Package leaflet: Information for the user

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

Keep this leaflet, as you may need to read it again.
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. It may harm them, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse immediately. 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 class of calcium antagonists. It exerts a spasmolytic 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 unaffected by disease.
Nimotop S is indicated for oral continuation of prophylaxis and treatment of ischemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage 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 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 low arterial blood pressure (systolic pressure less than 100 mm Hg),
in patients with unstable angina pectoris or in patients who have suffered 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
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or 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
Nimotop S can be taken regardless of meals. Do not take Nimotop S tablets with grapefruit juice or regularly consume grapefruit.
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 strictly 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, which may lead to semen abnormalities, have been observed. 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.
The 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 left 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
liver function impairment (especially cirrhosis) and in patients experiencing adverse reactions.
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: significant drop in arterial blood pressure,
heart rhythm disturbances, gastrointestinal complaints, nausea.
In case of acute overdose, Nimotop S should be discontinued immediately. Gastric lavage and administration of activated charcoal may be necessary. In case of low 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 take a double dose to make up for a missed tablet. If you are uncertain about what to do, 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 everybody gets 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);
frequency not known (cannot be estimated from the available data): low oxygen concentration in body tissues. 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, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration 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 provide more information on the safety of the medicine.

5. How to store Nimotop S

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use Nimotop S after the expiry date stated on the packaging.
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. Each coated tablet contains 30 mg of nimodipine.
The other ingredients are: microcrystalline cellulose, maize starch, povidone 25, crospovidone,
magnesium stearate.
Coating: hypromellose, polyethylene glycol 4000, titanium dioxide (E 171), yellow iron oxide (E 172).
What Nimotop S looks like and contents of the pack
The cardboard box contains: 100 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Portugal, country of export:
Bayer Portugal, Lda.
Avenida Vitor Figueiredo, nº 4 - 4º piso
2790-255 - Carnaxide, Portugal
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
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Portugal, country of export: 9666511
Parallel Import Authorisation number: 71/25