VASONASE 20 mg FILM-COATED TABLETS

Introduction

Leaflet: Information for the user

VASONASE 20 mg Coated Tablets

Nicardipine Hydrochloride

Read this leaflet carefully before starting to take 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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What VASONASE 20 mg Coated Tablets are and what they are used for
2. What you need to know before taking VASONASE 20 mg Coated Tablets
3. How to take VASONASE 20 mg Coated Tablets
4. Possible side effects
5. Storage of VASONASE 20 mg Coated Tablets
6. Package contents and additional information

1. What VASONASE 20 mg Coated Tablets are and what they are used for

Nicardipine Hydrochloride is the active ingredient of VASONASE 20 mg Coated Tablets, which is a medication belonging to the group of dihydropyridines that acts on blood vessels by relaxing smooth muscle. It also increases blood flow to the brain.

VASONASE 20 mg Coated Tablets are used for:

• Treatment of essential hypertension, moderate or mild
• 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 Coated Tablets

Do not take VASONASE 20 mg Coated Tablets

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take VASONASE 20 mg Coated Tablets

• If you have renal or hepatic insufficiency.
• If you are prescribed nicardipine, you should be cautious to avoid excessive blood pressure drop.
• If you are prescribed nicardipine to replace beta-blocker therapy, these should not be stopped abruptly, but 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 frequency may occur. If you experience this, you should inform your doctor promptly.
• If you have congestive heart failure or poor cardiac reserve.

Use of VASONASE 20 mg Coated Tablets with other medications

Inform your doctor, pharmacist, or nurse if you are using, have recently used, or may need to use any other medication.

Taking other medications at the same time may require adjusting the dose of one of them, especially cimetidine, carbamazepine, cyclosporine, tacrolimus, sirolimus, everolimus, digoxin, fentanyl, and beta-blockers.

In particular, inform your doctor if you are using other medications to control the body's immune system, such as cyclosporine, tacrolimus, or sirolimus.

Use of VASONASE 20 mg Coated Tablets with other medications

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

Pregnancy and lactation

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.

The use of VASONASE is not recommended during breastfeeding, as nicardipine has been observed to pass into milk in animals.

Driving and using machines

VASONASE 20 mg Coated Tablets are a hypotensive medication that should be used with caution in patients whose activities require attention and who have observed dizziness during treatment with this medication.

VASONASE 20 mg Coated Tablets contain lactose, sucrose, and sorbitol (E420).

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

3. How to take VASONASE 20 mg Coated Tablets

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

The recommended dose will range from 10 to 40 mg three times a day, depending on the type of pathology being treated.

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

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

Use in the elderly

Elderly patients should use VASONASE 20 mg Coated Tablets with caution.

Consult your doctor.

Use in children and adolescents

VASONASE 20 mg Coated Tablets should 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 Coated Tablets than you should

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

In case of overdose, cardiac and respiratory functions should be monitored, and you should consult your doctor promptly.

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

If you forget to take VASONASE 20 mg Coated Tablets

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

If you stop treatment with VASONASE 20 mg Coated Tablets

You should not stop any treatment without consulting your doctor first.

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

4. Possible side effects

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

The following side effects have been observed with unknown frequency (cannot be estimated from available data): thrombocytopenia (abnormal increase in platelet count), acute pulmonary edema (abnormal accumulation of fluid in the lungs), increased heart rate (tachycardia), feeling heartbeats (palpitations), excessive growth of soft tissues of the gums (gingival hyperplasia), nausea, vomiting, weakness (asthenia), feeling of heat, fluid accumulation in the extremities (peripheral edema), altered liver function (increased liver parameters), dizziness, headache, redness or inflammation of the skin or mucous membranes (erythema), itching (pruritus), rash, decreased blood pressure (hypotension), decreased blood pressure when standing up (orthostatic hypotension), flushing, intracranial hemorrhage, chest pain (angina pectoris), slow heart rate, heart attack (myocardial infarction), arrhythmias, brief loss of consciousness (syncope), severe allergic reaction causing difficulty breathing or dizziness, changes in blood tests on how your liver works.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of VASONASE 20 mg Coated Tablets

Do not store above 30°C.

Keep the medicine in its original packaging.

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

The shelf life of VASONASE 20 mg Coated Tablets is 2 years.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of VASONASE 20 mg Coated Tablets

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

Appearance and packaging of the product

White, biconvex, round tablets.

VASONASE 20 mg Coated Tablets are available in packs of 30 and 60 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

28700 San Sebastián de los Reyes (Madrid)

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

Beatriz López Pascual

Phone: +34 626 028 201

Email: [email protected]

Date of last revision of this leaflet: April 2017

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