PATIENT INFORMATION LEAFLET

Lercapress 20 mg/20 mg Film-Coated Tablets

enalapril maleate/lercanidipine hydrochloride

6.Contents of the pack and additional information.

Lercapress is a fixed combination of an angiotensin-converting enzyme (ACE) inhibitor (enalapril maleate) and a calcium channel blocker (lercanidipine hydrochloride), two medications that lower blood pressure.

Lercapress is used to treat high blood pressure (hypertension) in adult patients who are currently taking enalapril and lercanidipine in separate tablets.

Do not take Lercapress:

•If you are allergic to enalapril maleate or lercanidipine hydrochloride, or to any of the other components of this medication (listed in section 6).

•If you have ever experienced an allergic reaction to a type of medication similar to those contained in Lercapress, i.e., medications called ACE inhibitors or calcium channel blockers.

•If you have ever experienced swelling of the face, lips, mouth, tongue, or throat that has caused difficulty swallowing or breathing (angioedema) after taking a type of medication called ACE inhibitors, or if the cause of the reaction was unknown or if it was a hereditary condition.

•If you have taken or are currently taking sacubitrilo/valsartan, a medication used for the treatment of chronic heart failure in adults, the risk of angioedema (rapid swelling of the throat) increases.

•If you have diabetes or kidney insufficiency and are being treated with medications containing aliskirén.

•If you are more than 3 months pregnant (also recommended to avoid the use of Lercapress at the beginning of pregnancy, see Pregnancy section).

•If you have certain heart conditions:

•obstruction of blood flow out of the heart

•untreated heart failure

•unstable angina (chest pain that appears at rest or increases progressively)

•within the first month after experiencing a myocardial infarction.

•If you have severe liver problems

•If you have severe kidney problems or are undergoing dialysis.

•If you are taking medications that inhibit hepatic metabolism, such as:

•antifungals (such as ketoconazole or itraconazole).

•macrolide antibiotics (such as erythromycin, troleandomycin, or clarithromycin).

•antivirals (such as ritonavir).

•If you are taking another medication called ciclosporina (used after a transplant to prevent organ rejection).

•Jointly with grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lercapress:

•If you have low blood pressure (which may manifest as dizziness or fainting, especially when standing).

•If you have been very ill (with excessive vomiting) or have had diarrhea recently.

•If you are on a restricted salt diet.

•If you have a heart problem.

•If you have a condition that affects the blood vessels in the brain.

•If you have kidney problems (including kidney transplant). This may lead to high levels of potassium in the blood that can be serious. Your doctor may need to adjust your enalapril dose or monitor your potassium levels.

•If you have liver problems.

•If you have blood disorders, such as a low or absent white blood cell count (leucopenia, agranulocytosis), a low platelet count (thrombocytopenia), or a decrease in red blood cell count (anemia).

•If you have a vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are on immunosuppressive therapy, or are taking allopurinol or procainamide or a combination of both medications.

•If you are a black patient, you should be aware that these patients have a higher risk of experiencing allergic reactions with facial, lip, tongue, or throat swelling, accompanied by difficulty swallowing or breathing, when taking ACE inhibitors.

•If you are diabetic, you should control your blood sugar levels, especially during the first month of treatment, as your blood sugar levels may be low. Potassium levels in the blood may also be elevated.

•If you are taking potassium supplements, potassium-sparing agents, or salt substitutes that contain potassium.

•If you are over 70 years old.

•If you have intolerance to certain sugars (lactose).

If you are taking any of the following medications, the risk of angioedema may be increased:

• Racecadotrilo, a medication used in the treatment of diarrhea.
• Medications used in the prevention of organ rejection after a transplant or in the treatment of cancer (e.g., temsirolimus, sirolimus, everolimus).

• Vildagliptina, a medication used in the treatment of diabetes.

• Si está tomando algunos de los siguientes medicamentos para tratar la presión arterial alta (hipertensión:
• Un antagonista de los receptores de angiotensina II (ARA) (también conocidos como “sartanes” por ejemplo, valsartán, telmisartán, irbesartán), en particular si sufre problemas renales relacionados con la diabetes.
• Aliskirén.

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Lercapress”.

If you are about to undergo surgery or certain treatments soon

If you are about to undergo any of the following procedures, inform your doctor that you are taking Lercapress:

•any surgical intervention or if you are to be administered any anesthetic (including dental consultation)

•a treatment to extract cholesterol from the blood known as “apheresis of LDL”

•a desensitization treatment, to reduce the effect of an allergy to bees or wasps.

You should inform your doctor if youthink you are (or may be) pregnant or if you are breastfeeding (see the Pregnancy, lactation, and fertility section).

Children and adolescents

Lercapress has not been established as safe and effective in children under 18 years old.

Other medications and Lercapress

Lercapress should not be taken with certain medications.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications. This is because when Lercapress is taken with other medications, the effect of Lercapress or the other medications may be modified, or certain adverse effects may occur more frequently.

Specifically, inform your doctor or pharmacist if you are taking any of the following medications:

•other medications that lower blood pressure

•potassium supplements (including salt substitutes in the diet), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and sulfamethoxazole for bacterial infections; ciclosporina, an immunosuppressive medication used to prevent organ rejection; heparin, an anticoagulant medication used to prevent blood clots). See the “Do not take Lercapress” section

•lithium (a medication used to treat a certain type of depression)

•tricyclic antidepressants

•psychotropic medications

•nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (medications that reduce inflammation and are used to combat pain)

•certain medications for pain or arthritis, including gold therapy

•certain medications for cough and cold, and medications used to reduce weight that contain a substance called “sympathomimetic agent”

•diabetes medications (including oral diabetes medications and insulin), astemizol or terfenadine (allergy medications)

•amiodarone, quinidine, or sotalol (medications used to treat rapid heart rate)

•phenytoin, phenobarbital, or carbamazepine (medications used to treat epilepsy)

•rifampicin (a medication used to treat tuberculosis)

•digoxin (a medication used to treat heart problems)

•midazolam (a medication used to help you sleep)

•beta-blockers, e.g., metoprolol (medications used to treat high blood pressure, heart failure, and abnormal heart rhythm)

•cimetidine (administered at doses above 800 mg per day, a medication used for ulcers, indigestion, or acid reflux)

No take Lercapress, if you have taken or are currently taking sacubitrilo/valsartan, a medication used for the treatment of chronic heart failure in adults, the risk of angioedema (rapid swelling of the throat) increases.

If you are taking any of the following medications, the risk of angioedema may be increased:

• Racecadotrilo, a medication used in the treatment of diarrhea.
• Medications used in the prevention of organ rejection after a transplant or in the treatment of cancer (e.g., temsirolimus, sirolimus, everolimus).

Vildagliptina, a medication used in the treatment of diabetes.

Your doctor may need to modify your dose and/or take other precautions:

• Si está tomando antagonistas de los receptores de angiotensina II (ARA) o aliskirén (see also information under the heading “Do not take Lercapress” and “Warnings and precautions”).

Taking Lercapress with food, drinks, and alcohol

•Lercapress should be taken at least 15 minutes before meals.

•A meal rich in fat significantly increases the levels of the medication in the blood.

•Alcohol may increase the effect of Lercapress. During treatment with Lercapress, alcohol should not be consumed.

•Lercapress should not be taken with grapefruit or grapefruit juice, as it may increase its antihypertensive effect (see “Do not take Lercapress”).

Pregnancy, lactation, and fertility

Pregnancy and fertility

You should inform your doctor if you think you are (or may be) pregnant. Lercapress is not recommended for use in women who may become pregnant or at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to the fetus if used after the third month of pregnancy.

Lactation

Lercapress should not be taken during breastfeeding.

Driving and operating machinery

If you experience dizziness, weakness, or somnolence with this medication,
you should not drive or operate machinery.

Lercapress contains lactose and sodium

If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor . In case of doubt, consult your doctor or pharmacist again .

Adults: Unless your doctor tells you otherwise, the recommended dose is one tablet once a day, at the same time every day . The tablet should be taken preferably in the morning, at least 15 minutes before breakfast . The tablets should be swallowed whole with water . See “Taking Lercapress with food, drinks, and alcohol”

Patients with kidney problems/ elderly people: Your doctor will decide the dose of medication you should take, taking into account how well your kidneys are functioning

If you take more Lercapress than you should

Do not exceed the prescribed dose . If you have taken more Lercapress than you should or in case of overdose, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone (91) 562 04 20 or go to the hospital immediately . Bring the packaging and the medication leaflet with you to the healthcare professional . A dose higher than the correct one may cause excessive blood pressure drop and your heart may beat irregularly or faster

If you forget to take Lercapress

• If you forget to take your tablet, do not take the missed dose
• Take the next dose following the usual schedule
• Do not take a double dose to make up for the missed doses

What if you interrupt treatment with Lercapress

? Do not stop taking your medication unless your doctor tells you to

If you have any other doubts about the use of this medication, ask your doctor or pharmacist .

Like all medicines, this medicine can cause side effects, although not everyone will experience them. This medicine may cause the following side effects:

Some side effects may be serious.

Inform your doctor immediately if you notice any of the following side effects:

A hypersensitivity reaction accompanied by swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing;

When you start taking Lercapress, you may feel weakness or dizziness, or notice that your vision becomes blurry; this is caused by a sudden drop in blood pressure, and if it happens, it will be helpful to lie down. If you are concerned, consult your doctor.

Side effects observed with Lercapress

Frequent (may affect up to 1 in 10 people)

Cough, sensation of dizziness, headache.

Rare (may affect up to 1 in 100 people)

Changes in blood parameters, such as a decrease in platelet count, an increase in potassium levels in the blood, nervousness (anxiety), sensation of dizziness when standing up, vertigo, rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (erythema), low blood pressure, abdominal pain, constipation, feeling sick (nausea), increase in liver enzyme levels, skin redness, joint pain, increased urination frequency, feeling weak, fatigue, sensation of heat, inflammation of the ankles.

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

Anemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat, indigestion, salty sensation in the tongue, diarrhea, dry mouth, inflammation of the gums, allergic reaction with swelling of the face, lips, tongue, or throat that causes difficulty breathing or swallowing, skin rash, urticaria, nocturia, production of large amounts of urine, impotence.

Additional side effects observed with enalapril or lercanidipine alone

Enalapril

Frequent (may affect more than 1 in 10 people)

Blurry vision, sensation of dizziness, weakness, or discomfort, and cough.

Frequent (may affect up to 1 in 10 people)

Depression, headache, fainting (syncope), chest pain, dizziness due to low blood pressure, changes in heart rate, rapid or irregular heartbeat, angina, shortness of breath, alterations in taste, increased creatinine levels in the blood (usually detected through a blood test), high potassium levels in the blood, diarrhea, abdominal pain, fatigue (fatigue), rash, allergic reaction with inflammation of the face, lips, tongue, or throat that causes difficulty breathing or swallowing.

Rare (may affect up to 1 in 100 people)

Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure, confusion, nervousness, somnolence or insomnia, sensation of pins and needles or numbness, myocardial infarction (possibly caused by very low blood pressure in certain high-risk patients, including those with heart or brain blood supply problems), stroke (possibly due to very low blood pressure in high-risk patients), nasal congestion, sore throat, and hoarseness, asthma associated with chest tightness, slowed movement of food through the intestine (ileus), pancreatitis, feeling sick (vomiting), indigestion, constipation, stomach irritation (gastritis), dry mouth, ulcer, anorexia, itching or urticaria, hair loss, renal function alteration, renal insufficiency, increased sweating, high protein levels in the urine (measured through a blood test), muscle cramps, general feeling of discomfort, high temperature (fever), low blood sugar or sodium levels, high urea levels in the blood (all measured through a blood test), redness, rapid or irregular heartbeat (palpitations), vertigo (sensation of dizziness), tinnitus, 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 depression, autoimmune diseases, strange dreams or sleep disorders, "Raynaud's phenomenon" (in which hands and feet may become intensely cold and acquire a white color due to low blood flow), nasal inflammation, pneumonia, liver problems, such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased liver enzyme or bilirubin levels (measured through a blood test), erythema multiforme (red spots of different shapes that appear on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a severe skin condition characterized by skin redness and scaling, blistering, or open sores), dermatitis exfoliativa/erythroderma (severe skin rash with peeling or skin shedding), pemphigus (small blisters filled with fluid on the skin), decreased urine production, breast hypertrophy in men (gynecomastia), inflamed glands in the neck, armpits, or groin, fluid or other substance accumulation in the lungs (as seen on X-rays), inflammation of the cheeks, gums, tongue, lips, and throat.

Very rare (may affect up to 1 in 10,000 people)

Intestinal inflammation (intestinal angioedema).

Frequency not known (cannot be estimated from available data)

Excessive production of antidiuretic hormone causing fluid retention, leading to weakness, fatigue, or confusion.

A set of symptoms has been reported that may include one or more of the following: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

Lercanidipine

Some of these side effects may be serious. If you experience any of these side effects, consult your doctor.

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

Angina pectoris (chest pain caused by lack of blood supply to the heart), allergic reactions (with symptoms such as itching, rash, urticaria), fainting.

Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of attacks associated with treatment with the group of medications to which lercanidipine belongs. Isolated cases of myocardial infarction have been observed.

Other possible side effects:

Frequent (may affect up to 1 in 10 people): headache, rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest, swelling of the ankles.

Poorly Frequent (may affect up to 1 in 100 people): dizziness, drop in blood pressure, stomach burning, discomfort, stomach pain, skin rash, itching, muscle pain, increased urine production, weakness or fatigue.

Rare (may affect up to 1 in 1,000 people): somnolence, vomiting, diarrhea, urticaria, increased urination frequency, chest pain.

Frequency not known (cannot be estimated from available data): swelling of the gums, changes in liver function (detected through blood tests), cloudy fluid (during hemodialysis through a tube inside the abdomen), swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

If any of the side effects worsen, or if you experience any type of side effect that does not appear in this prospectus, inform your doctor or pharmacist. You can consult your doctor or pharmacist for more information about side effects, as both have a more complete list of side effects.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture. Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lercapress

The active principles are enalapril maleate and lercanidipine hydrochloride.

Each film-coated tablet contains: 20 mg of enalapril maleate (equivalent to 15.29 mg of enalapril) and 20 mg of lercanidipine hydrochloride (equivalent to 18.88 mg of lercanidipine).

The other components are:

Core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, potato starch, povidone K30, sodium bicarbonate, and magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), talc, and red iron oxide (E172).

Appearance of the product and contents of the package

Lercapress 20 mg/20 mg tablets are 12 mm, orange, circular, and biconvex tablets.

Lercapress 20 mg/20 mg is available in packages of 7, 14, 28, 30, 35, 42, 50, 56, 90, 98, and 100 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

RECORDATI IRELAND LTD.

Raheens East, Rengaskiddy Co.Cork. Ireland.

Local Representative:

Casen Recordati, S.L. Autovía de Logroño, km 13,300. 50180 Utebo (Zaragoza). Spain.

Responsible manufacturer:

RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali 1 – 20148 Milan, Italy

This medicinal product is authorized in the Member States of the EEA under the following trade names:

Germany: Carmen ACE

Italy: Atover

Spain: Lercapress

Last review date of this leaflet:07/2021.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/