Leaflet: information for the user

Enalapril/lercanidipino cinfa 20 mg/10 mg film-coated tablets

Enalapril maleate/lercanidipine hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

Do not takeenalapril/lercanidipino cinfa

• If you are allergic to enalapril maleate, lercanidipine hydrochloride, or any of the other ingredients in this medicine (listed in section 6).
• If you have ever had an allergic reaction to a type of medicine similar to those containing enalapril/lercanidipine, known as ACE inhibitors or calcium channel blockers.
• If you have ever experienced swelling of the face, lips, mouth, tongue, or throat that caused difficulty swallowing or breathing (angioedema) after taking a type of medicine 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 medicine used to treat chronic heart failure in adults, the risk of angioedema (rapid swelling of the throat) increases.

• If you have diabetes or kidney function impairment and are receiving treatment with a blood pressure-lowering medicine that contains aliskiren.
• If you are more than 3 months pregnant (it is also recommended to avoid using enalapril/lercanidipino 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 worsens progressively).
• During the first month after a heart attack.

• If you have severe liver problems.
• If you have severe kidney problems, or if you are undergoing dialysis.
• If you are taking medicines 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 medicine 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 enalapril/lercanidipino cinfa.

• 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 low-sodium diet.
• If you have a heart problem.
• If you have a condition 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 levels.
• If you have liver problems.
• If you have blood problems, 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 collagen vascular disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are on immunosuppressive therapy, or are taking allopurinol or procainamide or a combination of both medicines.

• 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 the level of potassium 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 are taking any of the following medicines, the risk of angioedema may be increased:
• Racecadotrilo, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection after a transplant or to treat cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptina, a medicine used to treat diabetes.

• If you are taking any of the following blood pressure-lowering medicines:

• 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) in your blood at regular intervals.

Also, see the information included under the heading “Do not take enalapril/lercanidipino cinfa”.

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 enalapril/lercanidipino:

• 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 “LDL apheresis”.
• 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

The safety and efficacy of enalapril/lercanidipino have not been established in children under 18 years of age.

Other medicines and enalapril/lercanidipino cinfa

Enalapril/lercanidipino should not be taken with certain medicines.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

This is because when enalapril/lercanidipino is taken with certain medicines, the effect of enalapril/lercanidipino or the other medicines 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 medicines:

• Blood pressure-lowering medicines.
• Potassium supplements (including salt substitutes in your diet).
• Potassium-sparing diuretics and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and sulfamethoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ rejection; heparin, an anticoagulant used to prevent blood clots). See the section “Do not take enalapril/lercanidipino cinfa”.
• Lithium (a medicine used to treat a certain type of depression).
• Tricyclic antidepressants.
• Antipsychotics.
• Nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and can be used to combat pain).
• Certain medicines for pain or arthritis, including gold therapy.
• Certain medicines for coughs and colds and medicines used to reduce weight that contain a substance called “sympathomimetic agent”.
• Diabetes medicines (including oral antidiabetic medicines and insulin).
• Astemizol or terfenadine (allergy medicines).
• Amiodarone, quinidine, or sotalol (medicines for rapid heart rate).
• Phenobarbital, phenytoin, or carbamazepine (medicines for epilepsy).
• Rifampicin (a medicine for tuberculosis).
• Digoxin (a medicine for heart problems).
• Midazolam (a medicine to help you sleep).
• Beta-blockers, e.g., metoprolol (medicines for high blood pressure, heart failure, and abnormal heart rhythm).
• Cimetidine (administered at doses above 800 mg per day, a medicine for ulcers, indigestion, or acid reflux).

Do not take enalapril/lercanidipino if you have taken or are currently taking sacubitrilo/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling of the throat) increases.

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

• Racecadotrilo, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection after a transplant or to treat cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptina, a medicine used to treat diabetes.

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

• If you are taking a blocker of the angiotensin II receptor (ARB) or aliskiren (also see the information included under the headings “Do not take enalapril/lercanidipino cinfa” and “Warnings and precautions”).

Taking enalapril/lercanidipino cinfa with food, drinks, and alcohol

Enalapril/lercanidipino should be taken at least 15 minutes before meals.

A fatty meal significantly increases the levels of the medicine in the blood.

Alcohol may increase the effect of enalapril/lercanidipino. During treatment with enalapril/lercanidipino, alcohol should not be consumed. Enalapril/lercanidipino should not be taken with grapefruit or grapefruit juice, as it may increase its antihypertensive effect (see “Do not take enalapril/lercanidipino cinfa”).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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 enalapril/lercanidipino before becoming pregnant or as soon as you know you are pregnant and recommend taking another medicine instead of enalapril/lercanidipino. Enalapril/lercanidipino 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 three months pregnant, as it may severely harm the fetus if used after the third month of pregnancy.

Breastfeeding

Enalapril/lercanidipino should not be taken during breastfeeding.

Driving and operating machinery

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

Enalapril/lercanidipino cinfa contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 enalapril/lercanidipino cinfa with food, drinks, and alcohol”.

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

If you take more enalapril/lercanidipino cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring the packaging and the medication leaflet 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 enalapril/lercanidipino cinfa

• 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 compensate for the missed doses.

If you interrupt the treatment with enalapril/lercanidipino cinfa

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:

• An allergic reaction accompanied by swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing;

When you start taking enalapril/lercanidipino, 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 enalapril/lercanidipino

Frequent(may affect up to 1 in 10 patients)

Cough, feeling of dizziness, headache.

Infrequent(may affect up to 1 in 100 patients)

Changes in blood parameters, such as a decrease in platelet count, an increase in potassium levels in the blood, 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), increased levels of liver enzymes, 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 patients)

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

Additional side effects observed with enalapril or lercanidipino alone

Enalapril

Very frequent(may affect more than 1 in 10 patients)

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

Frequent(may affect up to 1 in 10 patients)

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 potassium levels in the blood, diarrhea, abdominal pain, fatigue (fatigue), rash, allergic reaction with swelling of the face, lips, tongue, or throat that causes difficulty breathing or swallowing.

Infrequent(may affect up to 1 in 100 patients)

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 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 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 levels of protein in the urine (measured through a blood test), muscle cramps, general feeling of discomfort, high temperature (fever), low blood sugar or sodium levels, high levels of urea in the blood (all measured through a blood test), redness, rapid or irregular heartbeat (palpitations), vertigo (dizziness), tinnitus (ringing in the ears), impotence.

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

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 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 skin redness and scaling, blistering, or open sores), dermatitis exfoliativa/erythrodermia (severe skin rash with peeling or skin shedding), 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(may affect up to 1 in 10,000 patients)

Intestinal angioedema.

Unknown frequency(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.

Lercanidipino

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 patients)

Angina pectoris (chest pain caused by heart blood supply lack), 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 lercanidipino belongs. Isolated cases of myocardial infarction have been observed.

Other possible side effects:

Frequent(may affect up to 1 in 10 patients): 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 patients): dizziness, low 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 patients): somnolence, vomiting, diarrhea, urticaria, increased urination frequency, chest pain.

Unknown frequency(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 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 they have a more complete list of side effects.

Reporting side effects

If you experience any type of side effect,consult your doctor or pharmacist, evenifit is a possible side effect thatdoes not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 packaging after CAD. The expiration date is the last day of the month indicated.

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. If in doubt, 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 enalapril/lercanidipino cinfa

• The active principles are enalapril maleate and lercanidipino hydrochloride. Each film-coated tablet contains 20 mg of enalapril maleate (equivalent to 15.29 mg of enalapril) and 10 mg of lercanidipino hydrochloride (equivalent to 9.44 mg of lercanidipino).
• The other components are:

Tablet core: microcrystalline cellulose, sodium hydrogen carbonate, pregelatinized cornstarch, sodium carboxymethylcellulose (type A) (from potato), anhydrous colloidal silica, and magnesium stearate.

Coating: hypromellose, macrogol 6000, talc, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and contents of the package

Yellowish clear to yellowish round and biconvex film-coated tablets.

They are presented in blisters of polyamide-aluminum-PVC/aluminum.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

TEVA Gyógyszergyár Zrt.

Pallagi street 13, Debrecen H-4042

Hungary

or

Teva Pharma S.L.U.

C/ C, nº 4, Industrial Estate Malpica

Zaragoza 50016

or

Merckle GmbH

Ludwig-Merckle Street 3

Blaubeuren 89143

Germany

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:February 2022

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/79821/P_79821.html

QR code to:https://cima.aemps.es/cima/dochtml/p/79821/P_79821.html