Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Lercan (Lercanidipin-Omniapharm)
20 mg, film-coated tablets
Lercanidipini hydrochloridum
Lercan and Lercanidipin-Omniapharm are different trade names of 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 called 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 over 18 years of age (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 lerkanidipine 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 previous 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 liver metabolism, such as:
- antifungal medicines (e.g. ketoconazole or itraconazole)
- macrolide antibiotics (e.g. erythromycin, troleandomycin or clarithromycin)
- antiviral medicines (e.g. ritonavir)
if the patient is taking another medicine called cyclosporine (used after organ transplantation to prevent organ 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 pregnancy, planned pregnancy, or 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 plans to take. This is because when Lercan is taken together with other medicines, its effect or the effect of other medicines may change, and certain adverse effects 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 in the treatment of 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 in the treatment of high blood pressure, heart failure and heart rhythm disorders)
cimetidine (at 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 drug concentration in 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 are no data on the use of Lercan in pregnant women or in breastfeeding mothers. If the patient is pregnant or breastfeeding, if she is not using any contraceptive method, suspects she may be pregnant, or plans to become pregnant, 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 lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Lercan contains 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 doubt, consult
your doctor or pharmacist.
Lercan is available in the following doses: 10 mg, 20 mg.
Adults:

The recommended dose is 10 mg taken once daily at the same time each day, preferably in the morning, at least 15 minutes before breakfast.
If necessary, the doctor may recommend increasing the dose to one tablet of Lercan 20 mg per day (see section 2, subsection "Lercan with food, drink and alcohol").
The break line on the Lercan 10 mg 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:

No adjustment of the daily dose is necessary; however, particular caution is advised at the beginning of treatment.

Patients with hepatic or renal impairment:

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

Taking more Lercan than recommended
Do not take more than the recommended dose.
If you take more than the recommended amount, contact your doctor immediately
or go to the emergency department of your nearest hospital. Bring the medicine pack with you.
Taking more than the recommended dose may cause excessive lowering of blood pressure and irregular or rapid heart rate.
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 should be taken the following day according to the regular schedule. Do not take a double dose to make up for a missed dose.
Stopping treatment with Lercan
If treatment with Lercan is stopped, blood pressure may rise again.
Before discontinuing use of this medicine, consult your doctor.
If you have any further questions about 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, tell your doctor immediately:
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 chest (flushing), swelling of the ankle area.
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 of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C,
02-222 Warsaw,
Tel.: + 48 22 49 21 301,
Fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store the medicine Lercan

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

6. Contents of the packaging and other information

What Lercan contains

The active substance is lerkanidipine hydrochloride. One coated tablet of the medicinal product Lercan contains 20 mg of lerkanidipine hydrochloride, equivalent to 18.8 mg of lerkanidipine.
Other components are:
Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone K 30, magnesium stearate.
Tablet coating: hypromellose, talc, titanium dioxide (E 171), macrogol 6000, 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 28 or 56 coated tablets, packed in blisters made of Aluminium/PVC foil, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Germany, country of export:
Recordati Pharma GmbH
Eberhard-Finckh-Str. 55
89075 Ulm
Germany

Manufacturer
Recordati S.p.A. Industria Chimica e Farmaceutica
Via Matteo Civitali 1
I-20148 Milan
Italy

Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
Poland

CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Poland

Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A
11-001 Dywity
Poland

Pharma Innovations Sp. z o.o.
Jagiellońska 76
03-301 Warsaw
Poland

IVA Pharm Sp. z o.o.
Drawska 14/1
02-202 Warsaw
Poland

German Marketing Authorisation Number (country of export): 65406.00.00
Parallel Import Licence Number: 248/18