Nimodipine Altan

Package leaflet: Information for the user

Nimodipine Altan 0.2 mg/ml infusion solution

Nimodipine
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Nimodipine Altan is and what it is used for
2. What you need to know 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 is a medicine that belongs to the group of peripheral vasodilators and has primarily a peripheral vasodilating effect (dilates the heart arteries) and a cerebral anti-ischemic effect (improves blood supply to the brain). Studies in patients with cerebral circulation disorders have shown that nimodipine increases blood flow to the brain.
This medicine is indicated for the prevention of brain damage caused by cerebral vasospasm secondary to subarachnoid haemorrhage, a type of brain haemorrhage resulting from the rupture of an aneurysm (an abnormal enlargement or bulging of a portion of an artery, leading to weakening of the blood vessel wall).

2. What you need to know before using Nimodipine Altan

Do not use Nimodipine Altan
if you are allergic to nimodipine or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Nimodipine Altan:

• if you have blood pressure disorders or are undergoing treatment to lower your blood pressure, especially in patients with systolic blood pressure below 100 mmHg.
• if you have increased intracranial pressure or accumulation of fluid in brain tissue. Your doctor will be able to advise you accordingly.
• if you have kidney problems.
• if you have previously suffered any brain tissue injury leading to intracranial bleeding.
• if you suffer from unstable angina (a condition in which the heart does not receive enough blood and oxygen and may lead to heart attack) or if you have had a severe myocardial infarction within the last four weeks; in such cases, your doctor will evaluate the potential benefits against the potential risks.
• if you have heart problems such as cardiac arrhythmias or heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs); in these cases, your doctor will need to monitor you regularly.

Other medicines and Nimodipine Altan
Tell your doctor or pharmacist if you are using, have recently used, or might use any other
medicines, including medicines taken without prescription.
Some medicines may interact with nimodipine; in such cases, your doctor may need to adjust the dose or
discontinue treatment with one of these medicines. This is particularly important if you are taking:

• cimetidine (a medicine used for stomach ulcers) and sodium valproate (a medicine used for epilepsy), as they may increase blood pressure and reduce the effect of nimodipine.
• antihypertensive medicines (used to treat high blood pressure), as they may enhance the hypotensive effect of nimodipine. These include calcium antagonists (e.g. nifedipine, diltiazem or verapamil) or alpha-methyldopa, or concomitant intravenous administration of ß-blockers (used to treat hypertension and heart problems, e.g. atenolol, propranolol, carvedilol). Nimodipine Altan may increase the effect of these medicines.
• antiretroviral medicines (used to treat HIV infections) such as zidovudine.
• medicines that are potentially nephrotoxic (i.e. that damage the kidneys, such as aminoglycosides, cephalosporins, furosemide), which may lead to impaired renal function. In these cases, kidney function must be closely monitored and, if deterioration is observed, discontinuation of treatment should be considered.
• medicines that are incompatible with alcohol, as this medicine contains 24% alcohol by volume.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
If administration of nimodipine is necessary during pregnancy, your doctor will carefully
evaluate the potential benefits and risks based on the severity of your condition.
Breastfeeding is not recommended during treatment with nimodipine.
It is not known whether short-term administration of Nimodipine Altan affects fertility.

Driving and using machines
It is unlikely that you will have the opportunity to drive or operate machinery while being treated with
this medicine.

Nimodipine Altan contains ethanol 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.
The amount of alcohol contained in this medicine is unlikely to have an effect in adults and adolescents.
However, some effects may occur in young children, such as drowsiness.
The ethanol content should be taken into account in pregnant or breastfeeding women, in
children and in high-risk groups, such as people with liver disease or epilepsy.
The ethanol content in this medicine may alter the effect of other medicines.
Consult your doctor or pharmacist if you are taking other medicines. Since this medicine is
administered slowly via continuous infusion, the effects of alcohol may be reduced.
If you have alcohol dependence, consult your doctor or pharmacist before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml of solution, i.e. it is essentially “sodium-free”.

3. How to use Nimodipine Altan

Nimodipine Altan is a hospital-use medicine; therefore, it will be administered in hospital by healthcare professionals as a slow injection into a vein in the bloodstream.
The usual treatment consists of administering the infusion solution for 5–14 days, followed by 2 tablets of 30 mg, 6 times daily (6 x 60 mg of nimodipine) for approximately another 7 days.
If you weigh less than 70 kg or have unstable blood pressure, your doctor will calculate the required dose of Nimodipine Altan.
In case of liver or kidney disorders, your doctor will assess whether a dose reduction is necessary.
Use in children and adolescents
The use of nimodipine in children under 18 years of age is not recommended, as safety and efficacy have not been established.
If you use more Nimodipine Altan than you should
Symptoms you may experience include: marked decrease in blood pressure, increased or decreased heart rate.
If you forget to use Nimodipine Altan
As stated in the instructions, this medicine is for hospital use; therefore, this information is not applicable.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects are described using 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
Not known: frequency cannot be estimated from the available data

Blood and lymphatic system disorders:

• Thrombocytopenia (reduced platelet count) is uncommon.

Immune system disorders:

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

Nervous system disorders:

• Non-specific cerebrovascular symptoms include headache, which is uncommon.

Cardiac disorders:

• Changes in heart rate (non-specific cardiac arrhythmias): tachycardia (increased heart rate) is uncommon and bradycardia (decreased 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 oxygen levels in body tissues (frequency not known)

Gastrointestinal disorders:

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

Hepatobiliary disorders:

• Transient increase in liver enzymes is rare.
• Increase in transaminases, alkaline phosphatase and γ-GT.

General disorders and administration site conditions:

• Reactions at the infusion or injection site are rare (including phlebitis at the infusion site (thrombus) when a clot forms in a vein).

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

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 which is stated on the packaging after "Exp." The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nimodipina Altan contains

• The active substance is nimodipine. Each ml of 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, and water for injections.

Description of the appearance of Nimodipina Altan and contents of the pack
Nimodipina Altan is a solution for infusion.
Pack sizes of 50 ml vials:
1 vial of 50 ml
20 vials of 50 ml
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Altan Pharmaceuticals S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Laboratorio Reig Jofré S.A.
C/ Gran Capità, 10
08970 Sant Joan Despí
Barcelona – Spain

This medicinal product is authorized 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: Nimodipina Altan
Poland: Nimodipine Altan 0.2 mg/ml infuusioneste, liuos
United Kingdom: Nimodipine Altan 0.2 mg/ml solution for infusion

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).

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The following information is intended exclusively for physicians or healthcare professionals:
Nimodipina Altan 0.2 mg/ml solution for infusion
Instructions for use and handling

• Continuous intravenous infusion:

This medicinal product is administered as a continuous intravenous infusion via a central catheter connected to an infusion pump, using a three-way stopcock, co-infused with 5% glucose solution, 0.9% sodium chloride solution, Ringer's lactate solution, Ringer's lactate solution with magnesium, dextran 40, or 6% polyoxyethylated polyethylene glycol starch (HAES) in a ratio of approximately 1:4 (nimodipine: co-infusion). Mannitol, human albumin, or whole blood are also suitable for co-infusion.
The Nimodipina Altan solution must not be added directly 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 (it must not be extracted directly using a standard infusion set). Subsequently, the needle-free syringe is placed into the syringe chamber of the infusion pump and connected to the three-way stopcock via a polyethylene tubing (do not use standard PVC tubing). Connect the three-way stopcock, the co-infusion tubing, and the central catheter. Nimodipina Altan may be used during anesthesia, surgical procedures, and cerebral angiography.
In patients where administration of additional fluid volume is not recommended or may be contraindicated, the infusion solution may be administered via a central catheter without co-infusion.

Dosage

As a general rule, treatment is initiated with continuous intravenous infusion of nimodipine, followed by oral administration as specified below:
Treatment begins with a continuous intravenous infusion of nimodipine at a rate of 1 mg/h (5 ml of Nimodipina Altan over 2 hours) (equivalent to approximately 15 µg/kg/hour).
If the infusion is well tolerated and, in particular, if no significant drop in blood pressure occurs, the dose should be increased after the second hour to 2 mg/h of nimodipine (10 ml of Nimodipina Altan/h) (equivalent to approximately 30 µg/kg/hour). In patients with body weight below 70 kg or unstable arterial pressure, it is recommended to initiate treatment with a dose of 0.5 mg/h of nimodipine (2.5 ml of Nimodipina Altan/h), or lower if necessary.