Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Lecalpin (Lercanidipine Actavis), 20 mg, coated tablets
Lercanidipini hydrochloridum
Lecalpin and Lercanidipine Actavis are different trade names of the same medicine.
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

What Lecalpin is and what it is used for
Important information before taking Lecalpin
How to take Lecalpin
Possible side effects
How to store Lecalpin
Contents of the pack and other information

1. What Lecalpin is and what it is used for

The active substance in Lecalpin, lercanidipine, belongs to a group of medicines called calcium channel blockers. These medicines inhibit the influx of calcium ions into the cells of the heart muscle and the blood vessels carrying blood from the heart to the periphery (arteries). Calcium influx into these cells causes contraction of the heart muscle and narrowing of the arteries. By blocking calcium influx, calcium channel blockers reduce the force of heart contractions, dilate arteries, and thereby lower blood pressure.
Lecalpin is used in the treatment of high blood pressure (hypertension).

2. Important information before using Lecalpin

When not to use Lecalpin:

if the patient is allergic to lerkanidipine or any of the other ingredients of this medicine (listed in section 6)
if the patient has certain heart conditions:
uncontrolled heart failure
outflow tract obstruction of the heart
unstable angina (angina at rest or progressively worsening)
if the patient has had a myocardial infarction within the last 4 weeks
if the patient has severe liver disease
if the patient has severe kidney impairment or is undergoing dialysis
if the patient is taking drugs which are inhibitors of the CYP3A4 isoenzyme:
antifungal agents (such as ketoconazole, itraconazole)

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macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
antiviral drugs (such as ritonavir)
during concomitant administration of cyclosporine
with grapefruit or grapefruit juice.

Warnings and precautions
Before starting treatment with Lecalpin, discuss with your doctor:

if the patient has a heart condition called sick sinus syndrome and does not have a cardiac pacemaker implanted;
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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking Lecalpin together with certain other medicines (see below) may alter the effect of these medicines or of Lecalpin.
It is particularly important to inform your doctor if the patient is taking any of the following medicines:

phenytoin, phenobarbital or carbamazepine (medicines used in the treatment of epilepsy);
rifampicin (a medicine used to treat tuberculosis);
midazolam (a medicine used to aid sleep);
cimetidine at doses exceeding 800 mg/day (a medicine used in peptic ulcer disease, dyspepsia or heartburn);
digoxin (a medicine used in the treatment of heart disorders);
terfenadine or astemizole (medicines used in the treatment of allergies);
amiodarone, quinidine or sotalol (medicines used in the treatment of rapid heart rate);
metoprolol (a medicine used in the treatment of 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 consume grapefruit or grapefruit juice, as this may increase the effect of the medicine.
Do not consume alcohol while taking Lecalpin. If alcohol is consumed during treatment with Lecalpin, dizziness/fainting, tiredness or weakness may occur, as alcohol may enhance the effect of Lecalpin.

Pregnancy and breastfeeding
Lecalpin is not recommended for use in pregnant women and should not be used during breastfeeding.
If the patient is pregnant or breastfeeding, not using effective contraception, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Driving and operating machinery
If dizziness, weakness or drowsiness occur while taking this medicine, the patient should not drive or operate machinery.

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Lecalpin contains monohydrate lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Lecalpin

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The following products are available on the market: Lecalpin 10 mg and Lecalpin 20 mg.
The recommended dose is 1 tablet of Lecalpin 10 mg once daily. The tablet should be taken
every day at the same time, preferably in the morning, at least 15 minutes before breakfast, because a meal
high in fat significantly increases the concentration of the drug in the blood.
If necessary, your 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 break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing, and does not allow for division into equal doses.
Use in children and adolescents
Lecalpin is not recommended for use in children and adolescents under 18 years of age.
Taking more Lecalpin than prescribed
Seek immediate medical advice from your doctor or go to the nearest hospital emergency department.
Taking an excessive dose may cause excessive lowering of arterial blood pressure and irregular or
accelerated heartbeat. It may also lead to headache and loss of consciousness.
If you miss a dose of Lecalpin
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that
case, do not take the missed dose; instead, take the next dose at the usual time. Do not take a double dose to
make up for a missed dose.
Stopping treatment with Lecalpin
If treatment with Lecalpin is stopped, high blood pressure may recur. Consult your doctor before
discontinuing treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious. If any of the following situations occur,
tell your doctor immediately:
Rare (may affect fewer than 1 in 1,000 people):
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angina (e.g. chest pain caused by reduced blood flow to the heart), allergic reactions (symptoms include: itching, rash, urticaria), fainting.
In patients with pre-existing angina, increased frequency, duration or severity of angina attacks may occur with the group of medicines to which Lecalpin belongs. Isolated cases of heart attack may be observed.
Other possible adverse effects:
Common (may affect fewer than 1 in 10 people):
headache, increased heart rate, palpitations, hot flushes (sudden redness of the face and neck), swelling around the ankles.
Uncommon (may affect fewer than 1 in 100 people):
dizziness, low blood pressure which may lead to fainting, indigestion, nausea, abdominal pain, rash, itching, muscle pain, passing large amounts of urine, weakness, fatigue.
Rare (may affect fewer than 1 in 1,000 people):
drowsiness, vomiting, diarrhoea, increased frequency of urination, chest pain.
Frequency not known (cannot be estimated from available data):
gum swelling, increased liver enzyme activity in blood, cloudy fluid (during dialysis using a catheter placed in the abdominal cavity), swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lecalpin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and cardboard box.
The expiry date refers to the last day of the specified month.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
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6. Contents of the pack and other information

What Lecalpin contains

The active substance is lercanidipine hydrochloride. 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 carboxymethyl starch (type A), monohydrate lactose, microcrystalline cellulose; Coating: Opadry II Pink 85F34564: polyethylene glycol 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 break line on one side and the mark "L" on the other.
The break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not guarantee equal dosing.
Packaging: 28 or 56 coated tablets in a cardboard box.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Lithuania, country of export:
Teva B.V.
Swensweg 5
2031 GA Haarlem, The 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation numbers in Lithuania, 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 licence number: 143/25
This medicinal product is authorised 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 plėvele dengtos tabletės
Poland Lecalpin
Slovenia Lecalpin
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