Lercanidipine Recordati 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

LERCANIDIPINE RECORDATI 10 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 as 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 you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 side effects
5. How to store Lercanidipine Recordati
6. Contents of the pack and other information

1. What Lercanidipino 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.

Lercanidipino Recordati 10 mg is used for the treatment of high blood pressure, also known as arterial 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 10 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 blood flow from the heart, uncontrolled heart failure, unstable angina (chest discomfort at rest or progressively worsening), or during the first month after 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 (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin), antivirals (such as 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 10 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 (could become pregnant) or are breastfeeding (see section on pregnancy, breastfeeding and fertility).

Children and adolescents

The safety and efficacy of Lercanidipino Recordati 10 mg have not been established in children under 18 years of age.

Other medicines and Lercanidipino Recordati 10 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 with other medicines may alter the effect of Lercanidipino Recordati or the other medicine, or may increase the frequency of certain adverse effects (see section 2 “Do not take Lercanidipino Recordati 10 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 10 mg with food, drinks and alcohol

• High-fat meals significantly increase the concentration of the medicine in the blood (see section 3).
• Alcohol may enhance the effect of Lercanidipino Recordati 10 mg. Do not consume alcohol during treatment with Lercanidipino Recordati 10 mg.
• Lercanidipino Recordati 10 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 10 mg”).

Pregnancy, breastfeeding and fertility

It is not recommended to take Lercanidipino Recordati 10 mg during pregnancy, and it should not be taken during breastfeeding. There are no data on the use of Lercanidipino Recordati 10 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 use of machines

If you experience dizziness, weakness or drowsiness while taking this medicine, do not drive vehicles or operate machinery.

Lercanidipino Recordati 10 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 10 mg contains potato starch

This medicine contains sodium starch glycolate from potato starch.

Lercanidipino Recordati 10 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 Lercanidipine Recordati

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

If in doubt, 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 Lercanidipine Recordati 20 mg tablet per day if necessary (see section 2 “Taking Lercanidipine Recordati 10 mg with food, drinks and alcohol”).

Lercanidipine Recordati 10 mg: the tablet score is only intended to facilitate tablet splitting and improve ease of swallowing, but not to divide the tablet into two equal doses.

The tablets should be swallowed whole with a little water.

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

Elderly population: no adjustment of the daily dose is required. However, special caution may be needed at the beginning of treatment.

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

If you take more Lercanidipine Recordati than you should

Do not take more than the prescribed dose.

If you have taken more Lercanidipine Recordati 10 mg tablets than you should, or in case of overdose, contact your doctor immediately, go directly to the hospital, or call the Poison Information Service at telephone number (91) 562 04 20, indicating the medicine and the amount taken. Take the packaging with you.

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

If you forget to take Lercanidipine Recordati

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

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

If you stop taking Lercanidipine Recordati

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

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

4. Possible adverse effects

Like all medicines, Lercanidipine Recordati 10 mg may produce adverse effects, although not everyone experiences them. The following adverse effects may occur when taking this medicine:

Some of these adverse effects may be serious.

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

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

Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of these attacks with medicines in the group to which Lercanidipine Recordati 10 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, drop in 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): gum swelling, changes in liver function (detected in blood tests), cloudy fluid (during hemodialysis through a tube placed in 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 System for Pharmacovigilance of Human Medicines: www.notificaRAM.es.

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

5. Storage of Lercanidipine Recordati

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 on 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 should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Recordati 10 mg

• The active substance is lercanidipine hydrochloride. Each coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 9.40 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

Lercanidipine Recordati 10 mg are 6.5 mm, yellow, film-coated, round, biconvex tablets, scored on one side.

Lercanidipine Recordati is available in Spain in packs of 28 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 leaflet: June 2021

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