Nimotop S

Package Leaflet: Information for the User

Nimotop S, 0.2 mg/ml, Solution for Infusion

Nimodipine

Read the package leaflet carefully before using the medicine.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Nimotop S and what is it used for
• 2. Important information before using Nimotop S
• 3. How to use 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 has a vasodilating effect on cerebral blood vessels, thereby preventing cerebral ischemia.
Studies conducted in patients with acute cerebral blood flow disorders have shown that nimodipine dilates cerebral blood 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 unaffected areas.
Nimotop S is indicated for the prevention and treatment of ischemic neurological deficits caused by cerebral blood vessel spasm following subarachnoid hemorrhage due to ruptured aneurysm.

2. Important information before using Nimotop S

When not to use Nimotop S:

• if you are 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, discuss it with your doctor or nurse.

When to be careful when using 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 mm Hg),
• in patients with unstable angina pectoris or those who have had a myocardial infarction within 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

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of nimodipine or their action may be altered by nimodipine. Tell your doctor or pharmacist if you are taking any of the following medicines, as monitoring of blood pressure and adjustment of the dose of the medicine 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using 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 lead to sperm disorders. The significance of this finding for short-term treatment is unknown.

Driving and using machines

In cases where the use of the medicine is necessary, the patient's condition may prevent driving or operating machinery.

Important information about some ingredients of Nimotop S

This medicine contains 2 g of alcohol (ethanol) in each 10 ml hourly dose (23.7% v/v). The amount of alcohol in 10 ml of this medicine is equivalent to 50 ml of beer or 20 ml 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. It may cause some effect in younger children, such as drowsiness.
The alcohol in this medicine may alter the effect of other medicines. If you are taking other medicines, consult your doctor or pharmacist.
Since the medicine is administered slowly through continuous intravenous infusion, the effect of alcohol may be reduced.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are addicted to alcohol, consult your doctor or pharmacist before using this medicine.
Nimotop S is harmful to people with alcoholism. The presence of alcohol in the medicine should be taken into account when used in pregnant or breastfeeding women, children, and people at high risk, such as patients with liver disease or epilepsy.
The medicine contains 23 mg of sodium (the main component of common salt) in each 50 ml 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 using the medicine in people on a low-sodium diet (additional information intended only for healthcare professionals can be found at the end of the package leaflet).

3. How to use Nimotop S

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Nimotop S is administered as a continuous intravenous infusion, starting with a dose of 1 mg of nimodipine per hour, and then, if the dose is well tolerated by the patient, it is increased to 2 mg/hour. In patients with low body weight or unstable blood pressure, treatment is started with a dose of 0.5 mg/hour.
The maximum daily dose is 48 mg of nimodipine (i.e., 240 ml of Nimotop S solution).
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 intravenously for no more than 14 days.
If you feel that the effect of the medicine is too strong or too weak, ask your doctor.

Using more than the recommended dose of Nimotop S

Symptoms of overdose, occurring as a result of acute overdose, are: significant decrease in blood pressure, 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.

Missing a dose of Nimotop S

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Nimotop S

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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 (increased heart rate), vasodilation, decreased blood pressure, nausea,
• rarely (in more than 1 in 10,000, but less than 1 in 1000 patients): bradycardia (decreased 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.
• frequency not known (cannot be estimated from the available data): low oxygen levels in body tissues. In some people, other side effects may occur during treatment with Nimotop S.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 the medicine.

5. How to store Nimotop S

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, protected from light.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Medicines should 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 pack and other information

What Nimotop S contains

The active substance of Nimotop S is nimodipine. One milliliter of the solution contains 0.2 mg of nimodipine.
One 50 ml bottle of solution for infusion contains 10 mg 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 50 ml bottle of solution and an infusion tube made of polyethylene (HDPE) connecting the infusion pump to a three-channel tap in a foil-paper bag.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Laboratoire X.O
170 Bureaux de la Colline
92213 Saint-Cloud Cedex
France
Manufacturer
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
Or
KVP Pharma + Veterinär Produkte
Projensdorfer Strasse 324
24105 Kiel
Germany
Date of last revision of the package leaflet:06/2025
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Information intended only for healthcare professionals:
Information on patients on a low-sodium diet
The medicinal product contains 23 mg of sodium in a 50 ml bottle, which corresponds to 1.15% of the WHO-recommended maximum daily intake of 2 g of sodium in adults. When administering the Nimotop S solution for infusion, the sodium content of the solution for infusion should also be taken into account. The summary of product characteristics of the medicinal product used for the solution for infusion should be consulted to calculate the total sodium content in the prepared dilution of the product. This should be taken into account when recommending the medicinal product to patients on a low-sodium diet.
Dosage
If the doctor does not prescribe otherwise, the following dosage is recommended:
Intravenous infusion:
The Nimotop S solution for infusion is administered as a continuous intravenous infusion.
The maximum daily dose is 48 mg of nimodipine (i.e., 240 ml of Nimotop S solution).
At the beginning of treatment (for the first 2 hours): 1 mg of nimodipine (i.e., 5 ml of Nimotop S solution) per hour (approximately 15 μg/kg body weight per hour).
If this dose is well tolerated by the patient, particularly if no significant decrease in blood pressure is observed, after two hours the dose is increased to 2 mg (i.e., 10 ml of Nimotop S solution) per hour (approximately 30 μg/kg body weight per hour). In patients with a body weight significantly less than 70 kg or with unstable blood pressure, treatment should be started with a dose of 0.5 mg of nimodipine (i.e., 2.5 ml of Nimotop S solution) per hour.
In patients who experience side effects, the dose should be reduced or the medicine discontinued. Severe impairment of liver function, particularly liver cirrhosis, may lead to 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
The Nimotop S solution for infusion should be administered as a continuous intravenous infusion through a central venous catheter using an infusion pump. The product should be administered through a three-channel tap with one of the following solutions for infusion: 5% glucose solution, 0.9% sodium chloride solution, Ringer's solution with lactate, Ringer's solution with lactate and magnesium, 6% dextran 40 solution, or 6% hydroxyethyl starch (HAES) solution. The solutions should be mixed in a ratio of 1:4, i.e., 1 part of Nimotop S solution and 4 parts of the solution for infusion.
The Nimotop S solution for infusion can also be administered with a 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.
The Nimotop S solution for infusion should not be added to a bag or bottle with other solutions for infusion. It should not be mixed with solutions of other medicines.
Administration of the 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 vasospasm, i.e., for 10-14 days after the hemorrhage.
If surgical intervention at the source of the hemorrhage is necessary during prophylactic treatment, administration of the Nimotop S solution for infusion should be continued for at least 5 days after the surgery.
After completion of intravenous treatment, it is recommended to continue treatment by administering nimodipine orally at a dose of 6 x 60 mg per day, every 4 hours, for a further 7 days.
Therapeutic use:
If ischemic neurological deficits have occurred due to cerebral blood 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 completion of intravenous treatment, it is recommended to continue treatment by administering nimodipine orally at a dose of 6 x 60 mg per day, every 4 hours, for a further 7 days.
If a surgical procedure is performed during treatment with nimodipine, administration of the Nimotop S solution for infusion should be continued for at least 5 days after the surgery.
Special patient groups
The safety and efficacy of nimodipine in patients under 18 years of age have not been established.
The Nimotop S solution for infusion should be administered as a continuous intravenous infusion through a central venous catheter using an infusion pump.