Lerakta

Package Leaflet: Information for the Patient

Lerakta, 10 mg, coated tablets

Lerakta, 20 mg, coated tablets

Lercanidipine hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lerakta and what is it used for
• 2. Important information before taking Lerakta
• 3. How to take Lerakta
• 4. Possible side effects
• 5. How to store Lerakta
• 6. Contents of the pack and other information

1. What is Lerakta and what is it 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 in adults over 18 years of age (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 you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have certain heart diseases:
• narrowing of the blood vessels leaving the heart
• untreated heart failure
• unstable angina (chest pain at rest or worsening)
• within 1 month of a heart attack
• if you have severe liver disease
• if you have severe kidney problems or are undergoing dialysis
• if you are taking certain medicines that inhibit liver metabolism:
• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
• antiviral medicines (such as ritonavir)
• if you are taking another medicine called cyclosporin (used after organ transplantation to prevent rejection)
• if you consume grapefruit or drink grapefruit juice.

Warnings and precautions

Before starting treatment with Lerakta, discuss it with your doctor or pharmacist:

• if you have heart disease,
• if you have liver or kidney disease.

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, as well as if you are breastfeeding (see "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 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. If Lerakta is taken with other medicines, its effect or the effect of other medicines may change, and the frequency of side effects may increase (see also section 2, subsection "When not to take Lerakta").
Tell your doctor or pharmacist, especially if you are taking any of the following medicines:

• phenytoin, phenobarbital, or carbamazepine (medicines used to treat epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• astemizole or terfenadine (antihistamines)
• amiodarone, quinidine, or sotalol (medicines used for rapid heart rate)
• midazolam (a sedative)
• digoxin (a medicine used to treat heart conditions)
• beta-blockers, such as metoprolol (medicines used to treat high blood pressure, heart failure, and heart rhythm disorders)
• cimetidine (in doses greater than 800 mg per day; a medicine used to treat stomach ulcers, indigestion, or heartburn)
• simvastatin (a medicine that lowers blood cholesterol levels)
• other medicines used to treat high blood pressure.

Lerakta with food, drink, and alcohol

• Eating a meal high in fat significantly increases the concentration of the medicine in the blood (see section 3).
• Alcohol may enhance the effect of Lerakta. Do not drink alcohol while taking Lerakta.
• Do not take Lerakta with grapefruit or grapefruit juice (may enhance the blood pressure-lowering effect). See section 2, subsection "When not to take Lerakta".

Pregnancy and breastfeeding

Lerakta should not be used during pregnancy and breastfeeding. There are no data on the use of Lerakta in pregnant or breastfeeding women. If you are pregnant, think you may be pregnant, do not use any contraceptive method, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

If you experience dizziness, weakness, or drowsiness while taking this medicine, do not drive or operate machinery.

Lerakta contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Lerakta

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults

The recommended dose is 10 mg once daily, taken at the same time every day, preferably in the morning, at least 15 minutes before breakfast. If necessary, your doctor may increase the dose to one 20 mg Lerakta tablet per day (see also section 2, subsection "Lerakta with food, drink, and alcohol"). Swallow the tablets whole with a sufficient amount of water.

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age.

Elderly patients

No dose adjustment is necessary. However, caution should be exercised at the start of treatment.

Patients with liver or kidney problems

Caution should be exercised at the start of treatment and when increasing the daily dose to 20 mg.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Taking more than the recommended dose of Lerakta

Do not take more than the recommended dose. If you have taken more than the recommended dose, contact your doctor or go to the emergency department of your nearest hospital immediately. Take the medicine package with you. Taking more than the recommended dose may cause excessive lowering of blood pressure and irregular or rapid heart rate.

Missing a dose of Lerakta

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

Stopping treatment with Lerakta

If you stop taking Lerakta, your blood pressure may rise again.
Before stopping treatment, consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lerakta can cause side effects, although not everybody gets them.
The following side effects may occur while taking this medicine:

Some side effects can be serious

• if you experience any of the following symptoms, contact your doctor immediately

Rare (may affect up to 1 in 1,000 people):
angina (e.g., chest pain caused by insufficient blood flow to the heart), allergic reactions (such as itching, rash, hives), fainting.
In patients who have previously experienced angina, the use of medicines from the same group as Lerakta may cause an increase in frequency, duration, or severity of angina attacks. In rare cases, a heart attack may occur.
Other possible side effects:
Common (may affect up to 1 in 10 people):
headache, rapid heart rate, palpitations (feeling of rapid or irregular heart rate), sudden flushing of the face, neck, or upper chest, swelling of the ankles.
Uncommon (may affect up to 1 in 100 people):
dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, frequent urination, weakness, fatigue.
Rare (may affect up to 1 in 1,000 people):
drowsiness, vomiting, diarrhea, hives, frequent urination, chest pain.
Frequency not known (cannot be estimated from the available data):
gum swelling, liver function disorders (detected in blood tests), clouding of the fluid (during dialysis with a catheter in the abdominal cavity), swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lerakta

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lerakta contains

• The active substance is lercanidipine hydrochloride. Lerakta 10 mg, coated tablets: One tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine. Lerakta 20 mg, coated tablets: One tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
• The other ingredients are: Tablet core: magnesium stearate, povidone (K30), sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose (PH-101). Coating: 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 inscription "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 inscription "L" on the other side.
The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
Packaging:
Blisters of Aluminium/PVC/PVDC containing 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Balkanpharma Dupnitsa AD
Samokovsko Shosse Str. 3
2600 Dupnitsa
Bulgaria

Date of last revision of the leaflet: