Nimodipine altan

Package leaflet: Information for the patient

NIMODIPINE ALTAN, 0.2 mg/ml, solution for infusion
Nimodipinum
Please read all of this leaflet carefully before 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• It may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 blockers, peripheral vasodilators, and essentially has a vasodilating effect (dilates coronary arteries) and a cerebroprotective effect against ischemia (improves oxygen supply to the brain). Studies conducted in patients with cerebral circulation disorders have shown that nimodipine increases cerebral blood flow.
This medicine is indicated for the prevention of neurological disorders caused by cerebral vasospasm secondary to subarachnoid hemorrhage, a type of intracranial bleeding resulting from a ruptured aneurysm (an abnormal bulging or balloon-like dilation of a 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 to 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 arterial blood pressure

• if the patient has cerebral edema (generalized brain swelling) or significantly increased intracranial pressure, although treatment with nimodipine has not been associated with an increase in intracranial pressure

• if the patient has kidney disease

• if the patient has suffered brain tissue injury causing intracranial hemorrhage

• 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 if
  the patient has had an acute myocardial infarction within the last four weeks; in such
  circumstances, the doctor will assess the potential benefit versus 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 have not been established in patients under
18 years of age; therefore, administration of this medicine is not recommended in this patient group.
NIMODIPINE ALTAN with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as
any medicines you plan 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 in peptic ulcer disease) and sodium valproate (a medicine used in the treatment of epilepsy), as they may enhance the blood pressure-lowering effect of nimodipine
• Antihypertensive medicines (used in the treatment of 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 in the treatment of high blood pressure and heart diseases, e.g. atenolol, propranolol, carvedilol). NIMODIPINE ALTAN may enhance the effect of these medicines
• Antiretroviral medicines (used in the treatment of HIV infection), such as zidovudine
• Medicines that are 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 if deterioration occurs, treatment discontinuation should be considered
• Medicines contraindicated with alcohol, because 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 a 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 according to the severity of the disease.
Breastfeeding is not recommended during treatment with nimodipine.
It is unknown whether short-term administration of NIMODIPINE ALTAN affects fertility.
Driving and operating machinery
Nimodipine may cause dizziness. However, it is unlikely that the patient will be able to drive or
operate machinery during treatment with this medicine.
NIMODIPINE ALTAN contains ethanol and sodium
This medicine contains 24% v/v 96% ethanol (alcohol), equivalent to 12.5 ml per 50 ml dose, which corresponds to 250 ml of beer or 104 ml of wine.
This medicine is harmful for individuals with alcohol-related disorders.
The ethanol content 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 medicine and will therefore be administered in a hospital by a qualified healthcare professional as a slow intravenous infusion.
Typically, the infusion solution is 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 physician will determine the required dose of NIMODIPINE ALTAN for the patient.
In case of liver or kidney disease, the physician 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.

Overdose of NIMODIPINE ALTAN
Symptoms that may occur include marked decrease in blood pressure, increased or decreased heart rate.

Missed dose of NIMODIPINE ALTAN
Due to the indications, this medicine is intended for hospital use only, so this information does not apply.

Discontinuation of NIMODIPINE ALTAN
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions have been reported with the following frequency:
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 number of blood platelets) is uncommon.

Immune system disorders

• Acute hypersensitivity reactions, including mild or moderate allergic reactions, are uncommon.
• Skin-related clinical symptoms (uncommon skin rash).

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) is uncommon, and bradycardia (slowed 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 tissue oxygen levels, frequency not known

Gastrointestinal disorders

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

Hepatobiliary disorders

• Transient and rarely occurring increase in liver enzyme activity.

General disorders and administration site conditions

• Reactions at the infusion or injection site are rare (including (thrombophlebitis) inflammation of the vein at the infusion site due to blood clot formation).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 49 21 301, fax: +48 22 49 21 309,
e-mail: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorization Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store NIMODIPINE ALTAN

Keep this medicine out of sight and reach of children.
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 stated month.
Store in the original packaging to protect from light.
Medicines must not be disposed of via sewage or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 vial of infusion solution contains 10 mg of nimodipine.
• The other ingredients are: ethanol 96%, macrogol 400, pH 7.0 buffer solution consisting of: sodium citrate, citric acid anhydrous, water for injections.

What Nimodipine Altan looks like and contents of the pack
Nimodipine Altan is a solution for infusion.
50 ml vial made of amber glass type II, closed with a chlorobutyl rubber stopper coated with fluoropolymer, and an aluminium "flip-off" cap.
Pack sizes of 50 ml vials:
1 vial of 50 ml
20 vials of 50 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Altan Pharmaceuticals, S.A.
C/ Cólquide No 6, Portal 2, 1st floor, Office F. Edificio Prisma
Las Rozas, 28230 Madrid
Spain

Manufacturer:
Laboratorio Reig Jofré, S.A.
Gran Capitá 10
Sant Joan Despí
08970 Catalonia
Spain

This medicinal product is authorised in the European Economic Area countries 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

Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
http://urpl.gov.pl/pl >

Information intended exclusively for medical professionals:

NIMODIPINE 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 tap by continuous intravenous infusion through a central venous catheter using an infusion pump.
The product should be administered through a three-way tap together with one of the following infusion solutions: 5% glucose solution, 0.9% sodium chloride solution, Ringer's solution with lactate, Ringer's solution with lactate and magnesium, 40% dextran 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. Along with the NIMODIPINE ALTAN infusion solution, mannitol solution, human albumin, or blood may also be administered.
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 (see section 6.2).
The solution should be withdrawn from the vial using a syringe. Then, the needleless syringe should be placed into the infusion pump and connected to the three-way tap using the polyethylene tubing supplied with the medicinal product packaging. Do not use standard PVC tubing (see section 6.2). The polyethylene tubing delivering nimodipine and the infusion line containing the simultaneously administered solution should be connected to the venous catheter via a three-way tap.
In patients for whom administration of additional fluid volume is not recommended or may be contraindicated, the infusion solution may be administered via a central catheter without simultaneous co-infusion.

Dosage
Treatment is generally initiated with intravenous nimodipine administered as a slow infusion, followed by oral administration, according to the regimen 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 decrease in arterial blood pressure is observed, the dose should be increased after two hours 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.