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.

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and should not be given to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 has a vasodilating effect on cerebral vessels, thus 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 unaffected 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 you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if you are taking antiepileptic drugs, such as phenobarbital, phenytoin, or carbamazepine, as the effectiveness of nimodipine may be significantly reduced.
• if you are taking rifampicin (an antibiotic), as the effectiveness 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 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 the 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. 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, such as erythromycin, and other antibiotics - chinupristin/dalfopristin;
• antifungal agents such as ketoconazole;
• medicines used in HIV infection (e.g., ritonavir);
• other medicines that lower blood pressure
• 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 take 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 your ability to drive and use machines.

3. How to take Nimotop S

This medicine should always be taken exactly as your doctor has told you. If you are unsure, you should ask 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.
The tablets should be swallowed whole, with a small amount of liquid. The medicine can be taken independently of meals. You should leave at least 4 hours between doses.
You should not take 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, you should consult your doctor.

Taking a higher dose of Nimotop S than recommended

Symptoms of overdose, occurring as a result of acute overdose, are: significant decrease in blood pressure, heart rhythm disturbances, gastrointestinal disorders, nausea.
In case of acute overdose, you should immediately stop taking Nimotop S. It may be necessary to perform gastric lavage and administer activated charcoal, and in case of decreased blood pressure, it may be necessary to administer dopamine or noradrenaline intravenously.

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 a 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, this medicine 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 (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) 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 those 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.
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. 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 of the medicine 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, you should contact the marketing authorization holder or the 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:

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
Authorization number in Romania, the country of export:2213/2009/04
2213/2009/02

Parallel import authorization number: 357/22 Date of approval of the leaflet: 26.09.2022

[Information about the trademark]