Leaflet: information for the user

VASONASE 20 mg Coated Tablets

Nicardipine Hydrochloride

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

1. What isVASONASE20 mg Coated Tabletsand what it is used for

2. What you need to know before you start takingVASONASE 20 mg Coated Tablets

3. How to takeVASONASE 20 mg Coated Tablets

4. Possible side effects

5. Storage ofVASONASE 20 mg Coated Tablets

6. Contents of the pack and additional information

Nicardipine Hydrochloride is the active ingredient of VASONASE 20 mg Coated Tablets, 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.

VASONASE20 mg Coated Tabletsis 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 20 mg Coated Tablets

• If you are allergic to nicardipine hydrochloride or any of the other components of this medication (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 20 mg Coated Tablets

• 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 increased frequency of chest pain may rarely occur. If you experience this, you must inform your doctor immediately.
• If you have congestive heart failure or have a limited cardiac reserve.

Use of VASONASE 20 mg Coated Tablets with other medications

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

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

Especially, 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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

VASONASE 20 mg Coated Tablets is a hypotensive drug that should be used with caution in patients whose activity requires attention and who have observed dizziness during treatment with this drug.

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

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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 20 mg tablets 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 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 the 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, 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 20 mg Coated Tablets

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

If you interrupt treatment with VASONASE 20 mg Coated Tablets

You should not interrupt any treatment without having consulted 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 of heartbeats (palpitations), excessive growth of soft tissues 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 when standing (orthostatic hypotension), warmth, 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 20 mg Coated Tablets is 2 years.

Do not use this medication after the expiration date that appears 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 20 mg Coated Tablets

• The active ingredient is nicardipine hydrochloride
• The other components are:Sucrose, anhydrous lactose, sorbitol (E420), cornstarch, hydroxypropylcellulose (E463), calcium carmelose, 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 anhydrous ethanol).

Appearance of the product and content of the packaging

White, round, biconvex coated tablets.

VASONASE 20 mg Coated Tablets are presented in packaging of 30 and 60 coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratoire X.O

170 Bureaux de la Colline

92213 Saint-Cloud Cedex

France

Responsible for manufacturing:

Farmasierra Manufacturing S.L.

Carretera de Irún, Km. 26,200

28700 San Sebastián de los Reyes (Madrid)

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

Beatriz López Pascual

Tel: +34 626 028 201

Mail: [email protected]

Last review date of this leaflet: April 2017

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/