Lercan

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

LERCAN (Lercanidipine-Omniapharm)

20 mg, film-coated tablets
Lercanidipine hydrochloride
LERCAN and Lercanidipine-Omniapharm are different trade names for the same medicine.

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• 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 inform 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 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 channel blockers (dihydropyridine derivatives), which lower blood pressure.
Lercan is used to treat mild to moderate 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 any of the other ingredients of this medicine (listed in section 6)
• if the patient has certain heart diseases:
• narrowing of the blood vessel leaving the heart
• untreated heart failure
• unstable angina (chest pain at rest or with increasing severity)
• heart attack 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 "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 taking, have recently taken, or 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 (antihistamines)
• amiodarone, quinidine, or sotalol (medicines used to treat fast heart rhythm)
• midazolam (a sedative)
• 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. The patient should not consume alcohol while taking Lercan.
• The patient should not take Lercan with grapefruit or grapefruit juice (this may increase 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, breastfeeding, or planning 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 consult their doctor before taking the medicine.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it 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 10 mg and 20 mg strengths.
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 per day (see section 2, subsection "Lercan with food, drink, and alcohol").
• The score line on the 10 mg tablet 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:

• Caution should be exercised 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.
If a higher dose than recommended is taken, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital. They should take the medicine packaging with them.
Taking a higher dose than recommended may cause excessive lowering of blood pressure and irregular or rapid heart rhythm.

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 following 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 may be serious.

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

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, urticaria), 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, a heart attack may occur.

Other possible side effects:

Common (may occur in less than 1 in 10 people): headache, rapid heart rhythm, feeling of rapid or irregular heart rhythm (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, increased urination, weakness, fatigue.
Rare (may occur in less than 1 in 1000 people): drowsiness, vomiting, diarrhea, urticaria, 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 suspected side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered 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.
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 pack and other information

What Lercan contains

• The active substance of Lercan is lercanidipine hydrochloride. One film-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 carboxymethyl cellulose, 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 film-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 aluminum/PVC blisters in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 65406.00.00

Parallel import authorization number: 347/16 Date of approval of the leaflet: 15.11.2022

[Information about the trademark]