Nimotop S

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!

Nimotop S (НИМОТОП Ѕ)

0.2 mg/ml, solution for infusion

Nimodipine
Nimotop S and НИМОТОП Ѕ are the same trade names for the same drug written in Polish and Bulgarian.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Nimotop S and what is it used for
• 2. Important information before taking Nimotop S
• 3. How to take Nimotop S
• 4. Possible side effects
• 5. How to store Nimotop S
• 6. Contents of the pack and other information

1. What is Nimotop S and what is it used for

Nimodipine, the active substance of Nimotop S, is a dihydropyridine derivative, belonging to the group of calcium channel blockers. It acts as a vasodilator on cerebral vessels, thereby preventing cerebral ischemia.
Studies conducted in patients with acute cerebral blood flow disorders have shown that nimodipine dilates cerebral vessels and improves blood flow. As a rule, the increase in blood flow is more pronounced in damaged and underperfused areas of the brain compared to unchanged areas.
Nimotop S is indicated for the prevention and treatment of ischemic neurological deficits caused by cerebral vessel spasm after subarachnoid hemorrhage due to ruptured aneurysm.

2. Important information before taking Nimotop S

When not to take Nimotop S:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Nimotop S, the patient should discuss it with their doctor or nurse.

When to exercise special caution when taking Nimotop S:

• in patients with generalized cerebral edema and in cases of significant increase in intracranial pressure,
• in patients with significantly decreased blood pressure (systolic blood pressure less than 100 mmHg),
• in patients with unstable angina pectoris or those who have had a myocardial infarction in the last 4 weeks.

Children and adolescents

The safety and efficacy of nimodipine in patients under 18 years of age have not been established.

Nimotop S and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the action of nimodipine or their action may be altered by nimodipine. The patient should inform their doctor or pharmacist about taking any of the following medicines, as blood pressure monitoring and dose adjustment may be necessary:

• fluoxetine or nortriptyline (antidepressants);
• zidovudine used to treat HIV infection;
• other medicines that lower blood pressure;
• aminoglycoside antibiotics, cephalosporins, furosemide;
• medicines that inhibit or stimulate the cytochrome P-450 3A4 system.

Nimotop S contains 23.7% v/v ethanol. The alcohol in the medicine may alter the effect of other medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Nimotop S can be used during pregnancy only in cases of absolute necessity. Nimodipine passes into breast milk, so breastfeeding should be discontinued during treatment with Nimotop S.
In individual cases of in vitro fertilization, reversible biochemical changes in sperm heads have been observed, which may result in sperm disorders. The significance of this finding for short-term treatment is unknown.

Driving and using machines

In cases where the patient's condition requires the use of this medicine, they should not drive or operate machinery.

Important information about some ingredients of Nimotop S

This medicine contains 2g of alcohol (ethanol) in each 10ml hourly dose (23.7% v/v). The amount of alcohol in 10ml of this medicine is equivalent to 50ml of beer or 20ml of wine.
The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effect on children is likely to be negligible. However, it may cause some effect in younger children, such as drowsiness.
The alcohol in this medicine may alter the effect of other medicines. If the patient is taking other medicines, they should consult their doctor or pharmacist.
Since this medicine is administered slowly through continuous intravenous infusion, the effect of alcohol may be reduced.
If the patient is pregnant or breastfeeding, they should consult their doctor or pharmacist before taking this medicine.
If the patient is addicted to alcohol, they should consult their doctor or pharmacist before taking this medicine.
Nimotop S is harmful to individuals with alcoholism. The presence of alcohol in the medicine should be considered when administering it to pregnant or breastfeeding women, children, and individuals at high risk, such as patients with liver disease or epilepsy.
The medicine contains 23mg of sodium (the main component of common salt) in each 50ml bottle. This corresponds to 1.15% of the maximum recommended daily intake of sodium in the diet for adults.
This should be taken into account when administering the medicine to individuals on a low-sodium diet (additional information intended only for healthcare professionals can be found at the end of the leaflet).

3. How to take Nimotop S

This medicine should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult their doctor.
Nimotop S is administered through continuous intravenous infusion, starting with a dose of 1mg of nimodipine per hour, and then, if the dose is well tolerated by the patient, it is increased to 2mg/hour. In patients with low body weight or unstable blood pressure, treatment is started with a dose of 0.5mg/hour.
The maximum daily dose is 48mg of nimodipine (i.e., 240ml of Nimotop S solution for infusion).
If the patient experiences side effects or liver problems, the doctor will consider reducing the dose or discontinuing the medicine.
The doctor will decide on the duration of treatment. Nimodipine is usually administered through intravenous infusions for no longer than 14 days.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Overdose of Nimotop S

Symptoms of poisoning due to acute overdose are: significant decrease in blood pressure, cardiac arrhythmias, gastrointestinal disorders, nausea.
In case of acute overdose, Nimotop S should be discontinued immediately. In case of decreased blood pressure, intravenous administration of dopamine or noradrenaline may be necessary.

Missed dose of Nimotop S

A double dose should not be taken to make up for a missed dose.

Discontinuation of Nimotop S

If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Nimotop S can cause side effects, although not everybody gets them.
Side effects that occur:

• not very often (in more than 1 in 1000, but less than 1 in 100 patients) are: thrombocytopenia (decrease in platelet count), hypersensitivity reactions (allergic reactions, rash), headache, tachycardia (accelerated heart rate), vasodilation, decreased blood pressure, nausea,
• rarely (in more than 1 in 10,000, but less than 1 in 1000 patients): bradycardia (slow heart rate), intestinal obstruction, changes in laboratory test results (transient increase in liver enzyme activity), reactions at the infusion site or injection site, thrombophlebitis at the infusion site. Some people may experience other side effects while taking Nimotop S.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Nimotop S

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
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 pack and other information

What Nimotop S contains

The active substance of Nimotop S is nimodipine. One milliliter (ml) of solution contains 0.2mg of nimodipine.
One 50ml bottle of solution for infusion contains 10mg of nimodipine.
The other ingredients are: ethanol 96%, macrogol 400, sodium citrate, citric acid, water for injections.

What Nimotop S looks like and contents of the pack

The cardboard box contains a 50ml bottle of solution and an infusion tube with a PE connector connecting the infusion pump to a three-channel tap in a foil-paper bag.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer:

Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen, Germany

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
License number in Bulgaria, the country of export: 20020728

Parallel import license number: 907/12 Date of approval of the leaflet: 15.12.2022

[Information about the trademark]
Information intended only for healthcare professionals:
Information about patients on a low-sodium diet
Nimotop S contains 23mg of sodium in a 50ml bottle, which corresponds to 1.15% of the maximum recommended daily intake of sodium in the diet for adults, as recommended by the WHO. When administering Nimotop S solution for infusion, the sodium content in the infusion solution should also be taken into account. The patient should consult the characteristics of the infusion solution used to calculate the total sodium content in the prepared dilution of the product. This should be taken into account when recommending the medicine to individuals on a low-sodium diet.
Dosage
If the doctor does not prescribe otherwise, the following dosage is recommended:
Intravenous infusion:
Nimotop S solution for infusion is administered through continuous intravenous infusion.
The maximum daily dose is 48mg of nimodipine (i.e., 240ml of Nimotop S solution for infusion).
At the beginning of treatment (for the first 2 hours): 1mg of nimodipine (i.e., 5ml of Nimotop S solution for infusion) per hour (approximately 15 μg/kg body weight per hour).
If this dose is well tolerated by the patient, especially if no significant decrease in blood pressure is observed, the dose is increased to 2mg (i.e., 10ml of Nimotop S solution for infusion) per hour (approximately 30 μg/kg body weight per hour) after 2 hours. In patients with a body weight significantly less than 70kg or with unstable blood pressure, treatment should be started with a dose of 0.5mg of nimodipine (i.e., 2.5ml of Nimotop S solution for infusion) per hour.
In patients who experience side effects, the dose should be reduced or the medicine discontinued. Severe impairment of liver function, especially liver cirrhosis, may result in increased bioavailability of nimodipine due to reduced first-pass effect and impaired metabolism. Therapeutic and adverse effects, such as decreased blood pressure, may be significantly enhanced. In such cases, the dose of the medicine should be reduced or, if necessary, discontinued, depending on the blood pressure values.
Method of administration
Nimotop S solution for infusion should be administered through continuous intravenous infusion through a central venous catheter using an infusion pump. The medicine should be administered through a three-channel tap with one of the following infusion solutions: 5% glucose solution, 0.9% sodium chloride solution, Ringer's solution with lactate, Ringer's solution with lactate and magnesium, 40% dextran solution, or 6% hydroxyethyl starch (HAES) solution. The solutions should be mixed in a ratio of 1:4, i.e., 1 part Nimotop S solution for infusion and 4 parts of the infusion solution.
Nimotop S solution for infusion can also be administered with mannitol solution, human albumin, or blood.
The polyethylene catheter delivering nimodipine and the infusion line of the simultaneously administered solution should be connected to the venous catheter using a three-channel tap.
Nimotop S solution for infusion should not be added to a bag or bottle with other infusion solutions. It should not be mixed with solutions of other medicines.
Administration of Nimotop S solution for infusion should be continued during anesthesia, surgical procedures, and angiography.
Duration of treatment
Prophylactic use:
Treatment with intravenous infusion should be started no later than 4 days after the onset of subarachnoid hemorrhage and continued throughout the period of increased risk of cerebral vessel spasm, i.e., for 10-14 days after the hemorrhage.
If surgical intervention is necessary during prophylactic treatment, administration of Nimotop S solution for infusion should be continued for at least 5 days after the procedure.
After completing intravenous treatment, it is recommended to continue treatment by administering nimodipine orally at a dose of 6 x 60mg per day, every 4 hours, for a further 7 days.
Therapeutic use:
If ischemic neurological deficits have occurred due to cerebral vessel spasm after subarachnoid hemorrhage, treatment should be started as soon as possible and continued for at least 5 days (up to a maximum of 14 days).
After completing intravenous treatment, it is recommended to continue treatment by administering nimodipine orally at a dose of 6 x 60mg per day, every 4 hours, for a further 7 days.
If surgical intervention is performed during nimodipine treatment, administration of Nimotop S solution for infusion should be continued for at least 5 days after the procedure.
Special patient groups
The safety and efficacy of nimodipine in patients under 18 years of age have not been established.
Nimotop S solution for infusion should be administered through continuous intravenous infusion through a central venous catheter using an infusion pump.