Lernidum

Leaflet attached to the packaging: patient information

Lernidum, 10 mg, coated tablets

Lernidum, 20 mg, coated tablets

Lercanidipine hydrochloride

Read the 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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lernidum and what is it 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 packaging and other information

1. What is Lernidum and what is it used for

Lernidum contains the active substance lercanidipine hydrochloride, which belongs to a group of so-called calcium antagonists (dihydropyridine derivatives) - drugs that lower blood pressure. This medicine is used to treat high blood pressure (hypertension) in adults.

Indications for use of Lernidum

Treatment of mild to moderate essential hypertension in adults.

2. Important information before taking Lernidum

When not to take Lernidum

• if you are allergic to lercanidipine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced allergic reactions to similar medicines (such as: amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine);
• if you have heart disease, such as: untreated heart failure, narrowing of the outflow tract from the left ventricle, unstable angina (chest pain at rest or worsening), or if you have had a heart attack in the last month;
• if you have severe liver or kidney problems or are undergoing dialysis;
• if you are taking medicines that are inhibitors of the CYP3A4 enzyme: antifungal medicines (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin), or antiviral medicines (such as ritonavir);
• if you are taking a medicine called cyclosporin (used to prevent rejection of a transplanted organ);
• if you consume grapefruit or drink grapefruit juice.

Do not take this medicine if you are pregnant or breastfeeding (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Before taking Lernidum, discuss it with your doctor or pharmacist if you:

• have other heart problems and do not have a pacemaker or have previously experienced angina;
• have liver or kidney problems.

If you are pregnant (or think you may be pregnant) or are breastfeeding, tell your doctor (see section "Pregnancy, breastfeeding and fertility").

Children and adolescents

Do not use this medicine in children and adolescents under 18 years of age, as the safety and efficacy of lercanidipine have not been established due to lack of available data.

Lernidum and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, especially if you are taking:

• beta-blockers (e.g. metoprolol);
• cimetidine in a dose greater than 800 mg (a medicine used to treat stomach ulcers, indigestion or heartburn);
• digoxin (a medicine used to treat heart conditions);
• midazolam (a medicine that helps you fall asleep);
• rifampicin (a medicine used to treat tuberculosis);
• astemizole or terfenadine (antihistamines);
• amiodarone, quinidine or sotalol (medicines that slow down heart rate);
• phenytoin, phenobarbital or carbamazepine (medicines used to treat epilepsy) - your doctor will recommend more frequent blood pressure checks;
• simvastatin (a medicine that lowers cholesterol levels) - take Lernidum 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";
• cyclosporin (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 applies to you, tell your doctor before taking the medicine

your doctorbefore taking the medicine.

Lernidum with food, drink and alcohol

During treatment, do not:

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, do not take Lernidum.
Women of childbearing age should use effective contraception while taking Lernidum. If you become pregnant during treatment, tell your doctor immediately, who will decide on further treatment.

Driving and using machines

Lernidum does not have a significant effect on the ability to drive or use machines, but side effects such as dizziness, weakness, fatigue, and rarely - drowsiness may occur. Be cautious and do not drive or use machines until you know how the medicine affects you.

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, which means it 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, which means it is considered "sodium-free".

3. How to take Lernidum

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

Adults

The recommended dose is 10 mg (1 tablet) 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 20 mg (1 tablet) once daily.
Swallow the tablets whole with water.
The score line on the Lernidum, 10 mg tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
The Lernidum, 20 mg tablet can be divided into equal doses.

Elderly

No dose adjustment is necessary, but be cautious when starting treatment.

Patients with liver or kidney problems

Be cautious when starting treatment and when increasing the dose to 20 mg once daily.

Use in children and adolescents

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

Taking a higher dose of Lernidum than recommended

Do not take a higher dose than recommended.
If you have taken a higher dose than recommended or have taken an overdose, seek medical attention immediately and, if possible, take the remaining tablets and/or packaging with you.
Taking a higher dose than recommended may cause excessive lowering of blood pressure and irregular or rapid heart rate, which can also lead to loss of consciousness.

Missing a dose of Lernidum

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

Stopping treatment with Lernidum

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

4. Possible side effects

Like all medicines, Lernidum can cause side effects, although not everybody gets them.
You should immediatelystop taking this medicine 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 (such as itching, rash, hives), fainting - rare (may occur in less than 1 in 1000 people),
• swelling of the face, lips, tongue or throat, which may cause difficulty breathing or swallowing - frequency not known.

In patients with angina, the use of medicines from the same group as Lernidum may increase the frequency, duration or severity of pain attacks. Isolated cases of heart attack have been observed.

Other possible side effects

Common (may occur in less than 1 in 10 people):

• headache,
• rapid heart rate, palpitations (strong or rapid heart rate),
• sudden reddening of the face, neck or upper body, swelling of the ankles.

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

• dizziness,
• low blood pressure,
• nausea, indigestion, stomach pain,
• rash, itching,
• muscle pain,
• excessive urination,
• weakness, fatigue.

Rare (may occur in less than 1 in 1000 people):

• drowsiness,
• vomiting, diarrhea,
• hives,
• increased urination,
• chest pain.

Frequency not known (cannot be estimated from the available data):

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. 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:
Aleje 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 the medicine.

5. How to store Lernidum

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the 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.
Batch - means batch number.
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 packaging and other information

What Lernidum contains

Lernidum, 10 mg
The active substance is lercanidipine hydrochloride.
Each coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
The other ingredients are:
Core: corn starch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, microcrystalline cellulose, poloxamer 188, sodium stearyl fumarate, macrogol 6000.
Coating: hypromellose 6cps, macrogol 6000, yellow iron oxide (E 172), titanium dioxide (E 171).
Lernidum, 20 mg
The active substance is lercanidipine hydrochloride.
Each coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
The other ingredients are:
Core: microcrystalline cellulose, corn starch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, povidone K-30, sodium stearyl fumarate.
Coating: hypromellose 6cps, macrogol 6000, red iron oxide (E 172), titanium dioxide (E 171).

What Lernidum looks like and contents of the pack

Lernidum, 10 mg is a yellow, round, biconvex coated tablet with a score line on one side and a smooth surface on the other, approximately 6.5 mm x 3.3 mm in size.
Lernidum, 10 mg is packaged in blisters. One pack contains: 10, 14, 28 or 56 coated tablets in a carton.
Lernidum, 20 mg is a pink, round, biconvex coated tablet with a score line on one side and a smooth surface on the other, approximately 8.5 mm x 4.0 mm in size.
Lernidum, 20 mg is packaged in blisters. One pack contains: 10, 14, 28 or 56 coated tablets in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151,
95-200 Pabianice
Phone: (42) 22-53-100

Importer

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

Date of last revision of the leaflet: