Lercaprel

Package leaflet: Information for the patient

Lercaprel, 10 mg + 10 mg, film-coated tablets
Enalapril maleate + Lercanidipine hydrochloride
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you may read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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, inform your doctor or pharmacist. See section 4.

Table of contents

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

Lercaprel is a combination medicine containing two active substances that lower blood pressure – an angiotensin-converting enzyme (ACE) inhibitor, enalapril, and a calcium antagonist, lercanidipine.
Lercaprel is used in the treatment of high blood pressure (hypertension) in adult patients whose blood pressure is not adequately controlled on lercanidipine alone at a dose of 10 mg.
Lercaprel should not be used for the initial treatment of hypertension.

2. Important information before taking Lercaprel

When not to take Lercaprel:

• if the patient is allergic (hypersensitive) to enalapril maleate or lerkanidipine hydrochloride, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had an allergic reaction after taking medicines similar to those contained in Lercaprel, i.e. after taking other ACE inhibitors or other calcium antagonists;
• if the patient has ever experienced 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 occurred for unknown reasons, or is hereditary;
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat certain types of chronic heart failure in adults, because the risk of angioedema (sudden subcutaneous swelling, e.g. in the throat) increases;
• if the patient has diabetes or kidney function disorders and is taking a blood pressure-lowering medicine containing aliskiren;
• after the 3rd month of pregnancy (Lercaprel should also be avoided during early pregnancy – see section "Pregnancy, breastfeeding and fertility");
• if the patient has certain heart diseases:
  • narrowing of the outflow tract from the left ventricle of the heart, including aortic valve stenosis,
  • untreated heart failure,
  • unstable angina (chest pain at rest or progressively worsening),
  • within one month after a heart attack (myocardial infarction);
• if the patient has severe liver function impairment;
• if the patient has severe kidney function impairment or is undergoing dialysis;
• if the patient is taking medicines that inhibit liver enzyme activity, such as:
  • antifungal medicines (e.g. ketoconazole, itraconazole),
  • macrolide antibiotics (e.g. erythromycin, troleandomycin),
  • antiviral medicines (e.g. ritonavir);
• if the patient is taking the medicine called cyclosporine (used to prevent rejection of a transplanted organ);
• simultaneously with grapefruit or grapefruit juice.

Warnings and precautions
Before starting Lercaprel, discuss this with your doctor or pharmacist.
Inform your doctor or pharmacist:

• if the patient has low blood pressure (which may manifest as fainting or dizziness, especially when standing up);
• if the patient has severe vomiting or has recently had diarrhoea;
• if the patient is on a low-salt diet;
• if the patient has heart disorders;
• if the patient has disorders of blood vessels in the brain;
• if the patient has kidney function disorders (including post-kidney transplant status). This may lead to a serious increase in serum potassium concentration. The doctor may adjust the enalapril dose or monitor serum potassium levels;
• if the patient has liver function disorders;
• if the patient has blood disorders such as reduced number or absence of white blood cells (leukopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia);
• if the patient has collagenosis (e.g. systemic lupus erythematosus, rheumatoid arthritis or systemic sclerosis), is undergoing immunosuppressive treatment, takes medicines containing allopurinol or procainamide, or any combination of these medicines;
• patients of black race should be aware of an increased risk of allergic reactions with swelling of the face, lips, tongue or throat causing difficulty in swallowing or breathing while taking ACE inhibitors;
• if the patient has diabetes. Blood glucose levels should be monitored to detect hypoglycaemia, especially during the first month of treatment. Blood potassium levels may also be increased;
• if the patient is taking potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium;
• if the patient is over 70 years of age;
• if the patient has intolerance to certain sugars (lactose).

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

• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent rejection of transplanted organs and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

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

• an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney function disorders related to diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to take Lercaprel".
If a medical procedure is planned
If any of the following procedures are planned, inform the doctor about taking Lercaprel:

• surgical procedure or administration of anaesthesia (including at the dentist);
• treatment aimed at removing cholesterol from the blood (LDL apheresis);
• desensitisation treatment aimed at reducing allergy to bee or wasp venom.

Inform the doctor about pregnancy, suspected or planned pregnancy, as well as breastfeeding
(See section "Pregn游戏副本

3. How to take Lercaprel

This medicine should always be taken exactly as prescribed by your doctor. If in doubt,
consult your doctor or pharmacist.
Use in adults: Unless otherwise directed by your doctor, the usual dose is one
tablet once daily, taken at the same time each day. The tablet should preferably be taken in the morning,
at least 15 minutes before breakfast. Swallow the tablet whole with water. See section
"Lercaprel with food, drink and alcohol".
Use in patients with renal impairment/elderly patients: Your doctor will determine
the appropriate dose depending on kidney function.
Taking more Lercaprel than prescribed
Do not exceed the recommended dose. If you take more than the prescribed dose, contact your doctor immediately
or go to the nearest hospital emergency department.
Take the medicine pack with you. Taking more than the prescribed dose may cause
excessive lowering of blood pressure and irregular or rapid heartbeat.
Missed dose of Lercaprel

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

Stopping Lercaprel

• Do not stop taking this medicine unless your doctor tells you to.
• If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with this medicine:
Some adverse reactions may be serious.
You should contact your doctor immediately or go to hospital if any of the following adverse reactions occur:

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

After starting treatment with Lercaprel, fainting, dizziness or blurred vision may occur. These symptoms are caused by a sudden drop in blood pressure. If such symptoms occur, you should lie down until they subside. If in any doubt, consult your doctor.
Adverse reactions 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 decreased platelet count
• Increased potassium levels in blood
• Nervousness (anxiety)
• Dizziness when standing up, sensation of spinning (vertigo)
• Increased heart activity, rapid or irregular heartbeat (palpitations)
• Sudden redness of the face, neck or upper chest (hot flushes), low blood pressure
• Abdominal pain, constipation, nausea
• Increased liver enzyme activity
• Skin redness
• Joint pain
• Increased frequency of urination
• Feeling of weakness, fatigue, sensation of warmth, swelling around the ankles

Rare (may affect up to 1 in 1000 people):

• Anaemia
• Allergic reactions
• Ringing in the ears (tinnitus)
• Fainting
• Dryness of the throat mucosa, sore throat
• Indigestion, salty taste sensation on the tongue, diarrhoea, dryness of the oral mucosa, gum swelling
• Allergic reactions with swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing, skin rash, urticaria
• Nocturnal urination, increased urine volume
• Impotence

Additional adverse reactions associated with the individual components of the medicine
(enalapril or lercanidipine)
Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision, dizziness, feeling of 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 disturbances, increased heart activity, angina pectoris, shortness of breath, taste disturbances, increased creatinine levels in blood (usually detected in laboratory tests), high potassium levels in blood, diarrhoea, 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):
Anaemia (including aplastic and haemolytic), sudden drop in blood pressure, confusion, nervousness, insomnia or drowsiness, tingling or numbness sensations, heart attack (usually due to very low blood pressure in some high-risk patients, including patients with impaired blood flow to the heart or brain), stroke (usually due to very low blood pressure in high-risk patients), watery nasal discharge, sore throat and hoarseness, asthma with accompanying chest tightness, slowed intestinal peristalsis, pancreatitis, vomiting, indigestion, constipation, stomach irritation, dryness of the oral mucosa, peptic ulcer, loss of appetite, itching or urticaria, hair loss, kidney function disorders, kidney failure, excessive sweating, high protein levels in urine (detected in laboratory tests), muscle cramps, malaise, high temperature (fever), low blood sugar or sodium levels, high blood urea levels (detected in laboratory tests), hot flushes, rapid or irregular heartbeat (palpitations), vertigo (sensation of spinning), tinnitus, impotence
Rare (may affect up to 1 in 1000 people):
Changes in blood parameters such as decreased white blood cell count, bone marrow suppression, autoimmune diseases, strange dreams or sleep disturbances, Raynaud's phenomenon (feeling of cold and paleness of fingers and toes due to reduced blood flow), rhinitis, pneumonia, liver function disorders including liver failure, hepatitis, jaundice (yellowing of skin or eyes), increased liver enzymes or bilirubin in blood (detected in laboratory tests), erythema multiforme (red spots of various shapes appearing on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin reaction with redness and peeling of the skin, blistering or ulceration or separation of the upper skin layer from lower layers), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin) or bullous eruption (formation of small fluid-filled blisters on the skin), decreased urine output, breast enlargement in men (gynaecomastia), enlarged lymph nodes in the neck, armpits and groin, accumulation of fluid or other substances in the lungs (detected on X-rays), inflammation of the mucous membranes of the cheeks, gums, tongue, lips, throat
Very rare (may affect up to 1 in 10,000 people):
Intestinal angioedema (intestinal blood vessel swelling)
Not known (frequency cannot be estimated from available data):
Excessive production of antidiuretic hormone, causing fluid retention, leading to weakness, fatigue or confusion.
A syndrome has been reported which may include some or all of the following symptoms: fever, vasculitis (inflammation of serous membranes/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other skin symptoms may also occur.
Lercanidipine
Some adverse reactions may be serious.
You should contact your doctor immediately if any of the following adverse reactions occur:
Rare (may affect up to 1 in 1000 people):
Angina pectoris (chest pain due to inadequate blood supply to the heart), allergic reactions (symptoms include itching, rash, urticaria), fainting
In patients with angina pectoris, treatment with medicines of the class to which lercanidipine belongs may increase the frequency, prolong the duration or intensify angina attacks. Isolated cases of myocardial infarction have been observed.
Other possible adverse reactions:
Common (may affect up to 1 in 10 people): headache, increased heart rate, rapid or irregular heartbeat (palpitations), sudden redness of the face, neck or upper chest (hot flushes), ankle swelling
Uncommon (may affect up to 1 in 100 people): dizziness, sudden drop in blood pressure, heartburn, nausea, abdominal pain, rash, itching, muscle pain, passing large amounts of urine, feeling of weakness or fatigue
Rare (may affect up to 1 in 1000 people): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain
Not known (frequency cannot be estimated from available data): gum swelling, liver function disorders (detected in blood tests), cloudy fluid (during dialysis via a tube placed in the abdomen), swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing
If adverse reactions worsen or if any unlisted adverse symptoms occur, you should inform your doctor or pharmacist.
Your doctor or pharmacist can provide further information about adverse reactions.
They have a more detailed list of adverse reactions.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor or pharmacist. 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 .
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lercaprel

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton after "Expiry date (EXP)" and on the blister after "EXP". The expiry date refers to the last day of the stated 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 packaging to protect from light and moisture.
Do not store above 25°C.
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 Lercaprel contains

• The active substances are enalapril maleate and lercanidipine hydrochloride. Each 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).
• Other components:
  Tablet core – monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch (type A), povidone K-30, sodium hydrogen carbonate, 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 coated tablets, 8.5 mm in diameter.
Lercaprel is available in packs containing 14, 28, or 56 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised 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 Zanipril
Lithuania Lercaprel 10 mg/10 mg plėvele dengtos tabletės
Netherlands Lertec

Romania Lercaril 10 mg/10 mg
Slovenia Lercaprel 10 mg/10 mg
Sweden Zanitek