Lercan

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Lercan(Lercanidipine-Omniapharm)
20 mg, coated tablets
Lercanidipine hydrochloride
Lercan and Lercanidipine-Omniapharm are different trade names for the same drug.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lercan and what is it used for
• 2. Important information before taking Lercan
• 3. How to take Lercan
• 4. Possible side effects
• 5. How to store Lercan
• 6. Contents of the pack and other information

1. What is Lercan and what is it used for

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

2. Important information before taking Lercan

When not to take Lercan:

• if you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have certain heart diseases:
• narrowing of the blood outflow from the heart
• untreated heart failure
• unstable angina pectoris (chest pain at rest or with increasing severity)
• myocardial infarction within the last month
• if you have severe liver disease
• if you have severe kidney disease or are undergoing dialysis
• if you are taking medicines that are inhibitors of liver metabolism, such as:
• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
• antiviral medicines (such as ritonavir)
• if you are taking another medicine called cyclosporin (used after organ transplantation to prevent rejection)
• if you consume grapefruit or drink grapefruit juice

Warnings and precautions

Before starting to take Lercan, discuss it with your doctor or pharmacist:

• if you have heart disease,
• if you have liver or kidney disease.

Tell your doctor about pregnancy, suspected pregnancy, or planning pregnancy, as well as breastfeeding (see "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 you are taking now or have taken recently, as well as any medicines you plan to take. This is because if Lercan is taken with other medicines, its effect or the effect of other medicines may change, and certain side effects may occur more frequently (see also section 2, subsection "When not to take Lercan").
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• phenytoin, phenobarbital, or carbamazepine (medicines used to treat epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• astemizole or terfenadine (antihistamine medicines)
• amiodarone, quinidine, or sotalol (medicines used for rapid heart rate)
• midazolam (a sedative medicine)
• digoxin (a medicine used to treat heart disease)
• beta-blockers, such as metoprolol (a medicine used to treat high blood pressure, heart failure, and heart rhythm disorders)
• cimetidine (in a dose greater than 800 mg per day; a medicine used to treat stomach ulcers, 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. Do not consume alcohol during treatment with Lercan.
• Do not take Lercan with grapefruit or grapefruit juice (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 you are pregnant. Do not take it during breastfeeding. There is no data on the use of Lercan in pregnant or breastfeeding women. If you are pregnant or breastfeeding, or if you do not use any contraceptive method, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

If you experience dizziness or drowsiness while taking this medicine, do not drive or operate machinery.

Lercan contains lactose monohydrate

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Lercan contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Lercan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Lercan is available in the following strengths: 10 mg, 20 mg.
Adults:

• The recommended dose is 10 mg, taken once a day at the same time, preferably in the morning, at least 15 minutes before breakfast.
• If necessary, your doctor 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 score line on the 10 mg tablet of Lercan is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
• The 20 mg tablet can be divided into equal doses.
• Swallow the tablets whole with a small amount of water.

Use in children and adolescents

• Do not use Lercan in children and adolescents under 18 years of age.

Elderly:

• No dose adjustment is necessary, but caution should be exercised at the start of treatment.

Patients with liver or kidney impairment:

• Caution should be exercised at the start of treatment and when increasing the daily dose to 20 mg.

Taking more than the recommended dose of Lercan

Do not take more than the recommended dose.
If you have taken more than the recommended dose, contact your doctor or go to the emergency department of the nearest hospital immediately. Take the medicine packaging with you.
Taking more than the recommended dose of Lercan may cause excessive lowering of blood pressure and irregular or rapid heart rate.

Missing a dose of Lercan

If you forget to take a dose of Lercan, skip the missed dose and take the next dose the next day according to the established schedule. Do not take a double dose to make up for the missed dose.

Stopping treatment with Lercan

If you stop taking Lercan, your blood pressure may rise again.
Before stopping treatment, consult your doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lercan can cause side effects, although not everybody gets them.
The following side effects may occur when taking Lercan:

Some side effects can be serious.

If you experience any of the following side effects, tell your doctor immediately:

Rarely (may occur in less than 1 in 1000 people): angina pectoris (e.g., chest pain caused by insufficient blood flow to the heart), allergic reactions (symptoms include itching, rash, hives), fainting.
In patients with pre-existing angina pectoris, the frequency, duration, or severity of angina attacks may increase during treatment with medicines of the same class as Lercan. In rare cases, myocardial infarction may occur.

Other possible side effects:

Common (may occur in less than 1 in 10 people): headache, rapid heart rate, feeling of rapid or irregular heart rate (palpitations), sudden reddening of the face, neck, or upper chest (flushing), swelling of 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, frequent urination, weakness, fatigue.
Rare (may occur in less than 1 in 1000 people): drowsiness, vomiting, diarrhea, hives, increased urination, chest pain.
Frequency not known (frequency cannot be estimated from the available data): gum swelling, liver function disorders (detected in blood tests), clouding of the fluid (during dialysis with a catheter placed in the abdominal cavity), swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lercan

Keep the medicine out of the 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 month.
Store in the original packaging to protect from light.
Medicines should 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 pack and other information

What Lercan contains

• The active substance of Lercan is lercanidipine hydrochloride. One coated tablet of Lercan contains 20 mg of lercanidipine hydrochloride, which corresponds to 18.8 mg of lercanidipine.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (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 pink, round, biconvex, coated tablets 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 in aluminum/PVC blisters, in a cardboard box.
For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the 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.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Pharma Innovations Sp. z o. o.
ul. Jagiellońska 76
03-301 Warsaw
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warsaw
Marketing authorization number in Germany, the country of export: 65406.00.00
Parallel import authorization number: 248/18
Date of leaflet approval: 17.04.2023
[Information about the trademark]