LERCANIDIPINE PENSA 20 mg FILM-COATED TABLETS

2. What you need to know before you take Lercanidipine Pensa

Do not take Lercanidipine Pensa

• If you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from heart diseases such as:
• • obstruction of blood flow from the heart,
  • uncontrolled heart failure,
  • unstable angina pectoris (chest pain at rest or progressively increasing),
  • the first month after suffering a heart attack.
• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking certain medicines 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 medicines called cyclosporin or containing cyclosporin (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 medicine:

• 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 old.

Other medicines and Lercanidipine Pensa

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 also section 2 “Do not take Lercanidipine Pensa”).

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 (medicine for treating tuberculosis)
• astemizole or terfenadine (medicines for allergies)
• amiodarone, quinidine, or sotalol (medicines for treating heart rhythm disorders)
• midazolam (medicine to help you sleep)
• digoxin (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 Pensa 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 this medicine.
• 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 medicine.

Driving and using machines

If you suffer from dizziness, weakness, or numbness when taking this medicine, do not drive vehicles or use machines.

Lercanidipine Pensa contains sodium

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

3. How to take Lercanidipine Pensa

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

The usual recommended dose is one 10 mg tablet daily 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 be swallowed preferably whole with a little water.

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

Use in children

This medicine should not be used in children under 18 years old.

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 dose to 20 mg daily 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 medicine than you should, consult your doctor or go directly to the hospital. Take the pack with you.

Taking a higher dose than the correct dose may cause a significant 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, telephone 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 forgotten dose, and then continue the next day as your doctor indicated.

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

If you stop taking Lercanidipine Pensa

If you stop taking this medicine, your blood pressure will increase again. Consult your doctor before stopping treatment.

If you have any other questions about 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 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 pressure due to lack of blood in your 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 medicines of the group to which lercanidipine belongs. Isolated cases of heart attacks have been observed.

Other possible side effects

Common (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 urination, 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 the available data):gum swelling, changes in liver function (detected in 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 through the national reporting system: Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/. By reporting side effects, 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 carton after “EXP”. The expiry date is the last day of the month stated.

Lercanidipine Pensa 10 mg film-coated tablets EFG:

Store in the original package 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Pensa

• The active substance 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 contents of the pack

Lercanidipine Pensa 10 mg film-coated tablets EFG

Yellow, biconvex, film-coated tablets with a score line on one side and a diameter of approximately 6.5 mm.

Lercanidipine Pensa 20 mg film-coated tablets EFG

Pink, biconvex, film-coated tablets with a score line on one side and a diameter of approximately 8.5 mm.

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 Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicine is authorised 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: Lercanidipina cloridrato Pensa

Portugal: Lercanidipina toLife

Date of last revision of this leaflet:October 2024

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