Nimotop S

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Nimotop S (Nimotop)

30 mg, coated tablets

Nimodipine
Nimotop S and Nimotop are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, 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 your doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 pack 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 medicines

Tell your doctor or pharmacist about all medicines you are 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. Tell your doctor or pharmacist if you are taking any of the following medicines, 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 drug);
• certain macrolide antibiotics, such as erythromycin, and other antibiotics - quinupristin/dalfopristin;
• antifungal agents such as ketoconazole;
• medicines used in HIV infection (e.g., ritonavir);
• other blood pressure-lowering medicines;
• the use of nimodipine with antiepileptic drugs (such as phenobarbital, phenytoin, or carbamazepine) and rifampicin is contraindicated.

Nimotop S with food and drink

The medicine can be taken independently of meals. Do not drink Nimotop S tablets with grapefruit juice or regularly consume these fruits.

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 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 disturbances. 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

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Usually, nimodipine is 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 nimodipine) for about 7 days.
Swallow the tablets whole with a small amount of liquid. The medicine can be taken independently of meals. There should be at least 4 hours between doses.
Do not drink Nimotop S tablets with grapefruit juice.
Your doctor will consider whether to reduce the dose or stop the medicine in patients with severe liver function impairment (especially liver cirrhosis) and in patients who experience side effects.
If you feel that the effect of the medicine 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 are: 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 low 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 medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• not very common (in more than 1 in 1000 but less than 1 in 100 patients) are: thrombocytopenia (decreased platelet count), hypersensitivity reactions (allergic reactions, rash), headache, tachycardia (increased heart rate), vasodilation, decreased blood pressure, nausea;
• rare (in more than 1 in 10,000 but less than 1 in 1,000 patients) are: 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, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Nimotop S

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use Nimotop S after the expiry date stated on the packaging.
The expiry date refers to the last day of the 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 pack and other information

What Nimotop S contains

The active substance is nimodipine (30 mg).
The other ingredients are: 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 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 Romania, 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
Authorization number in Romania, the country of export:
2213/2009/01
2213/2009/02
2213/2009/03
2213/2009/04

Parallel import authorization number: 229/22 Date of approval of the leaflet: 26.05.2022

[Information about the trademark]