Lercaprel

Patient Information Leaflet: Information for the Patient

Lercaprel, 20 mg + 10 mg, film-coated tablets
Enalapril maleate + Lercanidipine hydrochloride
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• 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. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, 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 enalapril 20 mg alone.
Lercaprel should not be used for 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 experienced an allergic reaction to medicines similar to those contained in Lercaprel, i.e. to other ACE inhibitors or other calcium antagonists;
• if the patient has ever developed swelling of the face, lips, oral cavity, tongue or throat causing difficulty in swallowing or breathing (angioedema), due to 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 (long-term) heart failure in adults, as this increases the risk of angioedema (sudden subcutaneous swelling, e.g. in the throat);
• 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 (the use of Lercaprel should also be avoided early in 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 following a heart attack (myocardial infarction);
• if the patient has severe liver function disorders;
• if the patient has severe kidney function disorders 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 transplanted organs);
• concurrently with grapefruit or grapefruit juice.

Warnings and precautions
Before starting to take 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 affecting 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 levels. 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 therapy, is taking 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 that the patient is taking
Lercaprel:

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

Inform the doctor about pregnancy, suspected pregnancy or plans to become pregnant, as well as about 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. It is best to take the tablet 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 impaired kidney function/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 amount, contact your doctor immediately
or go to the nearest hospital emergency department.
Take the medicine package with you. Taking more than the recommended dose may cause
excessively low blood pressure and irregular or rapid heartbeat.
Missing a dose of Lercaprel

• If you miss a dose, skip the missed dose.
• Then take your 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 questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment with this medicine:
Some adverse effects may be serious.
Seek immediate medical attention or go to hospital if any of the following adverse effects occur:

• Allergic reaction with swelling of the face, lips, tongue or throat, which may cause difficulty 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, lie down until they resolve. If in doubt, consult a doctor.
Adverse effects observed during treatment with Lercaprel
Common (may occur in up to 1 in 10 patients):

• Cough
• Dizziness, headache

Uncommon (may occur in up to 1 in 100 patients):

• Changes in blood parameters such as reduced platelet count
• Increased potassium levels in blood
• Nervousness (anxiety)
• Dizziness upon standing, sensation of spinning (vertigo)
• Increased heart rate, 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 occur in up to 1 in 1000 patients):

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

Additional adverse effects associated with individual components of the medicine (enalapril or lercanidipine)
Enalapril
Very common (may occur in more than 1 in 10 patients):
Blurred vision, dizziness, feeling of weakness, nausea, cough
Common (may occur in up to 1 in 10 patients):
Depression, headache, fainting, chest pain, feeling of emptiness in the head due to low blood pressure, heart rhythm disturbances, increased heart rate, palpitations, 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 swallowing or breathing
Uncommon (may occur in up to 1 in 100 patients):
Anaemia (including aplastic and haemolytic), sudden drop in blood pressure, confusion, nervousness, insomnia or drowsiness, tingling or numbness sensations, myocardial infarction (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 (ringing in the ears), impotence
Rare (may occur in up to 1 in 1000 patients):
Changes in blood parameters such as reduced white blood cell count, bone marrow suppression, autoimmune diseases, unusual dreams or sleep disturbances, Raynaud's phenomenon (coldness 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), elevated 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, peeling of the skin, blistering or ulceration, or separation of the upper skin layer from underlying 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), reduced 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-ray images), inflammation of the mucous membranes of the cheeks, gums, tongue, lips, throat
Very rare (may occur in up to 1 in 10,000 patients):
Intestinal angioedema (intestinal swelling)
Unknown (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 described 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 effects may be serious.
Seek immediate medical attention if any of the following adverse effects occur:
Rare (may occur in up to 1 in 1000 patients):
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, duration or severity of angina attacks. Isolated cases of myocardial infarction have been observed.
Other possible adverse effects:
Common (may occur in up to 1 in 10 patients): headache, increased heart rate, rapid or irregular heartbeat (palpitations), sudden redness of the face, neck or upper chest (hot flushes), swelling around the ankles
Uncommon (may occur in up to 1 in 100 patients): 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 occur in up to 1 in 1000 patients): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain
Unknown (frequency cannot be estimated from available data): gum swelling, liver function disorders (detected in blood tests), cloudy fluid (during peritoneal dialysis), swelling of the face, lips, tongue or throat, which may cause difficulty swallowing or breathing

If adverse effects worsen or if any adverse symptoms not listed in this leaflet occur, inform your doctor or pharmacist.
Your doctor or pharmacist can provide further information about adverse effects. They have a more detailed list of adverse effects.
Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 4921301, Fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this 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 cardboard box 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 the sewage system or with 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 lefkanidipine hydrochloride. Each film-coated tablet contains: 20 mg enalapril maleate (equivalent to 15.29 mg enalapril) and 10 mg lefkanidipine hydrochloride (equivalent to 9.44 mg lefkanidipine).
• Other ingredients are:
  Tablet core – monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone K-30, sodium hydrogen carbonate, magnesium stearate
  Tablet coating – hypromellose 5cP, titanium dioxide (E 171), talc, macrogol 6000, quinoline yellow, lac (E 104), yellow iron oxide (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 containing 14, 28 or 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Recordati Ireland Ltd.
Raheens East
Ringaskiddy, Co. Cork
Ireland

Manufacturers:
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 European Economic Area and 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 Zanipril

Lithuania Lercaprel 20 mg/10 mg plėvele dengtos tabletės
Netherlands Lertec

Romania Lercaril 20 mg/10 mg
Slovenia Lercaprel 20 mg/10 mg
Sweden Zanitek