NEOPARIN FORTE

Package leaflet: Information for the patient

Neoparin Forte, 12,000 IU (120 mg)/0.8 ml, solution for injection
Neoparin Forte, 15,000 IU (150 mg)/1 ml, solution for injection
Enoxaparin sodium
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

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

Table of contents

1. What Neoparin Forte is and what it is used for
2. What you need to know before using Neoparin Forte
3. How to use Neoparin Forte
4. Possible side effects
5. How to store Neoparin Forte
6. Contents of the pack and other information

1. What Neoparin Forte is and what it is used for

Neoparin Forte contains an active substance called enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Neoparin Forte 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.
   Neoparin Forte may be used:

• To treat existing blood clots in the patient's blood.
• To prevent 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 the formation of new clots
  • In unstable angina (a condition in which insufficient blood reaches the heart)
  • After myocardial infarction (heart attack)
• To prevent clotting in the dialysis filter tubing (used in patients with severe kidney dysfunction).

2. Important information before using Neoparin Forte

When not to use Neoparin Forte

• 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 previously 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 platelet count (platelets are blood cells responsible for blood clotting) – this condition is 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 ulcer, recent brain or eye surgery), including recent hemorrhagic stroke.
• If the patient is being treated with Neoparin Forte for blood clots and spinal or epidural anaesthesia or lumbar puncture is planned within 24 hours.

Warnings and precautions
Neoparin Forte must not be used interchangeably with medicines containing other low-molecular-weight heparins. This is because they are not exactly the same and differ in activity and instructions for use.
Before starting Neoparin Forte, 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 to undergo spinal or epidural anaesthesia or lumbar puncture (see "Surgical procedures and anaesthetics"): the appropriate time interval between administration of Neoparin Forte and the procedure must be considered.
• The patient has had a heart valve replacement.
• The patient has endocarditis (an 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 disease (diabetic retinopathy).
• The patient has recently undergone eye or brain surgery.
• The patient is elderly (over 65 years of age), particularly if over 75 years old.
• 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 checked with a laboratory blood test).
• The patient is currently taking medications that may cause bleeding (see section below "Neoparin Forte and other medicines").

Before starting this medicine and periodically during treatment, the patient may undergo blood tests to monitor platelet count (platelets are blood cells involved in clotting) and blood potassium levels.
Neoparin Forte and 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
• Acetylsalicylic acid (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 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 epidural or spinal anaesthesia, inform the doctor that the patient is using Neoparin Forte. See section "When not to use Neoparin Forte". 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 have a child, she should consult her 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. The doctor should discuss this issue with the patient.
Women who are breastfeeding or intend to breastfeed should seek medical advice before starting this medicine.
Driving and operating machinery
Neoparin Forte has no influence on the ability to drive or operate machinery.
It is recommended that the doctor document the brand name and batch number of the product used.

3. How to use Neoparin Forte

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

Taking the medicine

• Neoparin Forte 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 Neoparin Forte and self-administer it (see the administration instructions provided below).
• Neoparin Forte is usually given as subcutaneous injections.
• Neoparin Forte may be administered as an intravenous injection following certain types of heart attack or after surgery.
• Neoparin Forte 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.
• Neoparin Forte must not be administered by intramuscular injection.

Dosage

• Your doctor will decide how much Neoparin Forte you should receive. The dose depends on the reason for treatment.
• If you have kidney disease, you may receive a lower dose of Neoparin Forte.

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 Neoparin Forte.

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 Neoparin Forte at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) daily.
• If you are undergoing 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 Neoparin Forte at a dose of 4000 IU (40 mg) daily.
• Your doctor will decide how long you should continue receiving Neoparin Forte.

❖ After a heart attack

Neoparin Forte may 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 Neoparin Forte 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 acetylsalicylic acid.
• Your doctor will decide how long you should continue receiving Neoparin Forte.

STEMI heart attack in patients under 75 years of age:

• An initial intravenous dose of Neoparin Forte of 3000 IU (30 mg) will be administered.
• Neoparin Forte 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 acetylsalicylic acid.
• Your doctor will decide how long you should continue receiving Neoparin Forte.

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 Neoparin Forte for the first two doses is 7500 IU (75 mg).
• Your doctor will decide how long you should continue receiving Neoparin Forte.

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

3. Prevention of blood clot formation in dialyzer tubing

• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Neoparin Forte 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 to 100 IU (0.5 to 1 mg) per kilogram of body weight.

Instructions for using a pre-filled syringe without a safety needle shield
How to self-administer Neoparin Forte injection
If you are able to self-inject this medicine, your doctor or nurse will show you how to do it.
Do not attempt to self-inject without prior training.
If you are unsure what to do, consult your doctor or nurse immediately.
Correctly administering the injection under the skin (known as a "subcutaneous injection") will help reduce pain and the risk of bruising at the injection site.

Before self-injecting Neoparin Forte

• Check the expiry date. Do not use if expired.
• Check whether the pre-filled syringe is damaged and whether the medicine is a clear solution. If not, use another pre-filled syringe.
• Do not use this medicine if you notice any changes in the appearance of the product.
• Make sure you know the intended dose to be administered.
• Examine the abdomen to check whether the previous injection caused redness, skin discoloration, swelling, oozing, or persistent pain.
• If so, consult your doctor or nurse.
• Decide where the injection will be given. The injection should be alternated between the left and right sides of the abdomen. The medicine should be injected just under the skin of the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Neoparin Forte

1) Wash your hands and the injection site with water and soap. Dry thoroughly.
2) Sit or lie down in a comfortable, relaxed position. Ensure the intended injection site is clearly visible. Using a bed, recliner, or bed with pillows is ideal.
3) Select a site on the right or left side of the abdomen, at least 5 cm away from the navel toward the side.
Important: Do not inject in areas less than 5 cm from the navel or near scars or bruises. Alternate between the left and right sides of the abdomen, changing sides each time.
4) Carefully remove the needle cap. The pre-filled syringe is factory-filled with medicine and ready to use.

Do not press the plunger before injecting to remove air bubbles.
This may result in loss of some medicine. After removing the cap, do not allow the needle to touch any surface to maintain sterility.
5) Hold the pre-filled syringe (like a pencil) in your dominant hand, and with the other hand, gently pinch the cleaned area of the abdomen between your thumb and index finger to create a skin fold.
Remember to keep holding the skin fold throughout the entire injection.
6) Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the full length of the needle into the skin fold.

7) Press the plunger with your finger. This will deliver the medicine into the fatty tissue of the abdomen. Continue holding the skin fold during the entire injection.
8) Remove the needle by pulling it straight out.

To avoid bruising, do not rub the injection site after administration.
9) Dispose of the used pre-filled syringe.
Do not dispose of pre-filled syringes in household waste.

Instructions for using a pre-filled syringe with a safety needle shield
How to self-administer Neoparin Forte injection
Your pre-filled syringe may have an attached needle shield that prevents needlestick injury. If you are able to self-inject this medicine, your doctor or nurse will show you how to do it. Do not attempt to self-inject without prior training. If you are unsure what to do, consult your doctor or nurse immediately.
Correctly administering the injection under the skin (known as a "subcutaneous injection") will help reduce pain and the risk of bruising at the injection site.

Before self-injecting Neoparin Forte

• Check the expiry date. Do not use if expired.
• Check whether the pre-filled syringe is damaged and whether the medicine is a clear solution. If not, use another pre-filled syringe.
• Do not use this medicine if you notice any changes in the appearance of the product.
• Make sure you know the intended dose to be administered.
• Examine the abdomen to check whether the previous injection caused redness, skin discoloration, swelling, oozing, or persistent pain.
• If so, consult your doctor or nurse.
• Decide where the injection will be given. The injection should be alternated between the left and right sides of the abdomen. The medicine should be injected just under the skin of the abdomen, but not too close to the navel or any scar tissue (at least 5 cm away).
• The pre-filled syringe is for single use only.

Instructions for self-injecting Neoparin Forte

1) Wash your hands and the injection site with water and soap. Dry thoroughly.
2) Sit or lie down in a comfortable, relaxed position. Ensure the intended injection site is clearly visible. Using a bed, recliner, or bed with pillows is ideal.
3) Select a site on the right or left side of the abdomen, at least 5 cm away from the navel toward the side.
Important: Do not inject in areas less than 5 cm from the navel or near scars or bruises. Alternate between the left and right sides of the abdomen, changing sides each time.
4) Carefully remove the needle cap. The pre-filled syringe is factory-filled with medicine and ready to use.

Do not press the plunger before injecting to remove air bubbles.
This may result in loss of some medicine. After removing the cap, do not allow the needle to touch any surface to maintain sterility.
5) Hold the pre-filled syringe (like a pencil) in your dominant hand, and with the other hand, gently pinch the cleaned area of the abdomen between your thumb and index finger to create a skin fold.
Remember to keep holding the skin fold throughout the entire injection.
6) Hold the syringe so that the needle points downward (vertically at a 90º angle). Insert the full length of the needle into the skin fold.

7) Press the plunger with your finger. This will deliver the medicine into the fatty tissue of the abdomen. Continue holding the skin fold during the entire injection.
8) Remove the needle by pulling it straight out. Do not release pressure on the plunger!

To avoid bruising, do not rub the injection site after administration.
9) Firmly press the plunger of the syringe. The safety shield, which is a plastic cylinder, will automatically slide over the needle, completely covering it.

10) Dispose of the used pre-filled syringe.
Do not dispose of pre-filled syringes in household waste.

Changing anticoagulant therapy

• Switching from Neoparin Forte to vitamin K antagonist anticoagulants (e.g., warfarin)
  Your doctor will order blood tests to monitor your INR value and will advise you when to stop using Neoparin Forte based on the results.
• Switching from vitamin K antagonist anticoagulants (e.g., warfarin) to Neoparin Forte
  Stop taking the vitamin K antagonist medicine. Your doctor will order a blood test to determine your INR value and will advise you when to start taking Neoparin Forte.
• Switching from Neoparin Forte to direct oral anticoagulants (DOACs)
  Stop taking Neoparin Forte. Begin taking the direct oral anticoagulant 0–2 hours before the scheduled time of the next injection. Then continue taking the oral medicine as usual.
• Switching from direct oral anticoagulants to Neoparin Forte
  Stop taking the direct oral anticoagulant. Neoparin Forte treatment may begin 12 hours after the last dose of the direct oral anticoagulant.

Use in children and adolescents
The safety and efficacy of Neoparin Forte in children and adolescents have not been established.

Overdose of Neoparin Forte
If you think you have used too much or too little Neoparin Forte, contact your doctor, nurse, or pharmacist immediately, even if you have no symptoms. In case of accidental injection or ingestion of Neoparin Forte by a child, seek emergency medical attention immediately.

Missed dose of Neoparin Forte
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for a missed dose. Keeping a diary can help ensure you do not miss doses.

Stopping Neoparin Forte treatment
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.
It is important to continue administering Neoparin Forte 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), Neoparin Forte
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 (such as severe weakness, fatigue, paleness, dizziness, headache, or unexplained sweating), medical advice should be sought immediately.
The doctor may decide to monitor the patient more closely or change the treatment.
Neoparin Forte should be discontinued and medical advice sought immediately from a doctor or nurse if signs of a severe allergic reaction occur (such as difficulty breathing, swelling of the lips, mouth, throat or eyes).
If any of the following symptoms occur, enoxaparin should be discontinued and immediate medical help sought:

• Red, scaly, widespread rash with lumps under the skin 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 skin rash or dark red spots under the skin that do not fade on pressure. The doctor may order blood tests to determine platelet count.

Summary 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 skin spots. These changes are more likely at the injection sites of Neoparin Forte.
• 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 bleeding into the brain.
• Sensation of tenderness and swelling in the stomach. This may indicate gastrointestinal bleeding.
• Large, red skin lesions with irregular shape, 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 1000 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 with a blood test.
• Increased number of eosinophils in the blood. The doctor may check this with a blood test.
• Hair loss.
• Osteoporosis (a condition in which bones are more prone to fractures) after long-term use of the medicine.
• 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, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 Neoparin Forte

Store below 25°C.
Do not freeze.
Keep the medicine 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Neoparin Forte contains

• The active substance is enoxaparin sodium.

Neoparin Forte, 12,000 IU (120 mg)/0.8 ml: One pre-filled syringe with needle containing 0.8 ml contains 12,000 IU (120 mg) of enoxaparin sodium.
Neoparin Forte, 15,000 IU (150 mg)/1 ml: One pre-filled syringe with needle containing 1 ml contains 15,000 IU (150 mg) of enoxaparin sodium.

• The other component (excipient) is: water for injections.

What Neoparin Forte looks like and contents of the pack
Pre-filled syringes with needle, with or without a needle protection cap to prevent needlestick injury after administration, packed in blisters within a cardboard box.
2, 6, 10 or 30 pre-filled syringes with needle of 0.8 ml
2, 6, 10 or 30 pre-filled syringes with needle of 1 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
SciencePharma spółka z ograniczoną odpowiedzialnością
ul. Chełmska 30/34, 00-725 Warszawa, Poland
Tel.: +48 22 841 16 64

Other sources of information
Detailed information on 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/pl