Lapress

Package leaflet: Information for the user

Lapress 10 mg, coated tablets
Lapress 20 mg, 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. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Lapress is and what it is 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 Lapress is and what it is used for

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

2. Important information before using the medicine Lapress When not to use Lapress

• if the patient is allergic to leracanidipine or any of the other ingredients of this medicine (listed in section 6)
• if the patient has certain heart diseases:
• obstruction of the blood outflow tract from the heart
• untreated heart failure
• unstable angina (chest pain occurring at rest or progressively worsening)
• within one month after a heart attack
• if the patient has severe liver problems
• if the patient has severe kidney problems or is undergoing dialysis
• if the patient is 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 the patient is concurrently taking cyclosporine (used after organ transplantation to prevent organ rejection)
• with grapefruit or grapefruit juice.

Warnings and precautions
Before starting treatment with Lapress, discuss this with your doctor:

• if the patient has heart disease
• if the patient has liver or kidney problems

Inform your doctor about suspected (or planned) pregnancy or breastfeeding (see section
"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 use in children and adolescents under 18 years of age.
Lapress and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Taking Lapress with certain other medicines (see below) may alter the effects of these medicines or of Lapress, 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 to treat epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• astemizole or terfenadine (antihistamines for allergies)
• amiodarone, quinidine or sotalol (medicines used to treat rapid heartbeat)
• midazolam (a medicine to aid sleep)
• digoxin (a medicine used to treat heart conditions)
• beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure and heart rhythm disorders)
• cimetidine at doses exceeding 800 mg (a medicine used for peptic ulcer, indigestion or heartburn)
• simvastatin (a medicine to lower blood cholesterol levels)
• 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 effects of Lapress. Do not consume alcohol during treatment with Lapress.
• Lapress should not be taken with grapefruit or grapefruit juice (as they may enhance the hypotensive effect). See section 2 "When not to use Lapress".

Pregnancy, breastfeeding and fertility
Lapress is not recommended during pregnancy and should not be used during breastfeeding. There is a lack of data on the use of leracanidipine in pregnant and breastfeeding women.
If the patient is pregnant or breastfeeding, is not using any contraceptive method, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
If the patient experiences dizziness, weakness or drowsiness while taking this medicine, driving and operating machinery should be avoided.
Lapress contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Lapress

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Adults
The recommended dose is one 10 mg tablet of Lapress once daily. The tablet should be taken
every day at the same time, preferably in the morning, at least 15 minutes before breakfast.
If necessary, the 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”).
Tablets should be swallowed whole with water.
Use in children and adolescents
Lapress must not be used in children and adolescents under 18 years of age.
Elderly patients
There is no need to adjust the daily dose. However, particular caution is recommended at the
beginning of treatment.
Patients with impaired liver or kidney function
Particular caution is required when initiating treatment in these patients, and caution should also
be exercised when increasing the daily dose to 20 mg.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.
Taking more Lapress than recommended
Do not take more than the prescribed dose. If you take more than you should, contact your doctor
immediately or go to the emergency department of your nearest hospital. Take the medicine pack
with you. Taking too much medicine may cause excessive lowering of blood pressure and irregular
or rapid heartbeat.
Missing a dose of Lapress
If the patient forgets to take a dose of Lercan, the missed dose should be skipped and the next
dose taken the following day according to the regular schedule.
Do not take a double dose to make up for a missed dose.
Stopping Lapress treatment
If treatment with Lapress is stopped, blood pressure may rise again. Consult your doctor before
stopping treatment.
If you have any further doubts regarding 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.
The following adverse reactions may occur after using this medicine.
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 people):
Angina (e.g. chest tightness due to insufficient blood flow to the heart), allergic reactions (with
symptoms such as: itching, rash, urticaria), fainting.
Patients with pre-existing angina may experience increased frequency, duration or severity of
attacks when taking medicines from the group to which Lapress belongs. Isolated cases of myocardial infarction may be observed.
Other possible adverse reactions:
Common (may affect up to 1 in 10 people):
Headache, fast heartbeat, sensation of rapid or irregular heartbeat (palpitations), sudden flushing of the face, neck or upper chest, swelling around the ankles.
Uncommon (may affect up to 1 in 100 people):
Dizziness, low blood pressure, heartburn, nausea, stomach pain, skin rash, itching, muscle pain, passing large amounts of urine, weakness, fatigue.
Rare (may affect up to 1 in 1,000 people):
Drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Frequency not known (frequency cannot be estimated from available data):
Gingival hyperplasia, liver function abnormalities (detected in blood tests), clouding of the fluid (during dialysis using a catheter placed in the abdominal cavity), 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, inform 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Lapress

Keep this medicine out of 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 specified month.
Storage conditions:
Store in the original packaging to protect from moisture.
Medicines must 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 lerkanidipine hydrochloride.
One 10 mg coated tablet contains 10 mg of lerkanidipine hydrochloride, equivalent to 9.4 mg of
lerkanidipine.
One 20 mg coated tablet contains 20 mg of lerkanidipine hydrochloride, equivalent to 18.8 mg of
lerkanidipine.
The other ingredients are:
Tablet core: Magnesium stearate, povidone K30, sodium carboxymethyl starch (type A), lactose
monohydrate, microcrystalline cellulose (PH-101).
Coating:
10 mg tablets: Opadry II Yellow 85F32553: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium
dioxide (E 171), yellow iron oxide (E 172).
20 mg tablets: Opadry II Pink 85F34564: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium
dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172).
What Lapress looks like and contents of the pack
Lapress 10 mg, coated tablets: yellow, round, biconvex coated tablets with a diameter of 6.5 mm,
with a score line on one side and the mark “L” on the other side.
Lapress 20 mg, coated tablets: pink, round, biconvex coated tablets with a diameter of 8.5 mm,
with a score line on one side and the mark “L” on the other side.
The score line is intended only to facilitate breaking the tablet for ease of swallowing and does not
ensure equal division of the dose.
Coated tablets are supplied in opaque blisters made of PVC/PVDC/Aluminum foil, packed in a
cardboard box.
Pack sizes:
Blisters (PVC/PVDC/Aluminum) containing 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised for supply in the European Economic Area countries under
the following names:
Denmark Lerkator