Leaflet: information for the user

Enalapril/ Lercanidipino Teva 20 mg/20 mg film-coated tablets EFG

enalapril maleate/lercanidipine hydrochloride

Read this leaflet carefully before you start taking 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.

6. Contents of the pack and additional information

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

Enalapril/lercanidipino is used to treat high blood pressure (hypertension) inadult patients who are currently taking enalapril and lercanidipino in separate tablets.

Do not takeEnalapril/Lercanidipine Teva

• if you are allergic to enalapril or lercanidipine or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had an allergic reaction to a type of medicine similar to those contained in Enalapril/Lercanidipine Teva, that is, medicines called ACE inhibitors or calcium channel blockers
• if you have ever had 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 sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high
• if you have diabetes or kidney problems and are being treated with a medicine to lower blood pressure that contains aliskiren

• if you are more than 3 months pregnant (it is also best to avoid Enalapril/Lercanidipine Teva in the early stages of pregnancy - see section “Pregnancy, breastfeeding and fertility”)

• if you have any of the following heart conditions:

• obstruction of blood flow out of the heart
• untreated congestive heart failure

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

• within the first month after having 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:
• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin, 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/Lercanidipine Teva if:

• you have low blood pressure (which may manifest as dizziness or fainting, especially when standing)
• you have been very ill (with excessive vomiting) or have had diarrhea recently
• you are on a low-sodium diet
• you have a heart problem
• you have a condition that affects the blood vessels in the brain

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

• you have liver problems

• 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)
• you have a vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with an immunosuppressant, are taking allopurinol or procainamide, or a combination of these
• you are a black patient, you should be aware that these patients have a higher risk of experiencing allergic reactions with inflammation of the face, lips, tongue, or throat, accompanied by difficulty swallowing or breathing, when taking ACE inhibitors
• you are diabetic. You should monitor your blood to detect low blood glucose levels, especially during the first month of treatment. Your potassium levels in the blood may also be high

• you have persistent dry cough
• you are taking potassium supplements, potassium-sparing diuretics, or salt substitutes that contain potassium

Sif you are taking any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

if you are taking any of the following medicines used to treat high blood pressure (hypertension).

-an angiotensin II receptor antagonist (ARA) (also known as “sartanes”-for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

-aliskiren.

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

See also the information under the heading “Do not take Enalapril/Lercanidipine Teva”.

Before undergoing the following procedures

if you are about to undergo any of the following procedures, inform your doctor that you are taking Enalapril/Lercanidipine Teva

• any surgical intervention or if you are to be given any anesthetic (even at the dentist's office)
• lipid-lowering treatment, known as “LDL apheresis”
• desensitization treatment, to reduce the effect of an allergy to bees or wasps.

You should inform your doctor if you think you are (or could be) pregnant or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Children and adolescents

The safety and efficacy of Enalapril/Lercanidipine Teva have not been established in children up to 18 years of age.

Taking Enalapril/Lercanidipine Teva with other medicines

Enalapril/Lercanidipine Teva 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, including medicines obtained without a prescription. This is because when Enalapril/Lercanidipine Teva is taken simultaneously with other medicines, the effect of Enalapril/Lercanidipine Teva or the other medicines may be modified, or certain adverse effects may occur more frequently.

Particularly, inform your doctor or pharmacist if you are taking any of the following medicines:

• other medicines to lower blood pressure
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase the amount of potassium in the blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to dilute the blood to prevent clots). See “Do not take Enalapril/Lercanidipine Teva”
• lithium (a medicine used to treat a certain type of depression)
• tricyclic antidepressants
• antipsychotics
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and are used to combat pain)
• medicines used to treat pain or arthritis, including gold therapy
• medicines used to treat coughs and colds and medicines used to reduce weight that contain a substance called “sympathomimetic agent”
• medicines used to treat diabetes (including oral antidiabetic medicines and insulin)
• astemizol or terfenadine (allergy medicines)
• amiodarone, quinidine, or sotalol (medicines used to treat a rapid heart rate)
• phenytoin, phenobarbital, or carbamazepine (medicines used to treat epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• digoxin (a medicine used to treat heart problems)
• midazolam (a medicine used to help you sleep)
• beta-blockers, e.g., metoprolol (a medicine used to treat high blood pressure, heart failure, and abnormal heart rhythm)
• cimetidine (more than 800 mg, a medicine used to treat ulcers, indigestion, or acid reflux)

Do not take Enalapril/Lercanidipine Teva if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

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

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

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

• if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Enalapril/Lercanidipine Teva” and “Warnings and precautions”).

Taking Enalapril/Lercanidipine Teva with food, drinks, and alcohol

• Enalapril/Lercanidipine Teva should be taken at least 15 minutes before a meal.
• A fatty meal significantly increases the blood levels of this medicine.

• Alcohol may increase the effect of Enalapril/Lercanidipine Teva. Do not consume alcohol during treatment with this medicine.
• Enalapril/Lercanidipine Teva should not be taken with grapefruit or grapefruit juice, as they may increase its blood pressure-lowering effect (see “Do not take Enalapril/Lercanidipine Teva”).

Pregnancy, breastfeeding, and fertility

Pregnancy and fertility

Inform your doctor if you think you are (or could be) pregnant. Enalapril/Lercanidipine Teva is not recommended for women who may become pregnant or in the early stages of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy

Breastfeeding

Enalapril/Lercanidipine Teva should not be used during breastfeeding.

Driving and operating machines

If you develop dizziness, weakness, fatigue, or somnolence during treatment with this medicine, DO NOT drive vehicles or operate machines.

Enalapril/Lercanidipine Teva contains sodium

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

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

Adults:Unless otherwise indicated by your doctor, the recommended dose is one tablet once a day at the same time every day. Tablets should preferably be taken in the morning at least 15 minutes before breakfast. Tablets should be swallowed whole with water. See““Taking Enalapril/Lercanidipino Teva 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 Teva than you should

Do not exceed the prescribed dose. If you have taken more tablets than you should, consult your doctor immediately or go to the hospital immediately. Bring the packaging with you.

A dose higher than the correct one may cause excessive blood pressure drop and your heart may beat irregularly or faster.

In case of overdose or accidental ingestion, call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Enalapril/Lercanidipino Teva

• 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 dose.

If you interrupt treatment with Enalapril/Lercanidipino Teva

• 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, Enalapril/ Lercanidipino Teva 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 Enalapril/ Lercanidipino Teva, 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 people)

Cough, feeling 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), 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 breathing or swallowing, skin rash, urticaria, waking up at night to urinate, producing large amounts of urine, impotence.

Additional side effects observed with enalapril or lercanidipine alone

Enalapril

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

Blurred vision, feeling dizzy, weak, or sick, and coughing

Frequent(may affect up to 1 in 10 people)

Depression, headache, fainting (syncope), chest pain, feeling dizzy due to low blood pressure, changes in heart rate, rapid heartbeat, angina, shortness of breath, alterations in taste, high 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 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 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 - chest tightness, slowed movement of food through the intestine (ileus), pancreatitis, feeling sick (vomiting), indigestion, constipation, stomach irritation (gastritis), dry mouth, ulcer, anorexia, increased sweating, itching or urticaria, hair loss, renal function alteration, increased sweating, renal insufficiency, 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 (sensation of spinning), 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), pulmonary infiltrates, 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/erythrodermia (severe skin rash with peeling or shedding of the skin), decreased urine production, gynecomastia (enlargement of breast tissue in men), inflammation of the glands in the neck, armpits, or groin, accumulation of fluid or other substances in the lungs (as seen on X-rays), inflammation of the cheeks, gums, tongue, lips, or throat.

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

Intestinal angioedema (inflammation of the intestinal lining)

Unknown frequency(frequency cannot be estimated from available data)

Overproduction of antidiuretic hormone causing fluid retention, resulting in weakness, fatigue, or confusion.

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

Lercanidipine

Some side effects may be serious.

Inform your doctor immediately if any of the following occurs:

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 (symptoms include 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 heart rate, rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (erythema), swelling of the ankles.

Infrequent(may affect up to 1 in 100 people):

Dizziness, low blood pressure, acid reflux, nausea, stomach pain, skin rash, itching, muscle pain, passing large amounts of urine, feeling weak or tired.

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

Somnolence, vomiting, diarrhea, urticaria, increased frequency of urination, chest pain.

Unknown frequency(frequency cannot be estimated from available data):

Gum inflammation, changes in liver function (detected through blood tests), cloudy fluids (when undergoing dialysis through a tube in your abdomen), inflammation of the face, tongue, or throat that may cause difficulty breathing or swallowing.

If any 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 comprehensive list of side effects.

Reporting side effects

If you experience any type of side effects,consult your doctor or pharmacist, eveniftheyare not listed 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 medication.

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 and 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 point of 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 Teva 20 mg/20 mg film-coated tablets EFG

The active substances are enalapril maleate and lercanidipine hydrochloride.

Each film-coated tablet contains: 20 mg of enalapril maleate (equivalent to 15.28 mg of enalapril) and 20 mg of lercanidipine hydrochloride (equivalent to 18.88 mg of lercanidipine).

The other components are:

Core: microcrystalline cellulose, sodium hydrogen carbonate, pregelatinized maize starch, sodium carboxymethyl starch (type IA), anhydrous colloidal silica, magnesium stearate.

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

Appearance of the product and content of the container

Enalapril/Lercanidipino Teva 20 mg/20 mg tablets are orange to light orange, round, biconvex, approximately 11 mm in diameter, and approximately 5 mm in thickness.

Enalapril/Lercanidipino Teva 20 mg/20 mg is available in containers of 14, 28, 30, 50, 56, 90, and 100 tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1st floor

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

Teva Gyógyszergyar Zrt

Pallagi út 13, Debrecen H-4042

Hungary

or

Teva Pharma S.L.U.

C/ C, nº 4, Polígono Industrial Malpica

Zaragoza 50016

or

Merckle GmbH

Ludwig-Merckle Strasse 3

Blaubeuren 89143

Germany

Last review date of this leaflet: September 2021

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es