Nimodipine altan

Package leaflet: Information for the patient

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Nimodipine Altan (Nimodipino Altan)
0.2 mg/ml, solution for infusion
Nimodipinum
Nimodipine Altan and Nimodipino Altan are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others.
• It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Nimodipine Altan is and what it is used for
2. Important information 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 a group of medicines called calcium channel antagonists, peripheral vasodilators, and has primarily a vasodilating effect (dilates coronary and cerebral arteries) and exerts a cerebral anti-ischaemic action (improves oxygen supply to the brain). Clinical studies in patients with cerebral circulation disorders have shown that nimodipine increases cerebral blood flow.
This medicine is indicated for the prevention of neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage, a type of brain haemorrhage resulting from a ruptured aneurysm (an abnormal bulging or balloon-like dilation of part of an artery, leading to weakening of the blood vessel wall).

2. Important information before using Nimodipine Altan

When not to use Nimodipine Altan:

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

Warnings and precautions
Before starting treatment with Nimodipine Altan, discuss this with your doctor or pharmacist.

• if the patient has low blood pressure.
• if the patient has cerebral oedema (generalised brain swelling) or significantly increased intracranial pressure, although treatment with nimodipine has not been associated with increased intracranial pressure.
• if the patient has kidney disease.
• if the patient has suffered a brain injury causing intracranial bleeding. Page 1 of 6
• if the patient has unstable angina (a condition in which the heart does not receive enough blood and oxygen and may lead to myocardial infarction) or has recently experienced an acute myocardial infarction within the past four weeks; in such cases, the doctor will assess the potential benefit against the risk.
• if the patient has heart problems such as cardiac arrhythmias or heart failure (a condition in which the heart is unable to pump sufficient blood to meet the body's needs); in such cases, the doctor will regularly monitor the patient's condition.

Children and adolescents
The safety and efficacy of nimodipine in patients under 18 years of age have not been established; therefore, administration of this medicine is not recommended in this patient group.
Nimodipine Altan and other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
Some medicines may interact with this medicine; in such cases, the doctor may need to adjust the dose or recommend discontinuation of one of the medicines. This is particularly important if the patient is taking:

• Cimetidine (a medicine used for peptic ulcer disease) and sodium valproate (a medicine used to treat epilepsy), as they may enhance the blood pressure-lowering 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 methyldopa, or concomitant intravenous administration of beta-blockers (used to treat high blood pressure and heart conditions, e.g. atenolol, propranolol, carvedilol). Nimodipine Altan may enhance the effect of these medicines.
• Antiretroviral medicines (used to treat HIV infection), such as zidovudine.
• Medicines potentially nephrotoxic (kidney-damaging, e.g. aminoglycosides, cephalosporins, furosemide) which may lead to kidney function disturbances. In such cases, kidney function should be carefully monitored, and treatment discontinuation should be considered if deterioration occurs.
• Medicines contraindicated with alcohol, as this medicine contains 24% v/v alcohol.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
If administration of nimodipine during pregnancy is necessary, the doctor will carefully weigh the potential benefits against the risks depending on the severity of the disease.
Breastfeeding is not recommended during treatment with nimodipine.
It is unknown whether short-term use of Nimodipine Altan affects fertility.
Driving and operating machinery
Nimodipine may cause dizziness. However, it is unlikely that the patient will be in a position to drive or operate machinery during treatment with this medicine.
Nimodipine Altan contains ethanol 96% and sodium
This medicine contains 24% v/v of 96% ethanol (alcohol), equivalent to 12.5 ml per 50 ml dose, corresponding to 250 ml of beer or 104 ml of wine.
This medicine is harmful for individuals with alcohol-related disorders.
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The presence of 96% ethanol should be taken into account in pregnant or breastfeeding women, children, and individuals in high-risk groups, such as patients with liver disease or epilepsy.
The amount of alcohol in this medicine may affect the action of other medicines.
The amount of alcohol in this medicine may impair the ability to drive and operate machinery.
This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml of solution, meaning the medicine is considered "sodium-free".

3. How to use Nimodipine Altan

Nimodipine Altan is a hospital-use medicinal product and will therefore be administered in hospital by a qualified healthcare professional as a slow intravenous infusion.
The infusion solution is usually given for 5–14 days, followed by 2 tablets of 30 mg nimodipine 6 times daily (6 x 60 mg nimodipine) for a further 7 days.
If the patient weighs less than 70 kg or has unstable blood pressure, the doctor will determine the required dose of Nimodipine Altan for the patient.
In case of liver or kidney disease, the doctor will consider whether a dose reduction is necessary.

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 take more Nimodipine Altan than you should
Symptoms which may occur include: marked lowering of blood pressure, increased or decreased heart rate.

If you forget to take Nimodipine Altan
Since this medicine is intended for hospital use only, this information does not apply.

If you stop using Nimodipine Altan
If you have any further questions concerning use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported at 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

Blood and lymphatic system disorders

• Thrombocytopenia (reduced platelet count) occurs uncommonly.

Immune system disorders

• Acute hypersensitivity reactions, including mild or moderate allergic reactions, occur uncommonly.
• Skin-related clinical symptoms (uncommonly rash). Page 3 of 6

Nervous system disorders

• Non-specific cerebrovascular symptoms including uncommon headaches.

Cardiac disorders

• Changes in heart rate (non-specific heart rhythm disturbances): tachycardia (increased heart rate) occurs uncommonly, and bradycardia (slowed heart rate) occurs rarely.

Vascular disorders

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

Gastrointestinal disorders

• Non-specific gastrointestinal and abdominal symptoms including nausea, which is uncommon.
• Intestinal obstruction has been reported rarely.

Hepatobiliary disorders

• Transient and rarely occurring increase in liver enzyme activity.

General disorders and administration site conditions

• Reactions at the infusion or injection site occur rarely (including (thrombotic) phlebitis at the infusion site, when a blood clot forms in the vein).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store 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.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Nimodipine Altan contains

• The active substance is nimodipine. One ml of solution contains 0.2 mg of nimodipine. Each 50 ml infusion solution vial contains 10 mg of nimodipine.
• The other ingredients are: ethanol 96%, polyethylene glycol 400, sodium citrate, citric acid, water for injections.

What Nimodipine Altan looks like and contents of the pack
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Nimodipine Altan is a solution for infusion.
50 ml vial made of amber type II glass, closed with a chlorobutyl rubber stopper coated with fluoropolymer, and fitted with a "flip-off" cap, packed in a cardboard box.
Pack sizes for 50 ml vials:
1 vial of 50 ml
20 vials of 50 ml
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Spain, country of export:
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
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Relabelled and repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish MA number, country of export: 600307.7
Parallel Import Licence Number: 285/25
This medicinal product is authorised in the European Economic Area under the following names:
Spain: Nimodipino Altan 0.2 mg/ml solución para perfusión EFG
France: Nimodipine Altan 10 MG/50 ML solution injectable/pour perfusion
Germany: Nimodipin Altan 200 Mikrogramm/ml Infusionslösung
Italy: Nimodipine Altan
Poland: Nimodipine Altan
United Kingdom: Nimodipine 0.2 mg/ml solution for infusion

Information intended exclusively for medical professionals:

Nimodipine Altan (Nimodipino Altan), 0.2 mg/ml, infusion solution
Instructions for use and handling

• Continuous intravenous infusion:

Nimodipine Altan infusion solution must be administered via a three-way stopcock in a continuous intravenous infusion through a central venous line using an infusion pump.
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The product should be administered through a three-way stopcock with one of the following infusion solutions:
5% glucose solution, 0.9% sodium chloride solution, Ringer's lactate solution, Ringer's lactate and magnesium solution, dextran 40 solution, or 6% poly-(O-2-hydroxy-ethyl)-starch (HAES) solution. The solutions should be mixed in a 1:4 ratio, i.e. 1 part Nimodipine Altan infusion solution and 4 parts of the appropriate infusion solution. Mannitol solution, human albumin, or blood may also be administered simultaneously with the Nimodipine Altan infusion solution.
The Nimodipine Altan infusion solution must not be added to a bag or bottle containing other infusion solutions, nor should it be mixed with solutions of other medicinal products.
The solution should be withdrawn from the vial using a syringe. Then, the needle-free syringe should be placed in the infusion pump and connected to the three-way stopcock via a polyethylene tubing. Do not use standard PVC tubing. The polyethylene tubing delivering nimodipine and the infusion line for the simultaneously administered solution should be connected to the venous catheter via a three-way stopcock.
In patients for whom administration of additional fluid volume is not recommended or may be contraindicated, the infusion solution may be administered through a central catheter without simultaneous co-infusion.
Dosage
Treatment is generally initiated with a slow intravenous infusion of nimodipine, followed by oral administration, according to the schedule specified below:
Treatment is initiated with a continuous intravenous infusion of 1 mg/hour of nimodipine (5 ml of Nimodipine Altan/hour), approximately 15 micrograms/kg/hour, for 2 hours. If this dose is well tolerated by the patient, particularly if no significant drop in arterial blood pressure is observed, after two hours the dose should be increased to 2 mg (i.e. 10 ml of Nimodipine Altan infusion solution/hour), approximately 30 μg/kg body weight/hour. In patients with body weight significantly less than 70 kg or with unstable arterial blood pressure, treatment should be initiated at a dose of 0.5 mg nimodipine (i.e. 2.5 ml of Nimodipine Altan infusion solution/hour) or lower, if necessary.
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