Nimotop s

Package leaflet: information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Nimotop S (Nimotop)
30 mg, film-coated tablets
Nimodipine
Nimotop S and Nimotop are different trade names of the same medicinal product.
Please read this leaflet carefully before taking 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 questions, please consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms of illness are the same.
• 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:

1. What Nimotop S is and what it is 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 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 of 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 not affected 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 medicines such as: phenobarbital, phenytoin or carbamazepine, as the effectiveness of nimodipine may be considerably reduced.
• if the patient is concurrently using rifampicin (an antibiotic), as the effectiveness 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 low 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 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 action 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;
• concomitant use of nimodipine with antiepileptic medicines (such as: phenobarbital, phenytoin or carbamazepine) and rifampicin is contraindicated.

Nimotop S with food and drink
This medicine may be taken regardless of meals. Do not take Nimotop S tablets with grapefruit juice or regularly consume grapefruit fruits.

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 not recommended 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 as directed by the physician. In case of 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. 6 times 2 tablets (6 times 60 mg of nimodipine) for approximately 7 days.
Tablets should be swallowed whole with a small amount of fluid. The medicine can be taken
regardless of meals. At least 4 hours should be allowed between consecutive doses.
Do not take Nimotop S tablets with grapefruit juice.
The physician will consider whether the dose should be reduced or treatment discontinued in patients
with severe hepatic impairment (particularly liver cirrhosis) and in patients experiencing adverse reactions.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Taking more Nimotop S than recommended
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 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 use a double dose to make up
for a missed tablet. If you are uncertain about further management, contact your doctor or pharmacist.
Stopping Nimotop S treatment
If you have any further questions 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.
The following adverse reactions have occurred:

• Uncommonly (in more than 1 in 1000 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 1000 patients): bradycardia (slowing of the heart rate), intestinal obstruction, changes in laboratory test results (transient increase in liver enzyme activity). In some individuals, other adverse reactions may occur during treatment with Nimotop S.

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

5. How to store Nimotop S

Keep this medicine out of the sight and reach of children.
Store below 25°C in the original packaging.
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 help protect the
environment.

6. Contents of the pack and other information

What Nimotop S contains
The active substance is nimodipine (30 mg).
Other ingredients: povidone K25, magnesium stearate, corn starch, microcrystalline cellulose, crospovidone.
Coating: hypromellose 15 cP, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (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),
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 marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Romania, 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, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation Numbers in Romania, country of export:
2213/2009/01
2213/2009/02
2213/2009/03
2213/2009/04

Parallel Import Licence Number: 229/22