ENALAPRIL/LERCANIDIPINE KRKA 20 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril/Lercanidipine Krka 20 mg/10 mg Film-Coated Tablets EFG

Enalapril Maleate/Lercanidipine Hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Enalapril/Lercanidipine Krka and what is it used for.
2. What you need to know before you take Enalapril/Lercanidipine Krka.
3. How to take Enalapril/Lercanidipine Krka.
4. Possible side effects.
5. Storage of Enalapril/Lercanidipine Krka.
6. Contents of the pack and other information.

Contents of the pack and other information.

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

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

Enalapril/Lercanidipine Krka is indicated for the treatment of high blood pressure (hypertension) in patients in whom enalapril 20 mg does not adequately control blood pressure on its own. Enalapril/Lercanidipine Krka should not be used as a first-line treatment for hypertension.

2. What you need to know before you take 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 a type of medicine similar to those contained in Enalapril/Lercanidipine Krka, i.e. medicines called ACE inhibitors or calcium channel blockers;
• if you have ever experienced swelling of the face, lips, tongue or throat that has caused difficulty in swallowing or breathing (angioedema) after taking a type of medicine called ACE inhibitors, or if the cause of the reaction is unknown or if it is 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 the use of Enalapril/Lercanidipine Krka during the first months of pregnancy – see section on pregnancy);
• if you suffer from certain heart conditions:
• untreated heart failure
• obstruction of blood flow from the left ventricle of the heart, including narrowing of the aortic valve (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 areas such as the throat) is high

Warnings and precautions

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

• If you have low blood pressure (which can 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 have a salt-restricted diet.
• If you have a heart problem.
• If you have a disorder that affects the blood vessels in the brain.

• If you have kidney problems (including kidney transplant). This can lead to high 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.

• If you have liver problems.
• If you have blood problems, such as a low or absent white blood cell count (leukopenia, agranulocytosis), a low platelet count (thrombocytopenia), or a decrease in the number of red blood cells (anemia).
• If you have a vascular disease of the collagen (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are undergoing immunosuppressive therapy, or are taking allopurinol or procainamide, or a combination of both medicines.
• If you are a black patient, you should be aware that these patients have a higher risk of experiencing allergic reactions with inflammation of the face, lips, tongue, or throat, accompanied by difficulty swallowing or breathing, when taking ACE inhibitors.
• If you are diabetic. You should check your blood sugar levels, especially during the first month of treatment. Your potassium levels 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):
• • 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 electrolyte levels (e.g. potassium) in your blood at regular intervals.

See also information under the heading "Do not take Enalapril/Lercanidipine Krka".

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

If you are going to undergo surgery or certain treatments soon

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

• any surgical procedure or if you are going to be given an anesthetic (even at the dentist)
• a treatment to remove cholesterol from the blood known as "LDL apheresis"
• a desensitization treatment to reduce the effect of an allergy to bees or wasps.

You should inform your doctor if you think you are (or might become) pregnant or if you are breast-feeding (see the section on Pregnancy, breast-feeding 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 should not be taken with certain medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This is because when you take Enalapril/Lercanidipine Krka at the same time as certain medicines, the effect of Enalapril/Lercanidipine Krka or the other medicines may be increased or decreased, or certain side effects may occur more frequently.

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

• potassium-sparing agents (e.g. triamterene, amiloride), medicines that contain potassium (including salt substitutes in the diet), 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 ciclosporin, an immunosuppressive medicine used to prevent organ 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)
• medicines for depression called "tricyclic antidepressants"
• medicines for mental problems, called "antipsychotics"
• non-steroidal anti-inflammatory medicines, 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 when given intravenously)
• certain medicines for cough and cold and weight loss medicines that contain a substance called "sympathomimetic agent"
• medicines for diabetes (including insulin and oral antidiabetic medicines)
• Astemizole or terfenadine (medicines for allergies)
• amiodarone or 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 that treat high blood pressure, heart failure, and irregular heart rhythm)
• cimetidine (a medicine for ulcers and acidity given 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, 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 in the prevention of organ rejection after a transplant 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 change your dose and/or take other precautions:

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

Enalapril/Lercanidipine Krka should be taken 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/Lercanidipine Krka. Do not consume alcoholic beverages during treatment with this medicine.

Enalapril/Lercanidipine Krka should not be taken with grapefruit or grapefruit juice, as it may increase its blood pressure-lowering effect (see "Do not take Enalapril/Lercanidipine Krka").

Pregnancy, breast-feeding, and fertility

Pregnancy and fertility

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Enalapril/Lercanidipine Krka before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enalapril/Lercanidipine Krka. It is not recommended to use Enalapril/Lercanidipine Krka at the start of pregnancy, and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on.

Breast-feeding

Enalapril/Lercanidipine Krka should not be taken during breast-feeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

If you experience dizziness, weakness, fatigue, or drowsiness while taking this medicine, do not drive or use hazardous 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 them 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 of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults: Unless your doctor tells you otherwise, the normal 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/Lercanidipine Krka with food, drinks, and alcohol".

Patient with kidney problems/elderly:your doctor will decide the dose of medicine you should take, taking into account how well your kidneys are working.

If you take more Enalapril/Lercanidipine Krka than you should

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

It is recommended to take the package and the leaflet of the medicine 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 faster.

If you forget to take Enalapril/Lercanidipine Krka

If you forget to take your tablet, do not take the forgotten dose. Take the next doses at the 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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine may cause the following side effects:

Some side effects can be serious.

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

• An allergic reaction with swelling of the face, lips, tongue, or throat that can cause difficulty in breathing or swallowing;

When you start taking Enalapril/Lercanidipine Krka, you may feel weak or dizzy, or notice that your vision becomes blurred; this is caused by a sudden drop in blood pressure, and if it happens, it will be useful to lie down. If you are concerned, consult your doctor.

Side effects observed with Enalapril/Lercanidipine Krka

Frequent (may affect up to 1 in 10 people)

Cough, feeling of dizziness, headache.

Uncommon (may affect up to 1 in 100 people)

Changes in blood test results, such as a decrease in platelet count, increase in potassium levels in the blood, nervousness (anxiety), feeling of dizziness when standing up, vertigo, rapid heart rate, 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 frequency of urination, feeling of weakness, fatigue, feeling of heat, swelling 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 taste in the mouth, diarrhea, dry mouth, gum inflammation, allergic reaction with swelling of the face, lips, tongue, or throat that causes difficulty in swallowing or breathing, skin rash, hives, nocturia, production of large amounts of urine, impotence.

Additional side effects observed with enalapril or lercanidipine alone

Enalapril

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

Blurred vision, feeling of 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, alterations in taste, increased blood creatinine levels (usually detected by a test), high blood potassium levels, diarrhea, abdominal pain, fatigue, rash, allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing.

Uncommon (may affect up to 1 in 100 people)

Anemia (including aplastic anemia and hemolytic anemia), sudden drop in blood pressure, confusion, drowsiness or insomnia, sensation of pins and needles in the skin or numbness, vertigo (feeling 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 blood supply problems to the heart or brain), stroke (possibly due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, asthma-associated chest tightness, slowing of food movement through the intestine (ileus), pancreatitis, feeling sick (vomiting), indigestion, constipation, irritated stomach (gastric irritation), dry mouth, ulcer, anorexia, increased sweating, itching or hives, hair loss, kidney function impairment, kidney failure, high protein levels in the urine (measured by a test), impotence, muscle cramps, feeling of general discomfort, high temperature (fever), high urea levels in the blood, low sugar or sodium levels in the blood (all measured by a blood test), sudden reddening of the face, neck or upper chest (erythema).

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

Changes in blood test results, such as a decrease in the number of white blood cells, bone marrow depression, autoimmune diseases, strange dreams, swollen glands in the neck, armpits or groin, sleep disorders, "Raynaud's phenomenon" (in which the hands and feet can become intensely cold and turn white due to low blood flow), lung infiltrates, fluid or substance accumulation in the lungs (as seen 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 whites of the eyes), increased bilirubin levels (measured by a blood test), erythema multiforme (red spots of different shapes that appear on the skin), Stevens-Johnson syndrome or toxic epidermal necrolysis (a severe skin condition in which the skin turns red and scales form, blisters or open sores form or the top layer of skin peels off with respect to the 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 tissue growth in males (gynecomastia).

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

• Intestinal inflammation (intestinal angioedema).

Frequency not known (cannot be estimated from the available data)

Excessive production of antidiuretic hormone that causes 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, blood vessel inflammation (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). A rash, photosensitivity or other skin manifestations may occur.

Lercanidipine

Some side effects can be serious.

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

Chest pain (angina pectoris, pain in the chest caused by lack of blood supply to the heart), allergic reactions (with symptoms such as itching, rash, hives), 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 may be observed.

Other possible side effects:

Common (may affect up to 1 in 10 people)

Headache, rapid heartbeat, sensation of rapid or irregular heartbeat (palpitations), sudden reddening 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, stomach burning, feeling sick (nausea), stomach 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, hives, increased urination frequency, chest pain (angina).

Frequency not known (cannot be estimated from the available data)

Gum swelling, changes in liver function (detected by blood tests), cloudy fluid (when performing hemodialysis through a tube into 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 leaflet, inform your doctor or pharmacist. You can consult your doctor or pharmacist for more information about side effects, as they have a more complete list of side effects.

Reporting side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication .

5. Storage of Enalapril/Lercanidipine Krka

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration 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 should not be thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Enalapril/Lercanidipine Krka:

• The active ingredients 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 ingredients are povidone K30, maleic acid, sodium starch glycolate (type A) 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 and packaging of Enalapril/Lercanidipine Krka

Enalapril/Lercanidipine Krka 20 mg/10 mg tablets are yellow, round, slightly biconvex with beveled edges, tablet diameter 10 mm.

Enalapril/Lercanidipine Krka 20 mg/10 mg is supplied in packages of 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 supplied in calendar-format blister packs: 14, 28, 56 or 98 film-coated tablets per box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

You can request more information about this medication from 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 under the following names:

Date of last revision of this leaflet:January 2022

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