LERCANIDIPINE CINFA 20 mg FILM-COATED TABLETS

2. What you need to know before you take 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 suffer from certain heart diseases:

• Obstruction of blood flow from the heart.
• Untreated heart failure.
• Unstable angina (chest pain at rest or that progressively increases).
• 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:

• 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 cyclosporin (used after transplants to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take lercanidipine cinfa

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

You should inform your doctor if you think you are (or may be) pregnant or are breast-feeding (see section on pregnancy, breast-feeding and fertility).

Children and adolescents

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

Other medicines and lercanidipine cinfa

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because when lercanidipine is combined with other medicines, the effect of lercanidipine or the other medicine may change or the frequency of certain side effects may increase (see section 2 "Do not take lercanidipine cinfa").

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

• phenytoin, phenobarbital or carbamazepine (medicines for treating epilepsy)
• rifampicin (a medicine for treating tuberculosis)
• astemizole or terfenadine (medicines for allergies)
• amiodarone, quinidine or sotalol (medicines for treating heart rhythm disorders)
• midazolam (a medicine to help you sleep)
• digoxin (a medicine for treating heart problems)
• beta-blockers, such as 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 to lower blood cholesterol levels)
• other medicines for treating high blood pressure

Taking lercanidipine cinfa with food, drinks and alcohol

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

Pregnancy, breast-feeding and fertility

It is not recommended to take lercanidipine if you are pregnant and it should not be taken during breast-feeding. There are no data on the use of lercanidipine in pregnant or breast-feeding women. If you are pregnant or breast-feeding, if you are not using an effective contraceptive method, think you may 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 when taking this medicine, do not drive vehicles or use machines.

lercanidipine cinfa contains sodium

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

3. How to take lercanidipine cinfa

Follow exactly the administration instructions of this medicine given 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 each day, preferably in the morning, and at least 15 minutes before breakfast. It is not possible to take the 10 mg dose with the tablets referred to in this leaflet. Your doctor may advise you to increase the dose to one 20 mg lercanidipine tablet per day, if necessary (see section 2 "Taking lercanidipine with food, drinks and alcohol").

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

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

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

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

The score line may help you to break the tablet if you have 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 dose prescribed by your doctor, consult your doctor or go to the hospital directly. Take the pack with you. Taking a dose higher than the correct dose may cause a significant drop in blood pressure and an irregular and faster heart rate.

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

If you forget to take lercanidipine cinfa

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

If you stop taking lercanidipine cinfa

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

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

4. Possible side effects

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

Some side effects can be serious.

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

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

Patients with pre-existing angina may experience an increase in frequency, duration or severity of these attacks with medicines of the group to which lercanidipine belongs. Isolated cases of heart attack may occur.

Other possible side effects:

Common (may affect up to 1 in 10 people): headache, rapid heart rate, sensation of rapid or irregular heartbeats (palpitations), sudden reddening 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, discomfort, stomach pain, skin rash, itching, muscle pain, increased urine production, weakness or fatigue.

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

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing lercanidipine cinfa

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

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date is the last day of the month stated.

Do not store above 25°C.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of lercanidipine cinfa

• The active substance is lercanidipine hydrochloride. One film-coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
• The other ingredients are:

Core:

Microcrystalline cellulose, maize starch, sodium carboxymethyl starch (type A) (potato), colloidal anhydrous silica, povidone K 30, sodium stearyl fumarate.

Coating:

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

Appearance and packaging

lercanidipine cinfais presented in the form of pink, round (diameter 8.5 mm), biconvex, film-coated tablets, with a score line 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, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) – Spain

Manufacturer

Torrent Pharma GmbH

Suedwestpark 50

90449 Nuremberg

Germany

or

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

(only for Germany)

This medicine is authorized in the Member States of the European Economic Areaunder the following names:

Germany: Lercanidipin Heumann 20 mg Filmtabletten

Romania: Lercanidipina Gemax Pharma 20 mg, film-coated tablets

Date of last revision of this leaflet: November 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71634/P_71634.html

QR code to: https://cima.aemps.es/cima/dochtml/p/71634/P_71634.html