Lercanidipino Cinfa 10 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

lercanidipine cinfa 10 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What lercanidipine cinfa is and what it is used for
2. What you need to know before taking lercanidipine cinfa
3. How to take lercanidipine cinfa
4. Possible adverse effects
5. How to store lercanidipine cinfa
6. Contents of the pack and other information

1. What lercanidipine cinfa is and what it is used for

Lercanidipine belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives) that lower blood pressure.

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

2. What you need to know before taking lercanidipine cinfa

Do not take lercanidipine cinfa

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

• If you have certain heart conditions:

• Obstruction of the outflow of blood from the heart.

• Untreated heart failure.

• Unstable angina (chest discomfort at rest or worsening 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 liver 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 another medicine called cyclosporine (used after organ transplants to prevent organ rejection).

• With grapefruit or grapefruit juice.

Warnings and precautions

Talk to your doctor or pharmacist before taking lercanidipine cinfa

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

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

Children and adolescents

The safety and efficacy of lercanidipine cinfa have not been established in children under 18 years of age.

Other medicines and lercanidipine cinfa

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

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

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

Taking lercanidipine cinfa with food, drinks and alcohol

• High-fat meals considerably increase the concentration of the medicine in the blood (see section 3).
• Alcohol may enhance the effect of lercanidipine. Do not consume alcohol during treatment with lercanidipine.
• Lercanidipine must not be taken with grapefruit or grapefruit juice (as it may increase the hypotensive effect). See section 2 – Do not take lercanidipine cinfa.

Pregnancy, breastfeeding and fertility

It is not recommended to take lercanidipine if you are pregnant and it should not be taken during breastfeeding. There are no data on the use of lercanidipine in pregnant or breastfeeding women. If you are pregnant or breastfeeding, if you are not using an effective contraceptive method, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

If you experience dizziness, weakness or numbness while taking this medicine, do not drive or operate machinery.

lercanidipine cinfa contains sodium

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

3. How to take lercanidipino cinfa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults: The recommended dose is 10 mg once daily, at the same time each day, preferably in the morning, and at least 15 minutes before breakfast. Your doctor may advise increasing the dose to two tablets daily of lercanidipine 10 mg, if necessary (see section 2 “Taking lercanidipino with food, drinks and alcohol”).

The tablets should be swallowed whole with a sufficient amount of liquid (e.g., a glass of water).

Elderly patients: No adjustment of the daily dose is required. However, special care should be taken when starting treatment.

Patients with kidney or liver problems: Special care is needed when starting treatment in these patients, and increasing the daily dose to 20 mg should be done cautiously.

Use in children and adolescents: This medicine must not be used in children and adolescents under 18 years of age.

The tablet scoring may help you split the tablet if you have difficulty swallowing the tablet whole.

If you take more lercanidipino cinfa than you should

Do not exceed the prescribed dose.

If you take more than the prescribed dose, consult your doctor or go directly to the hospital. Take the container with you. Taking a higher dose than correct may cause excessive lowering of blood pressure and make your heartbeat irregular and faster.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take lercanidipino cinfa

If you forget to take a dose, simply take the next tablet as usual. Do not take a double dose to make up for forgotten doses.

If you stop taking lercanidipino cinfa

If you stop taking lercanidipino, your blood pressure may rise again. Consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The following adverse effects may occur when taking this medicine:

Some adverse effects may be serious.

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 reduced blood flow to the heart), allergic reactions (with symptoms such as itching, rash, urticaria), and fainting.

Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of these attacks with medicines in the class 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 heartbeat, sensation of fast or irregular heartbeats (palpitations), sudden redness of the face, neck, or upper chest, swelling of the ankles.

Uncommon (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn, malaise, stomach pain, skin rash, itching, muscle pain, increased amount of urine, weakness or fatigue.

Rare (may affect up to 1 in 1,000 people): somnolence, vomiting, diarrhoea, urticaria, increased urinary frequency, chest pain.

Frequency not known (cannot be estimated from available data): swelling of the gums, changes in liver function (detected by blood tests), cloudy fluid (when undergoing peritoneal dialysis through a tube in the abdomen), swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of lercanidipine cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and outer packaging. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of lercanidipino cinfa

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

Core:

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

Coating:

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

Nature of the product and contents of the pack

lercanidipino cinfa is presented as yellow, round (6.5 mm diameter), biconvex, film-coated tablets with a score on one side and smooth on the other.

The tablets are presented in PVC-aluminum or PVC/PVDC-aluminum blisters.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) – Spain

or

MEDIS INTERNATIONAL a.s.

Výrobní závod Bolatice,

Prumyslová 961/16,

747 23 Bolatice

Czech Republic

or

Torrent Pharma (Malta) Ltd

HHF 028 Hal Far Industrial Estate

Birzebbuga BBG 3000 Malta

(for Germany only)

or

Dr. Max Pharma s.r.o.

Na Florenci 2116/15

Nové Mesto

110 00 Prague 1

Czech Republic

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

Germany: Lercanidipin Heumann 10 mg Filmtabletten

Romania: Lercanidipina Gemax Pharma 10 mg, comprimate filmate

Date of the latest revision of this leaflet: November 2020

Information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Detailed and up-to-date information on this medicinal product can be accessed by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71633/P_71633.html

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