Nimotop S

Leaflet attached to the packaging: Information for the user

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

Nimotop S, 0.2 mg/ml, solution for infusion

Nimodipine

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.
• If you have any doubts, you should consult a doctor or nurse.
• 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 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 using Nimotop S
• 3. How to use 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 channel blockers. 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 unchanged areas. Nimotop S is indicated for the prevention and treatment of ischemic neurological deficits caused by vasospasm of cerebral blood vessels after subarachnoid hemorrhage due to ruptured aneurysm.

2. Important information before using Nimotop S

When not to use Nimotop S:

Warnings and precautions

Before starting treatment with Nimotop S, you should discuss it with your doctor or nurse.

When to exercise special caution when using Nimotop S:

• in patients with generalized cerebral edema and in cases of significant increase in 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 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 changed by nimodipine. You should tell your doctor or pharmacist if you are taking any of the following medicines, as monitoring of blood pressure and adjustment of the dose of Nimotop S may be necessary:

• fluoxetine or nortriptyline (antidepressants);
• zidovudine used to treat HIV infection;
• other medicines that lower blood pressure;
• aminoglycoside antibiotics, cephalosporins, furosemide;
• medicines that inhibit or stimulate the cytochrome P-450 3A4 system.

Nimotop S contains 23.7% v/v ethanol. The alcohol in the medicine may change the action of other medicines.

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 before using this medicine. Nimotop S can be used 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 disturbances in semen. The significance of this finding for short-term treatment is unknown.

Driving and using machines

In case of necessity to use the medicine, the patient's condition may prevent driving and operating machines.

Important information about some ingredients of Nimotop S

This medicine contains 2 g of alcohol (ethanol) in each 10 ml hourly dose (23.7% v/v). The amount of alcohol in 10 ml of this medicine is equivalent to 50 ml of beer or 20 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effect on children is likely to be negligible. It may cause some effect in younger children, such as drowsiness. The alcohol in this medicine may change the action of other medicines. If you are taking other medicines, you should consult your doctor or pharmacist. Since the medicine is administered slowly by continuous intravenous infusion, the effect of alcohol may be reduced. If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before using this medicine. If you are addicted to alcohol, you should consult your doctor or pharmacist before using this medicine. Nimotop S is harmful to people with alcoholism. The presence of alcohol in the medicine should be taken into account when administering it to pregnant or breastfeeding women, children, and people at high risk, such as patients with liver disease or epilepsy. The medicine contains 23 mg of sodium (the main component of common salt) in each 50 ml bottle. This corresponds to 1.15% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account when administering the medicine to people on a low-sodium diet (additional information intended only for medical professionals can be found at the end of the leaflet).

3. How to use Nimotop S

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor. Nimotop S is administered by continuous intravenous infusion, starting with a dose of 1 mg of nimodipine per hour, and then, if the dose is well tolerated by the patient, it is increased to 2 mg per hour. In patients with low body weight or unstable blood pressure, treatment is started with a dose of 0.5 mg/hour. The maximum daily dose is 48 mg of nimodipine (i.e., 240 ml of Nimotop S infusion solution). If the patient experiences side effects or liver problems, the doctor will consider reducing the dose or discontinuing the medicine. The doctor will decide on the duration of treatment. Nimodipine is usually administered by intravenous infusion for no longer than 14 days. If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor.

Using a higher dose of Nimotop S than recommended

Symptoms of poisoning, occurring as a result of acute overdose, are: significant decrease in blood pressure, heart rhythm disturbances, gastrointestinal disorders, nausea. In case of acute overdose, Nimotop S should be discontinued immediately. In case of a drop in blood pressure, intravenous administration of dopamine or noradrenaline may be necessary.

Missing a dose of Nimotop S

A double dose should not be used to make up for a missed dose.

Stopping treatment with Nimotop S

In case of any further doubts related to the use of this medicine, you should consult a 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 (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): bradycardia (slow heart rate), intestinal obstruction, changes in laboratory test results (transient increase in liver enzyme activity), reactions at the infusion site or injection site, thrombophlebitis at the infusion site. Some people may experience other side effects while using 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 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, 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 gather more information 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 the original packaging to protect from light. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given 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 packaging and other information

What Nimotop S contains

The active substance of the medicine is nimodipine. One milliliter of the solution contains 0.2 mg of nimodipine. One 50 ml bottle of infusion solution contains 10 mg of nimodipine. The other ingredients are: ethanol 96%, macrogol 400, sodium citrate, citric acid, water for injections.

What Nimotop S looks like and what the packaging contains

The cardboard box contains a brown glass type II bottle with a rubber stopper and a colored cap, and an infusion tube with a PE connector connecting the infusion pump to a three-channel tap in a foil-paper bag. For more detailed information, you should 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:

Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Cesky Tesin, Czech Republic

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw, Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY, ul. Wł. Żeleńskiego 45, 31-353 Krakow, Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Permission number in Bulgaria, the country of export:

20020728

Parallel import permission number:

345/17

Date of leaflet approval: 12.10.2022

[Information about the trademark]

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Information intended only for healthcare professionals:

Information about patients on a low-sodium diet

The medicinal product contains 23 mg of sodium in a 50 ml bottle, which corresponds to 1.15% of the maximum recommended daily intake of sodium in the diet for adults, as recommended by the WHO. When administering the Nimotop S infusion solution, the sodium content of the infusion solution should also be taken into account. You should consult the summary of product characteristics of the infusion solution used to calculate the total sodium content in the prepared dilution of the product. This should be taken into account when recommending the product to people on a low-sodium diet.

Dosage

If the doctor does not prescribe otherwise, the following dosage is recommended:

Intravenous infusion:

The Nimotop S infusion solution is administered by continuous intravenous infusion. The maximum daily dose is 48 mg of nimodipine (i.e., 240 ml of Nimotop S infusion solution). At the beginning of treatment (for the first 2 hours): 1 mg of nimodipine (i.e., 5 ml of Nimotop S infusion solution) per hour (approximately 15 μg/kg body weight per hour). If this dose is well tolerated by the patient, especially if no significant decrease in blood pressure is observed, after two hours the dose is increased to 2 mg (i.e., 10 ml of Nimotop S infusion solution) per hour (approximately 30 μg/kg body weight per hour). In patients with a body weight significantly less than 70 kg or with unstable blood pressure, treatment should be started with a dose of 0.5 mg of nimodipine (i.e., 2.5 ml of Nimotop S infusion solution) per hour.

In patients who experience side effects, the dose should be reduced or the medicine discontinued. Severe impairment of liver function, especially liver cirrhosis, may result in increased bioavailability of nimodipine due to reduced first-pass effect and impaired metabolism. Therapeutic and adverse effects, such as decreased blood pressure, may be significantly enhanced. In such cases, the dose of the medicine should be reduced or, if necessary, discontinued, depending on the blood pressure values.

Method of administration

The Nimotop S infusion solution should be administered by continuous intravenous infusion through a central venous catheter using an infusion pump. The product should be administered through a three-channel tap with one of the following infusion solutions: 5% glucose solution, 0.9% sodium chloride solution, Ringer's solution with lactate, Ringer's solution with lactate and magnesium, 40% dextran solution, or 6% hydroxyethyl starch (HAES) solution. The solutions should be mixed in a ratio of 1:4, i.e., 1 part of Nimotop S infusion solution and 4 parts of the infusion solution. The Nimotop S infusion solution can also be administered with a mannitol solution, human albumin, or blood.

The polyethylene catheter delivering nimodipine and the infusion line of the simultaneously administered solution should be connected to the venous catheter using a three-channel tap. The Nimotop S infusion solution should not be added to a bag or bottle with other infusion solutions. It should not be mixed with solutions of other medicines. Administration of the Nimotop S infusion solution should be continued during anesthesia, surgical procedures, and angiography.

Duration of treatment

Prophylactic use:

Treatment with intravenous infusion should be started no later than 4 days after the onset of subarachnoid hemorrhage and continued throughout the period of increased risk of vasospasm, i.e., for 10-14 days after the hemorrhage. If surgical intervention at the source of the hemorrhage is necessary during prophylactic treatment, administration of the Nimotop S infusion solution should be continued for at least 5 days after the surgery. After completion of intravenous treatment, it is recommended to continue treatment by administering nimodipine orally at a dose of 6 x 60 mg per day, every 4 hours, for a further 7 days.

Therapeutic use:

If ischemic neurological deficits have occurred due to vasospasm of cerebral blood vessels after subarachnoid hemorrhage, treatment should be started as soon as possible and continued for at least 5 days (up to a maximum of 14 days). After completion of intravenous treatment, it is recommended to continue treatment by administering nimodipine orally at a dose of 6 x 60 mg per day, every 4 hours, for a further 7 days. If a surgical procedure is performed during nimodipine treatment, administration of the Nimotop S infusion solution should be continued for at least 5 days after the surgery.

Special patient groups

The safety and efficacy of nimodipine in patients under 18 years of age have not been established. The Nimotop S infusion solution should be administered by continuous intravenous infusion through a central venous catheter using an infusion pump.