Prospecto: information for the user

NIMOTOP0.2 mg/mlinfusion solution

nimodipine

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

Nimotop 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 dilation or bulging of a portion of an artery, resulting in weakness in the wall of said blood vessel).

No use Nimotop

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

- if you have a severe liver disease (e.g. cirrhosis).

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to use Nimotop.

- if you have blood pressure alterations or are being treated to lower blood pressure, especially in patients with systolic blood pressure below 100 mmHg.

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

- if you have 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 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 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.

Use of Nimotop with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including those purchased without a prescription.

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

• Cimetidine (a medication used to treat stomach ulcers) or valproic acid (used to treat epilepsy), as they may potentiate the hypotensive effect of nimodipine.
• Antihypertensive medications (used to treat high blood pressure), as they may potentiate the hypotensive effect of nimodipine.
• Antiretroviral medications (used to treat HIV infection) such as zidovudine.
• Other calcium channel blockers (e.g. nifedipine, diltiazem or verapamil) or with alpha-methyldopa. However, if it is necessary to administer a combination of this type, the patient's blood pressure will be monitored, especially.

• 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 may be suspended.

• The simultaneous intravenous administration of β-blockers (used to treat hypertension and heart problems, e.g. atenolol, propranolol, carvedilol) may cause additional blood pressure lowering and potentiation of the negative inotropic effect, which could lead to decompensation of a pre-existing heart failure.
• Incompatible medications with alcohol, given that this medication contains a 23.7% volume percentage of alcohol, i.e. up to 50 g per daily dose (250 ml).
• Fluoxetine and nortriptyline antidepressants.

Pregnancy, breastfeeding and fertility

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

Nimotop is contraindicated during pregnancy and breastfeeding, except on medical prescription.

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

Driving and operating machinery

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

Nimotop contains alcohol

This medication contains 23.7% ethanol (alcohol); which corresponds to a quantity of 1.89 g per hour of infusion, equivalent to 50 ml of beer or 20 ml of wine. It is unlikely that the amount of alcohol contained in this medication will have any perceptible effect in adults or adolescents. It may have some effects in young children, such as drowsiness.

The alcohol content should be taken into account in the case of pregnant women or 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.Consult your doctor or pharmacist if you are taking other medications. Since this medication is administered slowly through continuous infusion, the effects of alcohol may be reduced.

If you have a history of alcohol addiction, consult your doctor or pharmacist before taking this medication.

Nimotop contains sodium

This medication contains 23.46 mg of sodium (main component of table salt/for cooking) per 50 ml vial. This corresponds to 1.17% of the recommended daily maximum sodium intake for an adult.

Nimotop is a hospital-use medication, so it will be administered in a hospital by the corresponding healthcare staff.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist or nurse. In case of doubt, ask your doctor or pharmacist or nurse.

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

Use in children and adolescents

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

If you have been given more Nimotop 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 Nimotop

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

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 between 1 and 10 in 100 patients

Infrequent: may affect between 1 and 10 in 1,000 patients

Rare: may affect between 1 and 10 in 10,000 patients

Very rare: may affect fewer than 1 in 10,000 patients

Unknown: the frequency cannot be estimated from the available data

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) are related to the skin.

Nervous system disorders

• Unspecified cerebrovascular symptoms include infrequent headaches.

Cardiac disorders

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

Vascular disorders

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

Respiratory, thoracic, and mediastinal disorders

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

Gastrointestinal disorders

• Unspecified gastrointestinal and abdominal symptoms include nausea, which is infrequent.
• Rarely, intestinal obstruction has been reported.

Hepatobiliary disorders

• Hepatic reactions consist of a rare, transient increase in liver enzymes (including increased transaminases, alkaline phosphatase, and gamma-glutamyl transferase).

General disorders and administration site conditions

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

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

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 not listed in this leaflet. You can also report them directly through the Spanish System for the 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.

Store in the original packaging.

Protect from direct sunlight, if the bottle is removed from its packaging.

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.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Nimotop Composition

- The active ingredient is nimodipine.Cada ml of the solution contains 0.2 mg.

- The other components areethanol 96%, macrogol 400, sodium citrate, citric acid, and water for injectable preparations.

Product Appearance and Packaging Contents

Nimotop is presented in a bottle in the form of a slightly yellowish solution. Each package contains 20 bottles with 50 ml (Clinical Package).

Marketing Authorization Holder and Responsible Manufacturer:

The marketing authorization holder is:

Laboratoire X.O

170 Bureaux de la Colline

92213 Saint-Cloud Cedex

France

The manufacturer is:

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen Germany

Last review date of this leaflet:September 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

-------------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals.

NIMOTOP0.2 mg/ml,infusion solution

Instructions for use and handling

The medicine should be administered by continuous intravenous infusion through a central catheter connected to an infusion pump using a 3-way valve along with a 5% glucose solution, 0.9% sodium chloride, Ringer lactate, Ringer lactate with magnesium, dextran 40, or AESu poly(O-2-hydroxyethyl) starch 6% in a ratio of approximately 1:4 (Nimotop: Co-infusion). Manitol, albumin, or human blood are also suitable for simultaneous infusion.

Nimotop solution should not be added to an infusion bag or bottle and should not be mixed with other medications. The solution must be extracted from the bottle using a syringe (do not extract directly with a perfusor). Then, place the syringe without a needle in an infusion pump syringe and connect it to the 3-way valve using the polyethylene tube provided in the package (do not use standard PVC tubes). In turn, connect the co-infusion tube and the central catheter to the 3-way valve. Continue administering Nimotop during anesthesia, surgery, and cerebral angiography.

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

Intracisternal instillation:

During surgery, a diluted solution of Nimotop (1 ml of Nimotop solution and 19 ml of Ringer solution) warmed to blood temperature can be instilled into the cisterns.This diluted Nimotop solution should be used immediately after preparation.

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 continuous intravenous infusion of 1 mg/h of nimodipine (= 5 ml nimodipine solution/h for 2 h (approximately 15 µg/kg/h). If well tolerated and no significant drops in blood pressure are observed, after 2 h the dose is increased to 2 mg/h of nimodipine (= 10 ml nimodipine solution/h) (approximately 30 µg/kg/h). In patients with a body weight less than70 kgor 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.