Package leaflet: Information for the user

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Lecalpin (Lercanidipine Actavis), 10 mg, film-coated tablets
Lercanidipini hydrochloridum
Lecalpin and Lercanidipine Actavis are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further 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 other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Lecalpin is and what it is used for
What you need to know 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 into 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 contraction and dilate the arteries, thereby lowering 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 diseases:
- uncontrolled heart failure
- obstructive outflow tract disease 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 disorders
if the patient has severe kidney disorders or is undergoing dialysis
if the patient is taking drugs which are inhibitors of the CYP3A4 isoenzyme:
- antifungal agents (such as ketoconazole, itraconazole)
- 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 this with your doctor:

if the patient has a heart condition known as sick sinus syndrome and does not have a 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 and 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 with certain other medicines (see below) may alter the effect of these medicines or of Lecalpin.
It is especially important to inform the 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 facilitating sleep);
cimetidine at doses greater than 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 allergy);
amiodarone, quinidine or sotalol (medicines used in fast heart rate);
metoprolol (a medicine used in the treatment of high blood pressure);
simvastatin (a medicine reducing cholesterol levels);
other medicines used in the treatment of high blood pressure.

Lecalpin with food, drink and alcohol
Do not consume grapefruit or grapefruit juice, as this may enhance the effect of the medicine.
Do not consume alcohol during treatment with Lecalpin. Consumption of alcohol while taking Lecalpin may cause dizziness/fainting, feeling of fatigue or weakness, as alcohol may enhance 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 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 during treatment with 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 contact the 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 use Lecalpin

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
Available on the market are: 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, as a meal high in fat significantly increases the drug concentration in the blood.
If necessary, the doctor may decide to increase the dose of Lecalpin to 1 tablet of 20 mg once daily.
Tablets should be swallowed whole with half a glass of water.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not indicate 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 recommended
Seek immediate medical advice from a doctor or go to the emergency department of the nearest hospital.
Taking an excessive dose may cause excessive lowering of blood pressure and irregular or rapid heartbeat. It may also lead to headache and loss of consciousness.

If you miss a dose of Lecalpin
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. In that case, do not take the missed dose but 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 discontinued, blood pressure may rise again. Consult your doctor before stopping the medication.

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 experiences 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, hives), fainting.
In patients who previously had 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 1 in 1,000 people):
drowsiness, vomiting, diarrhoea, increased frequency of urination, chest pain.
Frequency not known (frequency 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 adverse effects 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 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
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 the outer carton.
The expiry date refers to the last day of the stated month.
Store below 30°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
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6. Contents of the pack and other information

What Lecalpin contains

The active substance is lerkanidipine hydrochloride. One coated tablet contains 10 mg of lerkanidipine hydrochloride, equivalent to 9.4 mg of lerkanidipine.
The other ingredients are: magnesium stearate, povidone K 29/32, sodium carboxymethyl starch (type A), lactose monohydrate, microcrystalline cellulose;
Coating: polyethylene glycol 3350, partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E 171), iron oxide yellow (E 172).

What Lecalpin looks like and contents of the pack
Yellow, round, biconvex coated tablets with a diameter of 6.5 mm, with a division line on one side and the mark "L" on the other.
The division line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Pack sizes: 28 or 56 coated tablets in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Latvia, country of export:
Teva B.V.
Swensweg 5
2031 GA Haarlem, The Netherlands

Manufacturer:
Balkanpharma – Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Actavis Ltd., BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Actavis ehf., Reykjavikurvegur 78, 220 Hafnarfjörður, Iceland

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorization Number in Latvia, country of export: 09-0290
Parallel Import Authorization Number: 290/25

This medicinal product is authorized for marketing in the European Economic Area countries under the following names:
Bulgaria Lecalpin
Estonia Lerkanidipin Actavis 10 mg
Hungary Lecalpin
Latvia Lercanidipin Actavis
Lithuania Lerkanidipin Actavis 10 mg plėvele dengtos tabletės
Poland Lecalpin
Slovenia Lecalpin
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