LERCANIDIPINE MABO 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lercanidipine Mabo 20 mg Film-Coated Tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Lercanidipine Mabo is a selective calcium channel blocker belonging to a class of medicines called dihydropyridines. Calcium channel blockers reduce high blood pressure. They work by relaxing and widening the blood vessels.

Lercanidipine is used to treat high blood pressure, also known as hypertension, in adults and the elderly (over 18 years). It is not recommended for children under 18 years.

2. What you need to know before you take Lercanidipine Mabo

Do not take Lercanidipine Mabo

• If you are allergic (hypersensitive) to lercanidipine or any of the other ingredients of this medicine (listed in section 6).
• If you have had allergic reactions to medicines closely related to Lercanidipine Mabo (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine, or lacidipine).
• If you have heart diseases such as:

• uncontrolled heart failure
• obstruction of the outflow of blood from the heart
• unstable angina (angina at rest or progressively increasing)
• within the first month after having a heart attack.
• If you have severe liver or kidney problems.

• If you are taking medicines that are inhibitors of the CYP3A4 enzyme:

• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin or troleandomycin)
• antivirals (such as ritonavir)
• a medicine called ciclosporin (used after organ transplants to prevent rejection)
• With grapefruit or grapefruit juice.

• If you are pregnant, wish to become pregnant, or are a woman of childbearing age and not using any contraceptive method.

• If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lercanidipine Mabo if:

• you have other heart diseases that have not been treated with a pacemaker.
• you have pre-existing angina.
• you have liver or kidney problems or are undergoing dialysis treatment.

Taking Lercanidipine Mabo with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important that your doctor knows if you are being treated with any of the following medicines:

• phenytoin or carbamazepine (medicines for treating epilepsy)
• rifampicin (a medicine for treating tuberculosis)
• midazolam (a medicine to help you sleep)
• cimetidine, more than 800 mg (a medicine for ulcers, indigestion, or heartburn)
• digoxin (a medicine for heart problems)
• terfenadine or astemizole (medicines for allergies)
• amiodarone or quinidine (medicines for treating irregular heart rhythms)
• beta-blockers, e.g., metoprolol, diuretics, or ACE inhibitors (medicines for high blood pressure)
• simvastatin (a medicine for high cholesterol)

Taking Lercanidipine Mabo with food, drinks, and alcohol

Do not eat grapefruit or drink grapefruit juice while taking this medicine, as it may increase the effect of lercanidipine.

Do not drink alcohol while being treated with lercanidipine, as you may experience dizziness, fainting, tiredness, or weakness. This is because the medicine can significantly lower your blood pressure if you consume alcohol.

Fertility, pregnancy, and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Lercanidipine Mabo should not be used if you are pregnant, wish to become pregnant, or are a woman of childbearing age and not using any contraceptive method.

Lercanidipine Mabo should not be used if you are breastfeeding.

Driving and using machines

Lercanidipine has a negligible influence on the ability to drive or use machines. However, side effects such as dizziness, weakness, tiredness, and rarely somnolence may occur. Do not drive until you know how lercanidipine affects you.

3. How to take Lercanidipine Mabo

Follow exactly the administration instructions of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Swallow the tablets whole with a glass of water, unless your doctor has told you to divide the 20 mg tablets in half into two equal doses. It is preferable to take the medicine in the morning, at least 15 minutes before breakfast.

Adults

The usual dose is one 10 mg tablet per day, taken at least 15 minutes before a meal.

Your doctor may decide to increase the dose to one 20 mg tablet of Lercanidipine Mabo per day if necessary.

Use in children and adolescents

The use of Lercanidipine Mabo is not recommended in children and adolescents under 18 years.

Elderly patients: No dose adjustment is required. However, they may require special care at the start of treatment.

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

If you take more Lercanidipine Mabo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest emergency department, or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medicine and the amount taken).

Exceeding the recommended dose may cause a significant drop in your blood pressure and your heart rate may become irregular or faster. It may also cause loss of consciousness.

If you forget to take Lercanidipine Mabo

If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose, then simply take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Lercanidipine Mabo

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (affect less than 1 in 1000 patients):

Angina pectoris (chest pain due to lack of blood to the heart).

Very rare (affect less than 1 in 10,000 patients):

Chest pain, decreased blood pressure, fainting, and allergic reactions (with symptoms including itching, rash, and hives).

If you have pre-existing angina, with medicines of the same class as lercanidipine, you may experience an increase in frequency, duration, or severity of these attacks. Isolated cases of heart attacks have been observed.

Other possible side effects:

Uncommon(affect less than 1 in 100 patients):headache, dizziness, increased heart rate, palpitations (strong or rapid heartbeats), sudden reddening of the face, neck, or upper chest, swelling of the ankles.

Rare(affect less than 1 in 1,000 patients): somnolence, discomfort, vomiting, heartburn, stomach pain, diarrhea, skin rash, muscle pain, increased urine production, fatigue.

Very rare(affect less than 1 in 10,000 patients): gum swelling, changes in liver function (detected in blood tests), and increased frequency of urination.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lercanidipine Mabo

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

Do not use this medicine after the expiry date which is stated on the packaging and blister after EXP:. The expiry date is the last day of the month stated.

Store below 30°C. Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Mabo 20 mg

• The active substance is lercanidipine hydrochloride. One film-coated tablet contains 20 mg of lercanidipine hydrochloride.
• The other ingredients are:

tablet core: corn starch, sodium carboxymethyl starch (type A) of potato, anhydrous colloidal silica, microcrystalline cellulose (pH113), microcrystalline cellulose (pH 112), povidone (K-30), and sodium stearyl fumarate.

tablet coating: hypromellose, macrogol 6000, red iron oxide (E172), and titanium dioxide (E171).

Appearance of the product and pack contents

Lercanidipine Mabo 20 mg film-coated tablets EFG are pink, round, biconvex tablets, scored on one side and smooth on the other.

Blister packs (Aluminum-PVC/PVdC) of 28 film-coated tablets.

Marketing authorisation holder:

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer:

Netpharmalab Consulting Services

Carretera de Fuencarral 22

Alcobendas 28108. Madrid

Date of last revision of this leaflet: September 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/