Nimotop s

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 the entire leaflet before using this medicine.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms of illness are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or nurse. See section 4.

Table of contents:

1. What Nimotop S is and what it is used for
2. What you need to know before receiving Nimotop S
3. How to use Nimotop S
4. Possible side effects
5. How to store Nimotop S
6. 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 spasmolytic effect on cerebral blood vessels, thereby preventing cerebral ischemia.
Clinical studies conducted in patients with acute disturbances in 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 areas.
Nimotop S is indicated for the prevention and treatment of ischemic neurological deficits caused by cerebral vasospasm following subarachnoid hemorrhage due to rupture of a cerebral aneurysm.

2. 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 in patients who have suffered an acute 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 about all medicines you are currently taking, have recently taken, or 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 lower 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 alcohol contained in this medicine may alter 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 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 operating machinery
Due to the patient's condition, the use of this medicine precludes driving and operating machinery.
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. It may cause some effects in younger children, for example drowsiness.
The alcohol contained in this medicine may alter the action of other medicines. If you are taking other medicines, you should consult your doctor or pharmacist.
Since this medicine is administered slowly by continuous intravenous infusion, the effects 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 alcohol-dependent, you should consult your doctor or pharmacist before using this medicine.
Nimotop S is harmful for patients with alcohol-related disorders. The presence of alcohol in this medicine should be taken into account when administering it to pregnant or breastfeeding women, children, and patients in high-risk groups, such as those with liver disease or epilepsy.
The medicine contains 23 mg of sodium (a main component of table 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 should always be used exactly as directed by the physician. In case of doubt, consult
your doctor.
Nimotop S is administered as a continuous intravenous infusion, starting at a dose of 1 mg
nimodipine per hour, then increasing to 2 mg/hour if the patient tolerates the dose well. In patients
with low body weight or unstable arterial blood pressure, treatment should be initiated 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 reactions or liver-related problems, the physician may consider
reducing the dose or discontinuing the treatment.
The duration of treatment will be determined by the physician. Intravenous nimodipine is usually
administered for no longer than 14 days.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Nimotop S
Symptoms of poisoning 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 decreased
arterial blood pressure, intravenous administration of dopamine or noradrenaline may be necessary.
Missing a dose of Nimotop S
Do not use a double dose to make up for a missed dose.
Stopping treatment with Nimotop S
If you have any further questions regarding the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
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,
• frequency not known (cannot be estimated from available data): low oxygen concentration in body tissues. Other adverse reactions may occur in some individuals during treatment with Nimotop S.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or nurse. Adverse reactions can be reported
directly to the Department of Monitoring 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 helps to provide more information on the safety of the medicine.

5. How to store Nimotop S

Keep the 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures 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 an amber glass type II bottle with a rubber stopper and coloured cap, containing 50 ml of solution, together with an infusion line made of PE connecting the infusion pump to the three-way tap in a foil-paper bag.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Bulgaria, country of export:
Laboratoire X.O
170 Bureaux de la Colline
92213 Saint-Cloud Cedex, France

Manufacturer:
Bayer AG
51368 Leverkusen
Germany
KVP Pharma + Veterinär Produkte
Projensdorfer Str. 324
24105 Kiel, Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Bulgaria, country of export: 20020728
Parallel Import Authorisation Number: 164/14
………………………………………………………………………………………………………

Information intended exclusively for medical 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. Refer to the product characteristics of the infusion fluid used in order to calculate the total sodium content in the prepared diluted product. This should be considered when prescribing the medicinal product to patients on a low-sodium diet.

Dosing
Unless otherwise prescribed by the physician, the following dosing is recommended:

Intravenous infusion:
Nimotop S infusion solution is administered as a continuous intravenous infusion.

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, particularly if no significant drop in arterial blood pressure is observed, after two hours the dose should be increased 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.

In patients experiencing adverse reactions, 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, if necessary, discontinuation of the drug should be considered.

Administration method
Nimotop S infusion solution must be administered via continuous intravenous infusion into a central vein using an infusion pump. The product should be administered through a three-way tap together with one of the following infusion fluids: 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) solution. 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 fluid.

Mannitol solution, human albumin, or blood may also be administered simultaneously with Nimotop S infusion solution.

The polyethylene tubing delivering nimodipine and the tubing for the concurrently administered solution should be connected to the venous catheter via a three-way tap.

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 anaesthesia, surgical procedures, and angiography.

Duration of treatment
Prophylactic use:
Treatment with intravenous infusion should be initiated no later than 4 days after subarachnoid haemorrhage and continued throughout the period of increased risk of vasospasm, i.e. for 10–14 days after the haemorrhage.

If surgical intervention on the source of subarachnoid haemorrhage is required 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 x 60 mg daily, every 4 hours, for a further 7 days is recommended.

Therapeutic use:
If ischemic neurological deficits occur due to cerebral vasospasm following subarachnoid haemorrhage, 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 x 60 mg daily, every 4 hours, for a further 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 groups
The safety and efficacy of nimodipine have not been established in patients under 18 years of age.

Nimotop S infusion solution must be administered via continuous intravenous infusion into a central vein using an infusion pump.