Leaflet: information for the user

Lercanidipine Mabo 10 mg film-coated tablets

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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 side effects

5. Storage of Lercanidipine Mabo

6. Contents of the pack and additional information

Lercanidipino Mabo is a selective calcium channel blocker that belongs to a group of medications known as dihydropyridines. Calcium channel blockers reduce high blood pressure. They work by relaxing and widening blood vessels.

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

Do not take Lercanidipino Mabo

• If you are allergic to lercanidipino or any of the other components of this medication (listed in section 6).
• If you have had allergic reactions to medications closely related to Lercanidipino Mabo (such as amlodipino, nicardipino, felodipino, isradipino, nifedipino, or lacidipino).
• If you have heart conditions such as:

- uncontrolled heart failure

- obstruction of the heart's outflow

- unstable angina (angina at rest or progressively increasing)

- during the first month after having a myocardial infarction

• If you have severe liver or kidney problems.

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

- antifungal medications (such as ketoconazol or itraconazol)

- macrolide antibiotics (such as erythromycin or troleandomycin)

- antivirals (such as ritonavir)

- a medication called ciclosporina (used after organ transplants to prevent rejection)

• With grapefruit or grapefruit juice.

• If you are pregnant, wish to become pregnant, or if you are a fertile woman and do not use any form of contraception.

• If you are breastfeeding.

Warning and precautions

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

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

Taking Lercanidipino Mabo with other medications

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

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

- phenytoin or carbamazepine (medications for treating epilepsy)

- rifampicin (medication for treating tuberculosis)

- midazolam (medication to help you sleep)

- cimetidine, more than 800mg (medication for ulcers, indigestion, or heartburn)

- digoxin (medication for treating a heart condition)

- terfenadine or astemizol (medications for allergies)

- amiodarone or quinidine (medications for treating arrhythmias)

- beta-blockers, e.g. metoprolol, diuretics, or ACE inhibitors (medications for treating high blood pressure)

- simvastatin (medication for treating high cholesterol)

Taking Lercanidipino Mabo with food, drinks, and alcohol

Do not eat grapefruit or take grapefruit juice while taking this medication, as it may increase the effect of lercanidipino.

Do not consume alcohol while taking lercanidipino, as it may cause dizziness, fainting, fatigue, or weakness. This is because the medication can significantly lower your blood pressure if you consume alcohol.

Fertility, pregnancy, and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

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

Lercanidipino Mabo should not be used if you are breastfeeding.

Driving and operating machinery

Lercanidipino has a negligible effect on the ability to drive or operate machinery. However, side effects such as dizziness, weakness, fatigue, and rarely somnolence may occur. Do not drive until you know how you tolerate lercanidipino.

Follow exactly the administration instructions for this medication as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

Swallow the whole tablets with a glass of water. It is recommended to take the medication 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

Lercanidipine Mabo is not recommended for use in children and adolescents under 18 years old.

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 service or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

Exceeding the recommended dose may cause excessive lowering of your blood pressure and irregular or faster heart rhythm. It may also cause loss of consciousness.

If you forget to take Lercanidipine Mabo

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

If you interrupt treatment with Lercanidipine Mabo

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

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

Senior patients

No dose adjustment is required. However, they may need to be extra careful at the start of treatment.

Patients with kidney or liver problems

Care is needed at the start of treatment in these patients and an increase in dose to 20 mg per day should be done with caution.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Rare (affect less than 1 in 1,000 patients):

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

Very rare (affect less than 1 in 10,000 patients):Chest pain, decreased blood pressure, syncope, and allergic reactions (with symptoms that include itching, hives, and urticaria).

If you have pre-existing angina pectoris, with the medications in the group to which Lercanidipino Mabo belongs, you mayexperience an increase in frequency, duration, or severity of these attacks. Isolated casesof heart attacks have been observed.

Other possible adverse effects:

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

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

Very rare(affect 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister after CAD:. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lercanidipino Mabo 10 mg

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

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

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

Appearance of the product and contents of the packaging

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

Blister packaging (Aluminum-PVC/PVdC) with 28 film-coated tablets.

Marketing Authorization Holder:

MABO-FARMA, S.A.

Vía de los Poblados, 3, Building 6

28033 Madrid,

Spain.

Responsible for manufacturing:

Netpharmalab Consulting Services

Fuencarral Road 22

Alcobendas 28108. Madrid

Last review date of this prospectus: September 2017

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/