LERCANIDIPINE CINFA 10 mg FILM-COATED TABLETS

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 components of this medication (listed in section 6).

• If you have certain heart diseases:

• Obstruction of blood flow from the heart.
• Untreated heart failure.
• Unstable angina (chest pain 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 medications 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 medication called cyclosporine (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 breastfeeding (see section on pregnancy, breastfeeding, and fertility).

Children and Adolescents

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

Other Medications and Lercanidipine Cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This is because when lercanidipine is combined with other medications, the effect of lercanidipine or the other medication may vary, 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 medications:

• phenytoin, phenobarbital, or carbamazepine (medications for treating epilepsy)
• rifampicin (medication for treating tuberculosis)
• astemizole or terfenadine (medications for allergies)
• amiodarone, quinidine, or sotalol (medications for treating heart rhythm disorders)
• midazolam (medication to help 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 to lower blood cholesterol levels)
• other medications for treating high blood pressure

Taking Lercanidipine Cinfa 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 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, 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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and Using Machines

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

Lercanidipine Cinfa Contains Sodium

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

3. How to Take Lercanidipine Cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, 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. Your doctor may advise you to increase the dose to two 10 mg lercanidipine tablets 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 (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 medication should not be used in children and adolescents under 18 years old.

The score line may help you to break the tablet in case 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. Bring the package with you. Taking a dose higher than the correct dose may cause an excessive drop in blood pressure and irregular and faster heartbeats.

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 medication and the amount ingested.

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 the missed doses.

If You Stop Taking Lercanidipine Cinfa

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

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

4. Possible Side Effects

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

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., oppression 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 medications in the same group as lercanidipine. Isolated cases of myocardial infarction may be observed.

Other Possible Side Effects:

Common (may affect up to 1 in 10 people): headache, rapid heartbeat, 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 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 Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lercanidipine Cinfa

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

Do not use this medication after the expiration date stated on the blister pack and carton. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lercanidipine Cinfa

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

Core:

Cornstarch, sodium carboxymethylcellulose (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).

Appearance of the Product and Package Contents

Lercanidipine Cinfais presented in the form of yellow, round (6.5 mm diameter), biconvex, film-coated tablets with a score line on one side and a smooth surface on the other.

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

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

Not all package 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 medication is authorized in the Member States of the European Economic Area with the following names:

Germany: Lercanidipin Heumann 10 mg Filmtabletten

Romania: Lercanidipina Gemax Pharma 10 mg, film-coated tablets

Date of the Last Revision of this Package Leaflet: November 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and carton with your smartphone. You can also access this information at 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