Lercanidipine Normon 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lercanidipine Normon 20 mg film-coated tablets EFG

lercanidipine 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 must not be given to other people, even if they have the same symptoms as you, because 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.

Contents of the leaflet:

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 adverse 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 class) that lower blood pressure.

Lercanidipine Normon 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 any of the other ingredients of this medicine (listed in section 6).
• If you have heart conditions such as: obstruction of the outflow of blood from the heart, uncontrolled heart failure, unstable angina (chest discomfort at rest or progressively worsening), or during 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 hepatic metabolism inhibitors such as: antifungal agents (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin), antiviral agents (such as ritonavir).
• If you are taking other medicines containing cyclosporine (used after transplantation to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 (or could become pregnant) or if you 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 medicines. 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 used 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 rhythms)
• 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, if you think you might be pregnant, or if you plan 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; that is, essentially “sodium-free”.

3. How to take Lercanidipine Normon

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults: the usual recommended dose is one 10 mg tablet 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 tablet of lercanidipine 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 population: no adjustment of the daily dose is required. However, special caution may be needed at the beginning of treatment.

Patients with kidney or liver problems: special care is needed at the beginning of treatment in these patients, 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 hospital, or call the Toxicology Information Service at telephone (91) 5620420. Take the packaging 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.

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 forgotten doses.

If you stop taking Lercanidipine Normon

If you stop taking lercanidipine, your blood pressure may 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 angina attacks with medicines in the group to which Lercanidipine Normon belongs. Isolated cases of heart attacks have been observed.

Other possible adverse effects:

Frequent (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, drop in 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 available data): swelling of the gums, changes in liver function (detected in blood tests), cloudy fluid (during peritoneal dialysis), swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help 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 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
• The other components (excipients) are:

Core:

Microcrystalline cellulose, corn starch, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica, povidone K 30 and sodium stearyl fumarate.

Coating:

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

Appearance of Lercanidipine Normon and contents of the pack

Lercanidipine Normon is presented as pink, round, biconvex, film-coated tablets, with a score line on one side and smooth on the other. The score line is intended to facilitate tablet splitting and swallowing, but not for dividing the tablet 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 10 mg film-coated tablets EFG

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