Lercan

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lercan (Lercanidipine-Omniapharm)

10 mg, coated tablets
Lercanidipine hydrochloride
Lercan and Lercanidipine-Omniapharm are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 packaging 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 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 lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has certain heart diseases:
• narrowing of the blood flow out of the heart
• untreated heart failure
• unstable angina pectoris (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 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 the patient is taking another medicine called cyclosporin (used after organ transplantation to prevent rejection)
• if the patient consumes grapefruit or drinks grapefruit juice.

Warnings and precautions

Before starting to take Lercan, the patient should discuss it with their doctor or pharmacist:

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

The patient should inform their doctor about pregnancy, suspected pregnancy, or planning 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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, the patient should inform their doctor or pharmacist if they 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 to treat fast 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 cholesterol levels in the blood)
• 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. The patient should not consume alcohol during treatment with Lercan.
• The patient should not take Lercan 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 during pregnancy. It should not be used during breastfeeding. There are no data on the use of Lercan in pregnant or breastfeeding women.
If the patient is pregnant or breastfeeding, or if they are not using any contraceptive method, suspect they may be pregnant, or plan to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

If the patient experiences dizziness or drowsiness while taking this medicine, they should not drive or operate machinery.

Lercan contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

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

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their 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, the 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 the tablet to make it easier to swallow, and not to divide it into equal doses.
• The 20 mg tablet can be divided into equal doses.
• The tablets should 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 dose adjustment is necessary, but caution should be exercised at the start of treatment

Patients with liver or kidney impairment:

• These patients should be cautious at the start of treatment and when increasing the daily dose to 20 mg.

Taking a higher dose of Lercan than recommended

The patient should not take a higher dose than recommended.
In case of taking a higher dose than recommended, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital. They should take the packaging of the medicine with them.
Taking a higher dose of Lercan than recommended may cause excessive lowering of blood pressure and irregular or rapid heart rate.

Missing a dose of Lercan

If the patient forgets to take a dose of Lercan, they should skip the missed dose and take the next dose the next day according to the established schedule. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Lercan

If the patient stops taking Lercan, their blood pressure may increase again.
Before stopping treatment, the patient should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their 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 this medicine:

Some side effects can be serious.

If the patient experiences any of the following side effects, they should immediately tell their doctor:

Rare (may affect up to 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 affect up to 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 affect up to 1 in 100 people): dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, increased urination, weakness, fatigue.
Rare (may affect up to 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Side effects can also be reported to the marketing authorization holder or parallel importer.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lercan

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should be stored in its original packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lercan contains

The active substance of Lercan is lercanidipine hydrochloride. One coated tablet of Lercan contains 10 mg of lercanidipine hydrochloride, which corresponds to 9.4 mg of lercanidipine.
The other ingredients are:
Core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, povidone K 30, magnesium stearate.
Coating: hypromellose, talc, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172).

What Lercan looks like and what the packaging contains

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 aluminum/PVC blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the 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

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Germany, the country of export:65405.00.00

Parallel import authorization number: 410/24

Date of leaflet approval: 21.11.2024

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