Lercanidipino Mabo 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lercanidipine Mabo 10 mg film-coated tablets EFG

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 other people, even if they have the same symptoms as you, because it may 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 Mabo is and what it is used for
2. What you need to know before taking Lercanidipine Mabo
3. How to take Lercanidipine Mabo
4. Possible adverse effects
5. How to store Lercanidipine Mabo
6. Contents of the pack and other information

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

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

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

2. What you need to know before taking Lercanidipine Mabo

Do not take Lercanidipine Mabo

• If you are allergic to lercanidipine or to 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, felodipino, isradipine, nifedipine, or lacidipine).

• If you have heart conditions such as:

  • uncontrolled heart failure
  • obstruction of the heart's outflow tract
  • unstable angina (angina at rest or progressively worsening)
  • during the first month after a myocardial infarction
  • if you have severe liver or kidney problems.

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

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

• If you are pregnant, planning to become pregnant, or if you 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 taking Lercanidipine Mabo if:

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

Taking Lercanidipine Mabo with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 used to treat epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• midazolam (a medicine used to help you sleep)
• cimetidine, more than 800 mg (a medicine used for ulcers, indigestion, or heartburn)
• digoxin (a medicine used to treat a heart condition)
• terfenadine or astemizole (medicines used for allergies)
• amiodarone or quinidine (medicines used to treat heart rhythm disorders)
• beta-blockers e.g. metoprolol, diuretics, or ACE inhibitors (medicines used to treat high blood pressure)
• simvastatin (a medicine used to treat 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 taking lercanidipine, as you may experience dizziness, fainting, tiredness, or weakness. This is because the medicine may significantly lower your blood pressure if alcohol is consumed.

Fertility, pregnancy, and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Lercanidipine Mabo must not be used if you are pregnant, planning to become pregnant, or if you are a woman of childbearing age not using a contraceptive method.

Lercanidipine Mabo must not be used if you are breastfeeding.

Driving and using machines

Lercanidipine has negligible influence on the ability to drive or operate machinery. However, adverse effects such as dizziness, weakness, fatigue, and rarely somnolence may occur. Do not drive until you know how you tolerate lercanidipine.

3. How to take Lercanidipino Mabo

Follow exactly the instructions for using this medicine as given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Swallow the tablets whole with a glass of water. 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 the meal.

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

Use in children and adolescents

Lercanidipino Mabo is not recommended for use in children and adolescents under 18 years of age.

If you take more Lercanidipino Mabo than you should

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

Exceeding the appropriate dosage may cause an excessive drop in your blood pressure and may make your heart rate irregular or faster. Loss of consciousness may also occur.

If you forget to take Lercanidipino Mabo

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

If you stop taking Lercanidipino Mabo

If you stop taking Lercanidipino Mabo, your blood pressure may 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.

Elderly patients

No adjustment of the daily dose is required. However, special care may be needed at the beginning of treatment.

Patients with kidney or liver problems

Special care is required at the beginning of treatment for these patients, and increasing the dose to 20 mg daily should be done with caution.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare (affects less than 1 in 1,000 patients):
angina pectoris (chest pain due to insufficient blood supply to the heart).

Very rare (affects 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 pectoris, treatment with medicines of the class to which Lercanidipine Mabo belongs may lead to an increase in the frequency, duration, or severity of these attacks. Isolated cases of heart attacks have been observed.

Other possible adverse effects:

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

Rare (affects less than 1 in 1,000 patients): drowsiness, malaise, vomiting, heartburn, stomach pain, diarrhea, skin rash, muscle pain, increased frequency of urination, fatigue.

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

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lercanidipino Mabo

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

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your usual pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Mabo 10 mg

• The active substance is lercanidipine hydrochloride. One film-coated tablet contains 10 mg of lercanidipine hydrochloride.
• The other components are:

Tablet core: maize starch, sodium carboxymethyl starch (potato type A), anhydrous colloidal silica, microcrystalline cellulose, poloxamer 188, sodium stearyl fumarate and macrogol 6000.

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

Appearance of the medicinal product and contents of the pack

Lercanidipine Mabo 10 mg film-coated tablets EFG are yellow, round, biconvex, film-coated tablets, scored on one side and smooth on the other.

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

Marketing Authorization 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 the most recent review of this product information: September 2017

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