Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Lercan (Lercanidipin-Omniapharm)
10 mg, film-coated tablets
Lercanidipini hydrochloridum
Lercan and Lercanidipin-Omniapharm are different brand names for the same medicinal product.
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 or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 lercanidipine hydrochloride as the active substance, which belongs to a group of medicines called calcium antagonists (dihydropyridine derivatives) that lower blood pressure.
Lercan is used for the treatment of mild to moderate essential 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 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 worsening in 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 hepatic 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 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.

Inform your doctor if you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding (see section "Pregnancy, breastfeeding and fertility").
Children and adolescents
The safety and efficacy of Lercan have not been established in children under 18 years of age.
Lercan with other medicines
Tell your doctor or pharmacist about any other 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, the effect of Lercan or of the other medicines may change, and certain side 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 (antihistamines)
amiodarone, quinidine or sotalol (medicines used for rapid heart rate)
midazolam (a sedative)
digoxin (a medicine used in the treatment of heart conditions)
beta-blockers, e.g. metoprolol (medicines used to treat high blood pressure, heart failure and heart rhythm disorders)
cimetidine (at doses higher than 800 mg daily; a medicine used for 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 (as 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 no data available on the use of Lercan in pregnant or breastfeeding women.
If the patient is pregnant or breastfeeding, not using contraception, 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 lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult 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 prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Lercan is available in the following strengths: 10 mg, 20 mg.
Adults:

The recommended dose is 10 mg 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 breakline 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:

Adjustment of the daily dose is not 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 prescribed
Do not take more medicine than prescribed.
If you have taken more than the prescribed dose, contact your doctor immediately or
go to the nearest hospital emergency department. Bring the medicine packaging with you.
Taking more than the prescribed 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 should be taken the following day according to the regular schedule. Do not take a double dose to make up
for the missed dose.
Stopping 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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
The following adverse effects may occur during treatment with this medicine:
Some adverse effects may be serious.
If any of the following adverse effects occur, you must immediately inform your
doctor:
Rare (may occur in less than 1 in 1,000 people): angina (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, increased frequency, prolonged duration, or increased 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 effects:
Common (may occur in less than 1 in 10 people): headache, fast heartbeat, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (hot flushes), 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): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Frequency not known (frequency cannot be estimated from available data): gum swelling, liver function abnormalities (detected in blood tests), clouding of 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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.
Adverse effects can also be reported to the marketing authorisation holder or the parallel importer.
By reporting adverse effects, additional information regarding the safety of this medicine can be collected.

5. How to store the medicine Lercan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified 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. This will help protect the environment.

6. Contents of the packaging and other information

What Lercan contains
The active substance in Lercan is lerkanidipine hydrochloride. One coated tablet of Lercan contains
10 mg of lerkanidipine hydrochloride, equivalent to 9.4 mg of lerkanidipine.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch, povidone
K 30, magnesium stearate.
Coating: hypromellose, talc, titanium dioxide (E 171), polyethylene glycol 6000, yellow iron oxide (E
172).
What Lercan looks like and contents of the pack
Lercan is a yellow, round, biconvex coated tablet with a diameter of 6.5 mm and a score line on one side.
Lercan is available in packs containing 28, 50, 56 or 100 tablets in aluminium/PVC blisters within a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Germany, country of export:
Recordati Pharma GmbH
Eberhard-Finckh-Str. 55
89075 Ulm
Germany
Manufacturer:
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan
Italy
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
German Marketing Authorisation Number, country of export: 65405.00.00
Parallel Import Licence Number: 410/24