Lernidum

Package leaflet: Information for the patient

Lernidum, 10 mg, coated tablets
Lernidum, 20 mg, coated tablets
Lercanidipini hydrochloridum
Please read the entire leaflet before taking the 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 questions, 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Lernidum is and what it is used for

Lernidum contains the active substance lercanidipine hydrochloride, which belongs to a group of medicines called calcium antagonists (dihydropyridine derivatives) that lower blood pressure. This medicine is used for the treatment of high blood pressure (essential hypertension) in adults.
Indications for Lernidum
Treatment of mild to moderate essential hypertension in adults.

2. Important information before taking Lernidum

When not to take Lernidum

• if the patient is allergic to leracanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced allergic reactions to similar medicines (such as: amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine);
• if the patient has a heart condition such as:  untreated heart failure,  left ventricular outflow tract obstruction,  unstable angina (chest pain at rest or worsening),  myocardial infarction within the last month;
• if the patient has severe liver or kidney dysfunction or is undergoing dialysis;
• if the patient is taking medicines which are inhibitors of the CYP3A4 enzyme:  antifungal medicines (i.e. ketoconazole or itraconazole),  macrolide antibiotics (i.e. erythromycin, troleandomycin or clarithromycin),  antiviral medicines (i.e. ritonavir);
• if the patient is taking a medicine called cyclosporine (used to prevent rejection of a transplanted organ);
• if the patient consumes grapefruit or drinks grapefruit juice.

Lernidum must not be used during pregnancy or breastfeeding (see section: "Pregnancy, breastfeeding and fertility").
Warnings and precautions
Before taking Lernidum, discuss with your doctor or pharmacist if the patient:

• has other heart conditions and does not have a cardiac pacemaker implanted or has previously been diagnosed with angina pectoris;
• has impaired liver or kidney function.

If the patient is pregnant (or could be pregnant) or is breastfeeding, she must inform her doctor (see section: "Pregnancy, breastfeeding and fertility").
Children and adolescents
Lernidum should not be used in children and adolescents under 18 years of age, as due to lack of available data, the safety and efficacy of leracanidipine have not been established.
Lernidum and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take, especially if taking:

• beta-blockers (e.g. metoprolol);
• cimetidine at doses exceeding 800 mg (a medicine used to treat peptic ulcer, indigestion or heartburn);
• digoxin (a medicine used in heart conditions);
• midazolam (a medicine that helps with sleep);
• rifampicin (a medicine used to treat tuberculosis);
• astemizole or terfenadine (antihistamine medicines);
• amiodarone, quinidine or sotalol (medicines that slow heart rate);
• phenytoin, phenobarbital or carbamazepine (medicines used to treat epilepsy) – the doctor will recommend more frequent blood pressure monitoring;
• simvastatin (a medicine that lowers cholesterol levels) – Lernidum should be taken in the morning and simvastatin in the evening;
• ketoconazole or itraconazole (antifungal medicines) – see section "When not to take Lernidum";
• erythromycin, troleandomycin or clarithromycin (macrolide antibiotics) – see section "When not to take Lernidum";
• ritonavir (an antiviral medicine) – see section "When not to take Lernidum";
• cyclosporine (a medicine used to prevent rejection of a transplanted organ) – see section "When not to take Lernidum";
• other medicines used to treat high blood pressure.

If any of the above situations apply to the patient, inform the doctor before taking the medicine.
Lernidum with food, drink and alcohol
During treatment, do not:

• drink alcohol,
• eat grapefruit or drink grapefruit juice,
• consume meals high in fat, as this may intensify the effect of the medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should not use Lernidum.
Women of childbearing potential should use effective contraception during treatment with Lernidum. If a woman becomes pregnant during treatment, she should inform her doctor immediately, who will decide on further management.
Driving and using machines
Lernidum has no significant effect on the ability to drive or operate machinery; however, adverse effects such as dizziness, weakness, fatigue, and rarely somnolence, may occur. Caution is advised and patients should not drive or operate machinery until they know how they individually react to the medicine.
Lernidum contains sodium
Lernidum 10 mg contains 0.928 mg of sodium per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
Lernidum 20 mg contains 1.437 mg of sodium per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Lernidum

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
Adults
The recommended dose is 10 mg (1 tablet) once daily, taken at the same time each day, preferably
in the morning, at least 15 minutes before breakfast.
If necessary, your doctor may recommend increasing the dose to 20 mg (1 tablet) once daily.
Tablets should preferably be swallowed whole with water.
The break line on the Lernidum 10 mg tablet is intended only to facilitate tablet splitting for
easier swallowing, and does not ensure equal dosing.
The Lernidum 20 mg tablet may be divided into equal doses.
Elderly patients
No adjustment of the daily dose is required; however, particular caution should be exercised at
the beginning of treatment.
Patients with liver or kidney function disorders
Particular caution should be exercised at the beginning of treatment and when increasing the dose to 20 mg
once daily.
Use in children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Taking more Lernidum than recommended
Do not take more than the recommended dose.
If you take more than the recommended amount or overdose, seek immediate medical help and, if possible, bring the remaining tablets and/or the medicine packaging with you.
Taking a higher than recommended dose may cause excessive lowering of blood pressure and
irregular or rapid heartbeat, which may also lead to loss of consciousness.
Missed dose of Lernidum
If a patient forgets to take a dose, the missed dose should be skipped and the next tablet taken
the following day at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Lernidum
If a patient stops taking this medicine, blood pressure may rise again. 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking this medicine immediately and contact your doctor or go to the
emergency department of the nearest hospital if you experience:

• angina (chest pain due to reduced blood flow to the heart), allergic reactions (with symptoms such as: itching, rash, urticaria), fainting – these are rare (may occur in less than 1 in 1,000 people),
• swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing – frequency of occurrence is unknown.

In patients with angina, using medicines from the group to which Lernidum belongs may
increase the frequency, duration or severity of chest pain attacks. Isolated cases of
myocardial infarction have been observed.
Other possible adverse effects
Common (may occur in less than 1 in 10 people):

• headache,
• increased heart rate, palpitations (strong or rapid heartbeat),
• sudden redness of the face, neck or upper part of the trunk, swelling of the ankle area.

Uncommon (may occur in less than 1 in 100 people):

• dizziness,
• low blood pressure,
• nausea, indigestion, stomach pain,
• rash, itching,
• muscle pain,
• increased frequency or volume of 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 unknown (frequency cannot be estimated from available data):

• gum swelling,
• liver function abnormalities (detected in blood tests),
• clouding of fluid (during dialysis using a catheter placed in the abdominal cavity).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects
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 4921 301;
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lernidum

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box
and blister pack following EXP. The expiry date refers to the last day of the stated month.
Lernidum, 10 mg
Store in the original packaging to protect from light.
Lernidum, 20 mg
Store below 30°C.
Store in the original packaging to protect from light.
Lot – batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Lernidum contains
Lernidum, 10 mg
The active substance is lerkanidipine hydrochloride.
The coated tablet contains 10 mg of lerkanidipine hydrochloride, equivalent to 9.4 mg of lerkanidipine.
Other ingredients are:
Tablet core: maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, microcrystalline cellulose, poloxamer 188, sodium stearyl fumarate, polyethylene glycol 6000.
Tablet coating: hypromellose 6cps, polyethylene glycol 6000, iron oxide yellow (E 172), titanium dioxide (E 171).

Lernidum, 20 mg
The active substance is lerkanidipine hydrochloride.
The coated tablet contains 20 mg of lerkanidipine hydrochloride, equivalent to 18.8 mg of lerkanidipine.
Other ingredients are:
Tablet core: microcrystalline cellulose, maize starch, sodium carboxymethyl starch (type A), colloidal anhydrous silica, povidone K-30, sodium stearyl fumarate.
Tablet coating: hypromellose 6cps, polyethylene glycol 6000, iron oxide red (E 172), titanium dioxide (E 171).

What Lernidum looks like and contents of the pack
Lernidum, 10 mg are yellow, round, biconvex coated tablets, with a score line on one side and smooth on the other, approximately 6.5 mm x 3.3 mm in size.
Lernidum, 10 mg is packed in blisters. Each pack contains: 10, 14, 28 or 56 coated tablets in a cardboard box.

Lernidum, 20 mg are pink, round, biconvex coated tablets, with a score line on one side and smooth on the other, approximately 8.5 mm x 4.0 mm in size.
Lernidum, 20 mg is packed in blisters. Each pack contains: 10, 14, 28 or 56 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151,
95-200 Pabianice
Tel. (42) 22-53-100

Importer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31,
95-054 Ksawerów
Poland