Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
LERCAN (Lercanidipin-Omniapharm)
20 mg, coated tablets
Lercanidipini hydrochloridum
LERCAN and Lercanidipin-Omniapharm are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Lercan is and what it is used for
Important information before taking Lercan
How to take Lercan
Possible side effects
How to store Lercan
Contents of the pack and other information

1. What Lercan is and what it is used for

Lercan contains the active substance lercanidipine hydrochloride, which belongs to a group of medicines known as calcium antagonists (dihydropyridine derivatives) that lower blood pressure.
Lercan is used in the treatment of mild to moderate arterial hypertension (high blood pressure) in adults aged over 18 years (the medicine is not recommended for use in children under 18 years of age).

2. Important information before taking Lercan

When not to take Lercan:

if the patient is allergic to leracandipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
if the patient has certain heart diseases:
- obstruction of the blood outflow tract from the heart
- untreated heart failure
- unstable angina (chest pain at rest or with increasing severity)
- myocardial infarction within the last month
if the patient has severe liver disease
if the patient has severe kidney disease or is undergoing dialysis
if the patient is taking medicines which are inhibitors of hepatic metabolism, such as:
- antifungal medicines (such as ketoconazole or itraconazole)
- macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
antiviral medicines (such as ritonavir)
- if the patient is taking another medicine called cyclosporine (used after organ transplantation to prevent rejection)
- if the patient consumes grapefruit or drinks grapefruit juice

Warnings and precautions
Before starting treatment with Lercan, discuss this with your doctor or pharmacist:

if the patient has heart diseases,
if the patient has liver or kidney disease.

The patient should inform the doctor about pregnancy, suspected or planned pregnancy, as well as breastfeeding
(see section "Pregnancy, breastfeeding and fertility").
Children and adolescents
The safety and efficacy of Lercan in children under 18 years of age have not been established.
Lercan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take. This is because when Lercan is used together with other medicines, its effect or the effect of other medicines may change, and certain adverse reactions may occur more frequently (see also section 2, subsection "When not to take Lercan").
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

phenytoin, phenobarbital or carbamazepine (medicines used in the treatment of epilepsy)
rifampicin (a medicine used to treat tuberculosis)
astemizole or terfenadine (antiallergic medicines)
amiodarone, quinidine or sotalol (medicines used for rapid heart rate)
midazolam (a sleeping medicine)
digoxin (a medicine used in the treatment of heart diseases)
beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure and heart rhythm disorders)
cimetidine (in doses exceeding 800 mg per day; a medicine used in peptic ulcer disease, indigestion or heartburn)
simvastatin (a medicine that lowers blood cholesterol levels)
medicines used to treat high blood pressure.

Lercan with food, drink and alcohol

A high-fat meal significantly increases the concentration of the medicine in the blood (see section 3).
Alcohol may enhance the effect of Lercan. Alcohol should not be consumed during treatment with Lercan.
Do not take Lercan together with grapefruit or grapefruit juice (this may enhance the blood pressure-lowering effect). See section 2, subsection "When not to take Lercan".

Pregnancy, breastfeeding and fertility
Lercan is not recommended if the patient is pregnant. It should not be used during breastfeeding. There is a lack of data on the use of Lercan in pregnant women and breastfeeding mothers. If the patient is pregnant or breastfeeding, if she is not using any contraceptive method, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
If the patient experiences dizziness or drowsiness while taking this medicine, driving or operating machinery should be avoided.
Lercan contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Lercan

This medicine should always be taken as directed by the physician. In case of doubts, consult a doctor or pharmacist.
Lercan is available in 10 mg and 20 mg strengths.
Adults:

The recommended dose is 10 mg once daily, taken at the same time each day, preferably in the morning, at least 15 minutes before breakfast.
If necessary, the physician may recommend increasing the dose to one 20 mg tablet of Lercan per day (see section 2, subsection "Lercan with food, drink and alcohol").
The breakline on the 10 mg Lercan tablet is intended only to facilitate crushing for easier swallowing, and does not allow for division into equal doses.
The 20 mg tablet may be divided into equal doses.
Tablets should preferably be swallowed whole, with a small amount of water.

Use in children and adolescents:

Lercan should not be used in children and adolescents under 18 years of age.

Elderly patients:

Dose adjustment is not usually necessary; however, particular caution should be exercised at the beginning of treatment.

Patients with impaired liver or kidney function:

In these patients, particular caution should be exercised at the beginning of treatment and when increasing the daily dose to 20 mg.

Taking more Lercan than recommended
Do not take more than the recommended dose.
If you have taken more than the prescribed dose, contact your doctor immediately or go to the emergency department of your nearest hospital. Bring the medicine packaging with you.
Taking more than the recommended dose may cause excessive lowering of blood pressure and irregular or rapid heartbeat.
Missing a dose of Lercan
If a patient forgets to take a dose of Lercan, the missed dose should be skipped and the next dose taken the following day as scheduled. Do not take a double dose to make up for a missed dose.
Stopping Lercan treatment
If treatment with Lercan is stopped, blood pressure may rise again. Consult your doctor before discontinuing the medicine.
In case of any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur while taking this medicine:
Some adverse reactions may be serious.
If any of the following adverse reactions occur, you must immediately inform your doctor:
Rare (may occur in less than 1 in 1,000 people): angina pectoris (e.g. chest tightness caused by inadequate blood flow to the heart), allergic reactions (symptoms include itching, rash, urticaria), fainting.
In patients with pre-existing angina pectoris, an increased frequency, prolonged duration, or worsening severity of angina attacks may occur during treatment with medicines of the group to which Lercan belongs. In isolated cases, myocardial infarction may occur.

Other possible adverse reactions:
Common (may occur in less than 1 in 10 people): headache, rapid heartbeat, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck or upper part of the chest (hot flushes), swelling around the ankles.
Uncommon (may occur in less than 1 in 100 people): dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, passing large amounts of urine, weakness, fatigue.
Rare (may occur in less than 1 in 1,000 people): somnolence, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Frequency not known (frequency cannot be estimated from the available data): gingival swelling, liver function abnormalities (detected in blood tests), clouding of the fluid (during dialysis using a catheter placed in the abdominal cavity), swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing.

Reporting suspected adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicinal product Lercan

Keep the medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Medicinal products must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Lercan contains

The active substance is lercanidipine hydrochloride. One coated tablet of Lercan contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
The other ingredients are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch, povidone K 30, magnesium stearate.
Coating: hypromellose, talc, titanium dioxide (E 171), macrogol 6000, and iron oxide red (E 172).

What Lercan looks like and contents of the pack
Lercan is a pink, round, biconvex coated tablet with a diameter of 8.5 mm and a score line on one side.
Lercan is available in packs containing 25, 28, 50 or 56 tablets in blisters made of aluminium/PVC foil in a cardboard carton.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Germany, the country of export:
Recordati Pharma GmbH
Eberhard-Finckh-Straße 55
89075 Ulm
Germany
Manufacturer:
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland
Marketing Authorisation number in Germany, the country of export: 65406.00.00
Parallel Import Authorisation number: 347/16