Lercan

Leaflet attached to the packaging: patient information

Lercan, 10 mg, film-coated tablets

Lercan, 20 mg, film-coated tablets

Lercanidipine hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Lercan and what is it used for

Lercan contains the active substance lercanidipine hydrochloride, which belongs to a group of medicines called calcium antagonists (dihydropyridine derivatives), which lower blood pressure. Lercan is used to treat mild to moderate hypertension (high blood pressure) in adults over 18 years of age (the medicine is not recommended for use in children under 18 years of age).

2. Important information before taking Lercan

When not to take Lercan:

• 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 vessel leaving the heart
• untreated heart failure
• unstable angina (chest pain at rest or with increasing severity)
• heart attack within the last month
• if you have severe liver disease
• if you have severe kidney disease or are undergoing dialysis
• if you are taking medicines that are inhibitors of liver metabolism, such as:
• 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 to take Lercan, 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 are planning to become pregnant, as well as if you are breast-feeding (see "Pregnancy, breast-feeding, and fertility").

Children and adolescents

The safety and efficacy of Lercan in children under 18 years of age have not been established.

Lercan with food, drink, and alcohol

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

Pregnancy, breast-feeding, and fertility

Lercan is not recommended if you are pregnant. It should not be used during breast-feeding. There are no data on the use of Lercan in pregnant or breast-feeding women. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Lercan contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Lercan

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

• The recommended dose is 10 mg, taken once a day at the same time, preferably in the morning, at least 15 minutes before breakfast.
• If necessary, your doctor may increase the dose to one 20 mg Lercan tablet per day (see section 2, subsection "Lercan with food, drink, and alcohol").
• The score line on the 10 mg Lercan tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
• The 20 mg tablet can be divided into equal doses.
• Swallow the tablets whole with a small amount of water.

Use in children and adolescents

• Do not use Lercan in children and adolescents under 18 years of age.

Elderly:

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

Patients with liver or kidney impairment:

• Caution should be exercised at the start of treatment and when increasing the daily dose to 20 mg.

Taking more Lercan than prescribed

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

Missing a dose of Lercan

If you forget to take a dose of Lercan, skip the missed dose and take the next dose the next day as scheduled. Do not take a double dose to make up for the missed dose.

Stopping Lercan treatment

If you stop taking Lercan, 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, Lercan 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 side effects, tell your doctor immediately:

Rarely (may affect up to 1 in 1000 people): angina pectoris (e.g., chest pain caused by insufficient blood flow to the heart), allergic reactions (symptoms include itching, rash, hives), fainting. In patients with pre-existing angina pectoris, the frequency, duration, or severity of angina attacks may increase during treatment with medicines like Lercan. In rare cases, a heart attack may occur.

Other possible side effects:

Common (may affect up to 1 in 10 people): headache, rapid heartbeat, feeling of rapid or irregular heartbeat (palpitations), sudden reddening of the face, neck, or upper chest (flushing), 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, increased urination, weakness, fatigue. Rare (may affect up to 1 in 1000 people): drowsiness, vomiting, diarrhea, hives, increased urination, chest pain. Frequency not known (frequency cannot be estimated from the available data): gum swelling, liver function disorders (detected in blood tests), clouding of the dialysate (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 suspected side effects If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lercan

Keep this 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.

Lercan 10 mg:

Store in the original packaging.

Lercan 20 mg:

Store below 25°C. 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 Lercan contains

Lercan, 10 mg

• The active substance is lercanidipine hydrochloride. One film-coated tablet of Lercan contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone K30, magnesium stearate. Film coating: hypromellose, talc, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172).

Lercan, 20 mg

• The active substance is lercanidipine hydrochloride. One film-coated tablet of Lercan contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone K30, magnesium stearate. Film coating: hypromellose, talc, titanium dioxide (E 171), macrogol 6000, red iron oxide (E 172).

What Lercan looks like and contents of the pack

Lercan, 10 mg, are yellow, round, biconvex film-coated tablets with a diameter of 6.5 mm and a score line on one side. Lercan, 10 mg, is available in packs containing 14, 28, 35, 50, 56, 98, or 100 tablets in aluminum/PVC blisters in a cardboard box. Not all pack sizes may be marketed. Lercan, 20 mg, are pink, round, biconvex film-coated tablets with a diameter of 8.5 mm and a score line on one side. Lercan, 20 mg, is available in packs containing 7, 14, 28, 35, 42, 50, 56, 98, or 100 tablets in aluminum/PVC blisters in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork Ireland

Manufacturer

RECORDATI Industria Chimica e Farmaceutica S.p.A. Via Civitali, 1 20148 Milan Italy

Date of last revision of the leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych http://www.urpl.gov.pl/