Neoparin multi

Package leaflet: Information for the patient

Neoparin Multi, 10,000 IU (100 mg)/1 ml, solution for injection
30,000 IU (300 mg)/3 ml
50,000 IU (500 mg)/5 ml
Enoxaparin sodium
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any 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 another person, 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.

Table of contents

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

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

Neoparin Multi contains the active substance enoxaparin sodium, which is a low molecular weight heparin (LMWH).
Neoparin Multi 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 Multi may be used in:

• Treating blood clots already present 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 machine tubing (used in patients with severe kidney dysfunction).

2. Important information before using Neoparin Multi

When not to use Neoparin Multi

• If the patient is allergic to enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6). Signs 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 platelet count (thrombocytes) 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 Neoparin Multi for blood clots and spinal or epidural anaesthesia or lumbar puncture is planned within 24 hours.
• If the patient is a premature infant or a newborn during the first month of life — due to the risk of severe toxic effects, including respiratory disorders ("respiratory distress syndrome").

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

• The patient has ever had a reaction to heparin that caused a significant drop in platelet count
• The patient is scheduled for spinal or epidural anaesthesia or lumbar puncture (see "Surgical procedures and anaesthetics"): appropriate time intervals between administration of Neoparin Multi and the procedure must be observed
• The patient has had a heart valve implanted
• 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 had or currently has a stroke
• The patient has high blood pressure
• The patient has diabetes or has eye blood vessel problems caused by diabetes (so-called diabetic retinopathy)
• The patient has recently undergone eye or brain surgery
• The patient is elderly (over 65 years of age), especially if over 75 years old
• The patient has kidney disease
• The patient has liver disease
• The patient has underweight or overweight
• The patient has elevated potassium levels in the blood (this can be checked by a blood laboratory test)
• The patient is currently taking medicines that may cause bleeding (see section below "Neoparin Multi and other medicines")

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

Neoparin Multi 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
• 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 medicines known as 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 blood, such as potassium salts, diuretics, and certain medicines used in heart diseases.

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 Multi. See section "When not to use Neoparin Multi". 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 might 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 treatment with this medicine.

Driving and operating machinery
Neoparin Multi does not affect the ability to drive or operate machinery.

Neoparin Multi contains benzyl alcohol (45 mg/3 ml or 75 mg/5 ml)
This is a preservative. It may cause poisoning and allergic reactions in infants and children under 3 years of age. This medicine should not be used in premature infants or newborns during the first month of life due to the risk of severe toxic effects, including respiratory disorders.
It is recommended that pregnant women use Neoparin formulations that do not contain benzyl alcohol.
It is recommended that the doctor document the brand name and batch number of the product used.

3. How to take Neoparin Multi

This medicine should always be taken exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Taking this medicine

• Neoparin Multi 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 taking Neoparin Multi and to give it yourself (see the injection instructions provided below).
• Neoparin Multi is usually given by subcutaneous injection.
• Neoparin Multi may be given by intravenous injection after certain types of heart attack or surgery.
• Neoparin Multi may be injected into the dialysis tube carrying blood away from the body (into the so-called arterial line) at the beginning of a dialysis session.
• Neoparin Multi must not be given by intramuscular injection.

Dose

• Your doctor will decide how much Neoparin Multi you should take. The dose depends on why the medicine is being used.
• If you have kidney disease, you may receive a lower dose of Neoparin Multi.

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 taking Neoparin Multi.

2. Prevention of blood clots in the patient in the following situations:

• Surgery or limited mobility due to illness
  The dose depends on the patient's risk of developing clots. You will receive Neoparin Multi at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) daily.

• Before 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 usually receive Neoparin Multi at a dose of 4000 IU (40 mg) daily.

• Your doctor will decide how long you should continue taking Neoparin Multi.

• After heart attack
  Neoparin Multi can be used in two different types of heart attack: ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI). The dose of Neoparin Multi depends 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 taking Neoparin Multi.

STEMI heart attack in patients under 75 years of age:

• An initial dose of Neoparin Multi, 3000 IU (30 mg), will be given by intravenous injection.
• Neoparin Multi 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 taking Neoparin Multi.

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

Patients undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Neoparin Multi was given, your doctor may decide to administer an additional dose of Neoparin Multi before percutaneous coronary intervention. 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 Multi is injected into the tube carrying blood away 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 give you an additional dose of 50 IU to 100 IU (0.5 to 1 mg) per kilogram of body weight.

Subcutaneous injection technique
The injection is best given while the patient is lying down.
Enoxaparin is administered by deep subcutaneous injection. The medicine should be injected alternately into the left or right anterolateral or posterolateral abdominal wall.
Insert the full length of the needle vertically into a skin fold created by pinching the skin with the thumb and index finger. Do not release the skin fold before completing the injection.
After administering the medicine, do not rub the injection site.

Switching anticoagulant therapy

• Switching from Neoparin Multi to vitamin K antagonists (e.g. warfarin)
  Your doctor will advise you to have blood tests to monitor your INR value and will inform you when to stop taking Neoparin Multi based on these results.

• Switching from vitamin K antagonists (e.g. warfarin) to Neoparin Multi
  Stop taking the vitamin K antagonist medicine. Your doctor will advise you to have a blood test to monitor your INR value and will inform you when to start taking Neoparin Multi based on these results.

• Switching from Neoparin Multi to direct oral anticoagulants (DOACs)
  Stop taking Neoparin Multi. Then start taking the direct oral anticoagulant 0–2 hours before the next scheduled injection. Continue taking the oral medicine as usual thereafter.

• Switching from a direct oral anticoagulant to Neoparin Multi
  Stop taking the direct oral anticoagulant. Treatment with Neoparin Multi 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 Multi in children and adolescents have not been established.

Taking more Neoparin Multi than you should
If you think you have taken too much or too little Neoparin Multi, contact your doctor, nurse, or pharmacist immediately, even if you do not have any symptoms. If a child accidentally injects or swallows Neoparin Multi, go immediately to the hospital emergency department.

If you forget to take Neoparin Multi
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 Multi
If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.
It is important to continue giving Neoparin Multi injections until your doctor tells you to stop. If you stop treatment, a blood clot may form, 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 Multi
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 (increased weakness, fatigue, paleness, dizziness, headache or unexplained sweating), medical advice must be sought immediately.
The doctor may decide to subject the patient to closer observation or to change the treatment.
Neoparin Multi 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 assistance sought:

• 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 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 upon pressure. The doctor may order blood tests to determine 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)

• Increased tendency to bruising more than usual. This may be caused by a reduced platelet count.
• Pink skin spots. These changes are more likely at the sites of Neoparin Multi injections.
• 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.
• Sensation of tenderness and swelling in the stomach. This may indicate bleeding into the stomach.
• Large, red skin lesions of 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 of such a reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• Increased potassium levels in the blood. This is more likely in people with kidney 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 anaesthesia.
• Loss of bladder or bowel control (a condition in which the patient cannot control when to go to the toilet).
• Hardening or nodule 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 this medicine.

5. How to store Neoparin Multi

Store below 25°C.
Do not freeze.
After opening the vial, store the medicine for no longer than 28 days.
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.
Do not use this medicine if visible signs of damage are observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Neoparin Multi contains

• The active substance is enoxaparin sodium.

Neoparin Multi, 30,000 IU (300 mg)/3 ml: One 3 ml vial contains 30,000 IU (300 mg)
of enoxaparin sodium (10,000 IU (100 mg)/1 ml).
Neoparin Multi, 50,000 IU (500 mg)/5 ml: One 5 ml vial contains 50,000 IU (500 mg)
of enoxaparin sodium (10,000 IU (100 mg)/1 ml).

• Other ingredients (excipients) are: benzyl alcohol (45 mg/3 ml or 75 mg/5 ml), water for injections.

What Neoparin Multi looks like and contents of the pack
Packs of 1, 5 or 25 vials of 3 ml in a cardboard box.
Packs of 1, 5 or 25 vials of 5 ml in a cardboard box.
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

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/pl