VASONASE 30 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

VASONASE 30 mg Hard Capsules

Nicardipine Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What VASONASE 30 mg Hard Capsules are and what they are used for
2. What you need to know before you take VASONASE 30 mg Hard Capsules
3. How to take VASONASE 30 mg Hard Capsules
4. Possible side effects
5. Storage of VASONASE 30 mg Hard Capsules
6. Contents of the pack and other information

1. What VASONASE 30 mg Hard Capsules are and what they are used for

Nicardipine Hydrochloride is the active substance of VASONASE 30 mg Hard Capsules, which is a medicine belonging to the group of dihydropyridines that acts on blood vessels by relaxing smooth muscle. It also increases blood flow at the cerebral level.

VASONASE 30 mg Hard Capsules are used in:

• 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 you take VASONASE 30 mg Hard Capsules

Do not take VASONASE 30 mg Hard Capsules

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take VASONASE 30 mg Hard Capsules:

• 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 interrupted abruptly, the dose should be gradually reduced over 8-10 days.
• If you feel chest pain, you should inform your doctor. Rarely, an increase in chest pain or frequency may occur. If you experience this, you should communicate it quickly to your doctor.
• If you have congestive heart failure or low cardiac reserve.

Using VASONASE 30 mg Hard Capsules with other medicines

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

Taking other medicines at the same time may make it necessary to modify the dose of one of them, especially cimetidine, carbamazepine, cyclosporine, tacrolimus, sirolimus, everolimus, digoxin, fentanyl, beta-blockers.

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

Using VASONASE 30 mg Hard Capsules with food and drinks

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

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.

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 30 mg Hard Capsules is a hypotensive medicine that should be used with caution in patients whose activity requires attention and who have observed dizziness during treatment with this medicine.

3. How to take VASONASE 30 mg Hard Capsules

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 to be treated.

The Vasonase 30 mg capsules 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 30 mg Hard Capsules with caution.

Use in children and adolescents

VASONASE 30 mg Hard Capsules 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 30 mg Hard Capsules 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 go to your doctor quickly.

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

If you forget to take VASONASE 30 mg Hard Capsules

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

If you stop taking VASONASE 30 mg Hard Capsules

You should not stop any treatment without having previously consulted your doctor.

If you have any other 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 everybody gets them.

The following side effects have been observed with unknown frequency (cannot be estimated from the available data): thrombocytopenia (abnormal increase in platelet count in the blood), 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, accumulation of fluid in the extremities (peripheral edema), altered liver function (increase in liver parameters (transaminases, etc.)), dizziness, headache, redness or inflammation of the skin or mucous membranes (erythema), itching (pruritus), rash, decrease in blood pressure (hypotension), decrease in blood pressure when standing up (orthostatic hypotension), flushing, and hemorrhage inside the skull, chest pain (angina pectoris), slow heart rate, heart attack (myocardial infarction), arrhythmias, brief loss of consciousness (syncope), severe allergic reaction that causes difficulty breathing or dizziness, changes in blood tests on how your liver works.

Reporting of side effects

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

5. Storage of VASONASE 30 mg Hard Capsules

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 30 mg Hard Capsules is 2 years.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of VASONASE 30 mg Hard Capsules

• The active substance is nicardipine hydrochloride
• The other ingredients are pregelatinized starch and magnesium stearate.

The capsule shell contains: indigotine (E132), titanium dioxide (E171), and gelatin.

Appearance and packaging of the product

Blue capsules containing a yellow powder.

VASONASE 30 mg Hard Capsules are presented in packs of 60 capsules.

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

Tel: +34 626 028 201

Mail: beatriz.lopez@baupharma.com

Date of the 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/