Prospecto: information for the user

VASONASE Retard 40 mg Hard capsules with modified release

Nicardipine Hydrochloride

Read this prospect carefully before starting to take this medicine, because 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 to you alone, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take VASONASE Retard

4.Possible adverse effects

5Storage of VASONASE Retard

6.Contents of the package and additional information

Nicardipine Hydrochloride is the active ingredient of VASONASE Retard, which is a medication belonging to the group of dihydropyridines that acts at the level of blood vessels by relaxing smooth muscle due to antagonizing 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 essential hypertension.
• Prevention and treatment of cerebral ischemia due to cerebral infarction and its sequelae.
• Prevention of neurological deterioration due to cerebral vasospasm secondary to subarachnoid hemorrhage.

Do not take VASONASE Retard

• If you are allergic to nicardipine hydrochloride or any of the other components of this medication (listed in section 6).

• If you have severe aortic valve stenosis.
• If you have had recent cerebral hemorrhages.
• If you have hypertensive encephalopathy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take VASONASE Retard:

• If you have liver and/or kidney impairments.
• If you are taking nicardipine, be cautious to avoid excessive lowering of blood pressure.
• If you are taking nicardipine to replace beta-blocker therapy, do not stop beta-blockers abruptly, but rather taper the dose gradually over 8-10 days.

• If you experience chest pain, inform your doctor. Rarely, it may cause an increase in chest pain or frequency. If you experience this, inform your doctor promptly.

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

Use of VASONASE Retard with other medications

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

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

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

• Cimetidine, a medication used to treat gastric ulcers: Monitor its use with nicardipine because it may increase the latter's plasma levels.
• Carbamazepine (antiepileptic): Monitor its use with nicardipine because it may increase carbamazepine plasma levels.
• Digoxin: Monitor if you are taking digoxin for heart failure treatment.
• Ciclosporina and tacrolimus (immunosuppressants used to control the body's immune response): Nicardipine increases ciclosporina and tacrolimus blood concentrations, so you may need to reduce their doses.
• Sirolimus (medication used to prevent organ rejection) and everolimus (cancer medication): Nicardipine may increase sirolimus blood concentrations.
• Fentanil (opioid analgesic): Hypotension may occur with the use of nicardipine with fentanil and a beta-blocker.
• Beta-blockers: Be cautious when using nicardipine with beta-blockers if you have reduced cardiac function.

Use of VASONASE Retard with food and beverages

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

Pregnancy and lactation

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

VASONASE Retard is not recommended during breastfeeding, as nicardipine has been observed to pass into animal milk.

Driving and operating machinery

VASONASE Retard is a hypotensive medication that may cause dizziness, which may impair your reaction time, and you should be aware of this if you need to drive or operate machinery. The effect is intensified if you consume alcohol simultaneously.

VASONASE Retard contains saccharose.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

VASONASE Retard is composed of rapid-release and slow-release systems of the active principle, which allow for an effective and sustained concentration of nicardipine to be achieved when administered twice a day.

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

Hypertension: the dose should be adjusted in each patient according to their blood pressure response. Treatment should be initiated 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 allow for stable plasma concentrations to be reached.

If nicardipine is considered necessary, it can be administered with thiazide diuretics or beta-blockers.

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

Use in the elderly:it is recommended to initiate treatment with 40 mg once a day, adjusting the dosage afterwards.

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

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

According to the response, this dosage may be modified.

Use in children and adolescents

It is not recommended for administration in children and adolescents under 18 years of age, as its 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, heat, dizziness, confusion, and stuttering 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, Telephone (91) 562 04 20, indicating the medication and the amount taken.

If you forgot to take VASONASE Retard

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

If you interrupt treatment with VASONASE Retard

You should not interruptany treatment without having consulted with your doctor beforehand.

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

Like all medications, this medication may produce adverse effects, although not all people may 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 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 when standing (orthostatic hypotension), heat, 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 at a temperature above 86°F (30°C).

Store the medication in its original packaging to protect it from light and moisture.

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

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 medications you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Nicardipine Hydrochloride Composition of VASONASE Retard

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

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

Appearance of the product and contents of the packaging

White opaque capsules.

VASONASE Retard is presented in packaging of 60 capsules.

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).

For more information about this medication, please contact 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

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