Enalapril/lercanidipine Krka 10 mg/10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril/Lercanidipine Krka 10 mg/10 mg film-coated tablets EFG

Enalapril maleate / Lercanidipine hydrochloride

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Enalapril/Lercanidipine Krka is and what it is used for.
2. What you need to know before taking Enalapril/Lercanidipine Krka.
3. How to take Enalapril/Lercanidipine Krka.
4. Possible adverse effects.
5. How to store Enalapril/Lercanidipine Krka.

Pack contents and additional information.

1. What Enalapril/Lercanidipine Krka is and what it is used for

Enalapril/Lercanidipine Krka is a fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two medicines that reduce blood pressure.

Enalapril/Lercanidipine Krka is indicated for the treatment of high blood pressure (hypertension) in patients in whom lercanidipine 10 mg alone does not adequately control blood pressure. Enalapril/Lercanidipine Krka should not be used as first-line treatment for hypertension.

2. What you need to know before taking Enalapril/Lercanidipino Krka

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 known as ACE inhibitors or calcium channel blockers;
• if you have ever experienced swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing (angioedema) after taking a medicine known as an ACE inhibitor, or if the cause of such 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 blood pressure-lowering medicine containing aliskiren;
• if you are more than 3 months pregnant (it is best to avoid using Enalapril/Lercanidipino Krka during the first months of pregnancy – see Pregnancy section);
• if you have certain heart conditions:
  • untreated heart failure
  • obstruction of blood outflow from the left ventricle of the heart, including narrowing of the aortic valve (aortic stenosis)
  • chest pain occurring at rest, worsening, or occurring more frequently (unstable angina)
  • during the first month after having suffered a myocardial infarction.
• 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 cyclosporine (used after organ transplantation to prevent organ rejection);
• together 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 beneath the skin, e.g., in 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 seriously ill (with excessive vomiting) or have recently had diarrhea, or if you are dehydrated.
• If you are on a salt-restricted diet.
• If you have a heart condition.
• If you have a disorder affecting 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, which 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 disorders, such as low or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anemia).
• If you have a collagen vascular disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are on immunosuppressive therapy, or are taking allopurinol or procainamide, or a combination of both.
• If you are a Black patient, you should be aware that such patients have a higher risk of 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 they may be low. Blood potassium levels may also be elevated.
• If you are taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium.
• If you are over 70 years of age.
• If you have intolerance to certain sugars (lactose)
• 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 “sartans” – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren.

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

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

• If you are using any of the following medicines, the risk of angioedema (rapid swelling beneath the skin, e.g., in the throat) increases:
  • Racecadotril, used in the treatment of diarrhea
  • Temsirolimus, sirolimus, everolimus, and other medicines used to prevent rejection of transplanted organs and in cancer treatment
  • Vildagliptin (used to treat diabetes).

If you are about to undergo surgery or certain treatments

If you are about to undergo any of the following procedures, inform your doctor that you are taking Enalapril/Lercanidipino Krka:

• any surgical intervention or if you are to receive an anesthetic (even at the dentist’s office)
• a treatment to remove cholesterol from your blood known as “LDL apheresis”
• a desensitization treatment to reduce the effect of an allergy to bees or wasps.

You must inform your doctor if you think you are (or might be) pregnant or if you are breastfeeding (see section Pregnancy, breastfeeding, and fertility).

Children and adolescents

Do not give 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 must not be taken with certain medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This is because when Enalapril/Lercanidipino Krka is taken together with certain medicines, the effect of Enalapril/Lercanidipino Krka or of the other medicines may be increased or decreased, 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 agents (e.g., triamterene, amiloride), medicines containing potassium (including dietary salt substitutes), or other medicines that may increase potassium in your body (such as heparin, a medicine used to thin the blood to prevent clots; trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, for bacterial infections; and cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection)

See “Do not take Enalapril/Lercanidipino Krka”

• other medicines that lower blood pressure,
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression called "tricyclic antidepressants"
• medicines for mental disorders, known as "antipsychotics"
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain)
• certain medicines for pain or arthritis, including gold therapy (especially when administered intravenously)
• certain medicines for cough and cold, and medicines used to reduce weight that contain a substance called "sympathomimetic agent"
• medicines for the treatment of diabetes (including insulin and antidiabetic medicines)
• astemizole or terfenadine (medicines for allergies)
• amiodarone, quinidine, or sotalol (medicines for treating fast heart rate)
• phenytoin, phenobarbital, or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine for the treatment of tuberculosis)
• digoxin (a medicine for treating 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, when taken at daily doses exceeding 800 mg)

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 beneath the skin, e.g., in 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 rejection of transplanted organs or in the treatment of cancer (e.g., temsirolimus, sirolimus, everolimus)
• vildagliptin, a medicine 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 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 high-fat meal significantly increases the levels of the medicine in the blood.

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

Do not take Enalapril/Lercanidipino Krka with grapefruit or grapefruit juice, as it may increase its hypotensive effect (see “Do not take Enalapril/Lercanidipino Krka”).

Pregnancy, breastfeeding, and fertility

Pregnancy and fertility

Inform your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop taking Enalapril/Lercanidipino Krka before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Enalapril/Lercanidipino Krka is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that point.

Breastfeeding

Do not take Enalapril/Lercanidipino Krka during breastfeeding.

Consult your doctor or pharmacist before taking any medicine, if you are taking or planning to take any other medicine.

Driving and use of machines

If you experience dizziness, weakness, fatigue, or drowsiness while taking this medicine, you should not drive or operate dangerous 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 him before taking this medicine.

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

3. How to take Enalapril/Lercanidipino Krka

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults: Unless otherwise instructed by your doctor, the usual dose is one tablet daily, 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/elderly patients: Your doctor will decide the dose of the medicine you should take, based on how well your kidneys are functioning.

If you take more Enalapril/Lercanidipino Krka than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

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

If you forget 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 times. Do not take a double dose to make up for the missed doses.

If you stop taking Enalapril/Lercanidipino Krka

Do not stop taking your medicine unless your doctor tells you to.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse reactions, although not everyone gets them. This medicine may cause the following adverse effects:

Some adverse effects can be serious.

Tell your doctor immediately if you notice any of the following adverse effects:

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

When you start taking Enalapril/Lercanidipino Krka, you may feel weak or dizzy, or notice blurred vision; this is caused by a sudden drop in blood pressure, and if it occurs, lying down may be helpful. If you are concerned, consult your doctor.

Adverse effects observed with Enalapril/Lercanidipino Krka

Frequent (may affect up to 1 in 10 people)

Cough, dizziness, headache.

Uncommon (may affect up to 1 in 100 people)

Changes in blood test values, such as decreased platelet count, increased blood potassium concentration, nervousness (anxiety), dizziness upon standing, vertigo, fast heartbeat, fast 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 frequency of urination, feeling weak, tiredness, sensation of warmth, swelling of the ankles.

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

Anaemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat, indigestion, salty taste in the mouth, diarrhoea, dry mouth, swelling of the gums, allergic reaction with swelling of the face, lips, tongue or throat causing difficulty swallowing or breathing, skin rash, urticaria, nocturia, production of large amounts of urine, impotence.

Additional adverse effects observed with enalapril or lercanidipino alone

Enalapril

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

Blurred vision, dizziness, weakness, feeling sick (nausea), and cough.

Common (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 heartbeat, angina, shortness of breath, disturbances in taste, increased levels of creatinine in blood (usually detected by a blood test), elevated potassium levels in blood, diarrhoea, abdominal pain, tiredness (fatigue), rash, allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing.

Uncommon (may affect up to 1 in 100 people)

Anaemia (including aplastic and haemolytic anaemia), sudden drop in blood pressure, confusion, drowsiness or insomnia, tingling sensation or numbness in the skin, vertigo (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 impaired blood supply to the heart or brain), stroke (possibly due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, asthma-related chest tightness, slowed movement of food through the intestine (ileus), inflammation of the pancreas, feeling sick (vomiting), indigestion, constipation, stomach irritation (gastric irritation), dry mouth, ulcer, anorexia, increased sweating, itching or hives, hair loss, impaired kidney function, kidney failure, high levels of protein in urine (measured by urine test), impotence, muscle cramps, general malaise, high temperature (fever), high levels of urea in blood, low blood sugar or sodium levels (all measured by 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 test values, such as decreased white blood cell count, bone marrow suppression, autoimmune disorders, unusual dreams, swollen glands in the neck, armpits, or groin, sleep disorders, Raynaud's phenomenon (in which hands and feet may become intensely cold and turn white due to reduced blood flow), pulmonary infiltrates, accumulation of fluid or other substances in the lungs (as seen on X-ray), inflammation of the nose, pneumonia, swelling of cheeks, gums, tongue, lips, or throat, liver problems such as decreased liver function, liver inflammation, jaundice (yellowing of the skin or whites of the eyes), increased bilirubin levels (measured by blood test), erythema multiforme (red spots of varying shapes appearing on the skin), Stevens-Johnson syndrome or toxic epidermal necrolysis (a serious skin condition involving redness, scaling, blistering, open sores, or peeling of the top layer of skin from underlying layers), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), or pemphigus (small fluid-filled blisters on the skin), decreased urine production, breast enlargement in men (gynaecomastia).

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

• Intestinal angioedema (intestinal swelling).

Frequency not known (cannot be estimated from available data)

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

A group of symptoms has been reported which may include one or more of the following: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity, or other skin manifestations may also occur.

Lercanidipine

Some adverse effects may be serious.

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

Angina (chest pain due to reduced blood flow to the heart), allergic reactions (with symptoms such as itching, rash, hives), fainting.

Patients with pre-existing angina may experience an increase in frequency, duration, or severity of attacks associated with treatment using the class of medicines to which lercanidipine belongs. Isolated cases of myocardial infarction may occur.

Other possible adverse effects:

Common (may affect up to 1 in 10 people)

Headache, rapid heartbeat, awareness of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (flushing), swelling of the ankles.

Uncommon (may affect up to 1 in 100 people)

Dizziness, low blood pressure, heartburn, feeling sick (nausea), stomach pain, skin rash, itching, muscle pain, increased amount of urine, weakness or tiredness.

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

Drowsiness, vomiting, diarrhoea, hives, increased frequency of urination, chest pain (angina).

Frequency not known (cannot be estimated from available data)

Swelling of the gums, changes in liver function (detected in blood tests), cloudy fluid (during peritoneal dialysis 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 adverse effects worsen, or if you experience any adverse effect not listed in this leaflet, inform your doctor or pharmacist. You may consult your doctor or pharmacist for further information about adverse effects, as both have access to a more complete list.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enalapril/Lercanidipine Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enalapril/Lercanidipine Krka:

• The active substances 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, malic acid, sodium starch glycolate (type A) from potato, lactose monohydrate and sodium stearyl 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 pack contents of Enalapril/Lercanidipine Krka

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

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

Enalapril/Lercanidipine Krka 10 mg/10 mg is also supplied in calendar pack blister packs: 14, 28, 56 or 98 film-coated tablets per box.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

For more information about this medicine, 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: January 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/