NIMOTOP S

Patient Information Leaflet

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Nimotop S (Nimotop S), 30 mg, coated tablets
Nimodipine
Nimotop S and Нимотоп Ѕ are the same brand names of the same medicine written in Polish and Bulgarian respectively.
Please read this leaflet carefully before taking the 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, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents:

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 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 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.
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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
You must 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 must 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 may be taken regardless of meals. Do not take Nimotop S tablets with grapefruit juice or regularly consume grapefruit fruit.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, 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 taken 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 disturbances in semen. 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 prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
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Nimodipine is usually 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
independently of meals. At least 4 hours should be maintained between consecutive doses.
Do not take Nimotop S tablets with grapefruit juice.
The doctor will consider whether the dose should be reduced or treatment discontinued in patients
with severe hepatic impairment (especially 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 prescribed
Symptoms of poisoning due to acute overdose include: significant decrease in arterial 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 case of decreased arterial 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 steps, contact your doctor or pharmacist.
Stopping treatment with 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);
• Frequency not known (cannot be estimated from available data): low oxygen concentration in body tissues. Other adverse reactions may also occur in some individuals during treatment with Nimotop S.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
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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 sight and reach of children.
Store below 25°C and 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 must 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. One coated tablet contains 30 mg of nimodipine.
The other ingredients are: microcrystalline cellulose, maize starch, povidone, crospovidone,
magnesium stearate.
Coating: hypromellose 15 cP, 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: 20, 50 or 100 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Bulgaria, country of export:
Laboratoire X.O
170 Bureaux de la Colline
92213 Saint-Cloud Cedex
France

Manufacturer:
Bayer AG, Kaiser-Wilhelm-Allee, 51368 Leverkusen, Germany
Haupt Pharma Münster GmbH
Schleebrüeggenkamp 15
48159 Münster
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

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Bulgaria, country of export, marketing authorisation number: 20020727
Parallel import authorisation number: 209/19
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