Lecalpin

Leaflet attached to the packaging: information for the user

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

Lecalpin (Lercanidipine Actavis), 20 mg, coated tablets
Lercanidipine hydrochloride
Lecalpin and Lercanidipine Actavis are different trade names for the same medicine.

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

• You should keep this leaflet, so that you can read it again if you need to.
• 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 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 packaging 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 cells of the heart muscle and blood vessels that carry blood from the heart to the periphery (arteries). The influx of calcium into these cells causes the heart muscle to contract and the arteries to constrict. By blocking the influx of calcium ions, calcium antagonists weaken the heart's contraction and dilate the arteries, which leads to 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 (angina at rest or progressively increasing)
• if the patient has had a heart attack in 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)
• 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, you should discuss it with your 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

You should 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 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, heartburn, or gastroesophageal reflux disease)
• 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

You should not eat grapefruits or drink grapefruit juice, as it may increase the effect of the medicine. You should 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 suspect you may be pregnant, or when planning to have a child, you should consult your doctor before taking this medicine.

Driving and using machines

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

Lecalpin contains lactose monohydrate and sodium

If you have previously been diagnosed with intolerance to some sugars, you should contact your 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 your doctor. If you have any doubts, you should consult your doctor or pharmacist. Lecalpin (10 mg) and Lecalpin (20 mg) are available on the market. The recommended dose is 1 tablet of Lecalpin 10 mg once a day. 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, your doctor may decide to increase the dose of Lecalpin to 1 tablet of 20 mg once a day. 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.

Taking a higher dose of Lecalpin than recommended

You should immediately contact your 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.

Missing a dose of Lecalpin

If you miss a dose, you should take it as soon as you remember, unless it is almost time for the next dose. In this case, you should not take the missed dose, but take the next one at the usual time. You should 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, you should consult your doctor. If you have any further doubts about taking this medicine, you should consult 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, you should immediately tell your 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 activity of liver enzymes 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 any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Lecalpin

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Do not store above 30°C. Store in the original packaging to protect from moisture. Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Lecalpin contains

• The active substance is lercanidipine hydrochloride. One 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: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 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. Packs of 28 and 56 tablets. For more detailed information on the medicine, you 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Lithuania, the country of export:LT/1/09/1764/014
LT/1/09/1764/019

Parallel import authorization number: 177/24

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

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

Date of revision of the leaflet: 26.04.2024

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