Vasonase 1 mg/ml solution for infusion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Vasonase 1 mg/ml solution for infusion
nicardipine hydrochloride
Read the entire leaflet carefully before you start using 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, ask your doctor, pharmacist, or nurse.
? This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
? If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Vasonase is and what it is used for
- What you need to know before using Vasonase
- How to use Vasonase
- Possible adverse effects
- How to store Vasonase
- Contents of the pack and other information
1. What Vasonase is and what it is used for
Vasonase contains nicardipine hydrochloride, which belongs to a class of medicines called calcium channel blockers.
Vasonase is used to treat severe high blood pressure. It may also be used to control high blood pressure after surgery.
2. What you need to know before using Vasonase
Do not take Vasonase:
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if you are allergic to nicardipine or to any of the other ingredients of this medicine (listed in section 6)
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if you have 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 within the last eight days
Warnings and precautions
Your doctor will take special precautions if:
- You have heart failure
- You have angina pectoris
- Your liver is not working properly, or you have had liver disease in the past
- You have high pressure in the brain
- You have recently had a stroke
- You are taking beta-blockers
- You are pregnant
- You are under 18 years of age.
If you have any of these conditions, your doctor may need to carry out additional tests or adjust your dose. If you have any of the conditions listed above, or are unsure about them, consult your doctor before starting to use Vasonase.
This medicine may cause low oxygen levels or breathing difficulties when administered by intravenous injection, especially in patients with lung problems or other conditions affecting breathing. Your doctor will monitor your oxygen levels during treatment.
Use of Vasonase with other medicines
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription and herbal medicines. This is because Vasonase may affect how some medicines work. In addition, some medicines may affect how Vasonase works.
In particular, inform your doctor if you are taking 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 body's 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 treating high blood pressure
- Cimetidine (used to treat indigestion or stomach ulcers)
- Digoxin (used to treat heart conditions)
- Amifostine (used to protect against harmful effects of certain cancer treatments)
- Medicines for treating depression, anxiety, or other mental health conditions
- Strong 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 are undergoing surgery, your anaesthetist will need to know which other medicines you are taking, as some of them may affect how Vasonase works.
Do not drink grapefruit juice or eat grapefruit while taking this medicine, as it may increase nicardipine concentrations in the 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. Therefore, it should not be used during breastfeeding. There are no data available on fertility.
Vasonase contains sorbitol (E420)
If your doctor has informed 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 how much Vasonase you will be given. This will depend on how much and how quickly your blood pressure needs to be reduced.
This medicine will be slowly injected into a vein. Your blood pressure will be monitored during 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 your condition. If in doubt, ask your doctor or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most common adverse effect is headache and may affect more than 1 in 10 people.
Other common adverse effects (may affect 1 in 10 people) are:
Dizziness
Swelling of the legs or ankles
Increased heart rate, awareness of heartbeats (palpitations)
Low blood pressure, especially when standing up. This may cause dizziness, lightheadedness or fainting
Feeling unwell
Flushing and redness of the face.
Other adverse effects
(Frequency not known) – Cannot be estimated from the available data
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Reduction in the number of platelets in the blood, which may increase the risk of bleeding or bruising
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Cardiac conduction disorders manifested by a decreased heart rate, which may progress to discomfort.
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Slow heart rate
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Chest pain
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Heart problems leading to fluid accumulation in the lungs and difficulty breathing
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Low levels of oxygen in the blood (hypoxia)
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Abdominal pain
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Redness of the skin (erythema)
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Rash
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Inflammation of the vein where the medicine was administered
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Abnormalities in liver function tests in blood analyses
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Generalized allergic reaction causing difficulty breathing or dizziness.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Vasonase
The hospital will be responsible for properly storing this medication.
6. Contents of the pack and other information
Composition of Vasonase
The active substance is nicardipine. Each 10 ml vial contains 10 mg of nicardipine hydrochloride.
The other components are: sorbitol (E420), hydrochloric acid, water for injections.
Appearance of the product and contents of the pack
Vasonase is a clear, slightly greenish-yellow solution, free from particles. It is marketed in 10 ml vials containing 10 mg of nicardipine hydrochloride.
Each pack contains 5 or 10 vials. Only certain pack sizes may be commercially available.
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
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Beatriz López Pascual
Tel: +34 626 028 201
Mail: [email protected]
Date of the most recent review of this leaflet: April 2026
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/