Nimodipine Altan 0.2 mg/ml solution for infusion EFG

Package leaflet: Information for the user

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, as you may need to read it again.

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

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

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

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

2. What you need to know before using Nimodipine Altan

Do not use Nimodipine Altan:

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

Warnings and precautions

Talk to your doctor or pharmacist before using Nimodipine Altan:

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

Children and adolescents

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

Use of Nimodipine Altan with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Certain medicines may interact with this medicine; in such cases, your doctor may need to adjust the dose or discontinue 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.

• Antihypertensive 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 concomitant intravenous administration of alpha-methyldopa or 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.
• Medicines that are potentially nephrotoxic (those that damage the kidneys, e.g., aminoglycosides, cephalosporins, furosemide); renal function may deteriorate. In such cases, kidney function will be carefully monitored, and if deterioration is observed, discontinuation of treatment will be considered.
• Medicines incompatible with alcohol, as this medicine contains 24% v/v alcohol.

Pregnancy, breastfeeding, and fertility

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

If nimodipine must be administered during pregnancy, your doctor will carefully evaluate the potential benefits and risks based on the severity of your clinical condition.

Breastfeeding is not recommended during treatment with nimodipine.

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

Driving and use of machines

You are unlikely to be able to perform these activities while receiving nimodipine by infusion.

Nimodipine Altan contains ethanol and sodium

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

The amount of alcohol contained in this medicine is unlikely to have any noticeable effect in adults or adolescents. However, it may have some effects in young children, such as drowsiness.

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

If you have 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 and is therefore considered essentially “sodium-free.”

3. How to use Nimodipine Altan

Nimodipine Altan is a hospital-use medicine, so it will be administered in a hospital by healthcare professionals as a slow intravenous injection into the bloodstream.

The usual treatment period involves administering the infusion solution for 5 to 14 days, followed by administration of 2 tablets of 30 mg, 6 times daily (6 x 60 mg of nimodipine) for approximately another 7 days.

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

If you have any liver or kidney disease, your doctor will consider whether a dose reduction is necessary.

Use in children and adolescents

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

If you have been given more Nimodipine Altan than you should have

The symptoms you may experience include a marked decrease in blood pressure, or an increase or decrease in heart rate.

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

If you forgot to use Nimodipine Altan

Since this medicine is used in hospital settings for its specific indications, this information does not apply.

If you stop treatment with Nimodipine Altan

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported with the following frequencies:
Frequent: 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 available data

Blood and lymphatic system disorders

• Thrombocytopenia (reduced platelet counts) is uncommon.

Immune system disorders

• Acute hypersensitivity reactions include mild or moderate allergic reactions, which are uncommon.
• Associated clinical symptoms involve the skin (rash, uncommon).

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 (low 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.
• Ileus (intestinal obstruction) has been reported rarely.

Hepatobiliary disorders

• Rare and transient increases in liver enzymes (including increases in transaminases, alkaline phosphatase and γ-GT).

General disorders and administration site conditions

• Reactions at the infusion or injection site are rare (including (thrombo)phlebitis at the infusion site when a clot lodges in a vein).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Human Medicines Pharmacovigilance System: https://www.notificaram.es By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original container to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Nimodipine Altan

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

Presentation of the product and contents of the container

Nimodipine Altan is presented as a solution for infusion.

Pack sizes of 50 ml vials:

1 vial of 50 ml

20 vials of 50 ml

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Altan Pharmaceuticals, S.A.
C/ Cólquide, 6
Portal 2, 1st floor - Prisma Building
28230 Las Rozas
Madrid
Spain

Manufacturer:

Laboratorio Reig Jofré S.A.
C/ Gran Capità, 10
08970 Sant Joan Despí
Barcelona – Spain

This medicinal product 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/ pour perfusion
Germany: NIMODIPIN Ethypharm 200 Mikrogramm/ml Infusionslösung
Italy: Nimodipine Altan 0.2 mg/ml soluzione per infusione
Poland: Nimodipine Altan 0.2 mg/ml infuusioneste, liuos
United Kingdom: Nimodipine Altan 0.2 mg/ml solution for infusion

Date of the most recent review of this leaflet: 05/2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Nimodipine Altan 0.2 mg/ml, solution for infusion EFG

Instructions for use and handling

• Continuous intravenous infusion:

This medicine must be administered by continuous intravenous infusion through a central catheter connected to an infusion pump, using a three-way tap, together with 5% glucose solution, 0.9% sodium chloride, lactated Ringer's solution, lactated Ringer's solution with magnesium, dextran 40 or AESG poly(O-2-hydroxyethyl) starch 6% in a ratio of approximately 1:4 (nimodipine: co-infusion). Mannitol, human albumin, or human blood may also be suitable for simultaneous infusion.

Nimodipine Altan solution must not be added directly to an infusion bag or bottle and must not be mixed with other medicinal products. The solution must be withdrawn from the vial using a syringe (do not withdraw directly with an infusion set). Then, place the needle-free syringe into a syringe pump and connect it to the three-way tap via a polyethylene tube (do not use standard PVC tubing). Connect the co-infusion tubing and the central catheter to the three-way tap as well. Nimodipine Altan may be used during anaesthesia, surgery, and cerebral angiography.

In patients for whom administration of additional fluid volume is not advisable or may be contraindicated, the infusion solution may be administered directly through a central catheter without co-infusion.

Dosage

As a general rule, the treatment regimen starts with intravenous administration of nimodipine, followed by oral administration, as specified below:

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