Package leaflet: Information for the patient

Lerakta, 10 mg, coated tablets
Lerakta, 20 mg, coated tablets
Lercanidipini hydrochloridum
Please read this leaflet carefully before taking this medicine, as 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.

Leaflet contents

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

1. What Lerakta is and what it is used for

Lerakta belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives), which lower blood pressure.
Lerakta is used to treat high blood pressure (hypertension) in adults aged 18 years and older (the medicine is not recommended for use in children and adolescents under 18 years of age).

2. Important information before taking Lerakta

When not to take Lerakta:

if the patient is allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
if the patient has certain heart diseases:
aortic stenosis
untreated heart failure
unstable angina (chest pain at rest or with increasing severity)
within 1 month following a myocardial infarction
if the patient has severe liver disease
if the patient has severe renal function impairment or is undergoing dialysis
if the patient is taking the following medicines, which are inhibitors of hepatic metabolism:
antifungal medicines (such as ketoconazole or itraconazole)
macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
antiviral medicines (such as ritonavir)
if the patient is taking another medicine called cyclosporine (used after organ transplantation to prevent rejection)
if the patient consumes grapefruit or drinks grapefruit juice.

Warnings and precautions
Before starting treatment with Lerakta, discuss this with your doctor or pharmacist:

if the patient has heart diseases,
if the patient has liver or kidney disease.

Inform your doctor if you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding
(see section “Pregnancy, breastfeeding and fertility”).
Children and adolescents
The safety and efficacy of Lerakta in children and adolescents under 18 years of age have not been established.
Lerakta 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. If Lerakta is taken simultaneously with other medicines, its effect or the effect of other medicines may change, and the frequency of adverse reactions may also increase (see also section 2, subsection “When not to take Lerakta”).
Inform your doctor or pharmacist, especially 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)
astemizole or terfenadine (antiallergic medicines)
amiodarone, quinidine or sotalol (medicines used in the case of rapid heart rate)
midazolam (a sedative medicine)
digoxin (a medicine used in the treatment of heart diseases)
beta-blockers, e.g. metoprolol (medicines used in the treatment of high blood pressure, heart failure and cardiac arrhythmias)
cimetidine (at doses exceeding 800 mg per day; a medicine used in peptic ulcer disease, indigestion or heartburn)
simvastatin (a medicine that reduces blood cholesterol levels)
other medicines used to treat high blood pressure.

Lerakta with food, drink and alcohol

Taking a high-fat meal significantly increases the drug concentration in blood (see section 3).
Alcohol may enhance the effect of Lerakta. Do not drink alcohol during treatment with Lerakta.
Do not take Lerakta together with grapefruit or grapefruit juice (this may enhance the blood pressure-lowering effect). See section 2, subsection “When not to take Lerakta”.

Pregnancy and breastfeeding
Lerakta is not recommended during pregnancy and should not be used during breastfeeding. There are no data on the use of Lerakta in pregnant or breastfeeding women. If the patient is pregnant or breastfeeding, is not using any contraceptive method, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
If the patient experiences dizziness, weakness or drowsiness while taking this medicine, driving vehicles or operating machinery should be avoided.
Lerakta contains 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.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Lerakta

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults
The recommended dose is 10 mg once daily, taken every day at the same time, preferably in the morning, at least 15 minutes before breakfast. If necessary, the doctor may recommend increasing the dose to one tablet of Lerakta 20 mg once daily (see also section 2, subsection “Lerakta with food, drink and alcohol”). The tablets should be swallowed whole, with a sufficient amount of water.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Elderly patients
No adjustment of the daily dose is necessary. However, particular caution should be exercised at the beginning of treatment.
Patients with impaired liver or kidney function
Particular caution should be exercised at the beginning of treatment and when increasing the daily dose to 20 mg in these patients.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.
Taking more Lerakta than recommended
Do not take more than the recommended dose. If you have taken more than the recommended dose, contact a doctor immediately or go to the emergency department of the nearest hospital. Take the medicine pack with you. Taking a higher than recommended dose may cause excessive lowering of blood pressure and irregular or rapid heartbeat.
Missing a dose of Lerakta
If a dose is missed, skip the missed dose and take the next dose at the usual time the following day. Do not take a double dose to make up for a missed dose.
Stopping treatment with Lerakta
If treatment with Lerakta is stopped, blood pressure may rise again. Consult your doctor before discontinuing treatment.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur during treatment with this medicine:
Some adverse reactions may be serious

if any of the following symptoms occur, contact your doctor immediately

Rare (may occur in less than 1 in 1,000 people):
angina pectoris (e.g. chest tightness caused by insufficient blood flow to the heart), allergic reactions (with symptoms such as itching, rash, urticaria), fainting.
In patients who have previously experienced angina pectoris, treatment with medicines of the class to which Lerakta belongs may lead to increased frequency, prolonged duration, or worsening of angina attacks. In isolated cases, myocardial infarction may occur.
Other possible adverse reactions:
Common (may occur in less than 1 in 10 people):
headache, rapid heartbeat, palpitations (sensation of fast or irregular heartbeat), sudden flushing of the face, neck or upper chest, swelling of the ankle area.
Uncommon (may occur in less than 1 in 100 people):
dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, excessive urination, weakness, fatigue.
Rare (may occur in less than 1 in 1,000 people):
drowsiness, vomiting, diarrhoea, urticaria, more frequent urination than usual, chest pain.
Frequency not known (frequency cannot be estimated from available data):
gingival swelling, liver function abnormalities (detected in blood tests), clouding of the fluid (during peritoneal dialysis using a catheter placed in the abdominal cavity), facial, lip, tongue or throat swelling, 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, inform 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
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Lerakta

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following:
EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Storage conditions:
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lerakta contains

The active substance is lerkanidipine hydrochloride.
Lerakta 10 mg, coated tablets: One tablet contains 10 mg of lerkanidipine hydrochloride, equivalent to 9.4 mg of lerkanidipine.
Lerakta 20 mg, coated tablets: One tablet contains 20 mg of lerkanidipine hydrochloride, equivalent to 18.8 mg of lerkanidipine.
Other ingredients are:
Tablet core: magnesium stearate, povidone (K30), sodium carboxymethyl starch (type A), monohydrate lactose, microcrystalline cellulose (PH-101).
Coating composition:
Lerakta 10 mg, coated tablets: macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172).
Lerakta 20 mg, coated tablets: macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Lerakta looks like and contents of the pack
Lerakta 10 mg, coated tablets are yellow, round, biconvex coated tablets with a diameter of 6.5 mm, with a score line on one side and the mark "L" on the other side.
Lerakta 20 mg, coated tablets are pink, round, biconvex coated tablets with a diameter of 8.5 mm, with a score line on one side and the mark "L" on the other side.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure division into equal doses.
Packaging:
Aluminum/PVC/PVDC foil blisters containing 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Balkanpharma Dupnitsa AD
Samokovsko Shosse Str. 3
2600 Dupnitsa
Bulgaria