Lecalpin

Package Leaflet: Information for the User

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

Lecalpin (Lercanidipine Actavis), 20 mg, film-coated tablets

Lercanidipine hydrochloride
Lecalpin and Lercanidipine Actavis are different trade names for the same medicine.

Before taking the medicine, the patient should carefully read the contents of the leaflet, 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 patient 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Lecalpin and what is it used for

The active substance of Lecalpin, lercanidipine, belongs to a group of medicines called calcium antagonists. These medicines inhibit the influx of calcium ions into cardiac muscle cells and blood vessels leading from the heart to the periphery (arteries). The influx of calcium into these cells causes cardiac muscle contraction and arterial constriction. By blocking the influx of calcium ions, calcium antagonists weaken cardiac contraction and dilate arteries, resulting in a decrease in blood pressure. Lecalpin is used to treat high blood pressure (hypertension).

2. Important information before taking Lecalpin

When not to take Lecalpin:

• if the patient is allergic to lercanidipine or any of the other ingredients of this medicine (listed in section 6)
• if the patient has certain heart diseases:
• uncontrolled heart failure
• obstruction of the outflow of blood from the heart
• unstable angina pectoris (rest angina or progressively increasing angina)
• if the patient has had a heart attack within the last 4 weeks
• if the patient has severe liver disorders
• if the patient has severe kidney disorders or is undergoing dialysis
• if the patient is taking medicines that are inhibitors of the CYP3A4 isoenzyme:
• antifungal medicines (such as ketoconazole, itraconazole)

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• macrolide antibiotics (such as erythromycin, troleandomycin, or clarithromycin)
• antiviral medicines (such as ritonavir)
• while taking cyclosporine
• with grapefruit or grapefruit juice.

Warnings and precautions

Before starting to take Lecalpin, the patient should discuss this with their doctor:

• if the patient has a heart disease called sick sinus syndrome and does not have a pacemaker;
• if the patient has other heart diseases or experiences chest pain (angina pectoris);
• if the patient has liver or kidney disorders or is undergoing dialysis.

Lecalpin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Taking Lecalpin with certain other medicines (see below) may change the effect of these medicines or Lecalpin. It is especially important to inform the doctor about taking any of the following medicines:

• phenytoin, phenobarbital, or carbamazepine (medicines used to treat epilepsy);
• rifampicin (a medicine used to treat tuberculosis);
• midazolam (a medicine that facilitates sleep);
• cimetidine in a dose greater than 800 mg/day (a medicine used to treat stomach ulcers, indigestion, or heartburn);
• digoxin (a medicine used to treat heart rhythm disorders);
• terfenadine or astemizole (medicines used to treat allergies);
• amiodarone, quinidine, or sotalol (medicines used to treat rapid heart rate);
• metoprolol (a medicine used to treat high blood pressure);
• simvastatin (a medicine that lowers cholesterol levels);
• other medicines used to treat high blood pressure.

Lecalpin with food, drink, and alcohol

The patient should not consume grapefruits or grapefruit juice, as this may increase the effect of the medicine. The patient should not drink alcohol while taking Lecalpin, as this may cause dizziness, fainting, fatigue, or weakness, as alcohol may increase the effect of Lecalpin.

Pregnancy and breastfeeding

Lecalpin is not recommended for pregnant women and should not be used during breastfeeding. If the patient is pregnant or breastfeeding, or is not using effective contraception, if they suspect they may be pregnant, or plan to have a child, they should consult their doctor before taking this medicine.

Driving and using machines

If the patient experiences dizziness, weakness, or drowsiness while taking this medicine, they should not drive or operate machinery. Page 2 of 6

Lecalpin contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Lecalpin

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. Lecalpin is available in 10 mg and 20 mg strengths. The recommended dose is 1 tablet of 10 mg once daily. The tablet should be taken daily at the same time, preferably in the morning, at least 15 minutes before breakfast, as a meal with a high fat content significantly increases the concentration of the medicine in the blood. If necessary, the doctor may decide to increase the dose of Lecalpin to 1 tablet of 20 mg once daily. The tablets should be swallowed whole, with half a glass of water. The dividing line on the tablet is only to facilitate breaking it, not to divide it into equal doses.

Use in children and adolescents

Lecalpin is not recommended for children and adolescents under 18 years of age.

Overdose of Lecalpin

The patient should immediately contact their doctor or go to the emergency room of the nearest hospital. Taking too much of the medicine may cause excessive lowering of blood pressure and irregular or rapid heart rate. It may also lead to headache and loss of consciousness.

Missed dose of Lecalpin

If a dose is missed, the patient should take it as soon as they remember, unless it is almost time for the next dose. In this case, the missed dose should not be taken, and the next dose should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping Lecalpin treatment

If the patient stops taking Lecalpin, their blood pressure may rise again. Before stopping the 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, Lecalpin can cause side effects, although not everybody gets them.

Some side effects may be serious. If any of the following situations occur, the patient should immediately inform their doctor:

Rare (may affect up to 1 in 1000 people):
angina pectoris (e.g., chest pain caused by lack of blood flow to the heart), allergic reactions (symptoms are: itching, rash, hives), fainting.
In patients with pre-existing angina pectoris, an increased frequency, duration, or severity of these episodes may occur in the group of medicines to which Lecalpin belongs. Single cases of heart attack may be observed.

Other possible side effects:

Common (may affect up to 1 in 10 people):
headache, rapid heart rate, palpitations, hot flashes (sudden reddening of the face and neck), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people):
dizziness, low blood pressure, which may lead to fainting, nausea, abdominal pain, rash, itching, muscle pain, increased urination, weakness, fatigue.
Rare (may affect up to 1 in 1000 people):
drowsiness, vomiting, diarrhea, increased frequency of urination, chest pain.
Frequency not known (frequency cannot be estimated from the available data):
gum swelling, increased liver enzyme activity in the blood, cloudy 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 inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lecalpin

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 blister pack and carton. The expiry date refers to the last day of the month. The medicine should not be stored above 30°C. The medicine should be stored in its original packaging to protect it from moisture. 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. Page 4 of 6

6. Contents of the pack and other information

What Lecalpin contains

• The active substance is lercanidipine hydrochloride. One film-coated tablet contains 20 mg of lercanidipine hydrochloride, which corresponds to 18.8 mg of lercanidipine. The other ingredients are: magnesium stearate, povidone K 29/32, sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose; Coating:Opadry II Pink 85F34564: macrogol 3350, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Lecalpin looks like and contents of the pack

Pink, round, biconvex film-coated tablets, 8.5 mm in diameter, with a dividing line on one side and the marking "L" on the other side. The dividing line on the tablet is only to facilitate breaking it, not to divide it into equal doses. The pack contains 28 or 56 film-coated tablets in a carton. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Teva B.V. Swensweg 5 2031 GA Haarlem, Netherlands

Manufacturer:

Balkanpharma – Dupnitsa AD 3 Samokovsko Str. Dupnitsa 2600, Bulgaria Actavis Ltd. BLB015-016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta

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 License number in Lithuania, the country of export: LT/1/09/1764/014 LT/1/09/1764/013 LT/1/09/1764/019 LT/1/09/1764/020

Parallel import license number: 143/25

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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Bulgaria Lecalpin Estonia Lerkanidipin Actavis 20 mg Hungary Lecalpin Latvia Lercanidipin Actavis Lithuania Lerkanidipin Actavis 20 mg film-coated tablets Poland Lecalpin Slovenia Lecalpin

Date of approval of the leaflet: 15.04.2025

[Information about the trademark]
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