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 drug.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on 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 tell 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. 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:

• 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 efficacy of nimodipine may be significantly reduced.
• if the patient is taking rifampicin (an antibiotic) as the efficacy of nimodipine may be significantly reduced.

Warnings and precautions

Before starting to take Nimotop S, you should 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

You should 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 should tell your doctor or pharmacist about taking 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 histamine H2-receptor antagonist used in gastric and duodenal ulcer disease);
• valproic acid (an antiepileptic drug);
• certain macrolide antibiotics, including erythromycin and other antibiotics - chinupristin/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. You should 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 are planning to have a baby, you should 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 disorders. The significance of this finding for short-term treatment is unknown.

Driving and using machines

Nimodipine may cause dizziness, which can affect the ability to drive and use machines.

3. How to take Nimotop S

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should 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 nimodipine) for about 7 days.
Tablets should be swallowed whole, with a small amount of liquid. The medicine can be taken independently of meals. Between doses, you should maintain an interval of at least 4 hours.
You should not drink Nimotop S tablets with grapefruit juice..
Your doctor will consider whether to reduce the dose or discontinue the medicine in patients with severe liver function disorders (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, you should consult your doctor.

Taking a higher dose of Nimotop S than recommended

Symptoms of poisoning, which can occur as a result of acute overdose, are: significant lowering of blood pressure, heart rhythm disorders, 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 lowered blood pressure, intravenous administration of dopamine or noradrenaline may be necessary.

Missing a dose of Nimotop S

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

Stopping treatment with Nimotop S

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

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) are: thrombocytopenia (reduced platelet count), hypersensitivity reactions (allergic reactions, rash), headache, tachycardia (increased heart rate), vasodilation, lowered blood pressure, nausea;
• rarely (in more than 1 in 10,000, but less than 1 in 1000 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, you should tell 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.
By reporting side effects, you can help provide 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.
Do not store above 25°C. Store in the original packaging.
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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 25, magnesium stearate, corn starch, microcrystalline cellulose, crospovidone,
Coating:hypromellose, 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, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the country of export:

Bayer SA-NV
J.E. Mommaertslaan 14
B-1831 Diegem (Machelen)
Belgium

Manufacturer:

Bayer AG
Kaiser-Wilhelm-Allee
51373 Leverkusen
Germany

Parallel importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Belgian marketing authorization number: BE144006

Parallel import authorization number: 302/22 Date of approval of the leaflet: 03.08.2022

[Information about the trademark]