PATIENT INFORMATION LEAFLET

Lercanidipine Aristo 20 mg Film-Coated Tablets

Lercanidipine Hydrochloride

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

2.Before taking Lercanidipine Aristo

3.How to take Lercanidipine Aristo

4.Possible side effects

5.Storage of Lercanidipine Aristo

6.Further information

Lercanidipino Aristo belongs to a group of medications called calcium channel blockers that prevent calcium from entering 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 Aristo has been prescribed to treat your high blood pressure, also known as hypertension.

Do not take Lercanidipino Aristo

-if you are allergic (hypersensitive) to lercanidipino or any of the other components of Lercanidipino Aristo.

-if you have had allergic reactions to medications that are closely related to Lercanidipino Aristo (such as amlodipino, nicardipino, felodipino, isradipino, nifedipino, or lacidipino).

-if you have certain heart conditions:

-uncontrolled heart failure

-obstruction of blood flow out of the heart

-unstable angina (chest pain at rest or progressively worsening)

-if you have had a heart attack within the past month

-if you have severe liver or kidney problems.

-if you are taking medications that inhibit the CYP3A4 enzyme:

-antifungal medications (such as ketoconazol or itraconazol)

-macrolide antibiotics (such as erythromycin or troleandomycin)

-antivirals (such as ritonavir)

-at the same time as other medications called ciclosporina

-with grapefruit or grapefruit juice

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

-if you are breastfeeding

Be especially careful with Lercanidipino Aristo

You must consult with your doctor before taking Lercanidipino Aristo:

-if you have other heart conditions, or if you have a pacemaker.

-if you have angina, lercanidipino may cause an increase in the frequency of attacks, which may be more prolonged and severe. In rare cases, myocardial infarction has been reported.

-if you have liver or kidney problems, or if you are undergoing dialysis.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

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

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 condition)

-terfenadine or astemizol (medications for allergies)

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

-metoprolol (a medication to treat high blood pressure)

-simvastatin (a medication for elevated cholesterol levels).

Taking Lercanidipino Aristo with food and beverages

You should not eat grapefruit or drink grapefruit juice as it may increase the effect of Lercanidipino Aristo.

If you take alcohol with Lercanidipino Aristo, you may experience dizziness/dizziness, fatigue, or weakness. This is because the medication can lower blood pressure significantly along with alcohol consumption.

Pregnancy and breastfeeding

Consult your doctor before taking this medication.

If you are taking Lercanidipino Aristo and think you may be pregnant, consult your doctor.

Lercanidipino Aristo should not be used if you are pregnant, wish to become pregnant, or are a woman of childbearing age and do not use any form of contraception.

Lercanidipino Aristo should not be used if you are breastfeeding.

Driving and operating machinery

Lercanidipino Aristo does not affect the ability to drive and operate machinery. However, side effects such as dizziness, weakness, fatigue, and rarely somnolence have been observed. You should be cautious until you know how you react to Lercanidipino Aristo.

Important information about some of the components of Lercanidipino Aristo

Lercanidipino Aristo contains lactose monohydrate. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Follow exactly the administration instructions for Lercanidipino Aristo as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

The usual dose of Lercanidipino Aristo is 10 mg per day taken at the same time every day, preferably in the mornings 15 minutes before breakfast, as fatty meals increase the levels of the medication in the blood.

Your doctor will decide if you need to increase your dose to one 20 mg Lercanidipino Aristo tablet per day.

The tablets should be taken preferably whole with half a glass of water. The groove is for splitting and facilitating swallowing but not for dividing into equal doses.

Lercanidipino Aristo is not recommended for use in children and adolescents under 18 years old.

If you take more Lercanidipino Aristo than you should

Contact your doctor, the nearest hospital, or a toxicology center immediately to receive advice.

If you take more than the correct dose, it may cause an excessive drop in blood pressure, and the heart may beat irregularly or more quickly. This may cause loss of consciousness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lercanidipino Aristo

If you forget to take the medication, take it as soon as you remember, unless that dose was very close to the next one. Then continue taking the tablets at the time that corresponds to you.

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

If you interrupt treatment with Lercanidipino Aristo

If you interrupt treatment with Lercanidipino Aristo, your blood pressure may increase again.

Consult with your doctor before stopping treatment.

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

Like all medications, Lercanidipine Aristo may produce adverse effects, although not all people will experience them.

The frequencies of adverse effects have been listed below according to the following definitions:

Very frequent: Affects more than 1 in 10 patients

Frequent: Affects between 1 and 10 in 100 patients

Infrequent: Affects between 1 and 10 in 1,000 patients

Rare: Affects between 1 and 10 in 10,000 patients

Very rare: Affects less than 1 in 10,000 patients

Unknown: Frequency that cannot be estimated from available data

Infrequent:headache, dizziness, rapid heart rate, awareness of heartbeats, flushing (transient episodes of facial and neck redness), swelling of ankles.

Rare:drowsiness, weakness, fatigue, nausea, vomiting, diarrhea, abdominal pain, indigestion, rash, muscle pain, urinating large amounts, chest angina.

Very rare, unknown:hypotension that may cause fainting, allergic reaction, gum swelling, increased liver enzyme values (transaminases) in blood tests, hypotension that may cause dizziness, feeling of empty-headedness or fainting, increased urination frequency, chest pain, and heart attack.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 notification system included in the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. Website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of that medication.

Keep out of the reach and sight of children.

Do not use Lercanidipino Aristo after the expiration date that appears on the label, after CAD. The expiration date is the last day of the month indicated.

Storage conditions: Do not store at a temperature above25ºC. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help to protect the environment..

Composition of Lercanidipino Aristo

• The active ingredient is lercanidipine hydrochloride: Each film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
• The other components are: Tablet core: Magnesium stearate, Povidone, Sodium starch glycolate, Lactose monohydrate, Microcrystalline cellulose; Tablet coating: Partially hydrolyzed polyvinyl alcohol, Titanium dioxide (E171), Macrogol, Talc, Iron oxide yellow (E172)

Appearance of Lercanidipino Aristo and contents of the package

Lercanidipino Aristo 20 mg are film-coated tablets of pink color, round, biconvex, and scored on one side.

Blister:

28 tablets: Lercanidipino Aristo 20 mg film-coated tablets EFG:

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid- Spain

Responsible for Manufacturing

Actavis Ltd

B16 Bulebel Industrial Estate

Zejtun ZTN 08

Malta

Ó

Actavis hf

Reykjavikurvegur 78

220 Hafnarfjördur

Islandia

Ó

Laboratorios de Medicamentos Internacionales, S.A. (MEDINSA)

c/ Solana, 26

28850 – Torrejón de Ardoz, Madrid

Spain

This leaflet was approved in May 2011

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”