Nimotop 0.2 mg/ml solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

NIMOTOP 0.2 mg/ml solution for infusion

nimodipine

Package leaflet contents

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

1. What Nimotop is and what it is used for

Nimodipine belongs to the group of peripheral vasodilators and has essentially a vasodilatory 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 disturbances have shown that nimodipine increases cerebral blood flow.

Nimotop is indicated for the prevention of neurological deterioration due to cerebral vasospasm following subarachnoid haemorrhage, a type of brain haemorrhage caused by rupture of an aneurysm (abnormal enlargement or bulging of a portion of an artery, resulting in weakening of the blood vessel wall).

2. What you need to know before using Nimotop

Do not use Nimotop

• if you are allergic (hypersensitive) to nimodipine or to any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver disease (e.g., cirrhosis).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Nimotop:

• if you have blood pressure disorders or are being treated for low 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, even though treatment with nimodipine has not been associated with increases in intracranial pressure.
• if you have kidney disease.
• if you have suffered brain tissue trauma resulting in intracranial hemorrhage.
• if you have 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 cases, 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 cannot pump enough blood to meet the body's needs); in such cases, your doctor will perform periodic monitoring.

Using Nimotop with other medicines

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

Certain medicines may interact with nimodipine; in such cases, your doctor may need to adjust the dose or discontinue treatment with one of the medicines. This is especially important if you are 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.

• Antiretroviral medicines (used to treat HIV infection), such as zidovudine.

• Other calcium antagonists (e.g., nifedipine, diltiazem, or verapamil) or alpha-methyldopa. However, if such a combination is essential, the patient will be closely monitored, particularly blood pressure.

• Potentially nephrotoxic medicines (those that damage the kidneys, e.g., aminoglycosides, cephalosporins, furosemide) may lead to deterioration in renal function. In such cases, kidney function should be carefully monitored, and if deterioration occurs, discontinuation of treatment should be considered.

• Concomitant intravenous administration of ß-blockers (used to treat hypertension and heart conditions, e.g., atenolol, propranolol, carvedilol) may cause additional lowering of blood pressure and mutual potentiation of negative inotropic effects, which could lead to decompensation of pre-existing heart failure.

• Medicines incompatible with alcohol, as this medicine contains 23.7% alcohol by volume, equivalent to up to 50 g per daily dose (250 ml).

• The antidepressants fluoxetine and nortriptyline.

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.

Nimotop is contraindicated during pregnancy and breastfeeding, unless prescribed by a doctor.

If nimodipine administration is necessary during pregnancy, your doctor will carefully evaluate the potential benefits and risks based on the severity of the clinical condition.

Driving and using machines

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

Nimotop contains alcohol

This medicine contains 23.7% ethanol (alcohol), corresponding to 1.89 g per hour of infusion, equivalent to 50 ml of beer or 20 ml of wine. The amount of alcohol 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 content 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 via continuous infusion, the effects of alcohol may be reduced.

If you are alcohol-dependent, consult your doctor or pharmacist before using this medicine.

Nimotop contains sodium

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

3. How to use Nimotop

Nimotop is a hospital-use medication, so it will be administered to you in a hospital by qualified healthcare personnel.

Follow exactly the administration instructions for this medicine as indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

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

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 administered more Nimotop than you should have

Symptoms you may experience include a marked decrease in blood pressure, or an increase or reduction 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 medication and the amount ingested.

If you forgot to use Nimotop

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

4. Possible adverse effects

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

The following adverse effects have been reported with the following frequencies:

Frequent: may affect between 1 and 10 in every 100 patients

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

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

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

Not known: frequency cannot be estimated from the available data

Blood and lymphatic system disorders

• Thrombocytopenia (reduced platelet count) is infrequent.

Immune system disorders

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

Nervous system disorders

• Non-specific cerebrovascular symptoms include infrequent headaches.

Cardiac disorders

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

Vascular disorders

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

Respiratory, thoracic and mediastinal disorders

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

Gastrointestinal disorders

• Non-specific gastrointestinal and abdominal symptoms include infrequent nausea.
• Ileus (intestinal obstruction) has been reported rarely.

Hepatobiliary disorders

• Hepatic reactions consist of a transient and rare increase in liver enzymes (including elevated 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nimotop

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

Store in the original packaging.

Protect from direct sunlight if the vial is removed from its packaging.

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 indicated.

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

6. Contents of the pack and other information

Composition of Nimotop

• The active substance is nimodipine. Each ml of solution contains 0.2 mg.
• The other components are 96% ethanol, macrogol 400, sodium citrate, citric acid, and water for injections.

Presentation of the product and contents of the pack

Nimotop is supplied in vials as a slightly yellowish solution. Each pack contains 20 vials with 50 ml (Clinical Pack).

Marketing Authorisation Holder and Manufacturer:

The Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Beatriz López Pascual
C/ Las artes, 13, 5°D,
33402-Avilés (Asturias)
Spain
Tel: +34 626 028 201
Mail: [email protected]

Date of the most recent review of this leaflet: September 2024

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

This information is intended for healthcare professionals only.

NIMOTOP 0.2 mg/ml, solution for infusion

Instructions for use and handling

The medicinal product must be administered by continuous intravenous infusion via 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 AESu poly(O-2-hydroxyethyl)starch 6%, in a ratio of approximately 1:4 (Nimotop: co-infusion). Mannitol, albumin, or human blood may also be suitable for simultaneous infusion.

Nimotop solution must not be added to an infusion bag or bottle and must not be mixed with other medicinal products. The solution should be withdrawn from the vial using a syringe (do not withdraw directly with an infusion set). Then attach the needle-free syringe to a syringe pump and connect it to the three-way tap using the polyethylene tubing supplied in the kit (do not use standard PVC tubing). Connect the co-infusion tubing and the central catheter to the three-way tap. Administration of Nimotop should continue during anaesthesia, surgery, and cerebral angiography.

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

Intracisternal instillation:

During surgery, a freshly prepared diluted solution of Nimotop (1 ml of Nimotop solution and 19 ml of Ringer's solution), warmed to blood temperature, may 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 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/h) for 2 hours (approximately 15 µg/kg/h). If well tolerated and no marked decreases in blood pressure occur, after 2 hours the dose may be increased to 2 mg/h of nimodipine (= 10 ml of nimodipine solution/h) (approximately 30 µg/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/h), or lower if necessary.