Nimodipine Altan

Leaflet included in the packaging: patient information

NIMODIPINE ALTAN, 0.2 mg/ml, solution for infusion

Nimodipine

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is NIMODIPINE ALTAN and what is it used for
• 2. Important information before taking NIMODIPINE ALTAN
• 3. How to take NIMODIPINE ALTAN
• 4. Possible side effects
• 5. How to store NIMODIPINE ALTAN
• 6. Contents of the packaging and other information

1. What is NIMODIPINE ALTAN and what is it used for

Nimodipine belongs to a group of medicines called calcium channel blockers, peripheral vasodilators, and essentially has a vasodilating effect (dilates coronary arteries) and cerebral anti-ischemic effect (improves oxygen supply to the brain). Studies conducted in patients with cerebral circulation disorders have shown that nimodipine increases cerebral blood flow. This medicine is indicated for the prevention of neurological disorders caused by spasm of cerebral blood vessels secondary to subarachnoid hemorrhage, a type of cerebral hemorrhage caused by a ruptured aneurysm (abnormal dilation or balloon-like expansion of a blood vessel, leading to weakening of the blood vessel wall).

2. Important information before taking NIMODIPINE ALTAN

When not to take NIMODIPINE ALTAN:

• if the patient is allergic to nimodipine or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Before starting treatment with NIMODIPINE ALTAN, the patient should discuss it with their doctor or pharmacist.

• if the patient has low blood pressure
• if the patient has water retention in brain tissue (generalized brain edema) or if there is a significant increase in intracranial pressure, even if nimodipine treatment has not been associated with an increase in intracranial pressure
• if the patient has kidney disease.
• if the patient has had a brain tissue injury causing intracranial bleeding.
• if the patient has unstable angina (a condition in which the heart does not receive enough blood and oxygen and may lead to a heart attack) or if the patient has had an acute heart attack in the last four weeks, in such cases the doctor will assess the potential benefits and risks.

The patient who has had a heart attack in the last four weeks should be under close medical supervision.

• if the patient has heart problems, such as arrhythmias and heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs), in such cases the doctor will regularly monitor the patient's condition.

Children and adolescents

The safety and efficacy of nimodipine in patients under 18 years of age have not been established, therefore, the use of this medicine in this age group is not recommended.

NIMODIPINE ALTAN and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines may interact with this medicine; in such cases, the doctor may need to adjust the dose or recommend stopping treatment with one of the medicines. This is especially important if the patient is taking:

• Cimetidine (a medicine used to treat stomach ulcers) and sodium valproate (a medicine used to treat epilepsy), as they may enhance the blood pressure-lowering effect of nimodipine.
• Antihypertensive medicines (used to treat high blood pressure), as they may enhance the hypotensive effect of nimodipine. These include other calcium channel blockers (e.g., nifedipine, diltiazem, or verapamil) or alpha-methyldopa or concomitant intravenous administration of beta-adrenolytics (used to treat high blood pressure and heart disease, e.g., atenolol, propranolol, carvedilol). NIMODIPINE ALTAN may enhance the effect of these medicines.
• Antiretroviral medicines (used to treat HIV infection), such as zidovudine.
• Potentially nephrotoxic medicines (damaging to the kidneys, e.g., aminoglycosides, cephalosporins, furosemide) may lead to kidney function disorders. In such cases, kidney function should be closely monitored, and if deterioration is detected, consideration should be given to stopping treatment.
• Medicines that are contraindicated with alcohol, as this medicine contains 24% v/v ethanol

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. If it is necessary to administer nimodipine during pregnancy, the doctor will carefully weigh the potential benefits and risks, depending on the severity of the disease. Breastfeeding is not recommended during treatment with nimodipine. It is not known whether short-term administration of NIMODIPINE ALTAN affects fertility.

Driving and using machines

Nimodipine may cause dizziness. However, it is unlikely that the patient will be able to drive or operate machinery while taking this medicine.

NIMODIPINE ALTAN contains ethanol and sodium

This medicine contains 24% v/v ethanol (alcohol), which is equivalent to 12.5 ml per 50 ml dose, equivalent to 250 ml of beer or 104 ml of wine. This medicine is harmful to people with alcohol dependence. The ethanol content should be taken into account in pregnant or breastfeeding women, children, and people at high risk, such as patients with liver disease or epilepsy. The amount of alcohol in this medicine may affect the effects of other medicines. The amount of alcohol in this medicine may impair the ability to drive or operate machinery. This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml of solution, which means it is considered "sodium-free".

3. How to take NIMODIPINE ALTAN

NIMODIPINE ALTAN is a hospital medicine, so it will be administered in a hospital by a qualified healthcare professional as a slow intravenous infusion. The infusion solution is usually administered for 5-14 days, followed by oral administration of 2 tablets of 30 mg of nimodipine 6 times a day (6 x 60 mg of nimodipine) for the next 7 days. If the patient weighs less than 70 kg or has unstable blood pressure, the doctor will recommend the required dose of NIMODIPINE ALTAN. In case of liver or kidney disease, the doctor will consider the need to reduce the dose.

Use in children and adolescents

The use of nimodipine in children under 18 years of age is not recommended, as its safety and efficacy have not been established.

Overdose of NIMODIPINE ALTAN

Symptoms that may occur include: marked decrease in blood pressure, acceleration or slowing of heart rate.

Missed dose of NIMODIPINE ALTAN

Due to the indications, this medicine is intended for hospital use, so this information does not apply.

Stopping treatment with NIMODIPINE ALTAN

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with the following frequency:

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Blood and lymphatic system disorders

• Thrombocytopenia (decreased platelet count) occurs uncommonly.

Immune system disorders

• Acute hypersensitivity reactions, including mild or moderate allergic reactions, occur uncommonly.
• Clinical symptoms related to the skin (uncommonly rash).

Nervous system disorders

• Non-specific cerebrovascular symptoms, including uncommonly headaches.

Cardiac disorders

• Changes in heart rate (non-specific arrhythmias): tachycardia (accelerated heart rate) occurs uncommonly, and bradycardia (slowed heart rate) occurs rarely.

Vascular disorders

• Non-specific cardiovascular symptoms, such as hypotension (low blood pressure) and vasodilation, are uncommon.

Gastrointestinal disorders

• Non-specific gastrointestinal and abdominal symptoms, including uncommonly nausea.
• Rarely, intestinal obstruction has been reported.

Hepatobiliary disorders

• Transient and rarely occurring increase in liver enzyme activity.

General disorders and administration site conditions

• Infusion site reactions and injection site reactions occur rarely (including thrombophlebitis at the infusion site, when a blood clot forms in the vein).

Reporting of side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, e-mail: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store NIMODIPINE ALTAN

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated. Store in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 NIMODIPINE ALTAN contains

• The active substance is nimodipine. One ml of solution contains 0.2 mg of nimodipine. Each 50 ml vial of infusion solution contains 10 mg of nimodipine.
• The other ingredients are: ethanol 96%, macrogol 400, buffer solution pH 7.0 consisting of: sodium citrate, anhydrous citric acid, water for injections.

What NIMODIPINE ALTAN looks like and contents of the pack

NIMODIPINE ALTAN is a solution for infusion. The 50 ml vial is made of orange type II glass, closed with a chlorobutyl rubber stopper, coated with a fluoropolymer and an aluminum flip-off cap. The pack sizes are: 1 vial of 50 ml, 20 vials of 50 ml. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Altan Pharma Limited, The Lennox Building, 50 South Richmond Street, Dublin 2, D02FK02, Ireland

Manufacturer

Laboratorio Reig Jofré, S.A., Gran Capitá 10, Sant Joan Despí, 08970 Cataluña, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Nimodipino Altan 0.2 mg/ml solución para perfusión EFG, France: Nimodipine Altan 10 MG/50 ML solution injectable/pour perfusion, Germany: Nimodipin Altan 200 Mikrogramm/ml Infusionslösung, Italy: Nimodipine Altan, Poland: Nimodipine Altan, United Kingdom: Nimodipine 0.2 mg/ml solution for infusion

Date of last revision of the leaflet:

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: http://urpl.gov.pl/pl

Information intended exclusively for healthcare professionals:

NIMODIPINE ALTAN, 0.2 mg/ml, solution for infusion

Instructions for use and handling

• Continuous intravenous infusion:

The NIMODIPINE ALTAN infusion solution should be administered using a triple-channel infusion set in a continuous intravenous infusion through a central venous catheter using an infusion pump. The product should be administered through a triple-channel infusion set 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 the NIMODIPINE ALTAN infusion solution and 4 parts of the infusion solution. The NIMODIPINE ALTAN infusion solution can also be administered with a mannitol solution, human albumin, or blood. The NIMODIPINE ALTAN infusion solution should not be added to a bag or bottle with other infusion solutions, nor should it be mixed with other medicinal products (see section 6.2). The solution should be drawn from the vial using a syringe. Then, a needle-free syringe should be inserted into the infusion pump and connected to the triple-channel infusion set using a polyethylene tubing provided with the medicinal product packaging. A standard PVC tubing should not be used (see section 6.2). The polyethylene tubing delivering nimodipine and the infusion line of the simultaneously administered solution should be connected to the venous catheter using a triple-channel infusion set. In patients for whom the administration of additional fluid is not recommended or may be contraindicated, the infusion solution may be administered through a central catheter without concurrent co-infusion.

Dosage

Treatment usually starts with the administration of nimodipine in a slow intravenous infusion, followed by oral administration, according to the scheme specified below: Treatment starts with a continuous intravenous infusion of 1 mg/hour of nimodipine (5 ml of NIMODIPINE ALTAN per hour), approximately 15 micrograms/kg/hour for 2 hours. 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 the NIMODIPINE ALTAN infusion solution per hour), approximately 30 micrograms/kg/hour. In patients weighing significantly less than 70 kg or with unstable blood pressure, treatment should start with a dose of 0.5 mg of nimodipine (i.e., 2.5 ml of the NIMODIPINE ALTAN infusion solution per hour) or less if necessary.