Neoparin Multi

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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 packaging 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 the growth of existing blood clots. This helps the body to dissolve existing blood clots, making them no longer harmful.
• 2) It prevents the formation of new blood clots in the patient's blood.

Neoparin Multi can be used for:

• Treating blood clots that have already formed in the patient's blood.
• Preventing the formation of blood clots in the patient's blood in the following situations:
• Before and after surgery
• During acute illness, when the patient has limited mobility
• In patients who have developed blood clots in the circulating blood due to cancer, to further prevent the formation of new blood clots
• In unstable angina (a condition in which the heart receives insufficient blood)
• After a heart attack
• Preventing the formation of blood clots in dialysis tubes (used in patients with severe kidney function disorders).

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). Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If the patient has been diagnosed with an allergy to heparin or other low molecular weight heparins, such as nadroparin, tinzaparin, or dalteparin.
• If the patient has been diagnosed with a reaction to heparin that caused a significant decrease in the number of blood platelets (thrombocytopenia) - a reaction known as heparin-induced thrombocytopenia - within the last 100 days or if the patient has antibodies against enoxaparin in their blood.
• If the patient has severe 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 using Neoparin Multi to treat blood clots and spinal or epidural anesthesia or lumbar puncture is planned within 24 hours.
• If the patient is a premature infant or a newborn in the first month of life - due to the risk of severe toxic effects, including respiratory distress syndrome (respiratory distress syndrome).

Warnings and precautions

Neoparin Multi should not be used interchangeably with medicines containing other low molecular weight heparins.
This is because they are not exactly the same, differ in activity and instructions for use.
Before starting to use Neoparin Multi, the patient should discuss this with their doctor or pharmacist if:

• the patient has ever had a reaction to heparin that caused a significant decrease in the number of platelets
• the patient is scheduled for spinal or epidural anesthesia or lumbar puncture (see "Surgical procedures and anesthetics"): an appropriate time interval should be allowed between the use of Neoparin Multi and this procedure
• the patient has a heart valve replacement
• the patient has endocarditis (infection of the membrane lining the heart)
• the patient has had stomach ulcers
• the patient has recently had a brain stroke
• the patient has high blood pressure
• the patient has diabetes or has problems with blood vessels in the eyes caused by diabetes (so-called diabetic retinopathy)
• the patient has recently had eye or brain surgery
• the patient is elderly (over 65 years), especially if they are over 75 years old
• the patient has kidney disease
• the patient has liver disease
• the patient is underweight or overweight
• the patient has an increased level of potassium in the blood (which can be checked with a blood test)
• the patient is currently taking medicines that may cause bleeding (see below "Neoparin Multi and other medicines")

Before starting to use this medicine and periodically during its use, the patient may undergo a blood test to check the number of platelets in the blood and the level of potassium.

Neoparin Multi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan 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 "Change of anticoagulant medicine")
• Dextrans injections - used as a blood substitute
• Ibuprofen, diclofenac, ketorolac, or other non-steroidal anti-inflammatory medicines 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 the level of potassium in the blood, such as potassium salts, diuretics, and certain heart medicines.

Surgical procedures and anesthetics

If the patient is scheduled for a lumbar puncture or surgery under spinal or epidural anesthesia, they should inform their doctor that they are using Neoparin Multi. See "When not to use Neoparin Multi". Additionally, the patient should inform their doctor if they have any spinal problems or if they have had spinal surgery.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
In pregnant women with a mechanical heart valve, there may be an increased risk of blood clots. The doctor should discuss this with the patient.
Women who are breastfeeding or plan to breastfeed should consult their doctor before using this medicine.

Driving and using machines

Neoparin Multi does not affect the ability to drive or use machines.
Neoparin Multi contains benzyl alcohol(45 mg/3 ml or 75 mg/5 ml)
This is a preservative. It can cause poisoning and allergic reactions in infants and children under 3 years old. The medicine should not be used in premature infants and newborns in the first month of life due to the risk of severe toxic effects, including respiratory distress syndrome.
It is recommended that pregnant women use Neoparin Multi formulations that do not contain benzyl alcohol.
It is recommended that the doctor documents the trade name and batch number of the product used.

3. How to use Neoparin Multi

This medicine should always be used exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Administration of the medicine

• Neoparin Multi will usually be administered to the patient by a doctor or nurse. This is because it requires injection.
• After returning home, the patient may need to continue using Neoparin Multi and administer it themselves (see the administration instructions below).
• Neoparin Multi is usually administered by subcutaneous injection.
• Neoparin Multi may be administered intravenously in certain types of heart attack or after surgery.
• Neoparin Multi may be introduced into the dialysis tube returning blood from the body (into the so-called arterial line) at the start of the dialysis session.
• Neoparin Multi must not be administered by intramuscular injection.

Dose of the medicine

• The doctor will decide what dose of Neoparin Multi the patient should take. This depends on the reason for using the medicine.
• In patients with kidney disease, the patient may receive a lower dose of Neoparin Multi.
• 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.
• The doctor will decide how long the patient should receive Neoparin Multi.
• 2. Prevention of blood clot formation in the patient's blood in the following situations:
• Surgery or period of limited mobility due to illness
• The dose depends on the patient's risk of blood clot formation. The patient will receive Neoparin Multi in a dose of 2000 IU (20 mg) or 4000 IU (40 mg) per day.
• In the case of planned surgery, the first injection is usually performed 2 hours or 12 hours before the procedure.
• If the patient has limited mobility due to illness, they will usually receive Neoparin Multi in a dose of 4000 IU (40 mg) per day.
• The doctor will decide how long the patient should receive Neoparin Multi.
• After a heart attackNeoparin 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 will depend on the patient's age and the type of heart attack they have had.

Non-ST-segment elevation myocardial infarction (NSTEMI):

• The usual dose of the medicine is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also takes aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Neoparin Multi.

ST-segment elevation myocardial infarction (STEMI) in patients under 75 years of age:

• The initial dose of Neoparin Multi is 3000 IU (30 mg) administered intravenously.
• At the same time, Neoparin Multi will also be administered subcutaneously. The usual dose of the medicine is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also takes aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Neoparin Multi.

ST-segment elevation myocardial infarction (STEMI) in patients 75 years of age or older:

• The usual dose of the medicine is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
• The maximum dose of Neoparin Multi in the first two doses is 7500 IU (75 mg).
• The doctor will decide how long the patient should receive Neoparin Multi.

Patients undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Neoparin Multi was administered, the doctor may decide to administer an additional dose of Neoparin Multi before the PCI procedure. The medicine will be administered intravenously.

• 3. Prevention of blood clot formation in dialysis tubes
• The usual dose of the medicine is 100 IU (1 mg) per kilogram of body weight.
• Neoparin Multi is injected into the tube returning blood from the body (into the so-called arterial line) at the start of the dialysis session. This dose usually lasts for a 4-hour dialysis session. However, if necessary, the doctor may administer 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 performed when the patient is lying down.
Enoxaparin is administered by deep subcutaneous injection. The medicine should be administered alternately into the left or right anterior or posterior abdominal wall.
The entire length of the needle should be inserted vertically into the skin fold created by pinching the skin with the thumb and index finger.
The skin fold should not be released before the injection is completed.
The injection site should not be rubbed after administration.

Change of anticoagulant medicine

• Changing from Neoparin Multi to vitamin K antagonist medicines (e.g., warfarin)The doctor will recommend that the patient undergoes blood tests to determine the INR and will inform the patient when to stop taking Neoparin Multi based on the results.
• Changing from vitamin K antagonist medicines (e.g., warfarin) to Neoparin MultiThe vitamin K antagonist medicine should be discontinued. The doctor will recommend that the patient undergoes blood tests to determine the INR and will inform the patient when to start taking Neoparin Multi based on the results.
• Changing from Neoparin Multi to direct oral anticoagulantsThe patient should stop taking Neoparin Multi. Then, they should start taking the direct oral anticoagulant 0-2 hours before the scheduled time of the next injection. The patient should then continue taking the oral medicine as usual.
• Changing from direct oral anticoagulants to Neoparin MultiThe patient should stop taking the direct oral anticoagulant. Treatment with Neoparin Multi can 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 evaluated.

Overdose of Neoparin Multi

If the patient thinks they have used too much or too little Neoparin Multi, they should immediately inform their doctor, nurse, or pharmacist, even if they do not notice any problems.
In case of accidental injection or ingestion of Neoparin Multi by a child, they should immediately go to the hospital emergency department.

Missed dose of Neoparin Multi

If a dose of the medicine is missed, it should be taken as soon as possible. A double dose should not be taken to make up for the missed dose. Keeping a diary helps to ensure that no dose is missed.

Stopping Neoparin Multi

In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.
It is important to continue administering Neoparin Multi injections until the doctor recommends stopping them. If treatment is stopped, a blood clot may form, which can be very dangerous.

4. Possible side effects

Like all medicines, Neoparin Multi can cause side effects, although not everybody gets them.
As with other similar medicines (used to reduce blood clotting), Neoparin Multi may cause bleeding, which can potentially be life-threatening.
In some cases, bleeding may not be immediately visible.
If any bleeding occurs that does not stop by itself, as well as signs of excessive bleeding (severe weakness, fatigue, paleness, dizziness, headaches, or unexplained sweating), the patient should immediately consult their doctor.
The doctor may decide to monitor the patient more closely or change the medicine.
The patient should stop using Neoparin Multi and immediately consult their doctor or nurse if they experience signs of a severe allergic reaction (such as difficulty breathing, swelling of the lips, mouth, throat, or eyes).
In case of any of the following symptoms, the patient should stop using enoxaparin and seek medical help immediately:

• Red, scaly, widespread rash with thickening of the skin and blisters, accompanied by fever. These symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).

The patient should immediately contact their doctor:

• If they experience any signs of a blood vessel being 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 experiences a painful rash or dark red spots under the skin that do not disappear when pressed. The doctor may order blood tests to check the platelet count.

List of possible side 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 bruise. This may be due to a decrease in the number of platelets.
• Pink spots on the skin. These changes are more likely to occur at the injection sites of Neoparin Multi.
• Skin rash (hives).
• Itching, red skin.
• Bruising or pain at the injection site.
• Decreased number of red blood cells.
• Increased number of platelets.
• Headaches.

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 be a sign of bleeding into the stomach.
• Large, red, irregularly shaped skin changes with blisters 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 level of potassium in the blood. This is more likely to occur in people with kidney disease or diabetes. The doctor can check this with a blood test.
• Increased number of eosinophils in the blood. The doctor can 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.
• Numbness, tingling, and muscle weakness (especially in the lower part of the body) after lumbar puncture or spinal or epidural anesthesia.
• Loss of control over the bladder or bowels (a condition in which the patient is unable to control when they need to go to the toilet).
• Hardening or a lump at the injection site.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Neoparin Multi

Store in a temperature below 25°C.
Do not freeze.
After opening the vial, the medicine should be stored for no more than 28 days.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not use this medicine if visible signs of damage are observed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Neoparin Multi contains

• The active substance of the medicine 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

1, 5, or 25 vials of 3 ml in a cardboard box.
1, 5, or 25 vials of 5 ml in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

SciencePharma Limited
Chełmska 30/34, 00-725 Warsaw, Poland

Date of last revision of the leaflet: December 2023

Other sources of information

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