Package Leaflet: Information for the Patient

Lercanidipine Aurovitas Spain 10 mg Film-Coated Tablets

Lercanidipine Hydrochloride

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

In this leaflet:

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

1. What you need to know before you start taking 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 additional information

Lercanidipino belongs to a group of medications called calcium channel blockers(from the dihydropyridines group) that lower blood pressure.

Lercanidipino is used to treat high blood pressure, also known as hypertension in adults over 18 years old (not recommended for children under 18 years of age).

Do not take Lercanidipino Aurovitas Spain

• if you are allergic (hypersensitive) to lercanidipino or to any of the other components of Lercanidipino Aurovitas Spain tablets
• if you have certain heart diseases such as:

• untreated heart failure
• obstruction of blood flow from the heart
• unstable angina (chest discomfort at rest or progressively increasing)
• if you have had a heart attack within less than one month

• if you have severe liver problems
• if you have severe kidney problems or are undergoing dialysis
• if you are taking certain medications that inhibit hepatic metabolism such as:

• antifungal medications (such as ketoconazol or itraconazol)
• macrolide antibiotics (such as erythromycin, troleandomycin or claritromycin)
• antivirals (such as ritonavir)

• if you are taking another medication called ciclosporina (used after a transplant to prevent organ rejection) at the same time
• with grapefruit or grapefruit juice

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lercanidipino Aurovitas Spain.

• if you have a heart disease
• if you have liver or kidney problems

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

Children and adolescents

The safety and efficacy of lercarnidipino have not been demonstrated in children under 18 years.

Other medications and Lercanidipino Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, as combining lercanidipino with other medications may alter the effect of lercanidipino or the other medication or increase the frequency of certain adverse effects (see section 2 “Do not take Lercanidipino Aurovitas Spain”).

Specifically, inform your doctor or pharmacist if you are being treated with any of the following medications:

• Phenitoína, phenobarbital or carbamazepine (medications for epilepsy)
• Rifampicina (a medication for tuberculosis)
• Midazolam (a medication that helps sleep)
• Cimetidina (more than 800 mg, a medication for ulcers, indigestion or heartburn)
• Digoxina (a medication to treat a heart problem)
• Terfenadina or astemizol (medications for allergies)
• Amiodarona or quinidina or sotalol (medications to treat rapid heart rhythm)
• Beta-blockers such as metoprolol (a medication to treat high blood pressure, heart failure and abnormal heart rhythm)
• Simvastatina (a medication for high cholesterol levels)
• Other medications to treat high blood pressure

Taking Lercanidipino Aurovitas Spain with food, drinks and alcohol

• Fatty meals significantly increase the concentration of the medication in the blood (see section 3)
• Alcohol may increase the effect of lercanidipino. Do not consume alcohol during treatment with lercanidipino.
• Lercanidipinoshould not be taken with grapefruit or grapefruit juice as it may increase the hypotensive effect. See section 2 “Do not take Lercanidipino Aurovitas Spain”.

Pregnancy, breastfeeding and fertility

It is not recommended to take lercanidipino if you are pregnant and it should not be taken during breastfeeding. There are no data on the use of lercanidipino in pregnant women and during breastfeeding. 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 medication.

Driving and operating machinery

If you experience dizziness, weakness or numbness when taking this medication, do not drive vehicles or operate machinery.

Lercanidipino Aurovitas Spain contains lactose and sodium

This medication contains lactose monohydrate. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults: The recommended dose is one 10 mg tablet per day taken at the same time every day, preferably in the morning 15 minutes before breakfast.

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

Tablets should be taken preferably whole with a little water.

Use in children and adolescents This medication should not be given to children under 18 years old.

Geriatric 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 at the start of 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 medication, ask your doctor or pharmacist.

If you take more Lercanidipino Aurovitas Spain than you should

Do not take more doses than prescribed.

If you have taken more lercanidipino tablets than you should, consult your doctor immediately, go directly to the hospital, or call the Toxicological Information Service, phone (91) 562 04 20. Bring the packaging with you. Taking a dose higher than the correct dose may cause excessive lowering of blood pressure and irregular and faster heartbeats.

If you forget to take Lercanidipino Aurovitas Spain

If you forget to take the medication, simply forget that dose and continue taking the tablets at the time that corresponds to you. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Lercanidipino Aurovitas Spain

If you interrupt treatment with lercanidipino, your blood pressure may increase again. Consult your doctor before stopping treatment.

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

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

Some of these side effects may 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 tightness due to lack of blood 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 these attacks with medicines in 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 redness of the face, neck, or upper chest, swelling of the ankles

Infrequent(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, urticaria, increased urination frequency, chest pain.

Unknown frequency(cannot be estimated from available data): gum swelling,changes in liver function (detected in blood tests), cloudy liquid (during hemodialysis through a tube inside the abdomen), facial swelling, lips, tongue, or throat that may cause breathing or swallowing difficulties.

Reporting of side effects:

If you experience any type of side effect, 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 System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label, carton, or bottle after CAD. The expiration date is the last day of the month indicated.

Storage Conditions:

Al/PVC Blister: Do not store above25ºC. Store in the original packaging to protect it from moisture.

Al/PVC/PVDC Blister: Do not store above25ºC. Store in the original packaging to protect it from moisture.

HDPE Bottles: This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Lercanidipine Aurovitas Spain

• The active ingredient is hydrochloride of lercanidipine.

Each tablet contains 10 mg of hydrochloride of lercanidipine, equivalent to 9.4 mg of lercanidipine.

• The other components are:

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

Tablet coating:macrogol, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of Lercanidipine Aurovitas Spain and packaging content

Lercanidipine Aurovitas Spain 10 mg are round, biconvex, yellow-coated tablets, 6.5 mm in size, with the mark “L” on one face and scored on the other.

The score serves to break and facilitate swallowing but not to divide into equal doses.

Packaging sizes:

Blister (Al/PVC):

Lercanidipine Aurovitas Spain 10 mg film-coated tablets: 14, 20, 28, 30, 50, 56, 60, 90, 98, and 100 tablets.

Blister (Al/PVC/PVDC):

Lercanidipine Aurovitas Spain 10 mg film-coated tablets: 14, 20, 28, 30, 50, 56, 60, 90, 98, and 100 tablets.

Bottles:

Lercanidipine Aurovitas Spain 10 mg film-coated tablets: 100, 250 tablets.

Only some packaging 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

Responsible for manufacturing

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 with the following names:

Germany: Lercanidipin Puren 10 mg Filmtabletten

Belgium: Lercanidipine AB 10 mg filmomhulde tabletten

Spain: Lercanidipino Aurovitas Spain 10 mg comprimidos recubiertos con película EFG

Netherlands: Lercanidipine HCLAurobindo10 mg, filmomhulde tabletten

Italy: Lercanidipina Aurobindo

Portugal: LercanidipinaAurovitas

Last review date of this leaflet:June2020

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