Leaflet: information for the user

Enalapril/Lercanidipino Krka 10 mg/10 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 doctoror 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.

Contents of the pack and additional information.

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

Enalapril/Lercanidipino Krka is indicated for the treatment of high blood pressure (hypertension) in patients in whom lercanidipino 10mg does not control it adequately on its own. Enalapril/Lercanidipino Krka should not be used as the first treatment for hypertension.

Do not take Enalapril/Lercanidipino Krka:

• if you are allergic to enalapril, lercanidipino, or 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/Lercanidipino Krka, i.e., medicines 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 medicine called ACE inhibitors, or if the cause of the reaction was unknown or if it was a hereditary condition (hereditary or idiopathic angioedema);
• 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 better to avoid taking Enalapril/Lercanidipino Krka during the first months of pregnancy – see the pregnancy section);
• if you have certain heart conditions:
• untreated heart failure
• obstruction of blood flow from the left ventricle of the heart, including aortic stenosis;
• chest pain that occurs at rest or worsens or occurs more frequently (unstable angina)
• within the first month after having a heart attack;
• if you have severe liver or kidney problems, or if you are undergoing dialysis;
• if you are taking medicines such as:
• • antifungals (e.g. ketoconazole, itraconazole),
  • macrolide antibiotics (e.g. erythromycin, troleandomycin, clarithromycin),
  • antivirals (e.g. ritonavir)
• if you are taking another medicine called ciclosporin (used after a transplant to prevent organ rejection);
• with grapefruit or grapefruit juice.
• 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

Warnings and precautions.

Consult your doctor or pharmacist before starting to take Enalapril/Lercanidipino Krka.

• if you have low blood pressure (which may manifest as dizziness or fainting, especially when standing up).
• if you have been very ill (with excessive vomiting) or have had diarrhea recently, or are dehydrated.
• if you are on a low-sodium 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 level.

• 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 the number of red blood cells (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 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 your 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 medicines used to treat high blood pressure (hypertension):
• • a receptor antagonist of the angiotensin II (ARA) (also known as "sartanes" – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren.

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

See also information under the heading “Do not take Enalapril/Lercanidipino Krka”.

• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• racecadotril, used in the treatment of diarrhea
• temsirolimus, sirolimus, everolimus, and other medicines used to prevent organ rejection and cancer
• vildagliptin (used to treat diabetes).

if you are about to undergo any 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 Krka:

You should inform your doctor if you think you are (or could be) pregnant or if you are breastfeeding (see the pregnancy section).

Children and adolescents

Do not administer this medicine to children and adolescents under 18 years of age, as there is no information on its efficacy and safety.

Other medicines and Enalapril/Lercanidipino Krka

Enalapril/Lercanidipino Krka 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 those obtained without a prescription. This is because when you take Enalapril/Lercanidipino Krka simultaneously with certain medicines, the effect of Enalapril/Lercanidipino Krka or the other medicines may be intensified or weakened, or certain adverse effects may occur more frequently.

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

• potassium-sparing diuretics (e.g. triamterene, amiloride), medicines containing potassium (including salt substitutes in your diet), other medicines that can increase potassium levels in your body (such as heparin, a medicine used to thin the blood to prevent clots; trimetoprim and the cotrimoxazole, also known as trimetoprima/sulfametoxazol, for bacterial infections; and ciclosporin, an immunosuppressant used to prevent organ rejection after a transplant)

See “Do not take Enalapril/Lercanidipino Krka”

• other medicines that lower blood pressure,
• lithium (a medicine used to treat a certain type of depression)
• tricyclic antidepressants
• psychotropic medicines
• non-steroidal 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 (especially intravenous administration)
• certain medicines for coughs and colds and medicines used to reduce weight that contain a substance called “sympathomimetic agent”
• diabetes medicines (including insulin and antidiabetic medicines)
• Astemizol or terfenadine (allergy medicines)
• amiodarone or quinidine or sotalol (medicines for rapid heart rate)
• phenytoin, phenobarbital, 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 that treat high blood pressure, heart failure, and abnormal heart rhythm)
• cimetidine (a medicine for ulcers and acid reflux, administered at doses above 800 mg per day)

Do not take enalapril/lercanidipino if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

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

• racecadotril, a medicine used in the treatment of diarrhea
• medicines used to prevent organ rejection after a transplant or to treat cancer (e.g. temsirolimus, sirolimus, everolimus).
• vildagliptin, a medicine used to treat 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 aliskiren (see also information under the headings “Do not take Enalapril/Lercanidipino Krka” and “Warnings and precautions”).

Taking Enalapril/Lercanidipino Krka with food, drinks, and alcohol

Take Enalapril/Lercanidipino Krka at least 15 minutes before a meal.

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

Alcohol may increase the effect of Enalapril/Lercanidipino Krka. Do not consume alcoholic beverages during treatment with this medicine.

Enalapril/Lercanidipino Krkashould not be taken with grapefruit or grapefruit juice, as it may increase its blood pressure-lowering effect (see “Do not take Enalapril/Lercanidipino Krka”).

Pregnancy, breastfeeding, and fertility

Pregnancy and fertility

You should inform your doctor if you think you are (or could be) pregnant. Your doctor will usually recommend that you stop taking Enalapril/Lercanidipino Krka before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medicine instead of Enalapril/Lercanidipino Krka. Enalapril/Lercanidipino Krka is not recommended for use during the first months of pregnancy, and in any case, should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Enalapril/Lercanidipino Krka should not be taken during breastfeeding.

Consult your doctor or pharmacist if you are taking, before taking any medicine.

Driving and operating machinery

If you experience dizziness, weakness, fatigue, or drowsiness while taking this medicine, do not drive or operate hazardous machinery.

Enalapril/Lercanidipino Krka contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) 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 usual dose is one tablet a day, every day, and always at the same time. It is preferable to take it in the morning 15 minutes before breakfast. The tablets should be swallowed whole with water. See “Taking Enalapril/Lercanidipino Krka with food, drinks, and alcohol”.

Patients with kidney problems/advanced age: 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 Krka 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.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Taking more than the correct dose may cause your blood pressure to drop too low and your heart to beat irregularly or more quickly.

If you forgot to take Enalapril/Lercanidipino Krka

If you forget to take your tablet, do not take the missed dose. Take the next doses at your usual time. Do not take a double dose to make up for the missed doses.

If you interrupt the treatment with Enalapril/Lercanidipino Krka

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 can be serious.

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

• A severe 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 Krka, 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 withEnalapril/Lercanidipino Krka

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 concentration 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, 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 lercanidipine alone

Enalapril

Frequent(may affect up to 1 in 10 people)

Blurred vision, sensation of dizziness, weakness, nausea, 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 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, drowsiness or insomnia, sensation of pins and needles in the skin or numbness, vertigo (sensation of dizziness), ringing in the ears (tinnitus), rapid or irregular heartbeat (palpitations), 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 chest tightness, slowed movement of food through the intestines (ileus), pancreatitis, nausea, indigestion, constipation, stomach irritation (gastritis), dry mouth, ulcers, anorexia, increased sweating, itching or urticaria, hair loss, renal function alteration, renal insufficiency, high levels of protein in the urine (measured through a blood test), impotence, muscle cramps, general feeling of discomfort, high temperature (fever), high levels of urea in the blood, low levels of sugar or sodium in the blood (all measured through a blood test), sudden redness of the face, neck, or upper chest (erythema).

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, swollen lymph nodes in the neck, armpits, or groin, sleep disorders, Raynaud's phenomenon (in which hands and feet may become intensely cold and white due to low blood flow), pulmonary infiltrates, fluid or other substances accumulation in the lungs (visible on X-rays), nasal inflammation, pneumonia, inflammation of the cheeks, gums, tongue, lips, and throat, liver problems, such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or eyes), increased levels of bilirubin (measured through a blood test), erythema multiforme (red spots of different shapes on the skin), Stevens-Johnson syndrome or toxic epidermal necrolysis (a severe skin condition characterized by redness, scaling, blistering, or open sores), dermatitis exfoliativa/erythroderma (severe skin rash with peeling or skin detachment), or pemphigus (small fluid-filled blisters on the skin), decreased urine production, gynecomastia (breast enlargement in men).

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

Lercanidipine

Some side effects can be serious.

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

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

Patients with pre-existing angina pectoris may experience an increase in the 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 heartbeat, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (rubor), swelling of the ankles.

Infrequent(may affect up to 1 in 100 people)

Dizziness, low blood pressure, heartburn, nausea, abdominal pain, skin rash, itching, muscle pain, increased urine production, weakness or fatigue.

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

Drowsiness, vomiting, diarrhea, urticaria, increased urination frequency, chest pain (angina).

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 in the abdomen), swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing (angioedema).

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 of the side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for 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 packaging after CAD. The expiration date refers to the last day of the month indicated.

Do not store at a temperature above 30 °C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines 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 medicines you no longer need. In this way, you will help protect the environment.

Composition of Enalapril/Lercanidipine Krka:

• The active ingredients are enalapril maleate and lercanidipine hydrochloride. Each film-coated tablet contains 10 mg of enalapril maleate (equivalent to 7.64 mg of enalapril) and 10 mg of lercanidipine hydrochloride (equivalent to 9.44 mg of lercanidipine).

• The other components are povidone K30, maleic acid, sodium starch glycolate (type A) from potato, lactose monohydrate, and sodium stearate fumarate in the core, and hypromellose, titanium dioxide (E171), talc, and macrogol 6000 in the film coating. See section 2 “Enalapril/Lercanidipine Krka contains lactose and sodium”

Appearance of the product and contents of the Enalapril/Lercanidipine Krka package:

Enalapril/Lercanidipine Krka 10 mg/10 mg tablets are white, round, slightly biconvex with beveled edges, compressed diameter 10 mm.

Enalapril/Lercanidipine Krka 10 mg/10 mg is supplied in packaging of 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets per carton.

Enalapril/Lercanidipine Krka 10 mg/10 mg is supplied in packaging with blisters in a calendar format: 14, 28, 56, or 98 film-coated tablets per carton.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For more information about this medication, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medication is authorized in the member states of the European Economic Area with the following names::

Last review date of this leaflet::January 2022

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/