Prospect: information for the user

Lercanidipine Normon 10 mg film-coated tabletsEFG

Lercanidipine hydrochloride

Read this prospect carefully before starting to take the medicine.

• 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 for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any effect not mentioned in this prospect, inform your doctor or pharmacist.

1.What is Lercanidipine Normon and for what it is used

2.What you need to know before starting to take Lercanidipine Normon

3.How to take Lercanidipine Normon

4.Possible adverse effects

5.Storage of Lercanidipine Normon

6.Contents of the package and additional information

Lercanidipino Normon belongs to a group of medications called calcium channel blockers (dihydropyridine derivatives), which prevent the entry of calcium into the cells of the heart muscle and blood vessels that transport blood to the heart (arteries). The entry of calcium into those cells produces heart contraction and narrowing of the arteries.

By blocking the entry of calcium, calcium channel blockers reduce heart contraction and dilate (widen) the arteries, and consequently, blood pressure decreases.

Lercanidipino Normon is used to treat mild to moderate hypertension in adults.

Do not take Lercanidipino Normon

• If you areallergicto lercanidipine hydrochloride or toany of the other components ofthis medication (listed in section 6).
• Si ha sufridoreacciones alérgicasa los medicamentos relacionados estrechamente con Lercanidipino Normon (como el amlodipino, nicardipino, felodipino, isradipino, nifedipino olacidipino).

• Si sufrealgunas enfermedades del corazón:

• Untreated heart failure.
• Obstruction of the blood flow out of the heart.
• Unstable angina (angina at rest or that increases progressively).
• During the first month after a myocardial infarction.

• Si usted padeceproblemas graves de los riñones o del hígado.
• Si está tomandomedicamentosthat are inhibitors of the isoenzyme CYP3A4:

• Antimicrobials (such as ketoconazole or itraconazole).
• Macrolide antibiotics (such as erythromycin or troleandomycin).
• Antivirals (such as ritonavir).

• Si está tomando otro fármaco llamado ciclosporina (que se emplea, por ejemplo, después de los trasplantes, para prevenir el rechazo de órganos).
• Si está tomando pomelo o zumo de pomelo.

-if you are pregnant, wish to become pregnant or if you are a woman of childbearing age and not using any form of contraception.

-if you are breastfeeding

Children and adolescents

Lercanidipino Normonmust not be used in children and adolescents under 18 years.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Lercanidipino Normon:

• Si usted padece ciertos problemas cardíacos (enfermedad del nodo sinusal) y no tiene implantado un marcapasos,.
• si tiene angina de pecho, lercanidipino puede producir en raras ocasiones un aumento de la frecuencia de ataques, que pueden ser más prolongados y graves. Se ha notificado infarto de miocardio en casos aislados.
• si tiene problemas de hígado o riñones o si está sometido a diálisis.

Administration of Lercanidipino Normon with other medications

Inform your doctor or pharmacist ifyou are taking, have taken recently or may have to take any other medication.

Taking Lercanidipino Normon with certain medications (see below), may alter the effect of these medications or that of Lercanidipino Normon.

It is essential that your doctor knows if you are being treated with any of the following medications:

• phenytoin or carbamazepine (medication for epilepsy)

-rifampicin (a medication for tuberculosis)

-midazolam (a medication that helps sleep)

-cimetidine, more than 800 mg (a medication for ulcers, indigestion or heartburn)

-digoxin (a medication to treat a heart problem)

-terfenadine or astemizole (medications for allergy)

-amiodarone or quinidine (medications to treat rapid heart rhythm)

-metoprolol (a medication to treat high blood pressure)

-simvastatin (a medication for high cholesterol levels).

Administration of Lercanidipino Normon with food and beverages

• Patientsmust not consume alcoholduring treatment with Lercanidipino Normon, as it may increase the effect of Lercanidipino Normon, and may experience dizziness/dizziness

• Patientsmust not consume grapefruit or grapefruit juice.

Pregnancy and lactation

Do not take this medication if you are pregnant or breastfeeding, or wish to become pregnant or are not using an effective form of contraception.

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

You should exercise caution, due to the possibility of dizziness, weakness and fatigue. Do not drive or operate machinery until you know how you tolerate Lercanidipino Normon.

Lercanidipino Normon contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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

Adults:The usual recommended dose is one 10 mg lercanidipine tablet daily at the same time every day, preferably in the morning,at least 15 minutes before breakfast, because a meal rich in fats significantly increases the levels of the medication in the blood.

If necessary, your doctor may gradually increase your dose to one 20 mg lercanidipine tablet per day.

The tablet should be taken with a sufficient amount of liquid (for example, a glass of water).

Senior citizens:No dosage adjustment is required. However, special care should be taken when starting treatment.

Patients with kidney or liver disease:Special care should be taken when starting treatment in these patients, and a daily dose increase to 20 mg should be done with caution.

Children and adolescents under 18 years:Since the safety and efficacy of lercanidipine have not been established in children and adolescents under 18 years, its use is not recommended in this population group.

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

If you take more Lercanidipino Normon than you should

Do not exceed the prescribed dose.

If you take more than the prescribed dose or in case of overdose, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone (91) 5620420, indicating the medication and the amount you have taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional

A dose higher than recommended can cause blood pressure to drop too low, and heartbeats to become irregular or faster. It can also cause loss of consciousness.

If you forgot to take Lercanidipino Normon

Take the missed dose as soon as you remember. Then, continue the next day as your doctor had indicated.Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Lercanidipino Normon

If you stop taking Lercanidipino Normon, your blood pressure may increase again. Consult your doctor before stopping treatment.

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

Like all medications, this medication may have adverse effects, although not all people may experience them.Some of these adverse effects may be severe.

The following adverse effects have been described, and the frequencies are also defined as follows:

Rare(affect between 1 and 10 of every 10,000 patients):Angina pectoris (chest pain due to a lack of blood in the heart).

Very Rare(affect fewer than 1 of every 10,000 patients):Chest pain, decreased blood pressure, syncope, and allergic reactions (with symptoms that include itching, hives, and urticaria).

If you have pre-existing angina pectoris, you may experience an increase in frequency, duration, or severity of these attacks. Isolated cases of heart attacks have been observed.

Other possible adverse effects:

Infrequent(affect fewer than 1 of every 100 patients): Headache, dizziness, increased heart rate, palpitations (strong or rapid heartbeats), sudden redness of the face, neck, or upper chest, swelling of the ankles.

Rare(affect fewer than 1 of every 1,000 patients): Drowsiness, discomfort, vomiting, heartburn, diarrhea, skin rash, muscle pain, increased urine production, fatigue.

Very Rare(affect fewer than 1 of every 10,000 patients): Swelling of the gums, changes in liver function (detected in blood tests) and increased frequency of urination.

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 theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging (on each blister strip and on the outer carton). The expiration date is the last day of the month indicated after CAD.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines you no longer need at the SIGRE collection pointat the pharmacyIf in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need.This will help protect the environment.

Composition of Lercanidipino Normon

• The active ingredient is lercanidipine hydrochloride. Each film-coated tablet contains 10mg of lercanidipine hydrochloride, equivalent to 9.4mg of lercanidipine
• The other components (excipients) are:

Core:

Maize starch, sodium glycolate starch (type A) (from potato), anhydrous colloidal silica, microcrystalline cellulose, poloxamer 188, sodium esterfumarate, macrogol 6000.

Coating:

Hydroxypropyl methylcellulose, macrogol 6000, yellow iron oxide (E 172), titanium dioxide (E 171).

Appearance of Lercanidipino Normon and content of the container

Lercanidipino Normon is presented in the form of yellow, round, biconvex, film-coated tablets, with a notch on one face and smooth on the other face. The notch serves to break and facilitate swallowing but not to divide into equal doses.

Container of28tablets.

Holder of the marketing authorizationand responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Lercanidipine NORMON 20 mg film-coated tablets EFG

This leaflet was approved in March 2011