Package leaflet: Information for the user

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

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents:

What Nimotop S is and what it is used for
What you should know 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 disturbances in cerebral blood flow 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 the 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 taking antiepileptic medicines such as phenobarbital, phenytoin, or carbamazepine, as the effectiveness of nimodipine may be considerably reduced;
if the patient is concurrently taking rifampicin (an antibiotic), as the effectiveness of nimodipine may be considerably reduced.

Warnings and precautions
Before starting to take Nimotop S, discuss this with your doctor or pharmacist.
When to exercise particular caution when taking 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 past 4 weeks.

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

Nimotop S and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of nimodipine, or their effects may be altered by nimodipine. Inform your doctor or pharmacist if you are taking any of the following medicines, as monitoring of blood pressure and 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.

Concurrent use of nimodipine with antiepileptic medicines (such as phenobarbital, phenytoin, or carbamazepine) and with rifampicin is contraindicated.

Nimotop S with food and drink
Nimotop S may be taken regardless of meals. Do not take Nimotop S tablets with grapefruit juice, and avoid regular consumption of grapefruit or grapefruit products.

Pregnancy, breastfeeding, and 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 is recommended to 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. In case of any doubts,
please 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. 6 times 2 tablets (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
regardless of meals. At least a 4-hour interval should be maintained 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 hepatic impairment (especially cirrhosis) and in patients experiencing adverse reactions.
If you feel that the medicine's effect is too strong or too weak, please consult your doctor.
Taking more Nimotop S than recommended
Symptoms of acute overdose may include a marked decrease in arterial blood pressure, cardiac
arrhythmias, gastrointestinal disturbances, and nausea.
In the event of acute overdose, Nimotop S should be discontinued immediately. Gastric lavage
and administration of activated charcoal may be necessary. In cases of low blood pressure, dopamine
or noradrenaline may need to be administered intravenously.
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 uncertain about how to proceed, contact your doctor or pharmacist.
Stopping Nimotop S
If you have any further questions about the use of this medicine, please 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 (slowing of the 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 any adverse effects not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Nimotop S

Keep Nimotop S out of 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. This will help protect the environment.

6. Contents of the packaging and other information

What Nimotop S contains
The active substance is nimodipine (30 mg).
Other ingredients: povidone 25, magnesium stearate, corn starch, microcrystalline cellulose, crospovidone,
Coating: hypromellose, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172).

What Nimotop S looks like and contents of the pack
In a cardboard box there is:
20 film-coated tablets (2 blisters of 10 tablets),
or 50 film-coated tablets (5 blisters of 10 tablets),
or 100 film-coated tablets (10 blisters of 10 tablets).

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
51373 Leverkusen
Germany

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Authorisation number in Belgium, country of export: BE144006
Parallel import authorisation number: 302/22