorders.
• Medicines that increase potassium levels in the blood, such as potassium salts, diuretics, and certain medicines used for heart conditions.

Surgical procedures and anaesthetics
If the patient is scheduled for a lumbar puncture or surgery under epidural or spinal anaesthesia, inform the doctor that the patient is using Losmina. See section "When not to use Losmina". Additionally, inform the doctor about any spinal problems or if the patient has ever undergone spinal surgery.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Women who are pregnant and have a mechanical heart valve may have an increased risk of blood clots. This issue should be discussed with the doctor.
Women who are breastfeeding or intend to breastfeed should seek medical advice before starting treatment with this medicine.
Driving and using machines
Losmina has no influence on the ability to drive or operate machinery.
The doctor is advised to 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, meaning the medicine is considered "sodium-free".

3. How to use Losmina

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Taking the medicine

• Losmina is usually administered by a doctor or nurse. This is because it must be given by injection.
• After returning home, you may need to continue using Losmina and self-administer it (see the administration instructions below).
• Losmina is usually given as subcutaneous injections.
• Losmina may be administered as an intravenous injection following certain types of heart attack or after surgery.
• Losmina may be introduced into the dialysis tubing that removes blood from the body (into the so-called arterial line) at the beginning of a dialysis session. Losmina must not be administered by intramuscular injection.

Dose of medicine to be administered

• Your doctor will decide how much Losmina you should receive. The dose depends on the reason for treatment.
• In patients with kidney disease, a lower dose of Losmina may be given.

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.
• Your doctor will decide how long you should continue receiving Losmina.

2. Prevention of blood clots in the patient's blood in the following situations:
   • Surgery or periods of limited mobility due to illness

• The dose depends on the individual patient's risk of clot formation. You will receive Losmina at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) daily.

• For planned surgery, the first injection is usually given 2 hours or 12 hours before the procedure.

• If you have limited mobility due to illness, you will usually receive Losmina at a dose of 4000 IU (40 mg) daily.

• Your doctor will decide how long you should continue receiving Losmina.

  • After myocardial infarction
    Losmina can be used in two 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.

NSTEMI heart attack:

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually also recommend taking aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should continue receiving Losmina.

STEMI heart attack in patients under 75 years of age:

• An initial dose of Losmina, 3000 IU (30 mg), will be administered by intravenous injection.
• Simultaneously, Losmina will also be administered subcutaneously. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually also recommend taking aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should continue receiving Losmina.

STEMI heart attack in patients aged 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 for the first two doses is 7500 IU (75 mg).
• Your doctor will decide how long you should continue receiving Losmina.

Patients undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Losmina was administered, your doctor may decide to give an additional dose of Losmina before the percutaneous coronary intervention. In this case, the medicine will be administered by intravenous injection.

3. Prevention of blood clots in dialyzer tubing
   • The usual dose is 100 IU (1 mg) per kilogram of body weight.
   • Losmina is injected into the tubing that removes blood from the body (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, your 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 pre-filled syringes
Self-administration of Losmina injection
If you are able to self-administer Losmina, your doctor or nurse will show you how to do it. Do not attempt to inject the medicine yourself until you have received proper instruction. If you are unsure what to do, speak immediately with your doctor or nurse. Proper subcutaneous injection (called a "subcutaneous injection") can help reduce pain and bruising at the injection site.

Before self-injecting Losmina

• Prepare the necessary items: the syringe, gauze or soap and water, and a sharps container.
• Check the expiry date on the packaging. Do not use the medicine after the expiry date.
• Check whether the syringe is damaged and whether the liquid is clear. If not, use another syringe.
• Confirm the correct dose to be injected.
• Examine the abdominal area to check whether the previous injection caused redness, skin discoloration, swelling, oozing, or if it is still painful. If so, consult your doctor or nurse.

Instructions for self-administering a Losmina injection:
(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, toward the sides.

• Do not inject within 5 cm of the navel or near existing scars or bruises.
• Rotate injection sites between the left and right sides of the abdomen depending on the previous injection site.

2. Wash your hands. Clean (do not rub) the injection site with an alcohol-soaked gauze pad or with soap and water.
3. Sit or lie down in a comfortable position to help you relax. Ensure the injection site is clearly visible. A chair, recliner, or bed with supportive pillows is suitable.
   Selecting the dose
4. Carefully remove the needle cap from the syringe. Discard the cap.

• Do not press the plunger before injection to remove air bubbles. This may result in a reduced dose.
• After removing the cap, do not touch the needle. This ensures sterility.

2. If the amount of medicine in the syringe matches the prescribed dose, no dose adjustment is needed. You may proceed with the injection.
3. If the dose is based on body weight, you may need to adjust the dose in the syringe according to the prescribed amount. In this case, remove the excess medicine by holding the syringe downward (to keep air bubbles in the syringe) and expel the excess into a sharps container.
4. A drop may appear at the needle tip. If so, remove the drop before injection by gently tapping the syringe with the needle pointing downward. You may now proceed with the injection.
   Injection
5. Hold the syringe in the hand you write with (like a pencil). With the other hand, gently pinch the cleaned abdominal skin between your thumb and index finger to create a skin fold.
   Ensure you maintain the skin fold during the injection.

2. Hold the syringe with the needle pointing downward (vertically at a 90° angle). Insert the full length of the needle into the skin fold.
3. Press the plunger with your thumb to inject the medicine into the abdominal fatty tissue. Inject the entire contents of the syringe.
4. Remove the needle straight out from the injection site. Keep the needle away from yourself and others. You may now release the skin fold.

After the injection

1. To avoid bruising, do not rub the injection site after the injection.
2. Dispose of the used syringe in a medical waste container. Close the container lid and store it out of sight and out of reach of children. If the container is full, dispose of it according to your doctor's or pharmacist's instructions.
   Any unused medicine or waste must be disposed of in accordance with local regulations.
   If you feel the dose is too strong (e.g., unexpected bleeding) or too weak (e.g., the dose seems ineffective), 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, toward the sides.

• Do not inject within 5 cm of the navel or near existing scars or bruises.
• Rotate injection sites between the left and right sides of the abdomen depending on the previous injection site.

Dosing

1. Carefully remove the needle cap from the syringe. The protective cap should be discarded.

• Do not press the plunger before administering the injection to remove air bubbles. This may result in a reduced dose being delivered.
• After removing the cap, do not touch the needle. This ensures the cleanliness (sterility) of the needle.

Injection

1. Hold the syringe in the hand the patient writes with (as if holding a pencil). With the other hand, gently grasp the cleaned abdominal skin between the thumb and index finger, creating a skin fold.
   Ensure that the skin fold is held throughout the injection procedure.
2. Hold the syringe with the needle pointing downward (perpendicularly at a 90° angle). Insert the full length of the needle into the skin fold.

3. Press the plunger with the thumb. This will deliver the medication into the abdominal fatty tissue. Inject the entire dose from the syringe.
4. Remove the needle from the injection site by pulling it straight out, while still keeping fingers on the plunger. Keep the needle pointed away from yourself and others. The safety mechanism is activated by firmly pressing the plunger. The protective needle cover will automatically cover the needle, accompanied by an audible "click" sound, confirming activation of the safety shield. The skin fold may now be released.

it should be disposed of according to the recommendations of the doctor or pharmacist.
Any unused medicines or waste materials must be disposed of in accordance with local regulations.
If you feel the dose is too strong (for example, unexpected bleeding occurs)
or too weak (for example, the dose appears ineffective), consult your doctor
or pharmacist.
To avoid bruising, do not rub the injection site after administering the injection.
Switching anticoagulant therapy

• Switching from Losmina to oral anticoagulants known as vitamin K antagonists (e.g., warfarin) Your doctor will arrange blood tests to monitor your INR value and will inform you when to stop taking Losmina based on these results.
• Switching from vitamin K antagonists (e.g., warfarin) to Losmina Discontinue the vitamin K antagonist medication. Your doctor will arrange blood tests to monitor your INR value and will inform you when to start taking Losmina based on these results.
• Switching from Losmina to direct oral anticoagulants (DOACs) Stop taking Losmina. Then start taking the direct oral anticoagulant 0–2 hours before the scheduled time of the next injection; thereafter continue taking the medication as usual.
• Switching from a direct oral anticoagulant to Losmina Discontinue the direct oral anticoagulant. Treatment with Losmina may be started only 12 hours after the last dose of the direct oral anticoagulant.

Use of a higher than recommended dose of Losmina
If you think you have used too much or too little of Losmina, contact your doctor, nurse, or pharmacist immediately, even if there are no signs of any problems. In case of accidental injection or ingestion of Losmina by a child, seek emergency medical attention at a hospital immediately.
Missed dose of Losmina
If you miss a dose, take it as soon as possible. Do not use a double dose to make up for a missed dose. Keeping a diary can help ensure you do not miss any doses.
Stopping treatment with Losmina
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.
It is important to continue administering Losmina injections until your doctor advises you to stop. Stopping treatment may lead to the formation of a blood clot, which could be very dangerous.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
As with other similar medicines (used to reduce blood clotting), Losmina
may cause bleeding, which could potentially be life-threatening. In some
cases, bleeding may not be immediately visible.
If any bleeding occurs that does not stop spontaneously, or if signs of excessive bleeding appear (severe weakness, fatigue,
pallor, dizziness, headache or unexplained sweating), medical advice should be sought immediately.
The doctor may decide to subject the patient to closer monitoring or to change the treatment.
If any of the following symptoms occur, enoxaparin should be discontinued and immediate medical help sought:

• Any symptoms of severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes).
• Red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Contact a doctor immediately:

• If the patient experiences any signs of blood vessel blockage by a blood clot, such as:
  • cramping pain, redness, increased warmth or swelling in one of the lower limbs – signs of deep vein thrombosis
  • shortness of breath, chest pain, fainting or coughing up blood – signs of pulmonary embolism
• If the patient develops painful rash or dark red spots under the skin that do not fade on pressure. The doctor may order blood tests to determine platelet count.

List of possible adverse reactions:
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 tendency than usual to bruising. This may be due to reduced platelet count.
• Pink spots on the skin. These changes are more likely at sites where Losmina injections are administered.
• Skin rash (urticaria).
• Itchy, red skin.
• Bruising or pain at the injection site.
• Decreased number of red blood cells.
• Increased platelet count.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache. This may indicate intracranial bleeding.
• Sensation of tenderness and swelling in the stomach. This may indicate gastrointestinal bleeding.
• Large, irregularly shaped red skin lesions, with 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 may include: rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.
• Increased potassium levels in the blood. This is more likely in patients with kidney disease or diabetes. The doctor may check this by performing a blood test.
• Increased eosinophil count in the blood. The doctor may check this by performing a blood test.
• Hair loss.
• Osteoporosis (a condition in which bones are more prone to fractures) after long-term use of the medicine.
• Tingling, numbness and muscle weakness (especially in the lower part of the body) after lumbar puncture or spinal/epidural anaesthesia.
• Loss of control over bladder or bowel movements (a condition in which the patient is unable to control when to go to the toilet).
• Hardening or nodule at the injection site.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Losmina

Store below 25°C. Do not freeze.
Losmina pre-filled syringes are single-dose containers – any unused portion of the product
should be discarded.
The medicine should be stored out of 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 indicated.
Do not use the medicine if the pre-filled syringe is damaged or if the solution 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. Such measures 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 anti-Xa activity (corresponding to 120 mg) in 0.8 ml of water for injections.
Each pre-filled sy游戏副本 contains enoxaparin sodium equivalent to 15,000 IU anti-Xa activity (corresponding to 150 mg) in 1.0 ml of water for injections.

• The other component is water for injections.

What Losmina looks like and contents of the pack
Losmina is a clear, colourless to slightly yellowish solution for injection, supplied in a 1 ml pre-filled syringe made of colourless type I glass, with a chlorobutyl rubber stopper, plunger, and needle in a protective cap, with or without an automatic needle protection 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 sizes 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 sizes of 10, 30 and 50 pre-filled syringes.
Not all pack sizes may be marketed.
In certain pack sizes, the pre-filled syringes may be equipped with a safety device.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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

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