Leaflet: information for the user

NIMODIPINE ALTAN 0.2 mg/ml solution for infusion EFG

Nimodipine

Read 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, consult your doctor, pharmacist or nurse.

• This medicine has been prescribed for you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

3. How to use Nimodipine Altan

4. Possible side effects

5. Storage of Nimodipine Altan

6. Contents of the pack and additional information

Nimodipine is a medication that belongs to the group of drugs known as calcium channel blockers, peripheral vasodilators, and has essentially a vasodilatory effect (dilates the heart arteries) and cerebral anti-ischemic effect (improves oxygen supply to the brain). Investigations in patients with cerebral circulatory disorders have shown that nimodipine increases cerebral blood flow.

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

Do not use Nimodipino Altan:

- if you are allergic to nimodipino, or to any of the components of this medication (listed in section 6).

Warnings and precautions

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

- if you have low blood pressure.

- if you have cerebral edema (generalized brain swelling) or if there is marked intracranial hypertension, despite nimodipino treatment not being associated with increased intracranial pressure.

- if you have any kidney disease.

- if you have suffered a head injury that has caused intracranial hemorrhage.

- if you have unstable angina (a condition in which the heart does not receive enough blood 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 evaluate the possible benefit against the risk.

- if you have heart problems such as cardiac arrhythmias and heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs), in these circumstances your doctor will perform regular checks.

Children and adolescents

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

Other medications and Nimodipino Altan

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

- Cimetidine (stomach ulcer medication) and valproate sodium (epilepsy medication) as they may potentiate the hypotensive effect of nimodipino. This includes other calcium antagonists (e.g. nifedipine, diltiazem, or verapamil) or with alpha-methyldopa or simultaneous intravenous administration of β-blockers (used to treat hypertension and heart problems, e.g. atenolol, propranolol, carvedilol). Nimodipino Altan may increase the effect of these medications.

- Antiretroviral medications (used in the treatment of HIV infection) such as zidovudine.

- Potentially nephrotoxic medications (those that damage the kidneys, e.g. aminoglycosides, cephalosporins, furosemide), a deterioration of renal function may occur. In these cases, renal function will be closely monitored and if a deterioration is observed, treatment will be considered for suspension.

- Incompatible medications with alcohol, given that this medication contains a 24% v/v of alcohol (96%) (alcohol), which corresponds to a quantity of 12.5 ml per dose of 50 ml, equivalent to 250 ml of beer or 104 ml of wine.

Pregnancy, breastfeeding, and fertility

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

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

It is not recommended to breastfeed during treatment with nimodipino.

The short-term administration of Nimodipino Altan is not known to affect fertility.

Driving and operating machinery

Nimodipino may cause dizziness. However, it is unlikely that you will have the opportunity to

drive or operate machinery while on treatment with this medication.

Nimodipino Altan contains ethanol and sodium

This medication contains a 24% v/v of ethanol (96%) (alcohol), which corresponds to a quantity of 12.5 ml per dose of 50 ml, equivalent to 250 ml of beer or 104 ml of wine.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

The amount of alcohol in this medication may alter the effects of other medications.

The amount of alcohol in this medication may reduce the ability to drive or operate machinery.

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

Nimodipino Altan is a hospital-use medication, so it will be administered in a hospital by the corresponding healthcare staff through a slow injection into a vein in the circulatory system.

The usual treatment period is to administer the perfusion solution for 5-14 days, followed by administration of 2 tablets of 30 mg, 6 times a day (6 x 60 mg of nimodipino) 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 Nimodipino Altan.

If you have any liver or kidney disease, your doctor will consider the need to reduce the dose.

Use in children and adolescents

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

If you have been given more Nimodipino Altan than you should

The symptoms you may experience are: marked decrease in blood pressure, increase or decrease in heart rate.In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Nimodipino Altan

Since this medication is for hospital use, this information does not apply.

If you interrupt treatment with Nimodipino Altan

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been described with the following frequencies: Frequent: may affect up to 1 in 10 patients

Infrequent: may affect up to 1 in 100 patients

Rare: may affectup to1 in 1,000 patients

Very rare: may affectup to1 in 10,000 patients

Blood and lymphatic system disorders

•Thrombocytopenia (decreased platelet count) is infrequent.

Immune system disorders

•Acute hypersensitivity reactions include mild or moderate allergic reactions, which are infrequent.

•Clinical symptoms associated with the skin (infrequent rash).

Nervous system disorders

•Cerebrovascular symptoms include infrequent headaches.

Cardiac disorders

•Changes in heart rate (arrhythmias): tachycardia (increased heart rate) is infrequent and bradycardia (decreased heart rate) is rare.

Vascular disorders

•Inspecific cardiovascular symptoms, such as hypotension (low blood pressure) and vasodilation, are infrequent.

Respiratory, thoracic and mediastinal disorders

•Low oxygen levels in the body tissues, unknown frequency.

Gastrointestinal disorders

•Inspecific gastrointestinal and abdominal symptoms include nausea, which is infrequent.

•Occasionally, ileus (intestinal obstruction) has been reported.

Hepatobiliary disorders

•Transient and rare increase in liver enzymes.

General disorders and administration site conditions

•Reactions at the infusion and injection sites are rare (including thrombo-) phlebitis at the infusion site, when a clot forms in a vein).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the National System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light.

Medications should not be disposed of through drains or trash. Ask your pharmacist

how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Nimodipino Altan Composition

• The active ingredient is nimodipine. Each ml of the 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 injectable preparations.

Appearance of the product and contents of the container

Nimodipino Altan is presented in the form of a perfusion solution.

Container sizes of 50 ml vials

1 vial of 50 ml

20 vials of 50 ml

Only some container sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Altan Pharmaceuticals, S.A.

C/ Cólquide, 6

Portal 2, 1st floor - Prisma Building

28230 Las Rozas

Madrid

Spain

Manufacturer responsible:

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) with the following names:

Spain: Nimodipino Altan 0.2 mg/ml perfusion solution EFG

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

Germany: NIMODIPIN ALTAN 200 Mikrogramm/ml Infusion solution

Italy: Nimodipine Altan 0.2 mg/ml infusion solution

Poland: Nimodipine Altan 0.2 mg/ml infusion solution, liuos

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

Last review date of this leaflet: 10/2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Nimodipino Altan 0,2 mg/ml, perfusion solution EFG

Instructions for use and handling

Intravenous continuous infusion:

This medicinal product is administered in the form of an intravenous continuous infusion through a central catheter connected to an infusion pump using a three-way valve along with 5% glucose solution, 0.9% sodium chloride solution, Ringer lactate, Ringer lactate with magnesium, dextran 40 or AESu poly(O-2-hydroxyethyl) starch 6% in a ratio of approx. 1:4 (nimodipine: co-infusion). Manitol, human albumin, or human blood are also suitable for simultaneous infusion.

Nimodipino Altan solution should not be added to an infusion bag or vial and should not be mixed with other medicinal products. The solution must be extracted from the vial using a syringe (do not extract directly with an infusion pump). Subsequently, place the syringe without a needle in an infusion pump with a syringe and connect this 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. Nimodipino Altan can be used during anesthesia, surgery, and cerebral angiography.

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

Dosage

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

The treatment starts with the intravenous continuous infusion of 1 mg/h of nimodipine (5 ml nimodipine solution/h for 2 h (approx. 15 μg/kg/h). If well tolerated and no pronounced decreases in blood pressure are observed, after 2 h the dose is increased to 2 mg/h of nimodipine (10 ml nimodipine solution/h) (approx. 30 μg/kg/h). In patients with a body weight of less than 70 kg or unstable blood pressure, treatment should start with doses of 0.5 mg/h of nimodipine (2.5 ml of nimodipine solution/h), or less if necessary.