Lapress

Package Leaflet: Information for the User

Lapress, 10 mg, coated tablets
Lapress, 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. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Lapress and what is it used for

Lapress contains the active substance lercanidipine, which belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives), which lower blood pressure.
Lapress is used to treat high blood pressure (hypertension) in adults over 18 years of age.

2. Important information before taking Lapress When not to take Lapress

• if you are allergic to lercanidipine 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 over time)
• within one month of a heart attack
• if you have severe liver problems
• if you have severe kidney problems or are undergoing dialysis
• if you are taking medicines that inhibit liver metabolism, such as:
• antifungal medicines (such as ketoconazole, itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin, or clarithromycin)
• antiviral medicines (such as ritonavir)
• if you are taking cyclosporin (used after transplants to prevent organ rejection)
• with grapefruit or grapefruit juice.

Warnings and Precautions

Before starting treatment with Lapress, discuss with your doctor:

• if you have heart disease
• if you have liver or kidney problems

Tell your doctor if you suspect or plan pregnancy or breastfeeding (see "Pregnancy, breastfeeding, and fertility").

Children and Adolescents

The safety and efficacy of Lapress in children under 18 years of age have not been established.
This medicine is not recommended for children and adolescents under 18 years of age.

Lapress with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Taking Lapress with certain other medicines (see below) may change their effects or the effect of Lapress, and some side effects may occur more frequently.
It is especially important to inform your doctor if you are taking any of the following medicines:

• phenytoin, phenobarbital, or carbamazepine (used to treat epilepsy)
• rifampicin (used to treat tuberculosis)
• astemizole or terfenadine (used to treat allergies)
• amiodarone, quinidine, or sotalol (used to treat irregular heartbeat)
• midazolam (a medicine that helps you sleep)
• digoxin (used to treat heart conditions)
• beta-blockers, such as metoprolol (used to treat high blood pressure, heart failure, and irregular heartbeat)
• cimetidine in doses greater than 800 mg (used to treat stomach ulcers, heartburn, or indigestion)
• simvastatin (a medicine that lowers cholesterol levels in the blood)
• other medicines used to treat high blood pressure.

Lapress 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 Lapress. Do not drink alcohol while taking Lapress.
• Do not take Lapress with grapefruit or grapefruit juice (they may enhance the blood pressure-lowering effect). See section 2 "When not to take Lapress".

Pregnancy, Breastfeeding, and Fertility

Lapress is not recommended during pregnancy and should not be taken during breastfeeding.
There are no data on the use of lercanidipine in pregnant or breastfeeding women.
If you are pregnant or breastfeeding, if you do not use any contraceptive method, suspect you may be pregnant, or plan to have a baby, 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.

Lapress contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Lapress

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 one 10 mg tablet of Lapress once daily.
Take the tablet at the same time each day, preferably in the morning, at least 15 minutes before breakfast.

If necessary, your doctor may decide to increase the dose of Lapress to one 20 mg tablet once daily (see section 2 "Lapress with food, drink, and alcohol").

Swallow the tablets whole with water.

Use in children and adolescents

Do not use Lapress 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 when starting treatment in these patients 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.

Overdose of Lapress

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

Missed dose of Lapress

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

Stopping treatment with Lapress

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

4. Possible side effects

Like all medicines, Lapress can cause side effects, although not everybody gets them.
The following side effects may occur after taking Lapress.

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 1000 people):
Angina pectoris (e.g., chest pain due to lack of blood to the heart), allergic reactions (with symptoms such as itching, rash, hives), fainting.
Patients with pre-existing angina pectoris may experience increased frequency, duration, or severity of these episodes when taking medicines like Lapress. Single cases of myocardial infarction may be observed.

Other possible side effects:

Common(may affect up to 1 in 10 people):
Headache, rapid heartbeat, feeling of rapid or irregular heartbeat (palpitations), 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, increased urination, weakness, fatigue.
Rare(may affect up to 1 in 1000 people):
Drowsiness, vomiting, diarrhea, hives, frequent urination, chest pain.
Frequency not known(frequency cannot be estimated from the available data):
Gingival swelling, liver function disorders (detected in blood tests), clouding of the fluid (during dialysis with a catheter placed 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 those not listed in this leaflet, please inform your doctor or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
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 Lapress

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after EXP.
The expiry date refers to the last day of the month.
Storage conditions:
Store in the original package to protect from moisture.
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 Lapress contains

The active substance is lercanidipine hydrochloride.
One 10 mg coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
One 20 mg coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
The other ingredients are:
Core: magnesium stearate, povidone K30, sodium carboxymethylcellulose (type A), lactose monohydrate, microcrystalline cellulose (PH-101).
Coating:
10 mg tablets:Opadry II Yellow 85F32553: macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172).
20 mg tablets:Opadry II Pink 85F34564: macrogol 3350, polyvinyl alcohol, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Lapress looks like and contents of the pack

Lapress, 10 mg, coated tablets: yellow, round, biconvex coated tablets, 6.5 mm in diameter, with a score line on one side and "L" on the other side.
Lapress, 20 mg, coated tablets: pink, round, biconvex coated tablets, 8.5 mm in diameter, with a score line on one side and "L" on the other side.
The score line is only for ease of breaking and not to divide into equal doses.
The coated tablets are provided in non-transparent blisters of PVC/PVDC/Aluminum in a cardboard box.
Pack sizes:
Blisters (PVC/PVDC/Aluminum) containing 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków

Manufacturer

Balkanpharma Dupnitsa AD,
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark
Lerkator

Date of last revision of the package leaflet: