VASONASE 1 mg/ml SOLUTION FOR INFUSION

Introduction

Leaflet: information for the patient

Vasonase 1 mg/ml solution for infusion

nicardipine hydrochloride

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

? Keep this leaflet, as you may need to read it again.

? If you have any questions, consult your doctor, pharmacist, or nurse.

? This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

? If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Vasonase and what is it used for
2. What you need to know before taking Vasonase
3. How to use Vasonase
4. Possible side effects
5. Storage of Vasonase
6. Package contents and additional information

1. What is Vasonase and what is it used for

Vasonase contains nicardipine hydrochloride, which belongs to a class of medicines called calcium channel blockers.

Vasonase is used to treat very severe high blood pressure. It can also be used to control high blood pressure after surgery.

2. What you need to know before taking Vasonase

Do not take Vasonase:

• if you are allergic to nicardipine or any of the other components of this medicine (listed in section 6)

• if you suffer from chest pain
  • if your high blood pressure is due to narrowing of a heart valve or other heart defects
  • if you have had a heart attack in the last eight days

Warnings and precautions

Your doctor will take special precautions:

• If you have heart failure
• If you have angina pectoris
• If your liver is not working properly, or you have had liver disease in the past
• If you have high blood pressure in the brain
• If you have recently had a stroke
• If you are taking beta-blockers
• If you are pregnant
• If you are under 18 years of age.

If you have any of these conditions, your doctor may need to perform additional tests or change the dose. If you have any of the above conditions, or are not sure, consult your doctor before taking Vasonase.

Using Vasonase with other medicines

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription and herbal medicines. This is because Vasonase may affect the way some medicines work. Also, some medicines may affect the way Vasonase works.

In particular, tell your doctor if you are using any of the following medicines:

• Dantrolene (used to treat prolonged muscle stiffness)
• Beta-blockers (used to treat high blood pressure and heart conditions) such as propranolol, atenolol, and metoprolol
• Medicines used to control seizures, such as carbamazepine, phenobarbital, primidone, and phenytoin
• Baclofen (used to treat muscle spasms)
• Medicines used to control the immune system, such as cyclosporine, tacrolimus, or sirolimus
• Itraconazole (used to treat certain types of fungal infections)
• Rifampicin (used to treat tuberculosis and other types of infections)
• Alpha-blockers (used to treat high blood pressure or prostate problems in men), such as doxazosin, prazosin, and terazosin
• Any other medicine for high blood pressure
• Cimetidine (for treating indigestion or stomach ulcers)
• Digoxin (used to treat heart conditions)
• Amifostine (used to protect against the harmful effects of some cancer treatments)
• Medicines for treating depression, anxiety, or other mental health problems
• Powerful painkillers such as morphine or codeine
• Medicines used to treat inflammation, such as steroids and tetracosactide
• Magnesium injection (used to treat severe high blood pressure during pregnancy)

If you need to undergo surgery, your anesthesiologist will need to know what other medicines you are taking, as some of them may affect the way Vasonase works.

Do not drink grapefruit juice or eat grapefruit while taking this medicine, as it may increase the levels of nicardipine in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine passes into breast milk. Consequently, it should not be used during breastfeeding. There is no available data on fertility.

Vasonase contains sorbitol (E420)

If your doctor has told you that you have an intolerance to certain sugars, consult with them before using this medicine.

3. How to use Vasonase

This medicine will be administered to you in the hospital.

Your doctor will decide the amount of Vasonase to be administered to you. This will depend on how much and how quickly you want to reduce your blood pressure.

This medicine will be slowly injected into a vein. Your blood pressure will be monitored while you receive the treatment, and the dose will be adjusted to ensure that your blood pressure decreases to a normal level.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

Vasonase will be administered by your doctor, who will ensure that you receive the correct dose for the condition you are suffering from. If in doubt, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The most common side effect is headache and may affect more than 1 in 10 people.

Other common side effects (may affect up to 1 in 10 people) are:

Dizziness

Swelling of the legs or ankles

Increased heart rate, feeling heartbeats (palpitations)

Low blood pressure, especially when standing up. This can cause dizziness, lightheadedness, or fainting

Feeling unwell

Flushes and reddening of the face.

Other side effects

(Frequency not known) - Cannot be estimated from available data

• Decrease in the number of platelets in the blood, which can increase the risk of bleeding or bruising
• Heart conduction disorders manifested by a decrease in heart rate, which can lead to discomfort.

• Slow heart rate
• Chest pain
• Heart problems that lead to an increase in fluid in the lungs and difficulty breathing
• Abdominal pain
• Redness of the skin (erythema)
• Rash
• Inflammation of the vein where the medicine was administered
• Changes in liver function tests in blood analyses
• Generalized allergic reaction that causes difficulty breathing or dizziness.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vasonase

The hospital will be responsible for storing this medicine correctly.

6. Package contents and additional information

Composition of Vasonase

The active substance is nicardipine. Each 10 ml ampoule contains 10 mg of nicardipine hydrochloride.

The other ingredients are: sorbitol (E420), hydrochloric acid, water for injection.

Appearance of the product and package contents

Vasonase is a clear, slightly greenish-yellow solution free of particles. It is marketed in 10 ml ampoules containing 10 mg of nicardipine hydrochloride.

Each package contains 5 or 10 ampoules. Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratoire X.O

170 Bureaux de la Colline

92213 Saint-Cloud Cedex

France

Manufacturer:

Haupt Pharma Livron S.A.S.

1 rue Comte de Sinard

26250 Livron sur Drôme

France

You can request more information about this medicine from the local representative of the marketing authorization holder:

Beatriz López Pascual

Phone: +34 626 028 201

Email: [email protected]

Date of the last revision of this leaflet:August 2025

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