Enalapril/lercanidipine Krka 20 mg/10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril/Lercanidipine Krka 20 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; 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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.
6. Contents of the pack and other information.

Contents of the pack and other 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 enalapril 20 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/Lercanidipine Krka

Do not take Enalapril/Lercanidipine Krka:

• if you are allergic to enalapril, lercanidipine, or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction to medicines similar to those contained in Enalapril/Lercanidipine Krka, i.e., drugs 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 an ACE inhibitor, or if the cause of such reaction was unknown or if it was due to 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 better to avoid using Enalapril/Lercanidipine 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 a heart attack (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 chronic heart failure in adults, since the risk of angioedema (rapid swelling under the skin, e.g., in the throat) is high.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril/Lercanidipine Krka.

• If you have low blood pressure (which may present as dizziness or fainting, especially when standing up).
• If you have been severely ill (with excessive vomiting) or have recently had diarrhea, or 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 (leukopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced 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 of Black race, 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 in 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 old.
• If you have intolerance to certain sugars (lactose)
• If you are taking any of the following medicines for 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/Lercanidipine Krka”.

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

• any surgical procedure 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/Lercanidipine Krka

Enalapril/Lercanidipine 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/Lercanidipine Krka is taken together with certain medicines, the effect of Enalapril/Lercanidipine 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 immunosuppressant used to prevent organ transplant rejection)

See “Do not take Enalapril/Lercanidipine Krka”

• other medicines that lower blood pressure,
• lithium (a medicine used to treat a certain type of depression)
• antidepressants known as "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 intravenous administration)
• certain medicines for cough and cold, and weight-reducing medicines containing a substance called "sympathomimetic agent"
• medicines for diabetes (including insulin and antidiabetic medicines)
• astemizole or terfenadine (medicines for allergies)
• amiodarone, quinidine, or sotalol (medicines for fast 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 for high blood pressure, heart failure, and abnormal heart rhythm)
• cimetidine (a medicine for ulcers and acidity, when taken at daily doses above 800 mg)

Do not take enalapril/lercanidipine 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, 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 to treat diarrhea
• medicines used to prevent rejection of transplanted organs 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/Lercanidipine Krka” and “Warnings and precautions”).

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

Take Enalapril/Lercanidipine 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/Lercanidipine Krka. Do not consume alcoholic beverages during treatment with this medicine.

Enalapril/Lercanidipine Krka must not be taken with grapefruit or grapefruit juice, as it may increase its hypotensive effect (see “Do not take Enalapril/Lercanidipine 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/Lercanidipine Krka before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Enalapril/Lercanidipine Krka is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby from that stage.

Breastfeeding

Enalapril/Lercanidipine Krka must not be taken during breastfeeding.

Consult your doctor or pharmacist before taking any medicine if you are already taking Enalapril/Lercanidipine Krka.

Driving and using machines

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

Enalapril/Lercanidipine 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; this is essentially “sodium-free”.

3. How to take Enalapril/Lercanidipine Krka

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults: Unless otherwise directed 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/Lercanidipine Krka with food, drinks and alcohol".

Patients with kidney problems/elderly patients: Your doctor will decide the appropriate dose of this medicine based on how well your kidneys are functioning.

If you take more Enalapril/Lercanidipine Krka than you should

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

It is recommended to bring the medicine 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/Lercanidipine Krka

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

If you stop taking Enalapril/Lercanidipine Krka

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

If you have any further questions about the use of 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 this occurs, it may be helpful to lie down. 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 parameters, such as decreased platelet count, increased blood potassium concentration, nervousness (anxiety), dizziness when standing up, 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 of weakness, fatigue, 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, gum swelling, 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 used 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 creatinine levels 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 of the skin, dizziness (vertigo), 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 levels of blood sugar or sodium (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 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), nasal inflammation, pneumonia, swelling of cheeks, gums, tongue, lips and throat, liver problems such as reduced 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 skin 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 males (gynaecomastia).

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

• Intestinal angioedema (intestinal inflammation).

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)

Chest pain due to reduced blood supply to the heart (angina), 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 angina attacks associated with treatment with 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, sensation 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, urticaria, 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), 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 they both have access to a more complete list of adverse effects.

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 Medicinal Products: 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 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 are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 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 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, macrogol 6000, yellow iron oxide (E172) and quinoline yellow (E104) 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 20 mg/10 mg tablets are yellow, round, slightly biconvex with bevelled edges, tablet diameter 10 mm.

Enalapril/Lercanidipine Krka 20 mg/10 mg is supplied in packs containing 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets per box.

Enalapril/Lercanidipine Krka 20 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 commercially available.

Marketing Authorisation Holder and Manufacturer

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

You can request more information about this medicine by contacting the local representative of the Marketing Authorisation Holder:

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

This medicinal product is authorised 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/