LECALPIN

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 for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 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 diseases:
• uncontrolled heart failure
• obstructive heart valve disease
• 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 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)
• when taken concomitantly with 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 called 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 disorders of the liver or kidneys, 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 particularly 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 to aid sleep)
• cimetidine at doses greater than 800 mg/day (a medicine used in peptic ulcer disease, indigestion or heartburn)
• digoxin (a medicine used in the treatment of 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 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 plans to become pregnant, she should consult a 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 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 directed by your doctor. If in doubt, consult your doctor or pharmacist.

The following products 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, as 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.

Swallow the tablets whole with half a glass of water.

The break line on the tablet is intended only to facilitate breaking for easier swallowing and does not indicate an equal division into 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 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 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 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions may be serious. If any of the following situations occur,
tell your doctor immediately:
Rare (may affect fewer than 1 in 1,000 people):
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 myocardial infarction may be observed.

Other possible adverse reactions:
Common (may affect fewer than 1 in 10 people):
headache, increased heart rate, palpitations, hot flushes (sudden redness of the face and neck), swelling of 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, increased volume 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 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 Reactions of Medicinal Products at 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 in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Lecalpin contains

• The active substance is lerkanidipine hydrochloride. One coated tablet contains 20 mg of lerkanidipine hydrochloride, equivalent to 18.8 mg of lerkanidipine.
• The other ingredients are: magnesium stearate, povidone (K-29/32), sodium carboxymethyl starch (type A), monohydrate lactose, microcrystalline cellulose.
  Coating: 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 score line on one side and the mark "L" on the other side.
The score line is intended only to facilitate tablet breaking for easier swallowing and does not ensure equal dose division.
Pack sizes: 28 and 56 tablets.
For further information about this medicine, please 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

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

Marketing authorisation numbers in Lithuania, country of export:
LT/1/09/1764/014
LT/1/09/1764/019

Parallel import authorisation number: 177/24

This medicinal product is authorised in the European Economic Area (EEA) under the following names:
Bulgaria Lecalpin
Estonia Lerkanidipin Actavis 20 mg
Hungary Lecalpin
Latvia Lercanidipin Actavis
Lithuania Lerkanidipin Actavis 20 mg plėvele dengtos tabletės
Poland Lecalpin
Slovenia Lecalpin