Lercanidipine Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lercanidipine Zentiva 10 mg film-coated tablets, 20 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Lercanidipine Zentiva belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives) that reduce blood pressure.
Lercanidipine Zentiva is used for the treatment of 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 taking Lercanidipine Zentiva

Do not take Lercanidipine Zentiva

• If you are allergic to lercanidipine or to any of the other ingredients of this medicine (listed in section 6),
• If you have had allergic reactions to medicines closely related to Lercanidipine Zentiva tablets (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine),
• If you suffer from certain heart conditions:
  • uncontrolled heart failure,
  • obstruction of blood flow from the heart,
  • unstable angina (angina at rest or worsening progressively),
  • if you have had a heart attack less than one month ago.
• If you have severe liver or kidney problems,
• If you are taking CYP3A4 enzyme inhibitors:
  • antifungal medicines (such as ketoconazole or itraconazole),
  • macrolide antibiotics (such as erythromycin or troleandomycin),
  • antiviral medicines (such as ritonavir).
• If you are taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection),
• With grapefruit or grapefruit juice,
• If you are pregnant, planning to become pregnant, or if you are of childbearing age and not using any contraceptive method,
• If you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lercanidipine Zentiva:

• If you suffer from other heart conditions that have not been treated with a pacemaker or if you have pre-existing angina;
• If you have liver or kidney problems, or if you are on dialysis.

Children and adolescents
The safety and efficacy of Lercanidipine Zentiva in children up to 18 years of age have not been established.
No data are available.

Other medicines and Lercanidipine Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Lercanidipine Zentiva with certain other medicines (listed below) may alter the effect of these medicines or of Lercanidipine Zentiva.
It is particularly important that your doctor knows if you are already being treated with any of the following medicines:

• Rifampicin (a medicine used to treat tuberculosis),
• Midazolam (a medicine that helps you sleep),
• Cimetidine, at doses higher than 800 mg (a medicine for ulcers, indigestion or heartburn),
• Digoxin (a medicine used to treat heart problems),
• Terfenadine or astemizole (medicines for allergies),
• Amiodarone or quinidine (medicines used to treat fast heartbeat),
• Beta-blockers such as metoprolol (a medicine used to treat high blood pressure),
• Simvastatin (a medicine for high cholesterol),
• Phenytoin or carbamazepine (medicines for epilepsy).
  Your doctor may want to monitor your blood pressure more frequently than usual.

Lercanidipine Zentiva with food, drinks and alcohol
Do not consume alcohol during treatment with Lercanidipine Zentiva tablets, as alcohol together with the tablets may considerably lower your blood pressure. You may experience dizziness/fainting, fatigue or weakness.
Do not take Lercanidipine Zentiva tablets with grapefruit or grapefruit juice, as this may increase the effect of Lercanidipine Zentiva.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use Lercanidipine Zentiva if you are pregnant, planning to become pregnant, or if you are of childbearing age and not using any contraceptive method.
Breastfeeding
Do not use Lercanidipine Zentiva if you are breastfeeding.

Driving and using machines
Lercanidipine Zentiva has a minor influence on the ability to drive or use machines.
Exercise caution, as dizziness, weakness, fatigue, and rarely drowsiness may occur. Do not drive or operate machinery until you know how Lercanidipine Zentiva affects you.

Lercanidipine Zentiva contains lactose monohydrate
If your doctor has informed you that you have an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Lercanidipine Zentiva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Adults
The recommended dose is one 10 mg film-coated tablet of Lercanidipine Zentiva once daily, always at the same time, preferably in the morning, at least 15 minutes before breakfast, as a high-fat meal significantly increases plasma levels of the medicine.
If necessary, your doctor may advise you to increase the dose to one 20 mg film-coated tablet of Lercanidipine Zentiva daily.
The tablets should preferably be swallowed whole with a glass of water. The break line is intended only to facilitate breaking the tablet for easier swallowing and not for dividing the tablet into equal doses.
Use in children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
Elderly patients
No adjustment of the daily dose is required. However, particular caution should be exercised at the beginning of treatment.
Patients with liver or kidney problems
Particular care is required at the beginning of treatment in these patients, and increasing the daily dose to 20 mg should be carefully evaluated.
If you take more Lercanidipine Zentiva than you should
Do not exceed the prescribed dose.
If you take more than prescribed or in case of overdose, consult your doctor immediately and, if possible, bring the tablets and/or the packaging with you.
Taking a higher than recommended dose may cause excessive lowering of blood pressure and irregular or rapid heartbeat. It may also cause loss of consciousness.
If you forget to take Lercanidipine Zentiva
If you forget to take your tablet, simply skip the missed dose and take the next dose at the usual time. Never take a double dose to make up for a forgotten tablet.
If you stop taking Lercanidipine Zentiva
If you stop treatment with Lercanidipine Zentiva, your blood pressure may rise again. Consult your doctor before stopping Lercanidipine Zentiva.
If you have any doubts about how to use Lercanidipine Zentiva, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious:
If you experience any of the following side effects, consult your doctor immediately.
Rare (may affect up to 1 in 1,000 patients): angina pectoris (chest pain caused by
insufficient blood supply to the heart).
Very rare (may affect up to 1 in 10,000 patients): chest pain, excessive drop in blood
pressure, fainting, and allergic reactions (symptoms include itching, rash, hives).
If you have pre-existing angina pectoris, with the group of medicines to which Lercanidipine Zentiva belongs,
an increase in frequency, duration, and severity of these attacks may occur.
Isolated cases of myocardial infarction may be observed.
Other possible side effects:
Uncommon (may affect up to 1 in 100 people):

• headache, dizziness
• tachycardia, palpitations (irregular or rapid heartbeat)
• sudden flushing of the face, neck, and upper chest
• swollen ankles.

Rare (may affect up to 1 in 1,000 people):

• drowsiness, weakness, fatigue
• malaise, vomiting, heartburn, diarrhoea, stomach pain, indigestion
• skin rash
• muscle pain
• increased amount of urine.

Very rare (may affect up to 1 in 10,000 people):

• swollen gums
• changes in liver function test results (detected by blood tests)
• need to urinate more frequently.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lercanidipine Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton or bottle after EXP.
The expiry date refers to the last day of that month.

Storage conditions
Al/PVC blister: Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Al/PVDC blister: Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
HDPE bottles: Do not store above 25°C. Keep in the original packaging. Keep the bottle tightly closed to protect the medicine from moisture.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Lercanidipine Zentiva Contains
The active substance is lercanidipine hydrochloride.
One 10 mg film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of
lercanidipine.
One 20 mg film-coated 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), Lactose monohydrate,
Microcrystalline cellulose.
Film coating of 10 mg tablets: Macrogol, Polyvinyl alcohol (partially hydrolysed), Talc, Titanium dioxide (E171), Iron oxide yellow (E172).
Film coating of 20 mg tablets: Macrogol, Polyvinyl alcohol (partially hydrolysed), Talc, Titanium dioxide (E171), Iron oxide yellow (E172), Iron oxide red (E172).

Description of the Appearance of Lercanidipine Zentiva and Package Contents
Lercanidipine Zentiva 10 mg tablets are yellow, round, biconvex, film-coated tablets with a diameter of 6.5 mm, marked with a score line on one side and "L" on the other.
Lercanidipine Zentiva 20 mg tablets are pink, round, biconvex, film-coated tablets with a diameter of 8.5 mm, marked with a score line on one side and "L" on the other.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.

Pack sizes:
Blister (Al/PVC)
Lercanidipine Zentiva 10 mg film-coated tablets: 14, 28, 30, 50, 56, 84, 100 tablets
Lercanidipine Zentiva 20 mg film-coated tablets: 28, 30, 50, 56, 84, 100 tablets
Blister (Al/PVDC)
Lercanidipine Zentiva 10 mg film-coated tablets: 28, 30, 50, 56, 84, 100 tablets
Lercanidipine Zentiva 20 mg film-coated tablets: 28, 30, 50, 56, 84, 100 tablets
Bottles:
Lercanidipine Zentiva 10 mg film-coated tablets: 100 tablets
Lercanidipine Zentiva 20 mg film-coated tablets: 100 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Zentiva Italia S.r.l.
Viale Bodio, 37/B
20158 Milan, Italy

Manufacturers
Actavis ehf.
Reykjavikurvegur 78, IS-220 Hafnarfjördur
Iceland
Actavis Ltd
BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000
Malta
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str., Dupnitsa 2600
Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Bulgaria Капидин 10 mg филмирани таблетки
Капидин 20 mg филмирани таблетки
Denmark Lercanidipinhydrochlorid Zentiva 10 mg
Lercanidipinhydrochlorid Zentiva 20 mg
Italy Lercanidipina Zentiva 10 mg compresse rivestite con film
Lercanidipina Zentiva 20 mg compresse rivestite con film
Portugal Lercanidipina Zentiva
Romania Lercanidipină Zentiva 10 mg comprimate filmate
Spain Lercanidipino Zentiva 10 mg comprimidos recubiertos con película
Lercanidipino Zentiva 20 mg comprimidos recubiertos con película