Prospect: information for the user

Zanipress 20 mg/10 mg film-coated tablets

enalapril maleate/lercanidipine hydrochloride

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Zanipress is and for what it is used

2.What you need to know before starting to take Zanipress

3.How to take Zanipress

4.Possible adverse effects

5.Storage of Zanipress

6.Contents of the package and additional information

Zanipress is a fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipino), two medications that reduce blood pressure.

Zanipress is used to treat high blood pressure (hypertension) in adult patients whose blood pressure is not adequately controlled by enalapril 20 mg alone. Zanipress should not be used for the initial treatment of hypertension.

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 sacubitril/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 have a kidney function disorder and are receiving treatment with a blood pressure medication that contains aliskiren.

•If you are more than 3 months pregnant (it is also recommended to avoid using Zanipress at the beginning of pregnancy, see section pregnancy).

•If you have certain heart conditions:

•Obstruction of blood flow from the heart

•Untreated heart failure

•Unstable angina (chest pain that occurs at rest or increases progressively)

•During the first month after a heart attack.

• •If you have severe liver problems

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

•If you are taking medications that inhibit liver 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 ciclosporin (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 have a disorder that affects 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 on 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 monitor 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 an intolerance to certain sugars (lactose)

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

• Rececadotrilo, 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 any of the following medications used to treat high blood pressure:

•A blocker of the angiotensin II receptor (ARB) (also known as sartans, such as valsartan, telmisartan, or irbesartan), particularly if you have kidney problems related to diabetes.

•Aliskiren.

Your doctor may review your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) present in your blood at regular intervals.

Also see the information included 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 an anesthetic (even at the dentist's office)

•A treatment to remove 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 you think you are (or may be) pregnant or if you are breastfeeding (see the section Pregnancy, breastfeeding, 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 dietary salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and sulfamethoxazole for bacterial infections; ciclosporin, an immunosuppressive medication used to prevent organ rejection; heparin, an anticoagulant medication 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

•Antipsychotics

•Nonsteroidal anti-inflammatory drugs, 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 cold, and medications 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)

•Fenitoin, 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 daily doses above 800 mg, a medication for ulcers, indigestion, or acid reflux)

Do not take Zanipress if you have taken or are currently taking sacubitril/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:

•If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (also see the information included 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, breastfeeding, and fertility

Pregnancy and fertility

You should inform your doctor if you think you are (or may be) pregnant. Generally, your doctor will advise you to stop taking Zanipress before becoming pregnant or as soon as you know you are pregnant and recommend taking another medication instead of Zanipress. 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.

Breastfeeding

Zanipress 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.

Zanipress contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this 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: Your doctor will decide the dose of medication 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 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 Zanipress:

• 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.

If you interrupt treatment with Zanipress:

• 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 can be serious.

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

Allergic 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, feeling of dizziness, headache.

Rare (may affect up to 1 in 100 people)

Changes in blood parameters, such as a decrease in platelet count, increase in blood potassium levels, nervousness (anxiety), feeling 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, feeling hot, 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, gum inflammation, allergic reaction with swelling of the face, lips, tongue, or throat that causes difficulty swallowing or breathing, skin rash, urticaria, nocturia, large amounts of urine production, impotence.

Additional side effects observed with enalapril or lercanidipine alone

Enalapril

Very frequent (affect more than 1 in 10 people)

Blurred vision, feeling of dizziness, weakness, or discomfort, and cough.

Frequent (affect less than 1 in 10 people)

Depression, headache, fainting (syncope), chest pain, dizziness due to low blood pressure, changes in heart rate, rapid 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, rash, allergic reaction with inflammation of the face, lips, tongue, or throat that causes difficulty swallowing or breathing.

Rare (affect less than 1 in 100 people)

Anemia (including aplastic and hemolytic anemia), sudden drop in blood pressure, confusion, nervousness, somnolence or insomnia, feeling of pins and needles or numbness, myocardial infarction (possibly caused by very low blood pressure in 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 intestines (ileus), pancreatitis, feeling sick (vomiting), indigestion, constipation, stomach irritation (gastritis), dry mouth, ulcers, 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 (dizziness), tinnitus (ringing in the ears), impotence.

Rare (affect less than 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 scaly formation, blistering, or open sores), dermatitis exfoliativa/erythroderma (severe skin rash with peeling or skin detachment), 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, fluid or other substance accumulation in the lungs (visible on X-rays), inflammation of the cheeks, gums, tongue, lips, and throat.

Very rare (affect less than 1 in 10,000 people)

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

Rare (affect less than 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 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.

Rare (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn, discomfort, abdominal 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): gum swelling, 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 they have a more comprehensive list of side effects.

Reporting 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: 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 Zanipress

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 10 mg of lercanidipine hydrochloride (equivalent to 9.44 mg of lercanidipine).

The other components are:

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

Film coating: hypromellose 5 cP, titanium dioxide (E171), talc, macrogol 6000, yellow quinoline aluminum lake (E104), and yellow iron oxide (E172).

Appearance of the product and contents of the package

Zanipress 20 mg/10 mg tablets are 8.5 mm, yellow, circular, and biconvex film-coated tablets.

Zanipress 20 mg/10 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 marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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

Responsible for manufacturing

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

Doppel Farmaceutici S.r.l., Via Volturno 48, Quinto de’Stampi, 20089 Rozzano (MI), Italy

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

AustriaZanipril 20 mg/10 mg Filmtabletten

BelgiumZanicombo

BulgariaLercapril

CyprusZaneril

DenmarkZanipress

EstoniaLercaril

FinlandZanipress

FranceZanextra

GermanyZanipress

GreeceLercaprel

HungaryCoripren

IcelandZanipress

IrelandLercaril

ItalyZanipril

LatviaLercaprel

LithuaniaLercaprel 20 mg/10 mg plevele dengtos tabletes

LuxembourgZanicombo

MaltaZanipress

NetherlandsLertec

NorwayZanipress

PolandLercaprel

PortugalZanipress

RomaniaLercaril 20 mg/10 mg

SloveniaLercaprel 20 mg/10 mgg

SpainZanipress

SwedenZanitek

United Kingdom (IN)Zaneril

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/