Lercaprel

Leaflet accompanying the packaging: patient information

Lercaprel, 20 mg + 10 mg, film-coated tablets

Enalapril maleate + 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 a 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Lercaprel and what is it used for

Lercaprel is a combination medicine that contains two active substances that lower blood pressure - an angiotensin-converting enzyme (ACE) inhibitor, enalapril, and a calcium antagonist, lercanidipine. Lercaprel is used to treat high blood pressure (hypertension) in adult patients whose blood pressure is not adequately controlled with enalapril alone at a dose of 20 mg. Lercaprel should not be used as initial treatment for hypertension.

2. Important information before taking Lercaprel

When not to take Lercaprel:

• after the 3rd month of pregnancy (it is also recommended to avoid taking Lercaprel in early pregnancy - see section "Pregnancy, breastfeeding, and fertility");
• narrowing of the outflow of blood from the left ventricle, including narrowing of the aortic valve,
• untreated heart failure,
• unstable angina pectoris (chest pain at rest or progressively worsening),
• within a month after a heart attack (myocardial infarction);
• antifungal medicines (such as ketoconazole, itraconazole),
• macrolide antibiotics (such as erythromycin, troleandomycin),
• antiviral medicines (such as ritonavir);
• together with grapefruit or grapefruit juice.

Warnings and precautions

Before starting to take Lercaprel, discuss it with your doctor or pharmacist. Inform your doctor or pharmacist:

• black patients should be aware of the increased risk of allergic reactions with facial, lip, tongue, or throat swelling, causing difficulty in swallowing or breathing when taking ACE inhibitors;

If the patient is taking any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.

If the patient is taking any of the following medicines used to treat high blood pressure:

• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g. valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood. See also the section "When not to take Lercaprel". If the patient is scheduled for a medical procedure, if the patient is scheduled for any of the following procedures, they should tell their doctor about taking Lercaprel:

• surgical procedure or administration of anesthesia (including at the dentist);
• treatment to remove cholesterol from the blood (LDL apheresis);
• desensitization treatment to reduce allergy to bee or wasp venom.

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy, as well as breastfeeding (see section "Pregnancy, breastfeeding, and fertility").

Children and adolescents

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

Lercaprel and other medicines

Lercaprel should not be taken with certain medicines. The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription. If Lercaprel is taken with other medicines, the effect of Lercaprel or the other medicine may change, and certain side effects may occur more frequently. In particular, the patient should inform their doctor about taking any of the following medicines:

• other blood pressure-lowering medicines;
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of a transplanted organ, and heparin, a medicine used to thin the blood to prevent clots). See section "When not to take Lercaprel";
• lithium (used to treat a certain type of depression);
• medicines used to treat depression, known as tricyclic antidepressants;
• medicines used to treat mental disorders, known as antipsychotics;
• non-steroidal anti-inflammatory medicines (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors (medicines that reduce inflammation and relieve pain);
• certain painkillers or medicines used to treat arthritis, including gold salts;
• certain medicines used to treat coughs and colds, and to aid weight loss, containing sympathomimetics;
• antidiabetic medicines (including oral antidiabetics and insulin);
• astemizole and terfenadine (antihistamines);
• amiodarone, quinidine, or sotalol (medicines used to treat rapid heart rhythm);
• phenytoin, phenobarbital, and carbamazepine (antiepileptic medicines);
• rifampicin (a medicine used to treat tuberculosis);
• digoxin (a medicine used to treat heart disorders);
• midazolam (a medicine used to treat sleep disorders);
• beta-blockers, e.g. metoprolol (medicines used to treat high blood pressure, heart failure, and heart rhythm disorders);
• cimetidine (in a daily dose greater than 800 mg, a medicine used to treat stomach ulcers and heartburn).

Do not take Lercaprel if the patient has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema may increase. If the patient is taking or has recently taken any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.

The doctor may recommend a dose change and/or take other precautions:

Lercaprel with food, drink, and alcohol

• Lercaprel should be taken at least 15 minutes before a meal.
• A high fat content in a meal significantly increases the concentration of the medicine in the blood.
• Alcohol may enhance the effect of Lercaprel. The patient should not drink alcohol during treatment with Lercaprel.
• Lercaprel should not be taken with grapefruit or grapefruit juice, as they may enhance the effect of the medicine (see section "When not to take Lercaprel").

Pregnancy, breastfeeding, and fertility

Pregnancy and fertility: if the patient is pregnant, thinks she may be pregnant, or plans to have a baby, she should consult her doctor before taking this medicine. The doctor will usually recommend stopping Lercaprel before becoming pregnant or as soon as pregnancy is detected and prescribe a different medicine instead of Lercaprel. Lercaprel should not be taken during pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby. Breastfeeding: Lercaprel should not be taken during breastfeeding.

Driving and using machines

If dizziness, weakness, or drowsiness occur, the patient should not drive or operate machinery.

Lercaprel contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the 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 Lercaprel

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. Adults:if the doctor has not prescribed otherwise, the usual dose is one tablet once a day, taken at the same time every day. The tablet is best taken in the morning, at least 15 minutes before breakfast. The tablets should be swallowed whole, with a glass of water. See section "Lercaprel with food, drink, and alcohol". Patients with kidney problems/elderly patients:the doctor will determine the appropriate dose of the medicine based on kidney function.

Taking a higher dose of Lercaprel than recommended

The patient should not exceed the recommended dose. If a higher dose than recommended is taken, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital. The patient should take the medicine packaging with them. Taking a higher dose than recommended may cause excessive lowering of blood pressure and irregular or rapid heart rhythm.

Missing a dose of Lercaprel

• then the patient should take the next dose at the usual time.
• the patient should not take a double dose to make up for the missed dose.

Stopping treatment with Lercaprel

• the patient should not stop taking this medicine unless their doctor tells them to.

4. Possible side effects

Like all medicines, Lercaprel can cause side effects, although not everybody gets them. The following side effects may occur when taking this medicine:

Some side effects can be serious.

The patient should immediately consult their doctor or go to the hospital if they experience any of the following side effects:

• allergic reaction with swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing.

After starting to take Lercaprel, the patient may experience dizziness, fainting, or blurred vision. This is due to a sudden drop in blood pressure. If such symptoms occur, the patient should lie down until they pass. If the patient has any doubts, they should consult their doctor.

Side effects observed during treatment with Lercaprel

Common (may affect up to 1 in 10 people):

• cough
• dizziness, headache

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

• changes in blood parameters, such as a decrease in platelet count
• increased potassium levels in the blood
• irritability (anxiety)
• dizziness when standing up, feeling of spinning (vertigo)
• rapid or irregular heart rhythm (palpitations)
• sudden flushing of the face, neck, or upper chest (hot flashes), low blood pressure
• abdominal pain, constipation, nausea
• increased liver enzyme activity
• skin rash
• joint pain
• increased urination
• feeling of weakness, fatigue, feeling of heat, swelling of the ankles

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

• anemia
• allergic reactions
• ringing in the ears (tinnitus)
• fainting
• dryness of the throat, sore throat
• indigestion, unpleasant taste, diarrhea, dry mouth, swollen gums
• allergic reactions with swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing, skin rash, hives
• nocturia, increased urine output
• impotence

Additional side effects related to the individual components of the medicine (enalapril or lercanidipine)

Enalapril

Very common (may affect more than 1 in 10 people):
blurred vision, dizziness, weakness, nausea, cough
Common (may affect up to 1 in 10 people):
depression, headache, fainting, chest pain, feeling of emptiness in the head due to low blood pressure, heart rhythm disorders, rapid heart rhythm, angina pectoris, shortness of breath, taste disturbances, increased creatinine levels in the blood (usually detected in laboratory tests), high potassium levels in the blood, diarrhea, abdominal pain, fatigue, skin rash, allergic reactions with swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing
Uncommon (may affect up to 1 in 100 people):
anemia (including aplastic and hemolytic), sudden drop in blood pressure, confusion, irritability, insomnia or drowsiness, feeling of tingling or numbness, heart attack (usually due to very low blood pressure in patients at high risk, including those with coronary or cerebral artery disease), stroke (usually due to very low blood pressure in patients at high risk), runny nose, sore throat, asthma with chest tightness, slowed intestinal movement, pancreatitis, vomiting, indigestion, constipation, dry mouth, stomach upset, hives, kidney problems, kidney failure, excessive sweating, high levels of urea in the blood (detected in laboratory tests), muscle cramps, malaise, high fever, low blood sugar or sodium levels, high levels of potassium in the blood, hot flashes, rapid or irregular heart rhythm (palpitations), vertigo (feeling of spinning), tinnitus (ringing in the ears), impotence
Rare (may affect up to 1 in 1,000 people):
changes in blood parameters, such as a decrease in white blood cell count, bone marrow suppression, autoimmune diseases, strange dreams or sleep disturbances, Raynaud's phenomenon (feeling of coldness and paleness of fingers and toes due to reduced blood flow), rhinitis, pneumonia, liver function disorders (including liver failure), hepatitis, jaundice (yellowing of the skin or eyes), high levels of liver enzymes or bilirubin in the blood (detected in laboratory tests), erythema multiforme (red patches of various shapes on the skin), Stevens-Johnson syndrome, and toxic epidermal necrolysis (severe skin reaction with redness and peeling of the skin, blistering, or separation of the upper layer of the skin from the lower layers), pemphigus (formation of small fluid-filled blisters on the skin)
Very rare (may affect up to 1 in 10,000 people):
intestinal angioedema (angioedema of the intestines)
Unknown (frequency cannot be estimated from available data):
excessive production of antidiuretic hormone, leading to water retention, causing weakness, fatigue, or confusion.
A syndrome has been reported that may include some or all of the following symptoms:
fever, vasculitis (inflammation of blood vessels), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis).
Skin rash, hypersensitivity to light, or other skin symptoms may occur.

Lercanidipine

Some side effects can be serious.

The patient should immediately consult their doctor if they experience any of the following side effects:

Rare (may affect up to 1 in 1,000 people):
angina pectoris (chest pain due to insufficient blood supply to the heart), allergic reactions (symptoms include itching, rash, hives), fainting
In patients with angina pectoris, taking medicines from the same class as lercanidipine may cause an increase in the frequency, duration, or severity of angina attacks. Isolated cases of myocardial infarction have been reported.
Other possible side effects:

Common (may affect up to 1 in 10 people): headache, rapid heart rhythm, rapid or irregular heart rhythm (palpitations), sudden flushing of the face, neck, or upper chest (hot flashes), swelling of the ankles
Uncommon (may affect up to 1 in 100 people): dizziness, sudden drop in blood pressure, heartburn, nausea, abdominal pain, skin rash, itching, muscle pain, increased urination, feeling of weakness or fatigue
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhea, hives, increased urination, chest pain
Unknown (frequency cannot be estimated from available data): gum swelling, liver function disorders (detected in blood tests), cloudy fluid (during dialysis through a tube inserted in the abdomen), swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing
If the side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist. The doctor or pharmacist can provide more information about side effects. They have a more detailed list of side effects.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. 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, more information can be collected on the safety of the medicine.

5. How to store Lercaprel

The medicine should be stored out of sight and reach of children. Do not take this medicine after the expiry date stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the month stated. The abbreviation "Lot" on the packaging and blister means "Batch number". The abbreviation "EXP" on the packaging and blister means "Expiry date". Store in the original packaging to protect from light and moisture. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Lercaprel contains

• The active substances of the medicine are enalapril maleate and lercanidipine hydrochloride. Each film-coated tablet contains: 20 mg of enalapril maleate (which corresponds to 15.29 mg of enalapril) and 10 mg of lercanidipine hydrochloride (which corresponds to 9.44 mg of lercanidipine).
• The other ingredients are: Tablet core - lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone K-30, sodium hydrogen carbonate, magnesium stearate; Tablet coating - hypromellose 5cP, titanium dioxide (E 171), talc, macrogol 6000, quinoline yellow, lake (E 104), iron oxide yellow (E 172)

What Lercaprel looks like and contents of the pack

Yellow, round, biconvex film-coated tablets, 8.5 mm in diameter. Lercaprel is available in packs of 14, 28, or 56 film-coated tablets. 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 Matteo Civitali 1
20148 Milan
Italy
Doppel Farmaceutici S.r.l.
Via Volturno 48
Quinto de’Stampi
20089 Rozzano (MI)
Italy

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Zanipril 20 mg/10 mg Filmtabletten
Belgium, Luxembourg
Zanicombo
Bulgaria
Lercapril
Cyprus, United Kingdom (Northern Ireland)
Zaneril
Denmark, Finland, Germany, Iceland, Malta, Norway, Portugal, Spain
Zanipress
Estonia, Ireland
Lercaril
France
Zanextra
Greece, Latvia, Poland
Lercaprel
Hungary
Coripren
Italy
Lithuania
Zanipril
Netherlands
Lercaprel 20 mg/10 mg filmomhulde tabletten
Romania
Lertec
Slovenia
Lercaprel 20 mg/10 mg
Sweden
Lercaril 20 mg/10 mg
Zanitek

Date of last revision of the leaflet: 07/2021