Lercanidipine Aurovitas Spain 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Lercanidipine Aurovitas Spain 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 you should not give it 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.

In this leaflet:

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

2. What you need to know before taking Lercanidipine Aurovitas Spain

3. How to take Lercanidipine Aurovitas Spain

4. Possible side effects

5. How to store Lercanidipine Aurovitas Spain

6. Contents of the pack and other information

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

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

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

Do not take Lercanidipine Aurovitas Spain

• if you are allergic (hypersensitive) to lercanidipine or to any of the other components of Lercanidipine Aurovitas Spain.

• if you have certain heart conditions such as:

• untreated heart failure

• obstruction of blood outflow from the heart

• unstable angina (chest discomfort or progressively worsening chest pain)

• if you have had a heart attack within the last month

• if you have severe liver problems

• if you have severe kidney problems or are undergoing dialysis

• if you are taking certain hepatic metabolism inhibitor medicines such as:

• antifungal medicines (such as ketoconazole or itraconazole)

• macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)

• antiviral medicines (such as ritonavir)

• if you are taking another medicine called 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 Aurovitas Spain.

• 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 have not been established in children under 18 years of age.

Other medicines and Lercanidipine Aurovitas Spain

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

Specifically, 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 fast heart rate).
• Beta-blockers 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, beverages 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. Do not consume alcohol during treatment with lercanidipine.
• Lercanidipine must not be taken with grapefruit or grapefruit juice, as this may increase its hypotensive effect. See section 2 “Do not take Lercanidipine Aurovitas Spain”.

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 might 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 drowsiness while taking this medicine, do not drive or operate machinery.

Lercanidipine Aurovitas Spain contains lactose and sodium

This medicine contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults: The usual recommended dose is one 10 mg tablet taken once daily at the same time each day, preferably in the morning 15 minutes before breakfast, since high-fat meals increase blood levels of the medicine.

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

The tablets should preferably be taken whole with a little water. The score line is only intended to assist in dividing 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 of age.

Elderly population: Daily dose adjustment is not required. However, special caution may be needed when starting treatment.

Patients with kidney or liver problems: Special care is needed when starting treatment in these patients, and increasing the dose to 20 mg daily should be done with caution.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

If you take more Lercanidipine Aurovitas Spain 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 number (91) 562 04 20. Take the container 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 Aurovitas Spain

If you forget to take your dose, simply skip that dose and continue taking your tablets at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Lercanidipine Aurovitas Spain

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

If you have any questions about how to use this medicine, 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 may be serious.

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

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

Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of attacks when taking medicines from the group to which lercanidipine 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, 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, diarrhoea, 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 (when performing peritoneal dialysis through a tube inside the abdomen), swelling of the face, lips, tongue, or throat that 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 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 Aurovitas Spain

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label, packaging, or bottle after EXP. The expiry date refers to the last day of the month indicated.

Storage conditions:

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

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

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

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

Tablet core: magnesium stearate, povidone, sodium starch glycolate (type A, potato), lactose monohydrate, microcrystalline cellulose.

Tablet coating: macrogol, polyvinyl alcohol (partially hydrolysed), 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 pink, round, biconvex, film-coated tablets, 8.5 mm in size, marked with the letter “L” on one side and scored on the other.

The score line is intended to facilitate breaking the tablet for ease of swallowing, but not for dividing into equal doses.

Pack sizes:

Blister (Al/PVC):

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

Blister (Al/PVC/PVDC):

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.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 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 medicinal product is authorized 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 the most recent revision of this leaflet: June 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/