PATIENT INFORMATION LEAFLET

Lerzam 10 mg film-coated tablets

Lerzam 20 mg film-coated tablets

lercanidipine hydrochloride

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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to 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 is Lerzam and what it is used for

2.What you need to know before you start taking Lerzam

3.How to take Lerzam

4.Possible side effects

5.Storage of Lerzam

6.Contents of the pack and additional information

Lerzam, lercanidipine hydrochloride, belongs to a group of medications called calcium channel blockers (of the dihydropyridines group) that lower blood pressure.

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

Do not take Lerzam

-If you are allergic to lercanidipine hydrochloride or any of the other components of this medication (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 increasing) and during the first month after suffering a myocardial infarction.

-If you have severe liver disease.

-If you have severe kidney problems or are undergoing dialysis.

-If you are taking certain medications that inhibit hepatic 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 ciclosporina (used after a transplant to prevent organ rejection).

-With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lerzam:

-If you have a heart problem.

-If you have liver or kidney problems.

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

Children and adolescents

The safety and efficacy of Lerzam have not been demonstrated in children under 18 years.

Other medications and Lerzam

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

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

-phenytoin, phenobarbital or carbamazepine (medications for treating epilepsy)

-rifampicin (medication for treating tuberculosis)

-astemizol or terfenadine (medications for allergies)

-amiodarone, quinidine or sotalol (medications for treating arrhythmias)

-midazolam (medication for helping you sleep)

-digoxin (medication for treating heart problems)

-beta-blockers such as metoprolol (a medication for treating high blood pressure, heart failure and abnormal heart rhythm)

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

-simvastatin (a medication for lowering blood cholesterol levels)

-other medications for treating high blood pressure

Taking Lerzam with food, drinks and alcohol

-Fatty meals significantly increase the concentration of the medication in the blood (see section 3).

-Alcohol may increase the effect of Lerzam. Do not consume alcohol during treatment with Lerzam.

-Lerzam should not be taken with grapefruit or grapefruit juiceas it may increase the hypotensive effect. See section 2 “Do not take Lerzam”.

Pregnancy, breastfeeding and fertility

Lerzam is not recommended for pregnant women and should not be taken during breastfeeding. There are no data on the use of Lerzam in pregnant women and during breastfeeding. If you are pregnant or breastfeeding, if you are not using an effective contraceptive method, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

If you experience dizziness, weakness,or numbness when taking this medication,do not drive vehicles or operate machinery.

Lerzam contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Lerzam contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult again your doctor or pharmacist.

Adults: The usual recommended dose is one 10 mg tablet daily at the same time every day, preferably in the mornings and at least 15 minutes before breakfast. Your doctor may increase your dose to one 20 mg tablet daily if necessary (see section 2 “Taking Lerzam with food, drinks, and alcohol”).

Lerzam 10 mg: the groove is only to facilitate the division of the tablet and improve its ingestion , but not to divide the same into two equal doses.

Lerzam 20 mg: the tablet can be divided into equal doses.

The tablets should be taken whole with a little water.

Use in children: : This medication should not be given to children under 18 years old.

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

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

If you take more Lerzam than you should:

Do not take more doses than prescribed.

If you have taken more Lerzam tablets than you should, consult your doctor immediately, go directly to the hospital or call the Toxicology Information Service, phone (91) 562 04 20. Bring the packaging with you.

Taking a dose higher than the correct dose may cause excessive lowering of blood pressure and irregular and faster heartbeats.

If you forget to take Lerzam:

If you forget to take your tablet, do not take the missed dose. Then, continue the next day as your doctor had indicated.

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

If you interrupt treatment with Lerzam:

If you stop taking Lerzam, your blood pressure will 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.

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

Some of these side effects can be serious.

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

Rare(may affect up to1 in 1,000 patients):angina pectoris (chest pain due to lack of blood to the heart),allergic reactions (with symptoms such as itching, hives, and urticaria) and fainting.

Patients with pre-existing angina pectoris may experience an increase in the frequency, duration, or severity of these attackswith medications in the group to which Lerzam belongs. Isolated cases of heart attacks have been observed.

Other possible side effects

Frequent(may affect up to1 in 10 patients):headache, increased heart rate, palpitations (strong or rapid heartbeats), sudden redness of the face, neck, or upper chest, swelling of the ankles.

Occasional(may affect up to 1 in 100patients):dizziness, drop in blood pressure,heartburn, discomfort, stomach pain, skin rash, itching, muscle pain, increased urine output, weakness or fatigue.

Rare(may affectup to1 in 1,000 patients):drowsiness, vomiting, diarrhea, urticaria, increased urine frequency, chest pain.

Unknown frequency(cannot be estimated from available data):swelling of the gums, changes in liver function (detected in blood tests),cloudy liquid (during hemodialysis through a tube inside the abdomen), swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system:Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

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

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

Composition of Lerzam:

• The active ingredient is lercanidipine hydrochloride. Each tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 9.4 mg of lercanidipine) or 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, povidone K30, magnesium stearate.

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

Appearance of the product and contents of the packaging

Lerzam 10 mg are coated tablets with a yellow film, 6.5 mm in diameter, circular, biconvex, and scored on one of their faces.

Lerzam 20 mg are coated tablets with a pink film, 8.5 mm in diameter, circular, biconvex, and scored on one of their faces.

Lerzam 10 mg is available in packaging of 7, 14, 28, 35, 50, 56, 98, 100 tablets. Not all packaging may be marketed.

Lerzam 20 mg is available in packaging of 7, 14, 28, 35, 42, 50, 56, 98, 100 tablets. Not all packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

CASEN RECORDATI, S.L.

Autovía de Logroño, km. 13,300

50180 Utebo (Zaragoza). Spain.

Responsible for manufacturing:

Recordati Industria Chimica e Farmaceutica S.p.A.

Via Matteo Civitali, 1

20148 Milan (Italy)

Last review date of this leaflet: June 2021

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.gob.es/