Prospect: information for the user

VASONASE 30 mg Hard Capsules

Nicardipine Hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take VASONASE 30 mg Hard Capsules

3. How to take VASONASE 30 mg Hard Capsules

4. Possible adverse effects

5. Storage of VASONASE 30 mg Hard Capsules

6. Contents of the pack and additional information

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

VASONASE 30 mg Hard Capsules is 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 stable chronic angina.

Do not take VASONASE 30 mg Hard Capsules

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

Warnings and Precautions

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

-If you have renal insufficiency or liver insufficiency.

-If you are prescribed nicardipine, you should be cautious to avoid excessive lowering of blood pressure.

-If you are prescribed nicardipine to replace a beta-blocker therapy, these should not be stopped abruptly, the dose should be gradually reduced over 8-10 days.

-If you experience chest pain, you must inform your doctor. Chest pain or an increase in its frequency may rarely occur. If you experience this, you must inform your doctor immediately.

-If you have congestive heart failure or a limited cardiac reserve.

Use of VASONASE 30 mg Hard Capsules with other medicines

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

The simultaneous use with other medicines may require modification of the dose of one of them, especially cimetidine, carbamazepine, ciclosporin, tacrolimus, sirolimus, everolimus, digoxin, fentanyl, beta-blockers.

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

Use of VASONASE 30 mg Hard Capsules with food and drinks

The levels of nicardipine may increase if you take Vasonase with grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 the milk in animals.

Driving and operating machinery

VASONASE 30 mg Hard Capsules is a blood pressure lowering medicine that should be used with caution in patients whose activity requires attention and who have experienced dizziness during treatment with this medicine.

Follow exactly the administration instructions for this medication 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 30 mg capsules should be taken with liquids and should be swallowed whole.

Lower doses are recommended for elderly patients and 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 the 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, heat, dizziness, confusion, and slurred speech may appear.

In case of overdose, cardiac and respiratory functions should be monitored, and you should seek medical attention quickly.

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

If you forgot to take VASONASE 30 mg Hard Capsules

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

If you interrupt treatment with VASONASE 30 mg Hard Capsules

You should not interrupt any treatment without having consulted with your doctor first.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been observed with unknown frequency (cannot be estimated from 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 the heartbeat (palpitations), excessive growth of soft tissue in the gums (gingival hyperplasia), nausea, vomiting, weakness (asthenia), sensation 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, decreased blood pressure (hypotension), decreased blood pressure upon standing (orthostatic hypotension), heatstroke, and 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 liver function.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store above 30°C.

Store the medication in the original packaging.

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

The shelf life of VASONASE 30 mg Hard Capsules is 2 years.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at thePharmacy SIGREcollection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of VASONASE 30 mg Hard Capsules

• The active ingredient is nicardipine hydrochloride
• The other components are pregelatinized starch and magnesium stearate.

The capsule coating contains: indigotin (E132), titanium dioxide (E171) and gelatin.

Appearance of the product and contents of the packaging

Blue capsules containing a yellow powder.

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

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Laboratoire X.O

170 Bureaux de la Colline

92213 Saint-Cloud Cedex

France

Responsible Manufacturer:

Farmasierra Manufacturing S.L.

Carretera de Irún, Km. 26,200

28700 San Sebastián de los Reyes (Madrid).

For more information about this medicine, please contact the local representative of the marketing authorization holder::

Beatriz López Pascual

Tel: +34 626 028 201

Mail: [email protected]

Last review date of this leaflet: April 2017

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/