Package leaflet: Information for the user

Warning! Keep this leaflet! 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 medicinal product.
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 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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 known as 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 ion influx, calcium channel blockers reduce the force of heart contraction, dilate arteries, and thereby lower arterial 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
left ventricular outflow tract obstruction
unstable angina pectoris (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 that 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)
when co-administered with 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 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 together 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 used to aid sleep)
cimetidine at doses exceeding 800 mg/day (a medicine used in peptic ulcer disease, indigestion or heartburn)
digoxin (a medicine used to treat heart disorders)
terfenadine or astemizole (medicines used in allergy)
amiodarone, quinidine or sotalol (medicines used in fast 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 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 pregnant women and should not be used during breastfeeding.
If the patient is pregnant or breastfeeding, or is 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 occurs while taking this medicine, the patient should not drive or operate machinery.

Lecalpin contains monohydrate lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their 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 exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The following are available in the market: Lecalpin (10 mg), 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, since a
meal high in fat significantly increases the drug concentration 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 division line on the tablet is intended only to facilitate breaking for easier swallowing and does
not allow for dividing the tablet 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 a doctor or go to the nearest hospital emergency department.
Taking an excessive dose may cause excessive lowering of blood pressure and irregular or rapid
heart rate. It may also lead to headache and loss of consciousness.

If you forget to take 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, skip the missed dose and take the next one at the regular time. Do not take a double dose
to make up for a forgotten dose.

Stopping Lecalpin
If you stop taking Lecalpin, high blood pressure may return. Consult your doctor before stopping
treatment with this medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious. If any of the following
situations occur, tell your doctor immediately:
Rare (may affect less than 1 in 1,000 people):
angina pectoris (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 pectoris, increased frequency, duration or severity of attacks may occur with the group of medicines to which Lecalpin belongs. Isolated cases of myocardial infarction may be observed.
Other possible adverse reactions:
Common (may affect less 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 less than 1 in 100 people):
dizziness, low blood pressure which may lead to fainting, indigestion, nausea, abdominal pain, rash, itching, muscle pain, increased urine output, 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):
gingival 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can 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, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 packaging. The expiry date refers to the last day of the mentioned month.
Store below 30°C. Keep 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Lecalpin contains

The active substance is lercanidipine hydrochloride. Each coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
Other ingredients are: magnesium stearate, povidone (K-29/32), sodium carboxymethyl starch (type A), monohydrate lactose, microcrystalline cellulose.
Coating: polyethylene glycol 3350, partially hydrolysed polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (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 side.
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, 30, 56 and 60 coated tablets.
For more detailed information about this medicine, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Latvia, country of export: 09-0290
Parallel Import Authorisation Number: 400/24

This medicinal product is authorised in the European Economic Area (EEA) Member States 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