Losmina

Package leaflet: Information for the patient

Losmina, 2000 IU (20 mg)/0.2 ml, solution for injection in pre-filled syringe
Losmina, 4000 IU (40 mg)/0.4 ml, solution for injection in pre-filled syringe
Losmina, 6000 IU (60 mg)/0.6 ml, solution for injection in pre-filled syringe
Losmina, 8000 IU (80 mg)/0.8 ml, solution for injection in pre-filled syringe
Losmina, 10,000 IU (100 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. Patients can also help by reporting any adverse reactions that occur after using the medicine. For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before using this medicine, as it contains important
information for the patient.

• Keep this leaflet, as 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. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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 cancer patients who have developed blood clots, to further prevent the formation of new clots
  • In unstable angina (a condition in which the heart receives insufficient blood supply)
  • After myocardial infarction (heart attack)
• Preventing clot formation in the dialysis filter tubing (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 serious drop in platelets (blood cells responsible for blood clotting), known as heparin-induced thrombocytopenia, within the last 100 days, or if the patient's blood contains antibodies against enoxaparin.
• 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 a 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 identical and differ in activity and dosing instructions.
Before starting treatment with Losmina, discuss with your doctor or pharmacist if:

• the patient has ever had 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 a prosthetic heart valve implanted
• 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 suffered a stroke
• the patient has high blood pressure
• the patient has diabetes or diabetic eye disease (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 by a blood laboratory test)
• the patient is currently taking medications that may cause bleeding (see section below "Losmina and other medicines")

Before starting treatment with this medicine and periodically during treatment, blood tests may be performed to monitor platelet count (platelets, responsible for blood clotting) and potassium levels in the patient's blood.
Children and adolescents:
The safety and efficacy of enoxaparin have not been established in children and adolescents.
Losmina and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

• 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 plasma 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 conditions
• 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 spinal or epidural 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, breastfeeding, suspects she might be pregnant, or plans 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 be at increased risk of developing blood clots. The doctor should discuss this issue with the patient.
Women who are breastfeeding or intend to breastfeed should seek medical advice before starting treatment with this medicine.
Driving and operating machinery
Losmina has no influence on the ability to drive or operate machinery.
It is recommended that the physician document the brand 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 it is considered "sodium-free".

3. How to use Losmina

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your 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 to self-administer the medicine yourself
  (see the administration instructions below).

• Losmina is usually given by subcutaneous injection.

• Losmina may be administered by 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.
  Do not administer Losmina by intramuscular injection.

Dosage

• Your doctor will decide how much Losmina you should receive. The dose depends on the reason for treatment.

• In case of kidney disease, you 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.

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

  2. Prevention of blood clots 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.

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

• If you have limited mobility due to illness, you 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 (non-ST-elevation myocardial infarction):

• 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 (ST-elevation myocardial infarction) 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 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 taking aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should continue receiving Losmina.

STEMI (ST-elevation myocardial infarction) 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 in 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 (PCI).
The medicine will then be administered by intravenous injection.

3. Prevention of blood clots in dialysis 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 (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, 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, you should immediately consult your doctor or nurse.
Proper subcutaneous injection technique (called a "subcutaneous injection") can help reduce pain and bruising at the injection site.
Before self-injecting Losmina

• Prepare the necessary items: the syringe, a gauze pad 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 that the syringe is undamaged and that the liquid is clear. If not, use another syringe.
• Confirm the correct dose to be injected.
• Examine the abdomen to check whether the previous injection caused redness, skin discoloration, swelling, oozing, or is still painful. If so, consult your doctor or nurse.

Instructions for self-injection of Losmina:
(Instructions for pre-filled syringes without a safety system)
Preparing the injection site

1. Select 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 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 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, examination table, 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 reduce the administered dose.
• After removing the cap, do not touch the needle. This ensures the needle remains clean (sterile).

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 depends 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 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 with your index finger and thumb, creating a skin fold between your fingers.
   Make sure you maintain the skin fold during the injection.
6. 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. This will deliver 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 sharps 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 medicines or waste materials should be disposed of in accordance with local regulations.
   If you feel the dose is too strong (e.g., unexpected bleeding occurs) or too weak (e.g., the dose does not seem effective), consult your doctor or pharmacist.
   Instructions for pre-filled syringes with a safety system
   Preparing the injection site
3. Select 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 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. Discard the cap.

• 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 will ensure 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 (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

3. Press the plunger with the thumb to inject the medication into the abdominal fatty tissue. Inject the entire dose of medication from the syringe.
4. Remove the needle from the injection site by pulling it straight out, 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 engage, producing an audible "click" to confirm activation of the safety shield. You may now release the skin fold.

it should be disposed of in accordance with the recommendations of the doctor or pharmacist.
Any unused medicines or waste materials should be disposed of in accordance with local regulations.
If you feel that the dose is too strong (for example, unexpected bleeding occurs)
or too weak (for example, the dose probably does not work), consult your doctor
or pharmacist.
Switching anticoagulant therapy

• Switching from Losmina to oral anticoagulants known as vitamin K antagonists (e.g., warfarin) The doctor will recommend blood tests to determine the INR value and, based on the results, will inform the patient when to stop taking Losmina.
• Switching from oral anticoagulants known as vitamin K antagonists (e.g., warfarin) to Losmina The vitamin K antagonist medication should be discontinued. The doctor will recommend a blood test to determine the INR value and, based on the results, will inform the patient when to start taking Losmina.
• Switching from Losmina to direct oral anticoagulants (DOACs) Losmina should be discontinued. Then, the direct oral anticoagulant should be started 0-2 hours before the scheduled time of the next injection; after that, continue taking the medication as usual.
• Switching from a direct oral anticoagulant to Losmina The direct oral anticoagulant should be discontinued. 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 the patient thinks they have taken too much or too little of Losmina, they should immediately
inform their doctor, nurse, or pharmacist, even if there are no signs of any problems. In case of accidental injection or ingestion of Losmina by a
child, seek immediate medical attention at the nearest hospital emergency department.
Missed dose of Losmina
If a dose is missed, 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 doses are missed.
Stopping the use of Losmina
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.
It is important to continue the injections of Losmina until your doctor advises you to stop. Stopping treatment may lead to the formation of a blood clot, which can be very dangerous.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
As with other similar medicines (used to reduce blood clotting), the medicine 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 (increased weakness, fatigue, paleness, dizziness, headaches 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 a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes).
• Red, scaly, widespread rash with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular eruption).

Immediate medical advice should be sought:

• If the patient develops any signs of a blood vessel blocked by a blood clot, 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 the patient develops painful skin rash or dark red spots under the skin that do not fade when pressed. 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 than usual tendency to bruising. This may be due to a reduced platelet count.
• Pink spots on the skin. These changes are more likely at the 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 be a sign of bleeding into the brain.
• Feeling 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 the 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 with a blood test.
• Increased eosinophil count 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.
• Tingling, numbness and muscle weakness (especially in the lower part of the body) after lumbar puncture or spinal/epidural anaesthesia.
• Loss of bladder or bowel control (a condition in which the patient cannot control when to go to the toilet).
• Hardening or lump at the injection site.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine 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 stated month.
Do not use the medicine if the pre-filled syringe is damaged or if the solution is not clear.
Medicines must 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 in Losmina is enoxaparin sodium.

Each pre-filled syringe contains enoxaparin sodium corresponding to 2000 IU of anti-Xa activity (equivalent to 20 mg) in 0.2 ml of water for injections.
Each pre-filled syringe contains enoxaparin sodium corresponding to 4000 IU of anti-Xa activity (equivalent to 40 mg) in 0.4 ml of water for injections.
Each pre-filled syringe contains enoxaparin sodium corresponding to 6000 IU of anti-Xa activity (equivalent to 60 mg) in 0.6 ml of water for injections.
Each pre-filled syringe contains enoxaparin sodium corresponding to 8000 IU of anti-Xa activity (equivalent to 80 mg) in 0.8 ml of water for injections.
Each pre-filled syringe contains enoxaparin sodium corresponding to 10,000 IU of anti-Xa activity (equivalent to 100 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 pre-filled syringe made of colourless type I glass, with a chlorobutyl rubber stopper, plunger, and needle in a protective sheath, with or without an automatic needle protection device. It is available in the following presentations:
Losmina 2000 IU (20 mg)/0.2 ml solution for injection in 0.5 ml pre-filled syringe without graduation marks. Pack sizes: 2, 6, 10, 20 and 50 pre-filled syringes.
Losmina 4000 IU (40 mg)/0.4 ml solution for injection in 0.5 ml pre-filled syringe without graduation marks. Pack sizes: 2, 6, 10, 20, 30 and 50 pre-filled syringes.
Losmina 6000 IU (60 mg)/0.6 ml solution for injection in 1 ml pre-filled syringe. Pack sizes: 2, 6, 10, 12, 20, 24, 30 and 50 pre-filled syringes.
Losmina 8000 IU (80 mg)/0.8 ml solution for injection in 1 ml pre-filled syringe. Pack sizes: 2, 6, 10, 12, 20, 24, 30 and 50 pre-filled syringes.
Losmina 10,000 IU (100 mg)/1 ml solution for injection in 1 ml pre-filled syringe. Pack sizes: 2, 6, 10, 12, 20, 24, 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 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

Other sources of 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/