Leaflet: information for the user

Lercanidipine cinfa 10 mg film-coated tabletsEFG

Read this leaflet carefully before you start taking this medicine, as 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 is lercanidipine cinfa and what is it used for

2.What you need to know before you start taking lercanidipine cinfa

3.How to take lercanidipine cinfa

4.Possible side effects

5.Storage of lercanidipine cinfa

6.Contents of the pack and additional information

Lercanidipinobelongs to a group of medications called calcium channel blockers (dihydropyridine derivatives) that lower blood pressure.

Lercanidipinois used forthe treatment ofhighblood 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 cinfa

• If you are allergic to lercanidipino hydrochloride or any of the other ingredients of this medicine (listed in section 6).

• If you have some heart diseases:

• Obstruction of blood flow out of the heart.
• Untreated heart failure.
• Unstable angina (chest discomfort at rest or that increases progressively).
• During the first month after a heart attack.

• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking medicines that are inhibitors of hepatic metabolism such as:

• Antimycotics (such as ketoconazol or itraconazol).
• Macrolide antibiotics (such as erythromycin, troleandomycin or claritromycin).
• Antivirals (such as ritonavir).

• If you are taking another medicine called ciclosporina (used after transplants, to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take lercanidipino cinfa

• If you have a heart problem.
• If you have liver or kidney problems.

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

Children and adolescents

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

Other medicines and lercanidipino cinfa

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

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

• phenytoin, phenobarbital or carbamazepine (medicines for treating epilepsy)
• rifampicin (medicine for treating tuberculosis)
• astemizol or terfenadine (medicines for allergies)
• amiodarone, quinidine or sotalol (medicines for treating arrhythmias)
• midazolam (medicine for helping you sleep)
• digoxin (medicine for treating heart problems)
• beta-blockers, for example, metoprolol (a medicine for treating high blood pressure, heart failure and abnormal heart rhythm)
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion or heartburn)
• simvastatin (a medicine for lowering blood cholesterol levels)
• other medicines for treating high blood pressure

Taking lercanidipino cinfa with food, drinks and alcohol

• Fatty meals significantly increase the concentration of the medicine in the blood (see section 3).
• Alcohol may increase the effect of lercanidipino. Do not consume alcohol during treatment with lercanidipino.
• Lercanidipino should not be taken with grapefruit or grapefruit juice (as it may increase the hypotensive effect). See section 2 – Do not take lercanidipino cinfa.

Pregnancy, breastfeeding and fertility

Lercanidipino is not recommended if you are pregnant and should not be taken during breastfeeding. There are no data on the use of lercanidipino 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 medicine.

Driving and operating machines

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

Lercanidipino cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 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 recommended dose is 10 mg once a day, at the same time every day, preferably in the morning, and at least 15 minutes before breakfast. Your doctor may advise you to increase the dose to two tablets of lercanidipine 10 mg per day, if necessary (see section 2 “Taking lercanidipine with food, drinks, and alcohol”.

The tablets should be taken whole with a sufficient amount of liquid (for example, a glass of water).

Older adults: No dose adjustment is required. However, special care should be taken when starting treatment.

Patients with kidney or liver problems: Special care should be taken when starting treatment in these patients and a daily dose increase to 20 mg should be done with caution.

Use in children and adolescents: This medication should not be used in children and adolescents under 18 years old.

The groove may help you to split the tablet if you have any difficulty swallowing the whole tablet.

If you take more lercanidipine cinfa than you should

Do not exceed the prescribed dose.

If you take more than the prescribed dose by your doctor, consult your doctor or go to the hospital directly. 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take lercanidipine cinfa

If you forget to take a dose, limit yourself to taking the next tablet as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with lercanidipine cinfa

If you interrupt the administration of lercanidipine, your blood pressure may increase again. Consult your doctor before interrupting treatment.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.The following adverse effects may occur when taking this medication:

Some adverse effects may be severe.

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

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

Patients with pre-existing angina pectoris may experience an increase in the frequency, duration, or severity of these attacks with medications in the group to which lercanidipine belongs. Isolated cases of myocardial infarction may be observed.

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people): headache, rapid heart rate, sensation of rapid or irregular heartbeats (palpitations), sudden redness of the face, neck, or upper chest, swelling of the ankles.

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

Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhea, urticaria, increased urination frequency, chest pain.

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

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products 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 blister pack and on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Store in the original packaging to protect it from light.

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

Composition of lercanidipine cinfa

• - The active ingredient is lercanidipine hydrochloride. A film-coated tablet contains 10mg of lercanidipine hydrochloride, equivalent to 9.4mg of lercanidipine.
• - The other components are:

Core:

Maize starch, carboxymethyl starch sodium (type A) (from potato), colloidal anhydrous silica, microcrystalline cellulose, poloxamer 188, sodium stearoylfumarate, macrogol 6000.

Coating:

Hydroxypropyl methylcellulose, macrogol 6000, yellow iron oxide (E-172), titanium dioxide (E-171).

Appearance of the product and contents of the package

lercanidipine cinfais presented in the form of yellow, round (diameter 6.5 mm), biconvex, film-coated tablets, with a notch on one face and smooth on the other face.

They are presented in PVC-aluminum or PVC/PVDC-aluminum blisters.

Package sizes:28, 30, 50, 60, 98, 100film-coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate.

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Torrent Pharma GmbH

Suedwestpark 50

90449 Nuremberg

Germany

or

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate.

31620 Huarte (Navarra) – Spain

or

MEDIS INTERNATIONAL a.s.

Bolatice Production Plant,

Prumyslová 961/16,

747 23 Bolatice

Czech Republic

or

Torrent Pharma (Malta) Ltd

Central Business Centre, Level 2,

Triq Hal Tarxien, Il-Gudja, GDJ 1907,

Malta

(only for Germany)

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Lercanidipin Heumann 10 mg Filmtabletten

Romania:Lercanidipina Gemax Pharma10 mg, film-coated tablets

Last revision date of this leaflet: November 2020

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

You can access detailed and updated information on this medicinal product by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/71633/P_71633.html

QR code to:https://cima.aemps.es/cima/dochtml/p/71633/P_71633.html