Lercaprel

Leaflet accompanying the packaging: patient information

Lercaprel, 10 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, 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 only. 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 any not listed in this leaflet, please tell your 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 pack 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 lercanidipine alone at a dose of 10 mg. Lercaprel should not be used to treat initial hypertension.

2. Important information before taking Lercaprel

When not to take Lercaprel:

• if you are allergic (hypersensitive) to enalapril maleate or lercanidipine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction after taking medicines similar to the substances contained in Lercaprel, i.e. after taking other ACE inhibitors or other calcium antagonists;
• if you have ever had swelling of the face, lips, mouth, tongue, or throat, causing difficulty in swallowing or breathing (angioedema), caused by treatment with an ACE inhibitor or if such swelling has occurred for unknown reasons, or is hereditary;
• if you are taking or have recently taken sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (sudden swelling of the skin and mucous membranes, e.g. of the throat) may increase;
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• after the 3rd month of pregnancy (you should also avoid taking Lercaprel during early pregnancy - see "Pregnancy, breastfeeding, and fertility");
• if you have certain heart diseases:
• narrowing of the outflow tract from the left ventricle, including narrowing of the aortic valve,
• untreated heart failure,
• unstable angina pectoris (chest pain at rest or progressively increasing),
• within a month after a heart attack (myocardial infarction);
• if you have severe liver function disorders;
• if you have severe kidney function disorders or are undergoing dialysis;
• if you are taking medicines that inhibit the activity of liver enzymes, such as:
• antifungal medicines (such as ketoconazole, itraconazole),
• macrolide antibiotics (such as erythromycin, troleandomycin),
• antiviral medicines (such as ritonavir);
• if you are taking a medicine called cyclosporine (used to prevent rejection of a transplanted organ);
• together with grapefruit or grapefruit juice.

Warnings and precautions

Before starting to take Lercaprel, discuss it with your doctor or pharmacist. You should inform your doctor or pharmacist:

• if you have low blood pressure (which may cause dizziness or fainting, especially when standing up);
• if you have severe vomiting or have recently had diarrhea;
• if you are on a low-salt diet;
• if you have heart problems;
• if you have problems with blood vessels in the brain;
• if you have kidney problems (including after a kidney transplant). This may lead to a serious increase in potassium levels in the blood. Your doctor may adjust the dose of enalapril or monitor potassium levels in the blood;
• if you have liver problems;
• if you have blood disorders, such as a decrease or lack of white blood cells (leukopenia, agranulocytosis), a low platelet count (thrombocytopenia), or a decrease in red blood cells (anemia);
• if you have collagenosis (e.g. systemic lupus erythematosus, rheumatoid arthritis, or systemic sclerosis), are undergoing immunosuppressive treatment, are taking allopurinol or procainamide, or any combination of these medicines;
• black patients should be aware of the increased risk of allergic reactions with swelling of the face, lips, tongue, or throat, causing difficulty in swallowing or breathing when taking ACE inhibitors;
• if you have diabetes. You should monitor your blood sugar levels to detect a decrease in blood sugar levels, especially during the first month of treatment. Potassium levels in the blood may also be increased;
• if you are taking potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes;
• if you are over 70 years old;
• if you have intolerance to some sugars (lactose).

If you are 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 you are 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 you have kidney problems related to diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood. See also "When not to take Lercaprel". If you are scheduled for a medical procedure If you are scheduled for any of the following procedures, tell your doctor that you are taking Lercaprel:

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

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant, as well as if you are breastfeeding (see "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 with other medicines

Lercaprel should not be taken with certain medicines. Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you 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, tell your doctor if you are 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 blood clots). See "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 cough and cold medicines and weight loss medicines that contain sympathomimetics;
• antidiabetic medicines (including oral antidiabetics and insulin);
• astemizole and terfenadine (antihistamines);
• amiodarone, quinidine, or sotalol (medicines used to treat irregular heartbeat);
• 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 irregular heartbeat);
• cimetidine (in a daily dose greater than 800 mg, a medicine used to treat stomach ulcers and heartburn).

Do not take Lercaprel if you have taken or are taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (sudden swelling of the skin and mucous membranes, e.g. of the throat) may increase. If you are taking or have 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.

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

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "When not to take Lercaprel" and "Warnings and precautions").

Lercaprel with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy and fertility If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will normally advise you to stop taking Lercaprel before you become pregnant or as soon as you know you are pregnant, and will prescribe another medicine instead of Lercaprel. You should not take Lercaprel during pregnancy, and you must not take it after the 3rd month of pregnancy, as it may seriously harm your baby. Breastfeeding You should not take Lercaprel while breastfeeding.

Driving and using machines

If you experience dizziness, weakness, or drowsiness, do not drive or operate machinery.

Lercaprel 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 Lercaprel

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Adults: If your doctor has not prescribed otherwise, the usual dose is one tablet once a day, taken every day at the same time. The tablet is best taken in the morning, at least 15 minutes before breakfast. Swallow the tablet whole with water. See "Lercaprel with food, drink, and alcohol" Patients with kidney problems/elderly patients: Your doctor will determine the appropriate dose of Lercaprel based on your kidney function.

Taking a higher dose of Lercaprel than recommended

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

Missing a dose of Lercaprel

• If you miss a dose, skip the missed dose.
• Then take the next dose at the usual time.
• Do not take a double dose to make up for the missed dose.

Stopping treatment with Lercaprel

• Do not stop taking this medicine unless your doctor tells you to.
• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 may be serious.

You should contact your doctor or go to the hospital immediately if you 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, you may experience fainting, dizziness, or blurred vision. This is due to a sudden drop in blood pressure. If you experience these symptoms, lie down until they pass. If you have any doubts, contact your doctor.

Side effects observed 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 test results, such as a decrease in platelet count
• increase in potassium levels in the blood
• irritability (nervousness)
• dizziness when standing up, feeling of spinning (vertigo)
• rapid or irregular heartbeat (palpitations)
• sudden reddening of the face, neck, or upper chest (flushing), low blood pressure
• abdominal pain, constipation, nausea
• increase in liver enzyme activity
• redness of the skin
• joint pain
• increased frequency of 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, dryness of the mouth, swelling of the 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, irregular heartbeat, rapid heartbeat, angina pectoris, shortness of breath, taste disturbances, increase in creatinine levels in the blood (usually detected in laboratory tests), high potassium levels in the blood, diarrhea, abdominal pain, fatigue, 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, nervousness, 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 heart or brain blood flow disorders), stroke (usually due to very low blood pressure in patients at high risk), runny nose, sore throat, asthma with chest tightness, slowed bowel movements, pancreatitis, vomiting, indigestion, constipation, dryness of the mouth, stomach ulcer, loss of appetite, itching or hives, kidney problems, kidney failure, excessive sweating, high levels of urea in the blood (detected in laboratory tests), hot flashes, rapid or irregular heartbeat (palpitations), vertigo (feeling of spinning), tinnitus (ringing in the ears), impotence
Rare (may affect up to 1 in 1,000 people):
changes in blood test results, 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 the fingers and toes due to reduced blood flow), rhinitis, pneumonia, liver problems, 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), decreased urine output, gynecomastia (breast enlargement in men), lymphadenopathy (enlargement of lymph nodes in the neck, armpits, and groin), fluid accumulation or other substances in the lungs (detected on X-rays), stomatitis (inflammation of the mucous membranes of the mouth), gingivitis
Very rare (may affect up to 1 in 10,000 people):
intestinal angioedema (angioedema of the intestines)
Unknown (frequency cannot be estimated from the 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 or myositis), joint pain (arthralgia or arthritis).
There may be a rash, increased sensitivity to light, or other skin symptoms.

Lercanidipine

Some side effects may be serious.

You should contact your doctor immediately if you 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 of 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 observed.
Other possible side effects:

Common (may affect up to 1 in 10 people): headache, rapid heartbeat, 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, sudden drop in blood pressure, heartburn, nausea, abdominal pain, rash, itching, muscle pain, increased frequency of urination, feeling of weakness or fatigue
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhea, hives, increased frequency of urination, chest pain
Unknown (frequency cannot be estimated from the available data): gum swelling, liver problems (detected in blood tests), cloudy dialysate (during dialysis through a tube in the abdomen), swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing
If you experience any worsening of side effects or any side effects not listed in this leaflet, tell your doctor or pharmacist. Your doctor or pharmacist can provide more information about side effects. They have a more detailed list of side effects.

Reporting 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 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 Lercaprel

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of that month. 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 package to protect from light and moisture. Do not store above 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 Lercaprel contains

• The active substances are enalapril maleate and lercanidipine hydrochloride. Each film-coated tablet contains 10 mg of enalapril maleate (equivalent to 7.64 mg of enalapril) and 10 mg of lercanidipine hydrochloride (equivalent to 9.44 mg of lercanidipine).
• The other ingredients are: Tablet core - lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), povidone K-30, sodium bicarbonate, magnesium stearate Tablet coating - hypromellose 5cP, titanium dioxide (E 171), talc, macrogol 6000

What Lercaprel looks like and contents of the pack

White, 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 10 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 Lercaprel 10 mg/10 mg plėvele dengtos tabletės Netherlands Romania Lertec Slovenia Lercaprel 10 mg/10 mg Sweden Lercaril 10 mg/10 mg

Date of last revision of the leaflet: 07/2021

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