Neoparin

Patient Information Leaflet

Neoparin, 2000 IU (20 mg)/0.2 ml, solution for injection
Neoparin, 4000 IU (40 mg)/0.4 ml, solution for injection
Neoparin, 6000 IU (60 mg)/0.6 ml, solution for injection
Neoparin, 8000 IU (80 mg)/0.8 ml, solution for injection
Neoparin, 10,000 IU (100 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 further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Neoparin is and what it is used for

Neoparin contains the active substance enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Neoparin 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 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 the 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 Neoparin

When not to use Neoparin

• 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 had a reaction to heparin that caused a significant drop in the number of blood cells responsible for blood clotting (platelets) – this condition is 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 Neoparin for blood clots and spinal or epidural anaesthesia or lumbar puncture is planned within 24 hours.

Warnings and precautions
Neoparin 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, discuss with your doctor or pharmacist if:

• the patient has ever had a reaction to heparine causing a significant drop in platelet count
• the patient is scheduled to receive spinal or epidural anaesthesia or lumbar puncture (see "Surgical procedures and anaesthetics"): the appropriate time interval between Neoparin administration and the procedure must be considered
• the patient has a heart valve prosthesis
• 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 affecting blood vessels in the eye (so-called diabetic retinopathy)
• the patient recently underwent eye or brain surgery
• the patient is elderly (over 65 years), especially if 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 (can be checked by a blood laboratory test)
• the patient is currently taking medications that may cause bleeding (see section below "Neoparin and other medicines")

Before starting this medicine and periodically during treatment, the patient may undergo blood tests to monitor platelet count (blood cells responsible for clotting) and blood potassium levels.

Neoparin 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 medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation 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 medicines used in heart disease

Surgical procedures and anaesthetics
If the patient is scheduled for lumbar puncture or surgery under epidural or spinal anaesthesia, inform the doctor that the patient is using Neoparin. See section "When not to use Neoparin". Additionally, inform the doctor about any spinal problems or if the patient has ever had 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 be at 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 using machines
Neoparin does not affect 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

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.

Taking the medicine

• Neoparin is usually administered by a doctor or nurse, as it must be given by injection.
• After returning home, you may need to continue treatment with Neoparin and self-administer the injections (see the self-injection instructions below).
• Neoparin is usually given as subcutaneous injections.
• Neoparin may be administered as an intravenous injection following certain types of heart attack or after surgery.
• Neoparin 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 must not be administered by intramuscular injection.

Dosage

• Your doctor will decide the dose of Neoparin you should receive. The dose depends on the reason for treatment.
• Patients with kidney disease may receive a lower dose of Neoparin.

1. Treatment of blood clots in the patient

• 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.

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 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 at a dose of 4000 IU (40 mg) daily.
• Your doctor will decide how long you should continue receiving Neoparin.

❖ After a heart attack
Neoparin may 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 Neoparin 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.

STEMI heart attack in patients under 75 years of age:

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

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

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

3. Prevention of blood clots in dialyser tubing
   • The usual dose is 100 IU (1 mg) per kilogram of body weight.

• Neoparin 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 the pre-filled syringe without a safety needle shield
How to self-administer Neoparin injections
If you are able to self-administer 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

• Check the expiry date of the medicine. Do not use it if the expiry date has passed.
• 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 your 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-administering Neoparin injections
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, couch, or reclining chair with pillows is ideal.
3) Choose 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 the medicine in areas less than 5 cm from the navel or near scars or bruises. Alternate injections 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 for use.

Do not press the plunger before injecting the medicine to remove air bubbles.
This may result in loss of some of the medicine. After removing the cap, do not allow the needle to touch any surface. This ensures the needle remains clean (sterile).
5) Hold the pre-filled syringe (like a pencil) in the hand used for writing. With the other hand, gently pinch the cleaned area of the abdomen between your thumb and index finger, creating a skin fold.
Remember to keep holding the skin fold throughout the entire injection.
6) Hold the pre-filled 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. Remember to keep 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 containers.

Instructions for using the pre-filled syringe with a safety needle shield
How to self-administer Neoparin injections
Your pre-filled syringe may have an attached needle shield that prevents needle-stick injuries. If you are able to self-administer 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

• Check the expiry date of the medicine. Do not use it if the expiry date has passed.
• 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 your 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-administering Neoparin injections
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, couch, or reclining chair with pillows is ideal.
3) Choose 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 the medicine in areas less than 5 cm from the navel or near scars or bruises. Alternate injections 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 for use.

Do not press the plunger before injecting the medicine to remove air bubbles.
This may result in loss of some of the medicine. After removing the cap, do not allow the needle to touch any surface. This ensures the needle remains clean (sterile).
5) Hold the pre-filled syringe (like a pencil) in the hand used for writing. With the other hand, gently pinch the cleaned area of the abdomen between your thumb and index finger, creating a skin fold.
Remember to keep holding the skin fold throughout the entire injection.
6) Hold the pre-filled 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. Remember to keep 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 needle safety device, in the form of 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 containers.

Changing anticoagulant therapy

• Switching from Neoparin to anticoagulants known as vitamin K antagonists (e.g., warfarin)
  Your doctor will recommend blood tests to measure your INR and, based on the results, will inform you when to stop taking Neoparin.
• Switching from vitamin K antagonists (e.g., warfarin) to Neoparin
  Stop taking the vitamin K antagonist medicine. Your doctor will recommend a blood test to measure your INR and, based on the results, will inform you when to start taking Neoparin.
• Switching from Neoparin to direct oral anticoagulants
  Stop taking Neoparin. Then start taking the direct oral anticoagulant 0–2 hours before the next scheduled injection. Continue taking the oral medicine as usual.
• Switching from direct oral anticoagulants to Neoparin
  Stop taking the direct oral anticoagulant. Neoparin treatment may be started 12 hours after the last dose of the direct oral anticoagulant.

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

Accidental overdose of Neoparin
If you think you have used too much or too little Neoparin, contact your doctor, nurse, or pharmacist immediately, even if you do not notice any problems. If Neoparin is accidentally injected or swallowed by a child, seek emergency medical attention at a hospital immediately.

Missed dose of Neoparin
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 a dose.

Stopping Neoparin treatment
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.
It is important to continue Neoparin 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 effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
As with other similar medicines (used to reduce blood clotting), Neoparin
may cause bleeding, which potentially could 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, paleness, 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 medicine.
Neoparin treatment should be discontinued and immediate medical advice sought 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 treatment should be stopped and immediate medical assistance sought:

• Red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular eruption).

Seek medical advice 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 – 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 on pressure. The doctor may order blood tests to check platelet count.

List of possible adverse 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)

• Greater than usual tendency to bruising. This may be due to reduced platelet count.
• Pink skin spots. These changes are more likely at the injection sites of Neoparin.
• 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 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 1000 people)

• Severe allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.
• Increased potassium levels in 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 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 anaesthesia.
• Loss of bladder or bowel control (a condition in which the patient cannot control when they need to go to the toilet).
• Hardening or lump at the injection site.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Neoparin

Store below 25°C. The medicine can also be stored in the refrigerator (2°C - 8°C), but not for longer than 1 month. 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 carton and pre-filled syringe after EXP. 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 package and other information

What Neoparin contains

• The active substance is enoxaparin sodium.

Neoparin, 2000 IU (20 mg)/0.2 ml: One pre-filled syringe with needle containing 0.2 ml contains 2000 IU (20 mg) of enoxaparin sodium.
Neoparin, 4000 IU (40 mg)/0.4 ml: One pre-filled syringe with needle containing 0.4 ml contains 4000 IU (40 mg) of enoxaparin sodium.
Neoparin, 6000 IU (60 mg)/0.6 ml: One pre-filled syringe with needle containing 0.6 ml contains 6000 IU (60 mg) of enoxaparin sodium.
Neoparin, 8000 IU (80 mg)/0.8 ml: One pre-filled syringe with needle containing 0.8 ml contains 8000 IU (80 mg) of enoxaparin sodium.
Neoparin, 10,000 IU (100 mg)/1 ml: One pre-filled syringe with needle containing 1 ml contains 10,000 IU (100 mg) of enoxaparin sodium.

• Other components (excipients): water for injections.

What Neoparin looks like and contents of the pack
Pre-filled syringes with needle, with or without a needle safety guard to prevent accidental needlestick injury after administration, packed in blisters within a cardboard box.
2 or 10 pre-filled syringes with needle of 0.2 ml
2 or 10 pre-filled syringes with needle of 0.4 ml
2 or 10 pre-filled syringes with needle of 0.6 ml
2 or 10 pre-filled syringes with needle of 0.8 ml
2 or 10 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