LERCANIDIPINE AUROVITAS SPAIN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Lercanidipine Aurovitas Spain 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.
• 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.

In this leaflet:

1. What is Lercanidipine Aurovitas Spain and what is it used for

1. What you need to know before you take Lercanidipine Aurovitas Spain
2. How to take Lercanidipine Aurovitas Spain
3. Possible side effects
4. Storage of Lercanidipine Aurovitas Spain
5. Contents of the pack and other information

1. What is Lercanidipine Aurovitas Spain and what is it used for

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

Lercanidipine is used to treat high blood pressure, also known as 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 Aurovitas Spain

Do not take Lercanidipine Aurovitas Spain

• if you are allergic (hypersensitive) to lercanidipine or any of the other ingredients of Lercanidipine Aurovitas Spain.
• if you have certain heart diseases such as:

• untreated heart failure
• obstruction of blood flow from the heart
• unstable angina (chest pain or progressively increasing)
• if you have had a heart attack less than a month ago

• 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:

• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
• antivirals (such as ritonavir)
• if you are taking another medicine called 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 Aurovitas Spain.

• if you have heart disease
• 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 have not been established in children under 18 years old.

Other medicines and Lercanidipine Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, as combining lercanidipine with other medicines may change the effect of lercanidipine or the other medicine, or increase the frequency of certain side effects (see section 2 "Do not take Lercanidipine Aurovitas Spain").

In particular, inform your doctor or pharmacist if you are being treated with any of the following medicines:

• Phenytoin, phenobarbital or carbamazepine (medicines for epilepsy).
• Rifampicin (a medicine for tuberculosis).
• Midazolam (a medicine that helps you sleep).
• Cimetidine, more than 800 mg (a medicine for ulcers, indigestion or heartburn).
• Digoxin (a medicine to treat a heart problem).
• Terfenadine or astemizole (medicines for allergies).
• Amiodarone, quinidine or sotalol (medicines to treat a fast heart rate).
• Betablockers such as metoprolol (a medicine to treat high blood pressure, heart failure and abnormal heart rhythm).
• Simvastatin (a medicine for high cholesterol levels).
• Other medicines to treat high blood pressure

Taking Lercanidipine Aurovitas Spain 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 lercanidipine.
• Lercanidipine should not be taken with grapefruit or grapefruit juice as it may increase the hypotensive effect. See section 2 "Do not take Lercanidipine Aurovitas Spain".

Pregnancy, breast-feeding and fertility

It is not recommended to take lercanidipine if you are pregnant and it should not be taken during breast-feeding. There are no data on the use of lercanidipine 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 feel dizzy, weak or numb when taking this medicine, do not drive vehicles or use machines.

Lercanidipine Aurovitas Spain contains lactose and sodium

This medicine contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Lercanidipine Aurovitas Spain

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 per day taken at the same time each day, preferably in the morning 15 minutes before breakfast, because fatty meals increase the levels of the medicine in the blood.

Your doctor will decide if it is necessary to increase your dose to one Lercanidipine Aurovitas Spain 20 mg tablet per day (see section 2 "Taking Lercanidipine Aurovitas Spain with food, drinks and alcohol").

The tablets should be taken preferably whole with a little water. The score line is only to help you break the tablet if you have difficulty swallowing it whole.

Use in children and adolescents:This medicine should not be given to children and adolescents 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 per day should be done with caution.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

If you take more Lercanidipine Aurovitas Spain than you should

Do not take more doses than prescribed.

If you have taken more tablets of lercanidipine than you should, consult your doctor immediately, go directly to the hospital or call the Toxicology Information Service, telephone (91) 562 04 20. Bring the package 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 Aurovitas Spain

If you forget to take the medicine, simply forget that dose and continue taking the tablets at the time that corresponds to you. Do not take a double dose to make up for the forgotten dose.

If you stop taking Lercanidipine Aurovitas Spain

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

If you have any doubts 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.

Rare (may affect up to 1 in 1,000 patients):angina pectoris (chest pressure 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 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 production, 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, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through 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 Aurovitas Spain

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 label, carton or bottle after EXP. The expiry date is the last day of the month indicated.

Storage conditions:

Al/PVC blister: Do not store above 25°C. Store in the original packaging to protect from moisture.

Al/PVC/PVDC blister: Do not store above 25°C. Store in the original packaging to protect from moisture.

HDPE bottles: This medicine does not require special storage conditions.

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 Aurovitas Spain

• The active substance is lercanidipine hydrochloride.

Each tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.

• The other ingredients are:

Core of the tablet:magnesium stearate, povidone, sodium starch glycolate (type A, potato), lactose monohydrate, microcrystalline cellulose.

Coating of the tablet:macrogol, polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of Lercanidipine Aurovitas Spain and contents of the pack

Lercanidipine Aurovitas Spain 20 mg are film-coated tablets, round and biconvex, pink in color, 8.5 mm in size, with the mark "L" on one face and scored on the other.

The score line is to facilitate breaking and swallowing but not to divide into equal doses.

Pack sizes:

Al/PVC blister:

Lercanidipine Aurovitas Spain 20 mg film-coated tablets: 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

Al/PVC/PVDC blister:

Lercanidipine Aurovitas Spain 20 mg film-coated tablets: 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

Bottles:

Lercanidipine Aurovitas Spain 20 mg film-coated tablets: 100, 250 tablets

Not all pack sizes may be marketed

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

APL Swift Services (Malta) Ltd.

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

or

Generis Farmacêutica, S.A.

Rua João de Deus, nº19,

Venda Nova, 2700-487

Amadora, Portugal

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Lercanidipin Puren 20 mg Filmtabletten

Belgium: Lercanidipine AB 20 mg filmomhulde tabletten

Spain: Lercanidipino Aurovitas Spain 20 mg comprimidos recubiertos con película EFG

Netherlands: Lercanidipine HCL Aurobindo 20 mg, filmomhulde tabletten

Italy: Lercanidipina Aurobindo

Portugal: Lercanidipina Aurovitas

Date of last revision of this leaflet:June 2020

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