Lercanidipine Recordati 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

LERCANIDIPINE RECORDATI 20 mg film-coated tablets EFG

lercanidipine hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the leaflet

1. What Lercanidipine Recordati is and what it is used for
2. What you need to know before taking Lercanidipine Recordati
3. How to take Lercanidipine Recordati
4. Possible adverse effects
5. How to store Lercanidipine Recordati
6. Contents of the pack and other information

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

Lercanidipine hydrochloride belongs to a group of medicines called calcium channel blockers (dihydropyridine group) that lower blood pressure.

Lercanidipine Recordati 20 mg is used for the treatment of high blood pressure, also known as hypertension, in adults over 18 years of age (it is not recommended for children under 18 years of age).

2. What you need to know before taking Lercanidipino Recordati

Do not take Lercanidipino Recordati 20 mg

• If you are allergic to lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart conditions such as: obstruction of the outflow of blood from the heart, uncontrolled heart failure, unstable angina (chest discomfort at rest or progressively worsening), or during the first month after suffering a myocardial infarction.
• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking certain medications that inhibit liver metabolism such as: antifungals (e.g., ketoconazole or itraconazole), macrolide antibiotics (e.g., erythromycin, troleandomycin, or clarithromycin), antivirals (e.g., ritonavir).
• If you are taking other medications containing cyclosporine (used after organ transplantation to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions

Talk to your doctor or pharmacist before starting Lercanidipino Recordati 20 mg:

• If you have a heart condition.
• If you have liver or kidney problems.

You must inform your doctor if you think you are pregnant (or could become pregnant) or if you are breastfeeding (see section on pregnancy, breastfeeding, and fertility).

Children and adolescents

The safety and efficacy of Lercanidipino Recordati 20 mg have not been established in children under 18 years of age.

Other medicines and Lercanidipino Recordati 20 mg

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because combining Lercanidipino Recordati 20 mg with other medicines may alter the effect of Lercanidipino Recordati 20 mg or the other medicine, or may increase the frequency of certain adverse effects (see section 2 “Do not take Lercanidipino Recordati 20 mg”).

Specifically, inform your doctor or pharmacist if you are taking any of the following medicines:

• phenytoin, phenobarbital, or carbamazepine (medicines used to treat epilepsy)

• rifampicin (a medicine used to treat tuberculosis)

• astemizole or terfenadine (medicines used for allergies)

• amiodarone, quinidine, or sotalol (medicines used to treat heart rhythm disorders)

• midazolam (a medicine to help you sleep)

• digoxin (a medicine used to treat heart problems)

• beta-blockers such as metoprolol (a medicine used to treat high blood pressure, heart failure, and abnormal heart rhythm)

  • • cimetidine (more than 800 mg, a medicine used for ulcers, indigestion, or heartburn)
  • • simvastatin (a medicine used to lower blood cholesterol levels)

• other medicines used to treat high blood pressure

Taking Lercanidipino Recordati 20 mg with food, beverages, and alcohol

• High-fat meals considerably increase the concentration of the medicine in the blood (see section 3).
• Alcohol may enhance the effect of Lercanidipino Recordati 20 mg. Do not consume alcohol during treatment with Lercanidipino Recordati 20 mg.
• Lercanidipino Recordati 20 mg must not be taken with grapefruit or grapefruit juice, as it may increase the hypotensive effect. See section 2 “Do not take Lercanidipino Recordati 20 mg”.

Pregnancy, breastfeeding, and fertility

It is not recommended to take Lercanidipino Recordati 20 mg if you are pregnant, and it should not be taken during breastfeeding. There are no data on the use of Lercanidipino Recordati 20 mg in pregnant or breastfeeding women. If you are pregnant or breastfeeding, if you are not using an effective contraceptive method, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

If you experience dizziness, weakness, or drowsiness while taking this medicine, do not drive or operate machinery until you know how lercanidipine affects you.

Lercanidipino Recordati 20 mg contains lactose

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

Lercanidipino Recordati 20 mg contains potato starch

This medicine contains sodium starch glycolate from potato starch.

Lercanidipino Recordati 20 mg contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; therefore, it is essentially “sodium-free”.

3. How to take Lercanidipino Recordati

Follow exactly the instructions for administration of this medicine as given by your doctor.

If you are unsure, consult your doctor or pharmacist again.

Adults:

The usual recommended dose is one 10 mg tablet taken at the same time each day, preferably in the morning and at least 15 minutes before breakfast. Your doctor may increase your dose to one 20 mg tablet per day if necessary (see section 2 "Taking Lercanidipino Recordati 20 mg with food, drinks and alcohol").

Lercanidipino Recordati 20 mg: the tablet may be divided into equal doses.

The tablets should be swallowed whole with a little water.

Use in children: This medicine should not be given to children under 18 years of age.

Elderly population: Daily dose adjustment is not required. However, special care may be needed when starting treatment.

Patients with kidney or liver problems: Special care is needed when starting treatment in these patients, and increasing the dose to 20 mg daily should be done with caution.

If you take more Lercanidipino Recordati 20 mg than you should

Do not take more than the prescribed dose.

If you have taken more tablets of Lercanidipino Recordati 20 mg than you should, contact your doctor immediately, go directly to the hospital, or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medicine and the amount taken. Take the packaging with you.

Taking a higher dose than the correct one may cause an excessive drop in blood pressure and make your heartbeat irregular and faster.

If you forget to take Lercanidipino Recordati 20 mg

If you forget to take your tablet, do not take the missed dose. Instead, continue the following day as directed by your doctor.

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

If you stop taking Lercanidipino Recordati 20 mg

If you stop taking Lercanidipino, your blood pressure will rise again. Consult your doctor before stopping treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur when taking this medicine:

Some of these adverse effects can be serious.

If you experience any of these adverse effects, consult your doctor.

Rare (may affect up to 1 in 1,000 patients): angina (chest tightness due to insufficient blood flow to the heart), allergic reactions (with symptoms such as itching, rash, and urticaria), and fainting.

Patients with pre-existing angina may experience an increase in frequency, duration, or severity of angina attacks when taking medicines of the class to which Lercanidipino Recordati 20 mg belongs. Isolated cases of heart attacks have been observed.

Other possible adverse effects

Common (may affect up to 1 in 10 patients): headache, increased heart rate or palpitations (strong or rapid heartbeat), sudden redness of the face, neck, or upper chest, swelling of the ankles.

Uncommon (may affect up to 1 in 100 patients): dizziness, low blood pressure, heartburn, malaise, stomach pain, skin rash, itching, muscle pain, increased amount of urine, weakness or fatigue.

Rare (may affect up to 1 in 1,000 patients): somnolence, vomiting, diarrhea, urticaria, increased frequency of urination, chest pain.

Frequency not known (cannot be estimated from available data): swelling of the gums, changes in liver function (detected in blood tests), cloudy fluid (when undergoing peritoneal dialysis through a tube inside the abdomen), swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.

Reporting of 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 leaflet. You may also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lercanidipine Recordati 20 mg Film-coated Tablets

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

Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect the medicine from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipino Recordati 20 mg

• The active substance is lercanidipine hydrochloride. Each tablet contains 20 mg of lercanidipine hydrochloride (equivalent to 18.8 mg of lercanidipine).

• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate from potato, povidone K30, magnesium stearate.

Coating: hypromellose, talc, titanium dioxide (E171), macrogol 6000, iron oxide (E172).

Appearance of the product and contents of the pack

Lercanidipino Recordati 20 mg are 8.5 mm pink, round, biconvex, film-coated tablets, scored on one side.

Lercanidipino Recordati is available in Spain in packs containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Casen Recordati, S.L., Autovía de Logroño, km. 13,300. 50180 Utebo (Zaragoza)

Manufacturer:

Recordati Industria Chimica e Farmaceutica S.p.A. Via Matteo Civitali, 1. 20148 Milan (Italy).

Date of the most recent revision of this package leaflet: June 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/