VASONASE RETARD 40 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

VASONASE Retard 40 mg Modified Release 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 experience 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 Package Leaflet

1. What VASONASE Retard is and what it is used for
2. What you need to know before you take VASONASE Retard
3. How to take VASONASE Retard
4. Possible side effects

5 Storage of VASONASE Retard

1. Contents of the pack and further information

1. What VASONASE Retard is and what it is used for

Nicardipine Hydrochloride is the active substance of VASONASE Retard, which is a drug belonging to the group of dihydropyridines that acts at the level of blood vessels by relaxing smooth muscle, due to the fact that it antagonizes the entry of calcium ions into this tissue. It also increases blood flow at the cerebral level.

VASONASE Retard is used for:

• Treatment of essential, moderate or mild arterial hypertension.
• Prevention and treatment of ischemia due to cerebral infarction and its sequelae.
• Prevention of neurological deterioration due to cerebral vasospasm secondary to subarachnoid hemorrhage.

2. What you need to know before you take VASONASE Retard

Do not take VASONASE Retard

• 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.
• If you have had recent cerebral hemorrhages.
• If you have intracranial hypertension.

Warnings and precautions

Consult your doctor or pharmacist before taking VASONASE Retard:

• If you have liver and/or kidney disorders.
• If you are prescribed nicardipine, you should be cautious to avoid excessive decrease in blood pressure.
• If you are prescribed nicardipine to replace beta-blocker therapy, these should not be interrupted abruptly, but rather 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 communicate it quickly to your doctor.

• If you have congestive heart failure or low cardiac reserve.

Using VASONASE Retard with other medicines

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

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

It is especially important that you inform your doctor if you are using:

• Cimetidine, a medicine used to treat gastroduodenal ulcers: Its use with nicardipine should be monitored because it can increase the plasma levels of the latter.
• Carbamazepine (antiepileptic): Its use with nicardipine should be monitored because it can increase the plasma levels of carbamazepine.
• Digoxin: It will be checked if you are taking digoxin for the treatment of heart failure.
• Cyclosporin and tacrolimus (immunosuppressants used to control the body's immune response): Nicardipine increases the blood concentrations of cyclosporin and tacrolimus, so their dose may need to be reduced if necessary.
• Sirolimus (a medicine indicated to prevent organ rejection) and everolimus (a medicine for cancer): Nicardipine can increase the blood concentrations of sirolimus.
• Fentanyl (an opioid analgesic): Hypotension may occur with the use of nicardipine with fentanyl and a beta-blocker.
• Beta-blockers: Caution should be exercised when using nicardipine in combination with beta-blockers if you have reduced cardiac function.

Using VASONASE Retard with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of VASONASE Retard is not recommended during breastfeeding, as nicardipine has been shown to pass into animal milk.

Driving and using machines

VASONASE Retard is a hypotensive drug that can cause dizziness, which may affect your ability to react, so this should be taken into account if you need to drive or operate machinery. The effect is increased if you also consume alcohol.

VASONASE Retard contains sucrose

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

3. How to take VASONASE Retard

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

VASONASE Retard is made up of rapid release and slow release systems of the active substance, which allow for an effective and sustained concentration of nicardipine over time when administered twice a day.

The capsules of VASONASE Retard should be taken with liquids and swallowed whole.

Arterial hypertension: the dose should be adjusted in each patient according to their blood pressure response. Treatment should be started with a dose of 40 mg twice a day, which can be increased to 40 mg three times a day. Before increasing the dose, three days should pass with the initial dose to achieve stable plasma concentrations.

If necessary, nicardipine can be administered along with thiazide diuretics or beta-blockers.

Cerebrovascular disease: the dose will be individually adjusted for each patient. In patients affected by cerebral infarction ischemia, the recommended dose is 40 mg twice a day. The recommended dose is 2 capsules a day (every 12 hours).

Elderly use: it is recommended to start treatment with 40 mg once a day, adjusting the dosage later.

Renal insufficiency: start with a dose of 40 mg, twice a day, adjusting the dosage later.

Hepatic insufficiency: it should be administered carefully in patients with altered liver function, starting treatment with 40 mg once a day.

According to the response, this dosage may be modified.

Use in children and adolescents

Its administration is not recommended in children and adolescents under 18 years of age, as safety and efficacy have not been established in this age group.

If you take more VASONASE Retard 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 see your doctor quickly.

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

If you forget to take VASONASE Retard

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

If you stop taking VASONASE Retard

Do not stop any treatment without consulting your doctor first.

If you have any further questions on 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 the number of platelets in the blood), acute pulmonary edema (abnormal accumulation of fluid in the lungs), increased heart rate (tachycardia), feeling the heartbeat (palpitations), excessive growth of the 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, intracranial hemorrhage, 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. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Retard

Do not store above 30°C.

Keep the medicine in the original packaging to protect it from light and moisture.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of VASONASE Retard

• The active substance is nicardipine hydrochloride
• The other ingredients are: sucrose, hypromellose (E464), macrogol 400, macrogol 6000, methacrylic acid copolymer, aminoalkyl methacrylate copolymer, polysorbate 80, and talc (E553b).

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

Appearance of the product and contents of the pack

White opaque capsules.

VASONASE Retard is available in packs of 60 capsules.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Beatriz López Pascual

Tel: +34 626 028 201

Email: beatriz.lopez@baupharma.com

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/