LERCANIDIPINE AUROVITAS SPAIN 10 mg FILM-COATED TABLETS

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 tablets
• if you have certain heart diseases such as:

• untreated heart failure
• obstruction of blood flow from the heart
• unstable angina (chest pain at rest or progressively increasing)
• if you have had a heart attack in the last month

• 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) at the same time.
• 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 when lercanidipine is combined with other medicines, the effect of lercanidipine or the other medicine may change or the frequency of certain side effects may increase (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 or 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 suffer from dizziness, weakness or numbness 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 recommended dose is one 10 mg tablet per day, taken at the same time each 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 Lercanidipine tablet per day (see section 2 “Taking Lercanidipine Aurovitas Spain with food, drinks and alcohol”).

Tablets should be taken preferably whole with a little water.

Use in children and adolescentsThis medicine should not be given to children 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 the 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 Lercanidipine tablets than you should, consult your doctor immediately, go directly to the hospital or call the Toxicology Information Service, telephone (91) 562 04 20. Take the packaging with you. Taking a dose higher than the correct dose may cause a significant 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 rise 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 (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 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 side effects 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 10 mg of lercanidipine hydrochloride, equivalent to 9.4 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, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E171), yellow iron oxide (E172).

Appearance of Lercanidipine Aurovitas Spain and contents of the pack

Lercanidipine Aurovitas Spain 10 mg are film-coated tablets, round and biconvex, yellow in color, 6.5 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 10 mg film-coated tablets: 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets.

Al/PVC/PVDC blister:

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.

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 authorized in the Member States of the European Economic Area under 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 HCL Aurobindo 10 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/