Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Nimotop S (Nimotop)
30 mg, coated tablets
Nimodipine
Nimotop S and Nimotop are different trade names of the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Nimotop S is and what it is used for
Important information before taking Nimotop S
How to take Nimotop S
Possible side effects
How to store Nimotop S
Contents of the pack and other information

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

Nimodipine – the active substance in Nimotop S – is a dihydropyridine derivative belonging to the group of calcium antagonists. It exerts a vasodilatory effect on cerebral blood vessels, thereby preventing cerebral ischemia.
Clinical studies conducted in patients with acute cerebral circulation disorders have shown that nimodipine dilates cerebral vessels and improves blood flow. Typically, the increase in blood flow is more pronounced in damaged and poorly perfused areas of the brain compared to areas unaffected by disease.
Nimotop S is indicated for oral continuation of prophylaxis and treatment of ischemic neurological deficits caused by cerebral vasospasm following 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 to any of the other ingredients of this medicine (listed in section 6).
if the patient is concurrently using antiepileptic drugs such as phenobarbital, phenytoin or carbamazepine, as the efficacy of nimodipine may be considerably reduced.
if the patient is concurrently taking rifampicin (an antibiotic), as the efficacy of nimodipine may be considerably reduced.

Warnings and precautions
Before starting treatment with Nimotop S, discuss this with your doctor or pharmacist.
When to exercise special caution when using Nimotop S:

in patients with generalized cerebral edema and in cases of significantly increased intracranial pressure,
in patients with markedly reduced arterial blood pressure (systolic pressure less than 100 mm Hg),
in patients with unstable angina pectoris or in patients who have suffered 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
You should tell your doctor or pharmacist about all medicines you are currently 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. You should inform your doctor or pharmacist if you are taking any of the following medicines, as monitoring of blood pressure and possible dose adjustment may be necessary:

fluoxetine, nefazodone, nortriptyline (antidepressants);
cimetidine (an H-\receptor antagonist used in peptic ulcer disease of the stomach and duodenum);
valproic acid (an anticonvulsant);
certain macrolide antibiotics, including erythromycin, and other antibiotics—quinupristin/dalfopristin;
antifungal medicines such as ketoconazole;
medicines used in HIV infection (e.g. ritonavir);
other medicines that lower blood pressure;
concomitant use of nimodipine with antiepileptic drugs (such as phenobarbital, phenytoin or carbamazepine) and rifampicin is contraindicated.

Nimotop S with food and drink
This medicine may be taken independently of meals. Do not take Nimotop S tablets with grapefruit juice or regularly consume grapefruit fruit.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Nimotop S may be used during pregnancy only if absolutely necessary.
Nimodipine passes into breast milk; therefore, breastfeeding should be discontinued during treatment with Nimotop S.
In isolated cases of in vitro fertilization, reversible biochemical changes in sperm heads have been observed, which may lead to semen abnormalities. The significance of this finding for short-term treatment is unknown.
Driving and operating machinery
Nimodipine may cause dizziness and thereby impair the ability to drive or operate machinery.

3. How to take Nimotop S

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Usually, nimodipine is first administered intravenously for 5–14 days, followed by oral administration
at a dose of 360 mg per day, i.e. 2 tablets taken 6 times daily (6 times 60 mg of nimodipine) for approximately 7 days.
The tablets should be swallowed whole with a small amount of liquid. The medicine can be taken
independently of meals. At least 4 hours should be left between consecutive doses.
Do not take Nimotop S tablets with grapefruit juice.
Your doctor will consider whether the dose should be reduced or treatment discontinued in patients
with severe liver function impairment (especially cirrhosis of the liver) and in patients who experience
adverse effects.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Taking more Nimotop S than prescribed
Symptoms of poisoning due to acute overdose include: marked decrease in arterial blood pressure,
cardiac arrhythmias, gastrointestinal disturbances, nausea.
In case of acute overdose, Nimotop S should be discontinued immediately. Gastric lavage and
administration of activated charcoal may be necessary. In cases of decreased arterial blood pressure,
intravenous administration of dopamine or noradrenaline may be required.
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 a missed tablet. If you are unsure what to do next, contact your doctor or pharmacist.
Stopping Nimotop S
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Adverse reactions occurring:

uncommonly (in more than 1 in 1,000 but less than 1 in 100 patients): thrombocytopenia (reduced number of blood platelets), hypersensitivity reactions (allergic reactions, rash), headache, tachycardia (increased heart rate), vasodilation, hypotension (low blood pressure), nausea;
rarely (in more than 1 in 10,000 but less than 1 in 1,000 patients): bradycardia (slowed heart rate), intestinal obstruction, changes in laboratory test results (transient increase in liver enzyme activity). Other adverse reactions may occur in some individuals during treatment with Nimotop S.

Reporting of adverse reactions
If any adverse effects occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nimotop S

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Protect from light.
Do not use Nimotop S after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Nimotop S contains
The active substance is nimodipine (30 mg).
The other ingredients are: povidone, magnesium stearate, maize starch, microcrystalline cellulose, crospovidone; coating: hypromellose, macrogol 4000, titanium dioxide (E 171), iron oxide yellow (E 172).
What Nimotop S looks like and contents of the pack
The cardboard box contains:
20 film-coated tablets (2 blisters of 10 tablets each),
or 50 film-coated tablets (5 blisters of 10 tablets each),
or 100 film-coated tablets (10 blisters of 10 tablets each).
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Belgium, country of export:
Bayer SA-NV, J.E. Mommaertslaan 14, B-1831 Diegem (Machelen), Belgium
Manufacturer:
Bayer AG, Kaiser-Wilhelm-Allee 1, 51373 Leverkusen, Germany
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Belgium, country of export: BE144006
Parallel Import Authorisation number: 135/22