Vasonase 20 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VASONASE 20 mg Film-coated Tablets

Nicardipine Hydrochloride

Read all of this leaflet carefully before you start taking this medicine, because 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 or pharmacist.
• 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 or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What VASONASE 20 mg Film-coated Tablets are and what they are used for
2. What you need to know before taking VASONASE 20 mg Film-coated Tablets
3. How to take VASONASE 20 mg Film-coated Tablets
4. Possible adverse effects
5. How to store VASONASE 20 mg Film-coated Tablets
6. Contents of the pack and other information

1. What VASONASE 20 mg Coated Tablets is and what it is used for

Nicardipine Hydrochloride is the active substance in VASONASE 20 mg Coated Tablets, a medicine belonging to the dihydropyridine group that acts on blood vessels by relaxing smooth muscle. It also increases blood flow at the cerebral level.

VASONASE 20 mg Coated Tablets is used for:

• Treatment of mild to moderate essential hypertension
• Prevention and treatment of ischemia due to cerebral infarction and its sequelae
• Prevention and treatment of neurological deterioration caused by cerebral vasospasm secondary to subarachnoid hemorrhage
• Treatment of chronic stable angina.

2. What you need to know before taking VASONASE 20 mg Film-coated Tablets

Do not take VASONASE 20 mg Film-coated Tablets

• If you are allergic to nicardipine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have severe valvular aortic stenosis.

Warnings and precautions

Talk to your doctor or pharmacist before taking VASONASE 20 mg Film-coated Tablets

• If you have renal or hepatic impairment.
• If you are prescribed nicardipine, caution should be taken to avoid excessive lowering of blood pressure.
• If you are prescribed nicardipine to replace beta-blocker therapy, beta-blockers must not be stopped abruptly; the dose should be gradually reduced over 8–10 days.
• If you experience chest pain, you should inform your doctor. Rarely, an increase in chest pain or its frequency may occur. If this happens, inform your doctor promptly.
• If you have congestive heart failure or limited cardiac reserve.

This medicine may cause low oxygen levels or breathing difficulties when administered intravenously, especially in patients with lung problems or other conditions affecting respiration. Your doctor will monitor your oxygen levels during treatment.

Taking VASONASE 20 mg Film-coated Tablets with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

Concomitant use with other medicines may require dose adjustments, especially with cimetidine, carbamazepine, cyclosporine, tacrolimus, sirolimus, everolimus, digoxin, fentanyl, and beta-blockers.

In particular, inform your doctor if you are taking other medicines that affect the body's immune system, such as cyclosporine, tacrolimus, or sirolimus.

Taking VASONASE 20 mg Film-coated Tablets with food and drink

Nicardipine levels may increase if you take Vasonase together with grapefruit juice.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

This medicine is not recommended during pregnancy.

This medicine passes into breast milk. Therefore, it should not be used during breast-feeding.

There are no data available on fertility.

Driving and using machines

VASONASE 20 mg Film-coated Tablets is a hypotensive medicine and should be used with caution in patients whose activities require alertness, particularly if dizziness has occurred during treatment with this medicine.

VASONASE 20 mg Film-coated Tablets contain lactose, sucrose, and sorbitol (E420).

If your doctor has informed you of an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take VASONASE 20 mg Film-coated Tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose ranges from 10 to 40 mg three times daily, depending on the type of condition being treated.

Vasonase 20 mg tablets should be taken with liquid and must be swallowed whole.

Lower doses are recommended in elderly patients and in patients with renal or hepatic impairment.

Use in the elderly

Elderly patients should use VASONASE 20 mg Film-coated Tablets with caution.

Consult your doctor.

Use in children and adolescents

VASONASE 20 mg Film-coated Tablets must not be administered to children under 18 years of age, as safety and efficacy have not been established in this age group.

If you take more VASONASE 20 mg Film-coated Tablets than you should

In case of overdose, hypotension, bradycardia, palpitations, flushing, dizziness, confusion, and slurred speech may occur.

In the event of overdose, cardiac and respiratory functions should be monitored, and you must seek immediate medical attention.

If you have taken more than you should, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number (91) 562 04 20, indicating the medicine and the amount taken.

If you forget to take VASONASE 20 mg Film-coated Tablets

Do not take a double dose to make up for forgotten doses.

If you stop taking VASONASE 20 mg Film-coated Tablets

Do not discontinue treatment without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

These effects occur more frequently at the beginning of treatment, are not serious, and disappear as soon as the treatment is discontinued.

Frequent adverse effects (may affect up to 1 in 10 people)

• edema (swelling) of the legs,
• headaches,
• a sensation of warmth in the face,
• dizziness and palpitations.

Rare adverse effects (may affect up to 1 in 1000 people)

• heart rhythm disorders,
• a drop in blood pressure,
• sudden loss of consciousness (syncope),
• digestive disturbances (nausea, vomiting),
• a decrease in the number of blood platelets,
• an increase in the size of the gums. These effects usually resolve when treatment is discontinued and require careful oral hygiene.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• disorders associated with stiffness, tremors, and/or abnormal movements,
• abnormalities in liver function which may result in inflammation of the liver (hepatitis).

The following adverse effects occur with unknown frequency (cannot be estimated from the available data)

• Cases of acute pulmonary edema have been reported, especially when nicardipine is used in pregnant women to reduce uterine contractions.
• Malaise due to a sudden drop in blood pressure, especially when moving from a lying/sitting position to a standing position.
• Fatigue.
• Sensation of warmth.
• Increase in liver enzymes.
• Chest, jaw, and back pain, which may frequently occur at the beginning of treatment in patients with ischemic heart disease.
• Severe and sudden allergic reaction with difficulty breathing.
• Skin redness and itching.

Patients with pre-existing angina may experience increased frequency, duration, or severity of these attacks with the nicardipine group of medicines.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VASONASE 20 mg Film-coated Tablets

Do not store above 30°C.

Keep the medicine in the original packaging.

Keep this medicine out of the sight and reach of children.

The shelf life of VASONASE 20 mg Film-coated Tablets is 2 years.

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 month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of VASONASE 20 mg Film-coated Tablets

• The active substance is nicardipine hydrochloride.
• The other components are: Sucrose, anhydrous lactose, sorbitol (E420), corn starch, hydroxypropylcellulose (E463), calcium carmellose, talc (E553b), magnesium stearate, calcium lactate pentahydrate, gelatin, gum arabic (E414), titanium dioxide (E171), macrogol 8000, Opaglos 6000 (carnauba wax (E903), white beeswax (E901), shellac (E904) and dehydrated ethanol).

Appearance of the medicine and contents of the pack

White, round biconvex tablets.

VASONASE 20 mg Film-coated Tablets are available in packs containing 30 and 60 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratoire X.O
170 Bureaux de la Colline
92213 Saint-Cloud Cedex
France

Manufacturer:

Farmasierra Manufacturing S.L.
Carretera de Irún, Km. 26,200
San Sebastián de los Reyes
28706 Madrid
Spain

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 revision of this leaflet: April 2026

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