Lercanidipino Pensa 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lercanidipino pensa 10 mg film-coated tablets EFG

Lercanidipino pensa 20 mg film-coated tablets EFG

lercadinipine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because 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 you should not give it to others, even if they have the same symptoms as you, because it could 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 Lercanidipino pensa is and what it is used for
2. What you need to know before taking Lercanidipino pensa
3. How to take Lercanidipino pensa
4. Possible side effects
5. How to store Lercanidipino pensa
6. Contents of the pack and other information

1. What Lercanidipine Pensa is and what it is used for

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

Lercanidipine is used for the treatment of high blood pressure, also known as arterial 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 starting to take Lercanidipine pensa

Do not take Lercanidipine pensa

• If you are allergic to lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart diseases such as:
  • obstruction of the blood outflow from the heart,
  • uncontrolled heart failure,
  • unstable angina (chest discomfort at rest or progressively worsening),
  • within the first month after having suffered 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 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 other medicines called cyclosporine or containing cyclosporine (used after organ 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 condition.
• If you have liver or kidney problems.

You must inform your doctor if you think you are pregnant (you 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 established in children under 18 years of age.

Other medicines and Lercanidipine pensa

Inform 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 also section 2 “Do not take Lercanidipine pensa”).

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 (antihistamines used to treat allergies)
• amiodarone, quinidine, or sotalol (medicines used to treat heart rhythm disorders)
• midazolam (a medicine used to help you sleep)
• digoxin (a medicine used to treat heart problems)
• beta-blockers such as metoprolol (medicines 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 Pensa 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 this medicine.
• Lercanidipine Pensa must 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

Lercanidipine is not recommended if you are pregnant and 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 method of contraception, if you suspect you may be pregnant, or if you intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

Lercanidipine tablets contain sodium

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

3. How to take Lercanidipine pensa

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

The tablets should preferably be swallowed whole with a small amount of water.

The tablet score mark is intended solely for dividing the tablet if you have difficulty swallowing it whole.

Use in children

This medicine must not be used in children under 18 years of age.

Elderly population

A daily dose adjustment is not required. However, special care may be needed when starting treatment.

Patients with kidney or liver problems

Special care is needed when starting treatment in these patients, and increasing the dose to 20 mg daily should be done with caution.

If you take more Lercanidipine Pensa than you should

Do not take a higher dose than prescribed.

If you have taken more tablets of this medicine than you should, consult your doctor or go immediately to the hospital. Take the package with you.

Taking a higher dose than the correct one may cause an excessive drop in 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 Lercanidipine pensa

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

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

If you stop treatment with Lercanidipine pensa

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

The following adverse effects may occur when taking this medicine:

Some of these adverse effects may be serious. If you experience any of these adverse effects, contact your doctor immediately.

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

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

Other possible adverse effects

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

Uncommon (may affect up to 1 in 100 patients): 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 patients): somnolence, vomiting, diarrhea, urticaria, increased frequency of urination, chest pain.

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Lercanidipine pensa

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 the carton after “EXP”. The expiry date refers to 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.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Lercanidipino pensa

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

Lercanidipino pensa 10 mg film-coated tablets EFG:

• Tablet core: Corn starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, microcrystalline cellulose, poloxamer, stearoyl fumarate and sodium, polyethylene glycol.
• Coating material: Hypromellose, polyethylene glycol, yellow iron oxide (E172) and titanium dioxide (E171).

Lercanidipino pensa 20 mg film-coated tablets EFG:

• Tablet core: Microcrystalline cellulose, corn starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, povidone, stearoyl fumarate and sodium.
• Coating material: Hypromellose, polyethylene glycol, red iron oxide (E172) and titanium dioxide (E171).

Appearance of the product and contents of the pack

Lercanidipino pensa 10 mg film-coated tablets EFG

Film-coated, round, biconvex tablets, yellow in colour, with a breakline on one side and flat on the other, approximately 6.5 mm in diameter.

Lercanidipino pensa 20 mg film-coated tablets EFG

Film-coated, round, biconvex tablets, pink in colour, with a breakline on one side and flat on the other, approximately 8.5 mm in diameter.

Lercanidipino pensa 10 mg is available in packs containing 14, 28 and 56 film-coated tablets.

Lercanidipino pensa 20 mg is available in packs containing 28 film-coated tablets.

Some pack sizes may not 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 medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Lercanidipino pensa 10 mg film-coated tablets EFG
Lercanidipino pensa 20 mg film-coated tablets EFG

Italy: Lercanidipina cloridrato Pensa

Portugal: Lercanidipina toLife

Date of the most recent review of this leaflet: October 2024

Detailed 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/