LERCANIDIPINE PENSA 10 mg FILM-COATED TABLETS

2. What you need to know before taking Lercanidipine Pensa

Do not take Lercanidipine Pensa

• If you are allergic to lercanidipine hydrochloride or any of the other components of this medication (listed in section 6).
• If you have heart diseases such as:
• • obstruction of blood flow from the heart,
  • uncontrolled heart failure,
  • unstable angina pectoris (chest discomfort at rest or progressively increasing),
  • the first month after suffering 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 called cyclosporine or containing cyclosporine (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 this medication:

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

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

Children and adolescents

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

Other medications and Lercanidipine Pensa

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 also section 2 "Do not take Lercanidipine Pensa").

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 Pensa 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 this medication.
• Lercanidipine should not be taken with grapefruit or grapefruit juice, as it may increase the hypotensive effect. See section 2 "Do not take Lercanidipine Pensa".

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 using 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 Pensa contains sodium

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

3. How to take Lercanidipine Pensa

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults

The recommended usual dose is one 10 mg tablet per day, at the same time each day, preferably in the morning and at least 15 minutes before breakfast. Your doctor may increase the dose to lercanidipine 20 mg per day if necessary (see section 2 "Taking Lercanidipine Pensa with food, drinks, and alcohol").

The tablets should be swallowed whole with a little water.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Use in children

This medication should not be used in children under 18 years of age.

Elderly population

No dose adjustment is required. However, they may require special care at the start of treatment.

Patients with kidney or liver problems

Special care is needed when starting treatment in these patients, and an increase in the dose to 20 mg per day should be done with caution.

If you take more Lercanidipine Pensa than you should

Do not take more than the prescribed dose.

If you have taken more tablets of this medication than you should, consult your doctor or go directly to the hospital. Take 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 Pensa

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

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

If you stop taking Lercanidipine Pensa

If you stop taking this medication, your blood pressure will 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 experiences them.

The following side effects may occur when taking this medication:

Some of these side effects can be serious. If you experience any of these side effects, consult your doctor immediately.

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

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

Other possible side effects

Frequent (may affect up to 1 in 10 patients):headache, rapid heartbeat, sensation of rapid or accelerated heartbeats (palpitations), sudden reddening of the face, neck, or upper chest (flushing), swelling of the ankles.

Uncommon (may affect up to 1 in 100 patients):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 patients):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 in blood tests), cloudy liquid (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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the national reporting system: Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/

5. Storage of Lercanidipine Pensa

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

Do not use this medication after the expiration date, which appears on the blister pack and carton after "EXP". The expiration date is the last day of the month indicated.

Lercanidipine Pensa 10 mg film-coated tablets EFG:

Store in the original packaging to protect from light. Do not store above 25 °C.

Lercanidipine Pensa 20 mg film-coated tablets EFG:

Do not store above 25 °C.

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. 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 Pensa

• The active ingredient is lercanidipine hydrochloride. Each film-coated tablet contains 10 mg or 20 mg of lercanidipine hydrochloride.
• The other ingredients (excipients) are:

Lercanidipine Pensa 10 mg film-coated tablets EFG:

• Core of the tablet: Cornstarch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, microcrystalline cellulose, poloxamer, sodium stearyl fumarate, and macrogol.
• Coating material: Hypromellose, macrogol, yellow iron oxide (E172), and titanium dioxide (E171).

Lercanidipine Pensa 20 mg film-coated tablets EFG:

• Core of the tablet: Microcrystalline cellulose, cornstarch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, povidone, and sodium stearyl fumarate.
• Coating material: Hypromellose, macrogol, red iron oxide (E172), and titanium dioxide (E171).

Appearance of the product and package contents

Lercanidipine Pensa 10 mg film-coated tablets EFG

Round, biconvex, yellow film-coated tablets with a score line on one side and a flat surface on the other, approximately 6.5 mm in diameter.

Lercanidipine Pensa 20 mg film-coated tablets EFG

Round, biconvex, pink film-coated tablets with a score line on one side and a flat surface on the other, approximately 8.5 mm in diameter.

Lercanidipine Pensa 10 mg is available in packs of 14, 28, and 56 film-coated tablets.

Lercanidipine Pensa 20 mg is available in packs of 28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Torrent Pharma (Malta) Limited

HHF 028 Hal Far Industrial Estate

Birzebbuga BBG 3000

Malta

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Lercanidipine Pensa 10 mg film-coated tablets EFG

Lercanidipine Pensa 20 mg film-coated tablets EFG

Italy: Lercanidipine hydrochloride Pensa

Portugal: Lercanidipine toLife

Date of the last revision of this leaflet:October 2024

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