NIMODIPINA 0.2 MG/ML Roztwór do infuzji

Treść ulotki

1. Nimodipina Altan 0.2 mg/ml solution for infusion
   1. What is Nimodipina Altan and what is it used for
   2. What you need to know before using Nimodipina Altan
   3. How to use Nimodipina Altan
   4. Possible side effects
   5. How to store Nimodipina Altan
   6. Package contents and other information

Nimodipina Altan 0.2 mg/ml solution for infusion

Nimodipina

Generic medicine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Nimodipina Altan and what is it used for

Nimodipine is a medicine that belongs to the group of peripheral vasodilators and has, primarily
a vasodilating effect (dilates the arteries of the heart) and a cerebral anti-ischemic effect (improves
blood supply to the brain). Studies on patients with cerebral circulatory 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 hemorrhage, a type of brain hemorrhage, resulting from the rupture of an
aneurysm (abnormal widening or swelling of a portion of an artery, which involves
weakening of the vessel walls).

2. What you need to know before using Nimodipina Altan

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

Warnings and precautions
Talk to your doctor or pharmacist before using Nimodipina Altan.

• if you suffer from blood pressure disorders or are undergoing treatment to lower blood pressure, especially in patients with systolic blood pressure below 100 mmHg.
• if you have increased pressure inside the skull or if you have an accumulation of fluid in the brain tissue. Your doctor will be able to advise you on this.
• if you have kidney problems.
• if you have suffered any trauma to the brain tissue that has led to intracranial bleeding.
• if you suffer from unstable angina (a condition in which the heart does not receive enough blood and oxygen and can lead to a heart attack) or if you have had a severe myocardial infarction in the last four weeks, in these cases the doctor will assess the possible benefits against the possible 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 the doctor will need to monitor you regularly.

Other medicines and Nimodipina Altan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines you bought without a prescription.
Some medicines can interact with nimodipine; in these cases, the doctor will need to adjust the dose
or stop 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 can increase blood pressure and decrease the effect of nimodipine.
• Antihypertensive medicines (used to treat high blood pressure), as they can increase the hypotensive effect of nimodipine. These include calcium channel blockers (e.g. nifedipine, diltiazem or verapamil) or alpha-methyldopa, or the concomitant intravenous administration of ß-blockers (used to treat hypertension and heart problems, e.g. atenolol, propanolol, carvedilol). Nimodipina Altan can 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), can lead to impaired kidney function. In these cases, kidney function must be carefully monitored and if deterioration is observed, discontinuation of treatment should be considered.
• Medicines that are incompatible with alcohol, as this medicine contains a percentage of alcohol by volume of 24%.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
If the administration of nimodipine is necessary during pregnancy, the doctor will carefully assess
the potential benefits and risks depending on the severity of your condition.
Breastfeeding is not recommended during treatment with nimodipine.
It is not known whether short-term administration of Nimodipina Altan has effects on fertility.

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

Nimodipina Altan contains ethanol and sodium
This medicine contains 24% v/v of 96% ethanol (alcohol) equivalent to 12.5 ml per 50 ml of dose,
equivalent to 250 ml of beer or 104 ml of wine.
The amount of alcohol contained in this medicine is unlikely to have an effect on adults and adolescents.
Some effects may occur in young children, such as drowsiness.
The ethanol content should be taken into consideration 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 an addiction, 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 Nimodipina Altan

Nimodipina Altan is a medicine for hospital use, therefore it will be administered to you in hospital by
healthcare professionals as a slow injection through a vein into the bloodstream.
The usual treatment is the administration of the infusion solution for 5-14 days, followed by the
administration of 2 tablets of 30 mg, 6 times a day (6 x 60 mg of nimodipine) for about another
7 days.
If you weigh less than 70 kg or have unstable blood pressure, your doctor will calculate the dose of Nimodipina
Altan needed.
In case of liver or kidney diseases, the doctor will assess the need to reduce the dose.

Use in children and adolescents
The use of nimodipine in children under the age of 18 is not recommended as safety and
efficacy have not been established.

If you use more Nimodipina Altan than you should
The symptoms you may experience are: marked decrease in blood pressure, increase or
decrease in heart rate.

If you forget to use Nimodipina Altan
As reported 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 everybody gets 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 1000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated based on available data
Blood and lymphatic system disorders:

• Thrombocytopenia (decreased number of platelets) is uncommon.

Immune system disorders:

• Acute hypersensitivity reactions including mild or moderate allergic reactions are uncommon.
• The associated clinical symptoms concern the skin (uncommon rash).

Nervous system disorders:

• Non-specific cerebrovascular symptoms include uncommon headache.

Cardiac disorders:

• Changes in heartbeat (non-specific cardiac arrhythmias): tachycardia (increased heartbeat) is uncommon and bradycardia (decreased heartbeat) is rare.

Vascular disorders:

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

Respiratory, thoracic and mediastinal disorders:
low level of oxygen 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

Systemic disorders and conditions related to the administration site:

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you can help to provide more information on the safety of
this medicine.

5. How to store Nimodipina 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 pack after Exp. The expiry date
refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water 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 ingredient is nimodipine. Each ml of solution contains 0.2 mg. Each 50 ml vial contains 10 mg.
• The other ingredients 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 presented as a solution for infusion.
Packs of 50 ml vials:
1 vial of 50 ml
20 vials of 50 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
Spain: Nimodipino Altan 0.2 mg/ml solution for perfusion EFG
France: Nimodipine Altan 10 mg/50 ml solution injectable/pour perfusion
Germany: NIMODIPIN ALTAN 200 Micrograms/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.
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The following information is intended exclusively for doctors or healthcare professionals:
Nimodipina Altan 0.2 mg/ml solution for infusion
Instructions for use and handling

• Continuous intravenous infusion:

This medicine is administered as a continuous intravenous infusion through a central catheter
connected to an infusion pump using a three-way valve with a 5% glucose solution,
a 0.9% sodium chloride solution, a Ringer's lactate solution, a Ringer's lactate solution
with magnesium, 40 dextran or 6% HAES poly-oxy-2-hydroxyethyl starch 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 to an infusion bag or bottle and must not
be mixed with other medicines. The solution must be removed from the vial using a
syringe (it must not be drawn up directly with a drip set). Subsequently, the syringe without a needle
is inserted into the pump syringe and connected to the three-way valve using the
polyethylene tube (do not use standard PVC tubes). Connect the three-way valve, the co-infusion tube and the central catheter. Nimodipina Altan can be used during anesthesia, surgical procedures and brain angiography.
In patients in whom the administration of additional fluid is not recommended or may
be contraindicated, the infusion solution may be administered through a central
catheter, without co-infusion.

Posology
As a general rule, treatment begins with a continuous intravenous infusion of nimodipine and
continues with oral administration as specified below:
Treatment begins with a continuous intravenous infusion of 1 mg/h of nimodipine (5 ml of
Nimodipina Altan for a duration of 2 hours (equivalent to approximately 15 µg/kg/hour)).
If the infusion is well tolerated and, above all, if a considerable drop in blood pressure does not occur, the dosage
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 a body weight of less than 70 kg or unstable blood pressure, it is
recommended to start treatment with a dosage of 0.5 mg/h of nimodipine (2.5 ml of
Nimodipina Altan/h), or lower if necessary.