Lecalpin

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging 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 the entire leaflet carefully before taking 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms appear identical.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Lecalpin is and what it is 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 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 ion influx, calcium channel blockers reduce the force of heart contraction, 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 lacidipine 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 cardiomyopathy
• unstable angina (angina at rest or progressively worsening)
• if the patient has suffered a myocardial infarction within the last 4 weeks
• if the patient has severe liver disease
• if the patient has severe renal impairment 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)
• when taking cyclosporine concomitantly
• 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 any other medicines the patient is currently taking, has recently taken, or 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 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 greater than 800 mg/day (a medicine used in peptic ulcer disease, dyspepsia or heartburn)
• digoxin (a medicine used to treat heart disorders)
• terfenadine or astemizole (medicines used for allergies)
• amiodarone, quinidine or sotalol (medicines used for 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 consume grapefruit or grapefruit juice, as this may increase the effect of the medicine.
Do not consume alcohol while being treated with Lecalpin. Drinking alcohol during treatment with Lecalpin may cause dizziness/fainting, fatigue or weakness, 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, 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 lactose monohydrate and sodium
If the patient has been previously 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. it is considered "sodium-free".

3. How to use Lecalpin

This medicine should always be taken as recommended by your doctor. If in doubt, consult your
doctor or pharmacist.
The following preparations are available on 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 rich in fat 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 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 allow for dividing 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 your doctor or go to the nearest hospital emergency department.
Taking too high a dose may cause excessive lowering of blood pressure and irregular or rapid heart
action. It may also lead to headache and loss of consciousness.

If you miss a dose of Lecalpin
If you forget to take 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, but take the next dose at the usual time. Do not take
a double dose to make up for a missed one.

Stopping Lecalpin
If you stop taking Lecalpin, high blood pressure may return. Consult your doctor before stopping
treatment.
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 occur in 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 when taking drugs from the same class as Lecalpin. Isolated cases of myocardial infarction may be observed.

Other possible adverse reactions:
Common (may occur in less than 1 in 10 people):
headache, increased heart rate, palpitations, hot flushes (sudden redness of the face and neck), swelling of the ankle area.

Uncommon (may occur in less than 1 in 100 people):
dizziness, drop in blood pressure which may lead to fainting, indigestion, nausea, abdominal pain, rash, itching, muscle pain, increased volume of urine, weakness, fatigue.

Rare (may occur in 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 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 for 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 this medicine can be collected.

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 packaging. The expiry date refers to the last day of the stated 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. Such measures will help protect the environment.

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.
• Other ingredients are: magnesium stearate, povidone (K-29/32), sodium carboxymethyl starch (type A), monohydrate lactose, microcrystalline cellulose.
  Coating: Opadry II Yellow 85F32553: polyethylene glycol 3350, partially hydrolyzed 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, 6.5 mm in diameter, with a break line on one side and the mark "L" on the other.
The break line is intended only to facilitate tablet fragmentation 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 Lithuania, the exporting country:
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:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland

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

Marketing Authorisation Numbers in Lithuania, the exporting country:
LT/1/09/1764/003
LT/1/09/1764/023

Parallel Import Authorisation Number: 328/25

This medicine is authorised for sale 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