Nimotop S

Package Leaflet: Information for the User

Nimotop S, 30 mg, Film-Coated Tablets

Nimodipine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 pharmacist. 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 antagonists. 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 non-affected areas.
Nimotop S is indicated as oral continuation of prophylaxis and treatment of ischemic neurological deficits caused by vasospasm of cerebral blood vessels after subarachnoid hemorrhage due to ruptured aneurysm.

2. Important information before taking Nimotop S

When not to take Nimotop S:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if you are taking antiepileptic drugs, such as phenobarbital, phenytoin, or carbamazepine, as the efficacy of nimodipine may be significantly reduced.
• if you are taking rifampicin (an antibiotic), as the efficacy of nimodipine may be significantly reduced.

Warnings and precautions

Before taking Nimotop S, discuss it with your doctor or pharmacist.

When to be particularly cautious when taking Nimotop S:

• in patients with generalized cerebral edema and in cases of significant increase in intracranial pressure,
• in patients with significantly lowered 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 or pharmacist 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 about taking any of the following medicines, as blood pressure monitoring and dose adjustment may be necessary:

• fluoxetine, nefazodone, nortriptyline (antidepressants);
• cimetidine (a histamine H2-receptor antagonist used in gastric and duodenal ulcer disease);
• valproic acid (an antiepileptic drug);
• certain macrolide antibiotics, such as erythromycin, and other antibiotics
• chinupristin/dalfopristin;
• antifungal agents such as ketoconazole;
• HIV protease inhibitors (e.g., ritonavir);
• other blood pressure-lowering agents
• concomitant use of nimodipine with antiepileptic drugs (such as phenobarbital, phenytoin, or carbamazepine) and rifampicin is contraindicated.

Nimotop S with food and drink

The medicine can be taken independently of meals. Do not drink grapefruit juice or regularly eat grapefruits while taking Nimotop S tablets.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nimotop S should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
Nimodipine passes into breast milk, and 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 disturbances in semen quality. The significance of this finding for short-term treatment is unknown.

Driving and using machines

Nimodipine may cause dizziness, which can affect your ability to drive or operate machinery.

3. How to take Nimotop S

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Usually, nimodipine is administered intravenously for 5-14 days, followed by oral administration at a dose of 360 mg per day, i.e., 6 times 2 tablets (6 times 60 mg nimodipine) for about 7 days.
Swallow the tablets whole with a small amount of liquid. The medicine can be taken independently of meals. There should be at least a 4-hour interval between doses.
Do not drink grapefruit juice while taking Nimotop S tablets.
Your doctor will consider whether to reduce the dose or discontinue the medicine in patients with severe liver function impairment (especially liver cirrhosis) and in patients who experience side effects.
If you feel that the effect of the medicine is too strong or too weak, talk to your doctor.

Taking a higher dose of Nimotop S than recommended

Symptoms of overdose, occurring as a result of acute overdose, include: significant decrease in blood pressure, cardiac arrhythmias, gastrointestinal disorders, nausea.
In case of acute overdose, Nimotop S should be discontinued immediately. Gastric lavage and administration of activated charcoal may be necessary, and in case of decreased blood pressure, intravenous administration of dopamine or noradrenaline may be necessary.

Missing a dose of Nimotop S

Take the next dose as soon as possible and inform your doctor. Do not take a double dose to make up for the missed tablet. If you are unsure about what to do, contact your doctor or pharmacist.

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:

• uncommon (in more than 1 in 1000, but less than 1 in 100 patients) include: thrombocytopenia (decreased platelet count), hypersensitivity reactions (allergic reactions, rash), headache, tachycardia (increased heart rate), vasodilation, decreased blood pressure, nausea;
• rare (in more than 1 in 10,000, but less than 1 in 1,000 patients) include: bradycardia (decreased heart rate), intestinal obstruction, changes in laboratory test results (transient increase in liver enzyme activity).
• frequency not known (cannot be estimated from the available data): low oxygen levels in body tissues. In some individuals, 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 pharmacist. 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, Tel.: +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.
By reporting side effects, you can help provide more information on the safety of this 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 Nimotop S 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 is nimodipine (30 mg).
The other ingredients are:
polyvidone, magnesium stearate,
corn starch,
microcrystalline cellulose, crospovidone, hypromellose 15 cP, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172).

What Nimotop S looks like and contents of the pack

The carton contains:
20 film-coated tablets (2 blisters of 10),
or 50 film-coated tablets (5 blisters of 10),
or 100 film-coated tablets (10 blisters of 10).
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
Haupt Pharma Münster
Schleebrueggenkamp 15
48159 Münster
Germany
Date of last revision of the leaflet:06/2025