Nimotop S

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Nimotop S, 30 mg, coated tablets

Nimodipine

Before taking the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted. This medicine has been prescribed specifically for this person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Nimotop S and what is it 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 packaging and other information

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

Nimodipine, the active substance of Nimotop S, is a dihydropyridine derivative, belonging to the group of calcium antagonists. It has a vasodilating effect on cerebral vessels, thereby preventing cerebral ischemia. Studies conducted in patients with acute cerebral blood flow disorders have shown that nimodipine dilates cerebral vessels and improves blood flow. As a rule, the increase in blood flow is more pronounced in damaged and underperfused areas of the brain compared to non-diseased areas. Nimotop S is indicated as an oral continuation of prophylaxis and treatment of ischemic neurological deficits caused by cerebral vessel spasm after 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 any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking antiepileptic drugs, such as phenobarbital, phenytoin, or carbamazepine, as the effectiveness of nimodipine may be significantly reduced.
• if the patient is taking rifampicin (an antibiotic) as the effectiveness of nimodipine may be significantly reduced.

Warnings and precautions

Before starting to take Nimotop S, the doctor or pharmacist should be consulted.

When to exercise special caution when taking Nimotop S:

• in patients with generalized cerebral edema and in cases of significant increased intracranial pressure,
• in patients with significantly reduced blood pressure (systolic blood pressure less than 100 mm Hg),
• in patients with unstable angina pectoris or in patients who have had 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

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take. Some medicines may affect the action of nimodipine or their action may be changed by nimodipine. The doctor or pharmacist should be informed about the use of any of the following medicines, as it may be necessary to monitor blood pressure and adjust the dose of the medicine:

• fluoxetine, nefazodone, nortriptyline (antidepressants);
• cimetidine (a medicine from the group of H receptor antagonists, used in gastric and duodenal ulcer disease);
• valproic acid (an antiepileptic medicine);
• certain macrolide antibiotics, including erythromycin and other antibiotics - chinupristin/dalfopristin;
• antifungal medicines such as ketoconazole;
• medicines used in HIV infection (e.g., ritonavir);
• other medicines that lower blood pressure;
• the use of nimodipine with antiepileptic medicines (such as phenobarbital, phenytoin, or carbamazepine) and rifampicin is contraindicated.

Nimotop S with food and drink

The medicine can be taken independently of meals. The tablets of Nimotop S should not be taken with grapefruit juice, and these fruits should not be consumed regularly.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Nimotop S can be taken during pregnancy only in cases of absolute necessity. Nimodipine passes into breast milk, so breastfeeding should be discontinued during treatment with Nimotop S. In individual cases of in vitro fertilization, reversible biochemical changes in sperm heads have been observed, which may result in semen disorders. The significance of this finding for short-term treatment is unknown.

Driving and using machines

Nimodipine may cause dizziness, which can impair the ability to drive and operate machines.

3. How to take Nimotop S

This medicine should always be taken according to the doctor's instructions. In case of doubts, the doctor or pharmacist should be consulted. Nimodipine is usually administered intravenously for 5-14 days, followed by oral administration in a dose of 360 mg per day, i.e., 6 times 2 tablets (6 times 60 mg of nimodipine) for about 7 days. The tablets should be swallowed whole, with a small amount of liquid. The medicine can be taken independently of meals. Between doses, an interval of at least 4 hours should be maintained. The tablets of Nimotop S should not be taken with grapefruit juice. The doctor will consider whether to reduce the dose or discontinue the medicine in patients with severe liver function impairment (especially with liver cirrhosis) and in patients who experience side effects. If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Nimotop S than recommended

Symptoms of poisoning, which can occur as a result of acute overdose, include: significant decrease in blood pressure, heart rhythm disturbances, gastrointestinal disorders, nausea. In case of acute overdose, Nimotop S should be discontinued immediately. Gastric lavage and administration of activated charcoal may be necessary, and in case of decreased blood pressure, intravenous administration of dopamine or noradrenaline may be necessary.

Missing a dose of Nimotop S

The next dose should be taken as soon as possible, and the doctor should be informed. A double dose should not be taken to make up for the missed tablet. In case of uncertainty about further action, the doctor or pharmacist should be consulted.

Stopping treatment with Nimotop S

In case of any further doubts about the use of this medicine, the doctor, pharmacist, or nurse should be consulted.

4. Possible side effects

Like all medicines, Nimotop S can cause side effects, although not everybody gets them. Side effects that occur:

• not very often (in more than 1 in 1000, but less than 1 in 100 patients) include: thrombocytopenia (decrease in platelet count), hypersensitivity reactions (allergic reactions, rash), headache, tachycardia (accelerated heart rate), vasodilation, decreased blood pressure, nausea;
• rarely (in more than 1 in 10,000, but less than 1 in 1000 patients) include: bradycardia (slow heart rate), intestinal obstruction, changes in laboratory test results (transient increase in liver enzyme activity). In some people, other side effects may occur during treatment with Nimotop S.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nimotop S

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Store in the outer packaging to protect from light. Do not use Nimotop S after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Nimotop S contains

The active substance of the medicine is nimodipine (30 mg). One coated tablet contains 30 mg of nimodipine. The other ingredients are: povidone 25, magnesium stearate, corn starch, microcrystalline cellulose, crospovidone, hypromellose, 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 coated tablets (2 blisters of 10), or 50 coated tablets (5 blisters of 10), or 100 coated tablets (10 blisters of 10). For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in the Czech Republic, the 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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Marketing authorization number in the Czech Republic, the country of export: 83/013/91-S/C

Parallel import authorization number: 872/12 Date of approval of the leaflet: 02.12.2022

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