PATIENT INFORMATION LEAFLET

Zanipress 2020 mg/20 mg film-coated tablets

enalapril maleate/lercanidipine hydrochloride

6.Contents of the pack and additional information.

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

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

Do not take Zanipress:

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

•If you have ever experienced an allergic reaction to a type of medication similar to those contained in Zanipress, that is, 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 Zanipress at the beginning of pregnancy, see section Pregnancy).

•If you suffer from 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 suffering 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).

•With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zanipress:

•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 have restricted salt use in your diet.

•If you have a heart problem.

•If you suffer from a disorder 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 level.

•If you have liver problems.

•If you have blood disorders, such as a low 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 undergoing immunosuppressive therapy, or are taking alopurinol 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 swelling of the face, lips, tongue, or throat, 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. 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.

If you are taking some of the following medications to treat high blood pressure (hypertension):

• A receptor antagonist of angiotensin II (ARA) (also known as "sartanes" for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to 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 Zanipress”.

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 Zanipress:

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

•lipid apheresis treatment to remove cholesterol from the blood.

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

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

Children and adolescents

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

Other medications and Zanipress

Zanipress 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 Zanipress is taken with other medications, the effect of Zanipress 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 immunosuppressant used to prevent organ rejection; heparin, an anticoagulant used to prevent blood clots). See the section “Do not take Zanipress”

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

•tricyclic antidepressants

•psychotropic medications

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

•certain medications for pain or arthritis, including gold therapy

•certain medications for cough and colds and medications used to reduce weight that contain a substance called "sympathomimetic agent"

•medications for diabetes (including oral antidiabetic medications and insulin)

•astemizol or terfenadine (medications for allergies)

•amiodarone, quinidine, or sotalol (medications for rapid heart rate)

•phenytoin, phenobarbital, or carbamazepine (medications for epilepsy)

•rifampicin (a medication for tuberculosis)

•digoxin (a medication for heart problems)

•midazolam (a medication to help you sleep)

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

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

Do not take Zanipress 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 adjust your dose and/or take other precautions:

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Zanipress” and “Warnings and precautions”).

Taking Zanipress with food, drinks, and alcohol

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

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

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

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

Pregnancy, lactation, and fertility

Pregnancy and fertility

You should inform your doctor if you think you are (or may be) pregnant. Zanipress 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

Zanipress should not be taken during breastfeeding.

Driving and operating machines

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

Zanipress contains lactose and sodium

If your doctor has indicated 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 Zanipress with food, drinks, and alcohol”.

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

If you take more Zanipress than you should

Do not exceed the prescribed dose. If you have taken more Zanipress 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 forgot to take Zanipress

• If you forgot 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.

If you interrupt treatment with Zanipress

• Do not stop taking your medication unless your doctor tells you to.

If you have any other questions 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 Zanipress, 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 Zanipress

Frequent (may affect up to 1 in 10 people)

Cough, sensation of dizziness, headache.

Infrequent (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, nausea, increased levels of liver enzymes, 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 on 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, excessive urine production, 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 (palpitations), angina, shortness of breath, alterations in taste, increased levels of creatinine in the blood (usually detected through a blood test), high levels of potassium 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.

Infrequent (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 pinpricks in the skin 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 discharge, 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, ulcers, anorexia, itching or urticaria, hair loss, renal function impairment, renal insufficiency, increased sweating, high levels of protein in the urine (measured through a blood test), muscle cramps, general feeling of discomfort, high temperature (fever), low levels of sugar or sodium in the blood, high levels of urea in the blood (all measured through a blood test) redness, rapid or irregular heartbeat (palpitations), vertigo (sensation of dizziness), 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, depression of the bone marrow, autoimmune diseases, strange dreams or sleep disorders, Raynaud's phenomenon (in which the 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 levels of liver enzymes or bilirubin (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 redness of the skin and the formation of scales, blisters, or open sores), dermatitis exfoliativa/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small blisters filled with fluid on the skin), decreased urine production, gynecomastia (breast enlargement in men), inflamed glands in the neck, armpits, or groin, accumulation of fluids or other substances 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 unknown (cannot be estimated from available data)

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

A set of symptoms 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 medicines to which lercanidipine belongs. Isolated cases of myocardial infarction may be 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.

Infrequent (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn, 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 unknown (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 not listed 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 not listed 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 packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zanipress

The active principles are enalapril maleate and lercanidipine hydrochloride.

Each film-coated tablet contains: 20mg of enalaprilmaleate(equivalent to 15.29mg ofenalapril) and 20mg of lercanidipine hydrochloride (equivalent to 18.88mgof 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

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder::

CASENRECORDATI , S.L.AutovíadeLogroño,km13,300-50180Utebo(Zaragoza)

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:

Austria: Zanipril 20mg/20mg Filmtabletten

Belgium, Luxembourg: Zanicombo

Bulgaria: Lercapril

Cyprus: Zaneril

Germany, Denmark, Finland, Iceland, Malta, Norway, Portugal, Spain: Zanipress

France: Zanextra

Greece, Latvia, Poland: Lercaprel

Hungary: Coripren

Ireland, Estonia: Lercaril

Italy: Zanipril

Lithuania: Lercaprel 20mg/20mg plevele dengtos tabletes

Netherlands: Lertec

Romania: Lercaril 20mg/20mgcomprimate filmate

Slovenia: Lercaprel 20mg/20mgfilmsko obložene tablete

Sweden: Zanitek:

Last review date of this leaflet: 07/2021

The 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/