Lercanidipine Normon 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lercanidipine Normon 10 mg film-coated tablets EFG

lercanidipine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, since it may 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 Lercanidipine Normon is and what it is used for
2. What you need to know before taking Lercanidipine Normon
3. How to take Lercanidipine Normon
4. Possible side effects
5. How to store Lercanidipine Normon
6. Contents of the pack and other information

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

Lercanidipine Normon belongs to a group of medicines called calcium channel blockers (dihydropyridine group), which 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 taking Lercanidipine Normon

Do not take Lercanidipine Normon

• 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 conditions such as: obstruction of blood flow out of the heart, uncontrolled heart failure, unstable angina (chest discomfort at rest or progressively worsening), or during 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: antifungal agents (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin, troleandomycin, or
• If you are taking other medications containing cyclosporine (used after organ transplant to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Lercanidipine Normon:

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

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

Children and adolescents

The safety and efficacy of Lercanidipine Normon have not been established in children under 18 years of age.

Other medicines and Lercanidipine Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is because when Lercanidipine Normon is combined with other medicines, the effect of Lercanidipine Normon or the other medicine may change, or the frequency of certain adverse effects may increase (see section 2 “Do not take Lercanidipine Normon”).

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 (medicines used for allergies)

• amiodarone, quinidine, or sotalol (medicines used to treat heart rhythm disorders)

• midazolam (a medicine to help you sleep)

• digoxin (a medicine used to treat heart problems)

• beta-blockers such as metoprolol (a medicine 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 Normon 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 Normon. Do not consume alcohol during treatment with Lercanidipine Normon.

• Lercanidipine Normon must not be taken with grapefruit or grapefruit juice, as it may increase the hypotensive effect. See section 2 “Do not take Lercanidipine Normon”).

Pregnancy, breastfeeding, and fertility

It is not recommended to take Lercanidipine Normon if you are pregnant, and it should not be taken during breastfeeding. There are no data on the use of Lercanidipine Normon 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 intend to become pregnant, consult your doctor or pharmacist before taking this medicine.

.

Driving and using machines

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

Lercanidipine Normon 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 Normon

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 lercanidipine 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 one 20 mg lercanidipine tablet daily, if necessary (see section 2 “Taking Lercanidipine Normon with food, drinks and alcohol”).

The tablet should be taken with a sufficient amount of liquid (for example, a glass of water).

Elderly patients: no adjustment of the daily dose is required. However, special care may be needed at the start of treatment.

Patients with kidney or liver disease: special care is required at the start of treatment, and increasing the dose to 20 mg daily should be done with caution.

Use in children: This medicine must not be given to children under 18 years of age.

If you take more Lercanidipine Normon than you should

Do not take more than the prescribed dose.

If you have taken more lercanidipine tablets than you should, contact your doctor immediately, go directly to the hospital, or call the Toxicology Information Service at telephone (91) 5620420. Take the container with you.

Taking a higher dose than recommended may cause an excessive drop in blood pressure and cause your heartbeat to become irregular and faster.

If you forget to take Lercanidipine Normon

If you forget to take your tablet, do not take the missed dose. Instead, continue the next day as directed by your doctor. Do not take a double dose to make up for the missed dose.

If you stop taking Lercanidipine Normon

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur when taking this medicine:

Some of these adverse effects can be serious.

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

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

Patients with pre-existing angina may experience an increase in frequency, duration, or severity of these attacks with medicines in the class to which Lercanidipine Normon 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 or palpitations (strong or rapid heartbeat), sudden redness of the face, neck, or upper chest, 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 urine output, weakness or fatigue.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lercanidipine Normon

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging (on each blister strip and on the outer carton). The expiry date refers to the last day of the month indicated after EXP.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Normon

• The active substance is lercanidipine hydrochloride. Each film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
• The other components (excipients) are:

Core:

Maize starch, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica, microcrystalline cellulose, poloxamer 188, sodium stearyl fumarate and macrogol 6000.

Coating:

Hypromellose, macrogol 6000, yellow iron oxide (E 172) and titanium dioxide (E 171).

Appearance of Lercanidipine Normon and contents of the pack

Lercanidipine Normon is available as yellow, round, biconvex, film-coated tablets, with a score line on one side and smooth on the other. The score line is intended to facilitate breaking the tablet for ease of swallowing and not to divide it into equal doses.

Pack of 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Lercanidipine Normon 20 mg film-coated tablets EFG

Date of the most recent revision of this leaflet: July 2025.

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