LECALPIN 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
2. What is Lecalpin and what is it used for
3. Important information before taking Lecalpin
   1. When not to take Lecalpin
   2. Warnings and precautions
   3. Lecalpin and other medicines
   4. Lecalpin with food, drink and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Lecalpin contains lactose and sodium
4. How to take Lecalpin
   1. Use in children and adolescents
   2. Taking a higher dose of Lecalpin than recommended
   3. Missing a dose of Lecalpin
   4. Stopping treatment with Lecalpin
5. Possible side effects
   1. Some side effects may be serious. If you experience any of the following, tell your doctor immediately:
   2. Other possible side effects:
   3. Reporting side effects
6. How to store Lecalpin
7. Contents of the pack and other information
   1. What Lecalpin contains
   2. What Lecalpin looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Lecalpin, 10 mg, coated tablets
Lecalpin, 20 mg, coated tablets
Lercanidipine hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. 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 the cardiac muscle cells and blood vessels carrying blood 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, and cause 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 you are allergic to lercanidipine or any of the other ingredients of this medicine (listed in section 6)
• if you have certain heart diseases:
• uncontrolled heart failure
• obstruction of the outflow of blood from the heart
• unstable angina (angina at rest or progressively increasing)
• if you have had a heart attack within the last 4 weeks
• if you have severe liver disorders
• if you have severe kidney disorders or are undergoing dialysis
• if you are taking medicines that are inhibitors of the CYP3A4 isoenzyme:
• antifungal medicines (such as ketoconazole, itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
• antiviral medicines (such as ritonavir)
• while taking cyclosporin
• with grapefruit or grapefruit juice

Warnings and precautions

Before starting treatment with Lecalpin, you should discuss it with your doctor:

• if you have a heart disease called sick sinus syndrome and you do not have a pacemaker
• if you have other heart diseases or experience chest pain (angina pectoris).
• if you have liver or kidney disorders or are undergoing dialysis therapy.

Lecalpin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you 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 your doctor 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)
• midazolam (a medicine that facilitates sleep)
• cimetidine at a dose greater than 800 mg/day (a medicine used to treat stomach ulcers, heartburn or acid reflux)
• 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

Do not eat grapefruits or drink grapefruit juice, as it may increase the effect of the medicine.
Do not drink alcohol while taking Lecalpin. If you drink alcohol while taking Lecalpin, you may experience 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 you are pregnant or breastfeeding, or do not use effective contraception, if you think you may be pregnant or plan to have a child, consult your doctor before taking this medicine.

Driving and using machines

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

Lecalpin contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered to be "sodium-free".

3. How to take Lecalpin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 10 mg Lecalpin tablet per day. Take the tablet every day 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, your doctor may decide to increase the dose of Lecalpin to one 20 mg tablet per day.
Swallow the tablets whole with a half glass of water.
The dividing line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and 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.

Taking a higher dose of Lecalpin than recommended

Contact your doctor or go to the emergency department of the nearest hospital immediately.
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.

Missing a dose of Lecalpin

If you miss a dose, take it as soon as you remember, unless it is almost time for the next dose. In this case, do not take the missed dose, just take the next one at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Lecalpin

If you stop taking Lecalpin, your blood pressure may rise again. Before stopping treatment, consult your doctor.
If you have any further questions about the use of this medicine, ask your 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 you experience any of the following, tell your doctor immediately:

Rare (may affect up to 1 in 1000 people):
angina (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, 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, flushing (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, vomiting, 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 you experience any side effects, including those not listed in this leaflet, please tell your doctor 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, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lecalpin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after: EXP. The expiry date refers to the last day of the month.
Do not store above 30°C. Store in the original package to protect from moisture.
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 Lecalpin contains

• The active substance is lercanidipine hydrochloride. Lecalpin, 10 mg: one coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine. Lecalpin, 20 mg: one coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
• The other ingredients are: magnesium stearate, povidone (K-29/32), sodium carboxymethylcellulose type A, lactose monohydrate, microcrystalline cellulose (Avicel PH-101) coating:Lecalpin, 10 mg: Opadry II Yellow 85F32553: macrogol 3350, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172),

Lecalpin, 20 mg: 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

Lecalpin, 10 mg, coated tablets: yellow, round, biconvex coated tablets with a diameter of 6.5 mm, with a dividing line on one side and the marking "L" on the other side.
Lecalpin, 20 mg, coated tablets: pink, round, biconvex coated tablets with a diameter of 8.5 mm, 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 the tablet to make it easier to swallow, and not to divide it into equal doses.
Pack sizes: 28, 30 and 56 tablets.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

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

Bulgaria
Lecalpin
Estonia
Lerkanidipin Actavis 10 mg
Lerkanidipin Actavis 20 mg
Hungary
Lecalpin
Latvia
Lercanidipin Actavis
Lithuania
Lerkanidipin Actavis 10 mg film-coated tablets
Lerkanidipin Actavis 20 mg film-coated tablets
Poland
Lecalpin
Slovenia
Lecalpin
Date of last revision of the leaflet:August 2023