PROSPECTO: INFORMATION FOR THE USER

LERCANIDIPINE RECORDATI 10 mg film-coated tablets

lercanidipine hydrochloride

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.See section 4.

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

2.What you need to know before starting to take Lercanidipine Recordati

3.How to take Lercanidipine Recordati

4.Possible adverse effects

5.Storage of Lercanidipine Recordati

6.Contents of the package and additional information

Lercanidipine hydrochloride belongs to a group of medicines called calcium channel blockers (of the dihydropyridines group) that lower blood pressure.

Lercanidipine Recordati 10 mg 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 Lercanidipino Recordati 10 mg

-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 problems.

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

-If you are taking certain medications that inhibithepatic metabolismsuch as: antifungals (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin, troleandomycinor 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 Lercanidipino Recordati 10 mg:

-If you have a heart problem.

-If you have liver or kidney problems.

You must inform your doctor if you think you are pregnant (you may 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 demonstrated in children under 18 years.

Other medications and Lercanidipino Recordati 10 mg

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medication. This is because combining Lercanidipino Recordati with other medications may alter the effect of Lercanidipino Recordati or the other medication or 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 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 Lercanidipino Recordati 10 mg 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 Lercanidipino Recordati 10 mg.Do not consume alcohol during treatment with Lercanidipino Recordati 10 mg.

-Lercanidipino Recordati 10 mgshould not be takenwith 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

Lercanidipino Recordati 10 mg is not recommended for pregnant women and should not be taken during breastfeeding. There are no data on the use of Lercanidipino Recordati 10 mg in pregnant women and breastfeeding women. 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 after taking this medication, do not drive vehicles or operate machinery.

Lercanidipino Recordati 10 mg contains lactose

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

Lercanidipino Recordati 10 mg contains potato starch

This medication contains sodium glycolate of potato starch.

Lercanidipino Recordati 10 mg contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

Adults:

The usual recommended dose is one 10 mg tablet 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 Lercanidipino Recordati tablet per day, if necessary (see section 2 “Taking Lercanidipino Recordati 10 mg with food, drinks, and alcohol”).

Lercanidipino Recordati 10 mg: the groove is only to facilitate the division of the tablet and improve its ingestion,but not to divide it into two 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.

Older population:They do not require a daily dose adjustment. However, they may need to take special care at the beginning of treatment.

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

If you take more Lercanidipino Recordati than you should

Do not take more doses than prescribed.

If you have taken more Lercanidipino Recordati 10 mg tablets than you should or in case of overdose, consult your doctor immediately,go directly to the hospitalor call the Toxicological Information Service, phone (91) 562 04 20 indicating the medication and the amount you have taken. 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 Lercanidipino Recordati

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 compensate for the missed doses.

If you interrupt treatment with Lercanidipino Recordati

If you stop taking lercanidipino, your blood pressure will increase again. Consult your doctor before interrupting treatment.

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

Like all medicines, Lercanidipino Recordati 10 mg 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 to 1 in 1000 patients):angina pectoris (chest tightness 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 medicines in the group to which Lercanidipino Recordati 10 mg belongs. Isolated cases of heart attacks have been observed.

Other possible side effects

Frequent(may affect up to 1 in 10 patients): headache, increased heart rate or palpitations (strong or rapid heartbeats), 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, discomfort, stomach pain, skin rash, itching, muscle pain, increased urine production, weakness or fatigue.

Rare(may affect up to 1 in 1000 patients):sleepiness, vomiting, diarrhea, urticaria, increased urine frequency, chest pain.

Frequency not known (cannot be estimated from available data): gum swelling, 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 breathing or swallowing difficulties.

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. This will help protect the environment.

Composition of Lercanidipino Recordati 10 mg

• The active ingredient 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, povidone K30, magnesium stearate.

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

Appearance of the product and contents of the packaging

Lercanidipino Recordati 10 mg are coated tablets with a 6.5 mm yellow film coating, circular, biconvex, and scored on one of their faces.

Lercanidipino Recordati is available in Spain in packs of 28 coated tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Casen Recordati, S.L., Autovía de Logroño, km. 13,300. 50180 Utebo (Zaragoza)

Responsible manufacturer:

Recordati Industria Chimica e Farmaceutica S.p.A. Via Matteo Civitali, 1. 20148 Milan (Italy)

Last review date of this leaflet: June 2021

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