Nimodipine Altan 0.2 mg/ml Solution for Infusion

Introduction

Package Leaflet: Information for the User

NIMODIPINE ALTAN 0.2 mg/ml solution for infusion EFG

Nimodipine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Nimodipine Altan and what is it used for
2. What you need to know before you use Nimodipine Altan
3. How to use Nimodipine Altan
4. Possible side effects
5. Storage of Nimodipine Altan
6. Contents of the pack and other information

1. What is Nimodipine Altan and what is it used for

Nimodipine belongs to the group of peripheral vasodilators and has, essentially, a vasodilating effect (dilates the heart arteries) and anti-ischemic cerebral effect (improves oxygen supply to the brain). Research in patients with cerebral circulatory disorders has shown that nimodipine increases cerebral blood flow.

This medicine is indicated for the prevention of neurological deterioration caused by cerebral vasospasm secondary to subarachnoid hemorrhage, a type of cerebral hemorrhage, due to rupture of an aneurysm (abnormal enlargement or bulging of a portion of an artery, resulting in weakness in the wall of the blood vessel).

2. What you need to know before you use Nimodipine Altan

Do not use Nimodipine Altan:

• if you are allergic to nimodipine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Nimodipine Altan:

• if you have blood pressure disorders or are being treated to lower blood pressure, especially in patients with systolic blood pressure below 100 mmHg.
• if you have cerebral edema (generalized brain tissue water retention) or if there is marked intracranial hypertension. Your doctor will advise you on this.
• if you have kidney disease
• if you have suffered a cerebral tissue trauma that has caused an intracranial hemorrhage.
• if you have unstable angina (a disease in which the heart does not receive enough blood flow and oxygen and can lead to a heart attack) or if you have had an acute myocardial infarction four weeks ago, in these circumstances your doctor will assess the potential benefit versus risk.
• if you have heart problems such as cardiac arrhythmias and heart failure (a disease in which the heart is unable to pump enough blood to meet the body's needs), in these circumstances your doctor will perform periodic checks.

Children and adolescents

Do not administer Nimodipine Altan to children under 18 years of age as its safety and efficacy have not been established.

Using Nimodipine Altan with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Certain medicines may interact with this medicine; in these cases, your doctor will adjust the dose or interrupt treatment with one of the medicines. This is especially important when taking:

• Cimetidine (a medicine used to treat stomach ulcers) or valproic acid (used to treat epilepsy), as they may enhance the hypotensive effect of nimodipine.

Anti-hypertensive medicines (used to treat high blood pressure), as they may enhance the hypotensive effect of nimodipine. These include other calcium antagonists (e.g., nifedipine, diltiazem, or verapamil) or with alpha-methyldopa or simultaneous intravenous administration of beta-blockers (used to treat hypertension and heart problems, e.g., atenolol, propranolol, carvedilol). Nimodipine Altan may increase the effect of these medicines.

• Antiretroviral medicines (used to treat HIV infection), such as zidovudine.
• Potentially nephrotoxic medicines (those that damage the kidneys, e.g., aminoglycosides, cephalosporins, furosemide), kidney function deterioration may occur. In these cases, kidney function will be carefully monitored, and if deterioration is observed, treatment suspension will be considered.
• Medicines incompatible with alcohol, as this medicine contains 24% v/v of ethanol (96%).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If it is necessary to administer nimodipine during pregnancy, your doctor will carefully assess the potential benefits and risks based on the severity of the clinical condition.

Breastfeeding is not recommended during treatment with nimodipine.

It is unknown whether short-term administration of Nimodipine Altan affects fertility.

Driving and using machines

It is unlikely that you will be able to perform these activities while receiving nimodipine infusion.

Nimodipine Altan contains ethanol and sodium

This medicine contains 24% v/v of ethanol (96%), which corresponds to an amount of 12.5 ml per 50 ml dose, equivalent to 250 ml of beer or 104 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect on adults or adolescents. It may have some effects on young children, such as drowsiness.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy. The amount of alcohol in this medicine may alter the effects of other medicines. Consult your doctor or pharmacist if you are taking other medicines. Since this medicine is administered slowly through continuous infusion, the effects of alcohol may be reduced.

If you have an alcohol addiction, consult your doctor or pharmacist before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml of solution, so it is considered essentially "sodium-free".

3. How to use Nimodipine Altan

Nimodipine Altan is a hospital medicine, so it will be administered to you in a hospital by the corresponding healthcare staff, through a slow injection into a vein.

The usual treatment period is to administer the infusion solution for 5-14 days, followed by oral administration of 2 tablets of 30 mg, 6 times a day (6 x 60 mg of nimodipine) for approximately 7 more days.

If your weight is less than 70 kg or you have unstable blood pressure, your doctor will calculate the required dose of Nimodipine Altan.

In case of liver or kidney disease, your doctor will consider the need to reduce the dose.

Use in children and adolescents

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

If you have been given too much Nimodipine Altan

The symptoms you may experience are: marked decrease in blood pressure, increased or decreased heart rate.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you miss a dose of Nimodipine Altan

Since this medicine is for hospital use due to its indications, this information is not applicable.

If you stop treatment with Nimodipine Altan

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been described with the following frequencies:

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

Not known: frequency cannot be estimated from the available data

Blood and lymphatic system disorders

• Thrombocytopenia (decrease in platelet count) is uncommon.

Immune system disorders

• Acute hypersensitivity reactions include mild or moderate allergic reactions, which are uncommon.
• Clinical symptoms associated with these reactions are related to the skin (uncommon rash).

Nervous system disorders

• Non-specific cerebrovascular symptoms include uncommon headaches.

Cardiac disorders

• Changes in heart rate (non-specific cardiac arrhythmias): tachycardia (increased heart rate) is uncommon and bradycardia (decreased heart rate) is rare.

Vascular disorders

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

Respiratory, thoracic, and mediastinal disorders

• Low oxygen levels in body tissues, frequency not known.

Gastrointestinal disorders

• Non-specific gastrointestinal and abdominal symptoms include uncommon nausea.
• Rarely, ileus (intestinal obstruction) has been reported.

Hepatobiliary disorders

• Transient and rare increase in liver enzymes (including increased transaminases, alkaline phosphatase, and γ-GT).

General disorders and administration site conditions

• Reactions at the infusion site and injection site are rare (including thrombophlebitis of the infusion site, when a clot forms in a vein).

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the national pharmacovigilance system for human medicines: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nimodipine Altan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Store in the original package to protect from light.

Medicines should 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 pack and other information

Composition of Nimodipine Altan

• The active substance is nimodipine. Each ml of the solution contains 0.2 mg. Each 50 ml vial contains 10 mg.
• The other ingredients are: ethanol (96%) macrogol 400, anhydrous citric acid, sodium citrate, water for injections.

Appearance of the product and pack size

Nimodipine Altan is presented as a solution for infusion.

Pack sizes are 50 ml vials

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 Pharmaceuticals, S.A.

C/ Cólquide, 6

Portal 2, 1st floor - Edificio Prisma

28230 Las Rozas

Madrid

Spain

Manufacturer:

Laboratorio Reig Jofré S.A.

C/ Gran Capità, 10

08970 Sant Joan Despí

Barcelona - Spain

This medicine is authorized in the Member States of the European Economic Area (EEA) under the following names:

Spain: Nimodipino Altan 0.2 mg/ml solution for infusion EFG

France: Nimodipine Altan 10 mg/50 ml solution injectable/for infusion

Germany: NIMODIPIN ALTAN 200 micrograms/ml infusion solution

Italy: Nimodipine Altan 0.2 mg/ml solution for infusion

Poland: Nimodipine Altan 0.2 mg/ml infusion solution

United Kingdom: Nimodipine Altan 0.2 mg/ml solution for infusion

Date of last revision of this leaflet: 05/2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Nimodipine Altan 0.2 mg/ml, solution for infusion EFG

Instructions for use and handling

• Intravenous continuous infusion:

This medicine should be administered through intravenous continuous infusion via a central catheter connected to an infusion pump using a three-way valve along with a 5% glucose solution, 0.9% sodium chloride solution, Ringer's lactate, Ringer's lactate with magnesium, 40% dextran, or 6% hydroxyethyl starch solution in a ratio of approximately 1:4 (nimodipine: co-infusion). Mannitol, human albumin, or human blood are also suitable for simultaneous infusion.

Nimodipine Altan solution should not be added to an infusion bag or bottle and should not be mixed with other medicines. The solution should be extracted from the vial using a syringe (do not extract directly with an infusion pump). Then, place the syringe without a needle in a syringe infusion pump and connect it to the three-way valve using a polyethylene tube (do not use standard PVC tubes). In turn, connect the co-infusion tube and the central catheter to the three-way valve. Nimodipine Altan can be used during anesthesia, cerebral surgery, and angiography.

In patients in whom the administration of an additional volume of fluids is not recommended or may be contraindicated, the infusion solution can be administered directly through a central catheter without using a co-infusion.

Posology

As a general rule, treatment is initiated with intravenous administration of nimodipine followed by oral administration, as specified below:

Treatment is initiated with intravenous infusion of 1 mg/h of nimodipine (= 5 ml nimodipine solution/hour for 2 hours) (approximately 15 micrograms/kg/h). If well tolerated and no marked decrease in blood pressure is observed, after 2 hours the dose is increased to 2 mg/h of nimodipine (= 10 ml nimodipine solution/hour) (approximately 30 micrograms/kg/h). In patients with a body weight below 70 kg or unstable blood pressure, treatment should be initiated with a dose of 0.5 mg/h of nimodipine (= 2.5 ml of nimodipine solution/hour) or less if necessary.