Nimotop S

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Nimotop S (Нимотоп S), 30 mg, Coated Tablets

Nimodipine
Nimotop S and Нимотоп S are different trade names for the same drug written in Polish and Bulgarian.

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. Do not give it to others. The medication may harm another person, even if their disease symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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. Package Contents 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 acts as a vasodilator 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. Usually, 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 aneurysm rupture.

2. Important Information Before Taking Nimotop S

When Not to Take Nimotop S:

Warnings and Precautions

Before starting to take Nimotop S, discuss it with your doctor or pharmacist.

When to be Particularly Cautious When Taking Nimotop S:

• in patients with generalized cerebral edema and in cases of significant increased intracranial pressure,
• in patients with significantly lowered 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 Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Some medications may affect the action of nimodipine or their action may be altered by nimodipine. Inform your doctor or pharmacist about taking any of the following medications, as blood pressure monitoring and dose adjustment may be necessary:

• fluoxetine, nefazodone, nortriptyline (antidepressants);
• cimetidine (a histamine H2-receptor antagonist used in gastric and duodenal ulcer disease);
• valproic acid (an antiepileptic medication);
• certain macrolide antibiotics, including erythromycin and other antibiotics - quinupristin/dalfopristin;
• antifungal medications such as ketoconazole;
• HIV medications (e.g., ritonavir);
• other blood pressure-lowering medications
• the use of nimodipine with antiepileptic medications (such as phenobarbital, phenytoin, or carbamazepine) and rifampicin is contraindicated.

Nimotop S with Food and Drink

The medication can be taken independently of meals. Do not take Nimotop S tablets with grapefruit juice or regularly consume grapefruits.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
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 disturbances. The significance of this finding for short-term treatment is unknown.

Driving and Operating Machines

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

3. How to Take Nimotop S

Always take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Usually, nimodipine is first administered intravenously for 5-14 days, and then orally in a dose of 360 mg per day, i.e., 6 times 2 tablets (6 times 60 mg of nimodipine) for about 7 days.
Swallow the tablets whole with a small amount of liquid. The medication can be taken independently of meals. There should be at least a 4-hour interval between doses.
Do not take Nimotop S tablets with grapefruit juice..
Your doctor will consider whether to reduce the dose or discontinue the medication in patients with severe liver function impairment (especially with liver cirrhosis) and in patients who experience side effects.
If you feel that the effect of the medication is too strong or too weak, consult your doctor.

Taking a Higher Dose of Nimotop S Than Recommended

Symptoms of poisoning due to acute overdose include: significant decrease in blood pressure, heart rhythm disturbances, gastrointestinal disorders, nausea.
In case of acute overdose, stop taking Nimotop S 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

Take the next dose as soon as possible and inform your doctor. Do not take a double dose to make up for the missed tablet. If you are unsure about what to do, consult your doctor or pharmacist.

Stopping Treatment with Nimotop S

If you have any further doubts about the use of this medication, consult your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, 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 (decreased platelet count), hypersensitivity reactions (allergic reactions, rash), headache, tachycardia (increased heart rate), vasodilation, decreased blood pressure, nausea;
• rarely (in more than 1 in 10,000, but less than 1 in 1000 patients) include: bradycardia (decreased heart rate), intestinal obstruction, changes in laboratory test results (transient increase in liver enzyme activity). Some people may experience other side effects while taking Nimotop S.

Reporting Side Effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects will help gather more information on the safety of the medication.

5. How to Store Nimotop S

Keep the medication out of sight and reach of children.
Store in a temperature below 25°C, protected from light.
Do not use Nimotop S after the expiration date stated on the packaging.
The expiration date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Nimotop S Contains

The active substance is nimodipine (30 mg).
Other ingredients are: povidone, 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 What the Package Contains

The carton 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, consult the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Bulgaria, the Country of Export:

Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer:

Bayer AG
51368 Leverkusen
Germany

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in Bulgaria, the Country of Export:20020727
Parallel Import Authorization Number:325/19

Date of Leaflet Approval: 06.08.2024

[Information about the Trademark]