Lercanidipine medreg

Package leaflet: information for the patient

Lercanidipine Medreg, 10 mg, film-coated tablets
Lercanidipine Medreg, 20 mg, film-coated tablets
Lercanidipini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Lercanidipine Medreg is and what it is used for

Lercanidipine Medreg belongs to a group of medicines called calcium channel blockers.
Calcium channel blockers prevent calcium from entering the cells of the heart muscle and blood
vessels that carry blood away from the heart (arteries). Calcium entry into these cells causes
contraction of the heart and narrowing of the arteries. By blocking calcium influx, calcium channel
blockers reduce the force of heart contraction and dilate the arteries, thereby lowering blood pressure.
Lercanidipine Medreg has been prescribed to treat high blood pressure, medically known as
arterial hypertension.
Lercanidipine Medreg is intended for use in adults.

2. Important information before using Lercanidipine Medreg

When not to use Lercanidipine Medreg

• 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 conditions:
• impaired outflow of blood from the heart
• untreated heart failure
• unstable angina (chest pain at rest or with increasing severity)
• within one month following a heart attack
• if the patient has severe liver disease
• if the patient has severe kidney dysfunction or is on 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 a medicine called cyclosporine (used after organ transplantation to prevent organ rejection)
• if the patient consumes grapefruit or grapefruit juice.

Warnings and precautions
Before starting treatment with Lercanidipine Medreg, discuss with your doctor:

• if the patient has been diagnosed with heart disease
• if the patient has been diagnosed with liver or kidney disorders. Inform your doctor if you are pregnant or breastfeeding, suspect you may be pregnant, or are planning pregnancy (see section "Pregnancy, breastfeeding and fertility").

Children and adolescents
The safety and efficacy of Lercanidipine Medreg in children under 18 years of age have not been established.
This medicine is not recommended for use in children and adolescents under 18 years of age.
Lercanidipine Medreg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. Taking Lercanidipine Medreg together with certain other medicines (see below) may alter the effect of these medicines or of Lercanidipine Medreg, and some adverse effects may occur more frequently.
It is particularly important to inform your doctor 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 in the treatment of tuberculosis)
• astemizole or terfenadine (antihistamine medicines)
• amiodarone, quinidine or sotalol (medicines used to treat rapid heartbeat)
• midazolam (a medicine used to aid sleep)
• beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure and cardiac arrhythmias)
• digoxin (a medicine used in the treatment of heart conditions)
• cimetidine at doses exceeding 800 mg (a medicine used for peptic ulcer, indigestion or heartburn)
• simvastatin (a medicine used to lower blood cholesterol levels)
• other medicines used to treat high blood pressure.

Lercanidipine Medreg with food, drink and alcohol
A high-fat meal significantly increases the concentration of the medicine in the blood (see section 3).
Lercanidipine Medreg should not be taken with grapefruit or grapefruit juice (as they may enhance the hypotensive effect). See section 2 "When not to use Lercanidipine Medreg".
Alcohol may enhance the effect of Lercanidipine Medreg. Do not consume alcohol during treatment with Lercanidipine Medreg.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The use of Lercanidipine Medreg is not recommended during pregnancy and should not be used during breastfeeding. There is a lack of data on the use of lercanidipine in pregnant and breastfeeding women.
Driving and operating machinery
If the patient experiences dizziness, weakness or drowsiness while taking this medicine, the patient should not drive or operate machinery.
Lercanidipine Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. this medicine is considered "sodium-free".

3. How to use Lercanidipine Medreg

This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.
Adults
The recommended dose is 1 tablet of Lercanidipine Medreg 10 mg once daily. The tablet should be taken every day at the same time, preferably in the morning, at least 15 minutes before breakfast, as a high-fat meal significantly increases the blood concentration of this medicine. If necessary, the doctor may decide to increase the dose to 20 mg once daily.
Tablets should be swallowed whole with water. Do not take this medicine with grapefruit juice (see section 2 "Lercanidipine Medreg with food, drink and alcohol").
The break line is intended solely for dividing the tablet in case of difficulty swallowing it whole.
Elderly patients
There is no need to adjust the daily dose. However, particular caution is required at the beginning of treatment.
Use in children and adolescents
Lercanidipine Medreg is not recommended for use in children and adolescents under 18 years of age.
Patients with hepatic or renal impairment
Particular caution is required when initiating treatment in these patients, and caution should also be exercised when increasing the daily dose to 20 mg.
Lercanidipine Medreg must not be given to patients with severe hepatic impairment or to patients with severe renal impairment, including those undergoing dialysis (see section 2 "When not to take Lercanidipine Medreg").
Taking more Lercanidipine Medreg than recommended
Do not take more than the prescribed dose. If an overdose is taken, contact a doctor immediately or go to the nearest hospital emergency department. Take the medicine packaging with you. Taking too high a dose may cause excessive lowering of blood pressure and irregular or rapid heartbeat.
If you miss a dose of Lercanidipine Medreg
If a dose is missed, skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Lercanidipine Medreg
If treatment with Lercanidipine Medreg is stopped, blood pressure may rise again. Consult your doctor before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious. If any of the following symptoms occur, contact your doctor immediately:
Rare (may affect up to 1 in 1,000 patients):

• Angina pectoris (e.g. chest tightness due to insufficient blood flow to the heart). Patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these episodes when taking medicines from the class to which Lercanidipine Medreg belongs. Isolated cases of myocardial infarction may be observed.
• Allergic reactions (with symptoms such as itching, rash, urticaria)
• Fainting.

Other possible adverse reactions:
Common (may affect up to 1 in 10 patients):

• Headache
• Fast heart rate, sensation of rapid or irregular heartbeat (palpitations)
• Sudden redness of the face, neck or upper chest (hot flush)
• Swelling around the ankles.

Uncommon (may affect up to 1 in 100 patients):

• Dizziness
• Low blood pressure
• Heartburn, nausea, stomach pain
• Skin rash, itching
• Muscle pain
• Passing large amounts of urine
• Feeling of weakness or fatigue.

Rare (may affect up to 1 in 1,000 patients):

• Drowsiness
• Vomiting, diarrhoea
• Urticaria
• More frequent urination than usual
• Chest pain.

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

• Gum swelling, clouding of fluid (during dialysis using a catheter placed in the abdominal cavity)
• Liver function disorders (detected in blood tests)
• Swelling of the face, lips, tongue or throat, 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, tell your doctor or nurse. 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.
Adverse reactions can also be reported to the responsible entity.

5. How to store Lercanidipine Medreg

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister or carton:
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Lercanidipine Medreg contains
Lercanidipine Medreg, 10 mg, film-coated tablets

• The active substance is lercanidipine hydrochloride. Each film-coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 9.4 mg of lercanidipine).
• The 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.
  Coating: hypromellose (6 cps), polyethylene glycol 6000, iron oxide yellow (E 172), titanium dioxide (E 171).

Lercanidipine Medreg, 20 mg, film-coated tablets

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

What Lercanidipine Medreg looks like and contents of the pack
Lercanidipine Medreg, 10 mg, film-coated tablets: yellow, round, biconvex film-coated tablets (approximately 6.5 ± 0.2 mm in diameter), with a score line on one side and smooth on the other. The score line is intended only to facilitate tablet breaking for easier swallowing and does not ensure equal dosing.
Lercanidipine Medreg, 20 mg, film-coated tablets: pink, round, biconvex film-coated tablets (approximately 8.5 ± 0.2 mm in diameter), with a score line on one side and smooth on the other. The score line is intended only to facilitate tablet breaking for easier swallowing and does not ensure equal dosing.
The film-coated tablets are supplied in opaque PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Pack sizes: 7, 14, 28, 30, 35, 42, 50, 56, 60, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer/Importer:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Lercanidipine Medreg
Poland: Lercanidipine Medreg