Nimotop s
Poland
Table of Contents
Package leaflet: Information for the user
Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Nimotop S, 0.2 mg/ml, solution for infusion
Nimodipine
Please read all of this leaflet carefully before use, as it contains important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any questions, please consult your doctor or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
- If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.
Table of contents:
- What Nimotop S is and what it is used for
- Important information before using Nimotop S
- How to use Nimotop S
- Possible side effects
- How to store Nimotop S
- Contents of the pack and other information
1. What Nimotop S is and what it is used for
Nimodipine – the active substance in Nimotop S – is a dihydropyridine derivative belonging to the group of calcium channel antagonists. It exerts a vasodilatory effect on cerebral vessels, thereby preventing cerebral ischemia.
Clinical studies in patients with acute disturbances of cerebral blood flow have shown that nimodipine dilates cerebral vessels and improves blood flow. Typically, the increase in blood flow is more pronounced in damaged and poorly perfused areas of the brain compared to unaffected regions.
Nimotop S is indicated for the prevention and treatment of ischemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage due to ruptured aneurysm.
2. Important information before using Nimotop S
When not to use Nimotop S:
- if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Nimotop S, discuss this with your doctor or nurse.
When to exercise special caution when using Nimotop S:
- in patients with generalized cerebral edema or significantly increased intracranial pressure,
- in patients with markedly reduced arterial blood pressure (systolic pressure less than 100 mm Hg),
- in patients with unstable angina pectoris or who have suffered acute myocardial infarction within the last 4 weeks.
Children and adolescents
The safety and efficacy of nimodipine have not been established in patients under 18 years of age.
Nimotop S and other medicines
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 altered by nimodipine. Inform your doctor or pharmacist if you are taking any of the following medicines, as monitoring of blood pressure and dose adjustment may be necessary:
- fluoxetine or nortriptyline (antidepressants);
- zidovudine used in the treatment of HIV infection;
- other medicines that reduce arterial blood pressure;
- aminoglycoside antibiotics, cephalosporins, furosemide;
- medicines that inhibit or induce cytochrome P-450 3A4 system.
Nimotop S contains 23.7% v/v ethanol. The ethanol contained in this medicine may alter the effect 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, consult your doctor before using this medicine. Nimotop S may be used during pregnancy only if absolutely necessary.
Nimodipine passes into breast milk; therefore, breastfeeding should be discontinued during treatment with Nimotop S.
In isolated cases of in vitro fertilization, reversible biochemical changes in sperm heads have been observed, which may lead to semen abnormalities. The significance of this finding for short-term treatment is unknown.
Driving and using machines
Due to the patient's condition requiring this medicine, driving vehicles or operating machinery is not possible.
Important information about certain 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 affect adults and adolescents, and its effect in children is likely to be negligible. However, it may cause some effects in younger children, for example, drowsiness.
The alcohol contained in this medicine may alter the effect of other medicines. If you are taking other medicines, consult your doctor or pharmacist.
Since this medicine is administered slowly by continuous intravenous infusion, the effect of alcohol may be reduced.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are alcohol-dependent, consult your doctor or pharmacist before using this medicine.
Nimotop S is harmful for patients with alcohol-related disease. The presence of alcohol in the medicine should be taken into account when administering to pregnant or breastfeeding women, children, and patients at high risk, such as those with liver disease or epilepsy.
Nimotop S contains 23 mg of sodium (a main component of common salt) in each 50 ml vial. This corresponds to 1.15% of the maximum recommended daily dietary intake of sodium in adults.
This should be taken into account when administering the medicine to patients on a low-sodium diet (additional information intended exclusively for healthcare professionals is provided at the end of the leaflet).
3. How to use Nimotop S
This medicine must always be used exactly as prescribed by your doctor. If in doubt, consult your doctor.
Nimotop S is administered by continuous intravenous infusion, starting at a dose of 1 mg nimodipine per hour, and then, if this dose is well tolerated, increasing to 2 mg per hour. In patients with low body weight or unstable blood pressure, treatment should start at a dose of 0.5 mg/hour.
The maximum daily dose is 48 mg nimodipine (i.e. 240 ml of Nimotop S infusion solution).
If the patient experiences adverse effects or liver-related problems, the doctor may consider reducing the dose or discontinuing the medicine.
The duration of treatment will be determined by the doctor. Typically, intravenous nimodipine is administered for no longer than 14 days.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Nimotop S
Symptoms of intoxication due to acute overdose include: marked decrease in arterial blood pressure, cardiac arrhythmias, gastrointestinal disturbances, nausea.
In case of acute overdose, Nimotop S should be discontinued immediately. In case of low blood pressure, intravenous administration of dopamine or noradrenaline may be required.
Missed dose of Nimotop S
Do not administer a double dose to make up for a missed dose.
Stopping treatment with Nimotop S
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions occurring:
- uncommonly (in more than 1 in 1,000 but less than 1 in 100 patients): thrombocytopenia (reduced number of blood platelets), hypersensitivity reactions (allergic reactions, rash), headache, tachycardia (increased heart rate), vasodilation, hypotension (low blood pressure), nausea,
- rarely (in more than 1 in 10,000 but less than 1 in 1,000 patients): bradycardia (slowed heart rate), intestinal obstruction, changes in laboratory test results (transient increase in liver enzyme activity), reactions at the infusion or injection site, thrombophlebitis at the infusion site. Other adverse reactions may occur in some individuals during treatment with Nimotop S.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 adverse reactions enables the collection of further information on the safety of the medicine.
5. How to store Nimotop S
Keep this medicine out of the 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 specified month.
Medicines must 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 package and other information
What Nimotop S contains
The active substance is nimodipine. One millilitre of solution contains 0.2 mg of nimodipine.
One 50 ml infusion bottle 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 contents of the pack
The cardboard box contains a 50 ml amber glass type II bottle with a rubber stopper and coloured cap, and an infusion line made of PE connecting the infusion pump to the three-way stopcock, packed in a foil-paper pouch.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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 Czesky Tesin, Czech Republic
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Euceryna Pharmaceutical Laboratory COEL S.J. E.Z.M. KONSTANTY, ul. Wł. Żeleńskiego 45, 31-353 Kraków
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
Marketing Authorisation Number in Bulgaria, the country of export: 20020728
Parallel Import Licence Number: 345/17
Information intended exclusively for healthcare professionals:
Information for patients on a low-sodium diet
The medicinal product contains 23 mg of sodium in a 50 ml vial, which corresponds to 1.15% of the WHO-recommended maximum daily intake of 2 g of sodium for adults. When administering Nimotop S infusion solution, the sodium content of the infusion fluid used must also be taken into account. Please refer to the product characteristics of the infusion fluid used in order to calculate the total sodium content in the prepared dilution. This should be considered when prescribing the medicinal product to patients on a low-sodium diet.
Dosage
Unless otherwise prescribed by the physician, the following dosage is recommended:
Intravenous infusion:
Nimotop S infusion solution is administered as a continuous intravenous infusion.
The maximum daily dose is 48 mg of nimodipine (i.e., 240 ml of Nimotop S infusion solution).
- Initial treatment (first 2 hours): 1 mg of nimodipine (i.e., 5 ml of Nimotop S infusion solution) per hour (approximately 15 μg/kg body weight/hour).
- If this dose is well tolerated by the patient, especially if no significant drop in arterial blood pressure is observed, the dose should be increased after two hours to 2 mg (i.e., 10 ml of Nimotop S infusion solution) per hour (approximately 30 μg/kg body weight/hour).
In patients with body weight significantly less than 70 kg or with unstable arterial blood pressure, treatment should be initiated at a dose of 0.5 mg of nimodipine (i.e., 2.5 ml of Nimotop S infusion solution) per hour.
If adverse reactions occur, the dose should be reduced or administration of the drug discontinued.
Severe impairment of liver function, particularly cirrhosis, may lead to increased bioavailability of nimodipine due to reduced first-pass effect and impaired metabolism. Therapeutic and adverse effects, such as reduction in arterial blood pressure, may be significantly enhanced. In such cases, the dose should be reduced depending on blood pressure values, or discontinuation of the drug should be considered if necessary.
Administration method
Nimotop S infusion solution must be administered as a continuous intravenous infusion via a central venous access using an infusion pump. The product should be administered through a three-way stopcock together 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, dextran 40 solution, or 6% poly-(O-2-hydroxyethyl)-starch (HAES). The solutions should be mixed in a 1:4 ratio, i.e., 1 part Nimotop S infusion solution and 4 parts of the appropriate infusion solution.
Mannitol solution, human albumin, or blood may also be administered simultaneously with the Nimotop S infusion solution.
The polyethylene administration line for nimodipine and the infusion line for the concomitantly administered solution should be connected to the venous catheter via a three-way stopcock.
Nimotop S infusion solution must not be added directly to a bag or bottle containing other infusion solutions. It must not be mixed with solutions of other medicinal products.
Administration of Nimotop S infusion solution should be continued during anesthesia, surgical procedures, and angiography.
Duration of treatment
Prophylactic use:
Intravenous treatment should be initiated no later than 4 days after the occurrence 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 on the source of subarachnoid hemorrhage becomes necessary during prophylactic treatment, administration of Nimotop S infusion solution should be continued for at least 5 days after the procedure.
After completion of intravenous treatment, continuation of therapy with oral nimodipine at a dose of 6 × 60 mg daily, every 4 hours, for an additional 7 days is recommended.
Therapeutic use:
If ischemic neurological deficits due to cerebral vasospasm following subarachnoid hemorrhage have occurred, treatment should be initiated as soon as possible and continued for at least 5 days (up to a maximum of 14 days).
After completion of intravenous treatment, continuation of therapy with oral nimodipine at a dose of 6 × 60 mg daily, every 4 hours, for an additional 7 days is recommended.
If a surgical procedure is performed during nimodipine treatment, administration of Nimotop S infusion solution should be continued for at least 5 days after the procedure.
Special patient populations
The safety and efficacy of nimodipine have not been established in patients under 18 years of age.
Nimotop S infusion solution must be administered as a continuous intravenous infusion via central venous access using an infusion pump.