PROSPECTO: INFORMATION FOR THE USER

LERCANIDIPINE RECORDATI 20 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 only for you, and you should not give it to others, even if they have the same symptoms, 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 what is it used for

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 (from the dihydropyridines group) that lower blood pressure.

Lercanidipine Recordati 20 mg is used for the treatment of high blood pressure, also known as hypertension in adults aged 18 years and older (not recommended for children under 18 years of age).

Do not take Lercanidipino Recordati 20 mg

-If you are allergic to lercanidipine hydrochloride or to any of the other ingredients 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 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 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 Lercanidipino Recordati 20 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 20 mg have not been demonstrated in children under 18 years.

Other medications and Lercanidipino Recordati 20 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 20 mg with other medications may alter the effect of Lercanidipino Recordati 20 mg or the other medication, or increase the frequency of certain adverse effects (see section 2 “Do not take Lercanidipino Recordati 20 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 20 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 20 mg.Do not consume alcohol during treatment with Lercanidipino Recordati 20 mg.

-Lercanidipino Recordati 20 mg should not be taken with grapefruit or grapefruit juice as it may increase the hypotensive effect. See section 2 “Do not take Lercanidipino Recordati 20 mg”.

Pregnancy, breastfeeding and fertility

It is not recommended to take Lercanidipino Recordati 20 mg if you are pregnant and it should not be taken during breastfeeding. There are no data on the use of Lercanidipino Recordati 20 mg in pregnant women and breastfeeding women. If you are pregnant or breastfeeding, and not using an effective contraceptive method, or if you 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 until you know how it may affect you when taking lercanidipine.

Lercanidipino Recordati 20 mg contains lactose

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

Lercanidipino Recordati 20 mg contains potato starch

This medication contains sodium glycolate of potato starch.

Lercanidipino Recordati 20 mg 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 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 tablet per day, if necessary (see section 2 “Taking Lercanidipino Recordati 20 mg with food, drinks, and alcohol”).

Lercanidipino Recordati 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 need to be especially careful at the start of treatment.

Patients with kidney or liver problems:Special 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 take more Lercanidipino Recordati 20 mg than you should

Do not take more doses than prescribed.

If you have taken more Lercanidipino Recordati 20 mg tablets than you should, consult your doctor immediately, go directly to the hospital, or call the Toxicology 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 an excessive drop in blood pressure and irregular and faster heartbeats.

If you forget to take Lercanidipino Recordati 20 mg

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

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

If you interrupt treatment with Lercanidipino Recordati 20 mg

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

If you have any other questions about the use of this medication, consult 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 tightness due to a 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 whichLercanidipino Recordati 20 mg 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 or 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 affect up to1 in 1,000 patients): drowsiness, vomiting, diarrhea, urticaria, increased urine frequency, chest pain.

Unknown frequency (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 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 in the trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Lercanidipino Recordati 20 mg

• The active ingredient is lercanidipine hydrochloride. Each tablet contains 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.

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

Appearance of the product and content of the packaging

Lercanidipino Recordati 20 mg are film-coated tablets, 8.5 mm in diameter, circular, biconvex, and scored on one side, with a pink color.

Lercanidipino Recordati is available in Spain in packaging of 28 film-coated tablets.

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)

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

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/