LERCANIDIPINE NORMON 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lercanidipine Normon 20 mg Film-Coated Tablets EFG

lercanidipine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Lercanidipine Normon and what is it used for
2. What you need to know before you take Lercanidipine Normon
3. How to take Lercanidipine Normon
4. Possible side effects
5. Storage of Lercanidipine Normon
6. Contents of the pack and other information

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

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

Lercanidipine Normon is used to treat high blood pressure, also known as arterial hypertension in adults over 18 years old (it is not recommended for children under 18 years old).

2. What you need to know before you take 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 diseases such as: obstruction of blood flow from the heart, uncontrolled heart failure, unstable angina (chest pain at rest or progressively increasing) and during 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 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 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 Lercanidipine Normon:

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

You should inform your doctor if you think you are pregnant (or might become pregnant) or are breast-feeding (see section on pregnancy, breast-feeding and fertility).

Children and adolescents

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

Other medicines and Lercanidipine Normon

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

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 for lowering blood cholesterol levels)
• other medicines for treating high blood pressure

Taking Lercanidipine Normon 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 Normon. Do not consume alcohol during treatment with Lercanidipine Normon.
• Lercanidipine Normon should not be taken with grapefruit or grapefruit juice as it may increase the hypotensive effect. See section 2 “Do not take Lercanidipine Normon”.

Pregnancy, breast-feeding and fertility

It is not recommended to take Lercanidipine Normon if you are pregnant and it should not be taken during breast-feeding. There are no data on the use of Lercanidipine Normon in pregnant or breast-feeding women. If you are pregnant or breast-feeding, 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 taking 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 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 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 at the same time each day, preferably in the morning, and at least 15 minutes before breakfast. Your doctor may increase the dose to one 20 mg lercanidipine tablet per day, if necessary (see section 2 “Taking Lercanidipine Normon with food, drinks and alcohol”).

The tablet should be swallowed with a sufficient amount of liquid (e.g. a glass of water).

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 per day should be done with caution.

Use in children:this medicine should not be given to children under 18 years old.

If you take more Lercanidipine Normon than you should

Do not take more than the prescribed dose.

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

Taking a dose higher than the correct dose may cause an excessive drop in blood pressure and irregular and faster heartbeats.

If you forget to take Lercanidipine Normon

If you forget to take your tablet, do not take the forgotten dose. 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 Normon

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

If you have any further questions on the use of this product, 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 suffer from any of these side effects, consult your doctor.

Rare(may affect up to 1 in 1,000 patients):angina pectoris (chest pain 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 medicines of the group to which Lercanidipine Normon belongs. Isolated cases of heart attacks have been observed.

Other possible side effects:

Frequent(may affect up to 1 in 10 patients):headache, increased heart rate or palpitations (strong or rapid heartbeats), sudden reddening 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, discomfort, 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, 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 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lercanidipine Normon

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging (on each blister strip and on the outer carton). The expiry date is the last day of the month shown.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 ingredients (excipients) are:

Core:

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

Coating:

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

Appearance of Lercanidipine Normon and contents of the pack

Lercanidipine Normon is presented in the form of pink, round, biconvex film-coated tablets with a score line on one face and smooth on the other face. The score line is to facilitate breaking and swallowing but not to divide into equal doses.

Package of 28 tablets

Marketing authorisation 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 last revision of this leaflet:July 2025