Enalapril and lercanidipine Krka

PACKAGE LEAFLET

Package leaflet: Information for the user

Enalapril and Lercanidipine Krka 20 mg/10 mg film-coated tablets

enalapril maleate/lercanidipine hydrochloride
Generic medicine
Please read this leaflet carefully before using 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Enalapril and Lercanidipine Krka is a fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two medicines that reduce blood pressure.
Enalapril and Lercanidipine Krka is indicated for the treatment of high blood pressure (hypertension) in adult patients whose blood pressure has not been adequately controlled with enalapril 20 mg alone. Enalapril and Lercanidipine Krka is not indicated for the initial treatment of hypertension.

2. What you should know before taking Enalapril and Lercanidipine Krka

Do not take Enalapril and Lercanidipine Krka:

• if you are allergic to enalapril or lercanidipine or to any of the other ingredients of this medicine (listed in section 6);
• if you have had or currently have an allergic reaction to medicines similar to those contained in Enalapril and Lercanidipine Krka, e.g. medicines called ACE inhibitors or calcium channel blockers;
• if you have ever developed angioedema (swelling of the face, lips, mouth, tongue or throat) causing difficulty in swallowing or breathing after taking a medicine of the ACE-inhibitor class, or when the cause was unknown or inherited;
• if you have diabetes or impaired kidney function and are being treated with a medicine containing aliskiren for high blood pressure;
• if you are more than three months pregnant (in addition, Enalapril and Lercanidipine Krka should best be avoided during the first months of pregnancy – see section on pregnancy);
• if you suffer from certain heart conditions such as:
• untreated heart failure;
• obstruction of blood flow from the left ventricle of the heart, including narrowing of the aortic valve (aortic stenosis);
• chest pain occurring at rest, worsening or progressively increasing (unstable angina pectoris);
• heart attack occurred less than one month ago (myocardial infarction);
• if you have severe liver or kidney problems, or if you are on dialysis;
• if you are taking medicines such as:
• antifungal agents (e.g. ketoconazole, itraconazole);
• macrolide antibiotics (e.g. erythromycin, troleandomycin);
• antiviral agents (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, as this increases the risk of angioedema (rapid swelling under the skin, e.g. in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril and Lercanidipine Krka:

• if you have low blood pressure (you may experience this as weakness or dizziness, especially when standing up);
• if you have been severely ill (excessive vomiting) or have recently had diarrhoea or are dehydrated;
• if you are on a low-salt diet;
• if you have heart problems;
• if you have a condition affecting the blood vessels in the brain;
• if you have kidney problems (including kidney transplant);
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism);
• 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 (anaemia);
• if you have collagen vascular diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis or scleroderma);
• if you are of Black origin, you should be aware that Black patients have an increased risk of allergic reactions with swelling of the face, lips, tongue or throat and difficulty in swallowing or breathing while taking ACE inhibitors;
• if you have diabetes mellitus;
• if you develop a persistent dry cough;
• if you are taking potassium supplements, potassium-sparing agents or salt substitutes containing potassium;
• if you have an intolerance to certain sugars (lactose);
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• aliskiren. Your doctor may check your kidney function, blood pressure and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section “Do not take Enalapril and Lercanidipine Krka”.
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, e.g. in the throat) may be higher:
• temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment),
• racecadotril (used to treat diarrhoea),
• vildagliptin (a medicine used to treat diabetes).

If you are about to undergo a procedure
If you are about to undergo any of the following procedures, inform your doctor that you are taking Enalapril and Lercanidipine Krka:

• any surgical procedure or administration of anaesthetics (including at the dentist);
• a treatment to remove cholesterol from the blood called "LDL apheresis";
• a desensitisation treatment to reduce the effect of any allergy to bees or wasps.

You must inform your doctor if you think you are (or might become) pregnant or if you are breastfeeding (see section on 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 available on its effects and safety in this age group.
Other medicines and Enalapril and Lercanidipine Krka
Enalapril and Lercanidipine Krka must not be taken with certain medicines.
Inform 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 Enalapril and Lercanidipine Krka is taken together with certain medicines, their effects may be enhanced or weakened, or certain side effects may occur more frequently.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines together with Enalapril and Lercanidipine Krka:

• Potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements or medicines containing potassium (including salt substitutes), and other medicines that may increase potassium levels in the blood (such as heparin, a medicine used to thin the blood and prevent clotting; trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; and cyclosporine, an immunosuppressant used to prevent organ transplant rejection);
• Other medicines that lower blood pressure, such as angiotensin II receptor blockers, diuretics or a medicine called aliskiren;
• Lithium (a medicine used to treat certain types of depression);
• Medicines for depression called “tricyclic antidepressants”;
• Medicines for mental disorders called “antipsychotics”;
• Non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation or may help relieve pain);
• Medicines for certain types of pain or arthritis including gold therapy (especially when administered intravenously);
• Certain cough and cold medicines and weight-reducing medicines containing a “sympathomimetic agent”;
• Medicines for diabetes (including insulin and oral antidiabetic medicines such as vildagliptin);
• Astemizole or terfenadine (medicines for allergies);
• Amiodarone or quinidine (medicines for treating fast heart rate);
• Phenytoin or carbamazepine (medicines for epilepsy);
• Rifampicin (a medicine used to treat tuberculosis);
• Digoxin (a medicine used to treat heart problems);
• Midazolam (a medicine that helps you sleep);
• Beta-blockers (medicines used to treat high blood pressure and heart problems);
• A medicine for ulcers and heartburn called cimetidine, when taken at daily doses exceeding 800 mg;
• Medicines commonly used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions".

Your doctor may consider it necessary to adjust the dose and/or take additional precautions:

• If you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under "Do not take Enalapril and Lercanidipine Krka" and "Warnings and precautions").

Enalapril and Lercanidipine Krka with food, drinks and alcohol
Enalapril and Lercanidipine Krka should be taken at least 15 minutes before a meal.
Consumption of alcohol may enhance the effects of Enalapril and Lercanidipine Krka. Therefore, you are advised not to drink alcohol or to limit alcohol consumption as much as possible.
Enalapril and Lercanidipine Krka must not be taken with grapefruit or grapefruit juice.
Pregnancy, breastfeeding and fertility
Pregnancy and fertility
You must inform your doctor if you think you are (or might become) pregnant.
Your doctor will usually advise you to stop taking Enalapril and Lercanidipine Krka before starting pregnancy or as soon as you find out you are pregnant, and will recommend an alternative medicine. Enalapril and Lercanidipine Krka is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to your unborn baby if used after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding of newborns (in the first weeks after birth), and especially of premature infants, is not recommended while taking Enalapril and Lercanidipine Krka. For older infants, your doctor will advise you on the benefits and risks of taking Enalapril and Lercanidipine Krka while breastfeeding, compared to other treatments.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Avoid driving or operating machinery if you experience dizziness, weakness, fatigue or drowsiness while taking this medicine.
Enalapril and Lercanidipine Krka contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Enalapril and Lercanidipine Krka

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Adults: Unless otherwise prescribed by your doctor, the usual dose is one tablet once daily at the same time each day. The tablet should preferably be taken in the morning, at least 15 minutes before breakfast. Swallow the tablets whole with water.
Patients with kidney problems/elderly patients: Your doctor will determine the dose based on how well your kidneys are functioning.
If you feel that the effect of Enalapril and Lercanidipine Krka is too strong or too weak, talk to your doctor.
If you take more Enalapril and Lercanidipine Krka than you should
If you take more medicine than prescribed by your doctor, in case of overdose, contact your doctor immediately. If possible, bring the tablets and/or the packaging with you when you see the doctor.
Taking a larger amount than the correct dose may cause excessive drop in blood pressure and irregular or faster heartbeat.
If you forget to take Enalapril and Lercanidipine Krka
If you forget to take your tablet, take the missed tablet as soon as possible, unless it is almost time for the next dose. Then continue taking the tablets as usual.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Enalapril and Lercanidipine Krka
If you stop treatment with Enalapril and Lercanidipine Krka, your blood pressure may rise again. Before stopping treatment with Enalapril and Lercanidipine Krka, talk to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Some side effects can be serious.
If you experience any of the following, contact your doctor immediately:

• allergic reactions with swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing. When you first start taking Enalapril and Lercanidipine Krka, you may feel weak or dizzy or experience blurred vision; this is caused by a sudden drop in blood pressure, and lying down may help. If you are concerned, please discuss this with your doctor.

Side effects observed with Enalapril and Lercanidipine Krka
Common (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 a lower number of platelets in the blood, increased potassium levels in the blood, nervousness (anxiety), dizziness when standing, vertigo, tachycardia, fast or irregular heartbeat (palpitations), sudden flushing of the face, neck, or upper chest (hot flushes), low blood pressure, abdominal pain, constipation, feeling unwell (nausea), increased levels of liver enzymes, skin redness, joint pain, increased frequency of urination, feeling of weakness, fatigue, feeling hot, ankle swelling.
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 sensation on the tongue, diarrhoea, dry mouth, gum swelling, allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing, skin rash, urticaria, need to get up at night to urinate, production of large amounts of urine, impotence.

Additional side effects observed with enalapril and lercanidipine used alone

Enalapril
Very common (may affect more than 1 in 10 people):
Blurred vision.
Common (may affect up to 1 in 10 people):
Depression, chest pain, changes in heart rhythm, angina, shortness of breath, changes in taste sensation, increased creatinine levels in blood (usually detected through blood tests).
Uncommon (may affect up to 1 in 100 people):
Anaemia (including aplastic and haemolytic), sudden drops in blood pressure, confusion, insomnia or drowsiness, tingling or numbness sensation of the skin, heart attack (likely due to very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (possibly due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, asthma, slow movement of food through the intestine, pancreatitis, vomiting, stomach irritation (gastric irritation), ulcer, anorexia, increased sweating, itching, urticaria, hair loss, impaired kidney function, kidney failure, high levels of protein in urine (detectable in urine tests), muscle cramps, general feeling of malaise, high temperature (fever), increased levels of urea in blood, reduced sodium or blood sugar levels (all measured in blood tests).
Rare (may affect up to 1 in 1,000 people):
Changes in blood values such as decreased number of lymphocytes in blood, reduced bone marrow function, autoimmune diseases, altered dreams, sleep disorders, Raynaud's syndrome (when hands and feet become very cold and white due to poor blood circulation), pulmonary infiltrates, inflammation of the nose, pneumonia, liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin and/or whites of the eyes), elevated bilirubin levels (measured in blood tests), erythema multiforme (red spots of various shapes on the skin), Stevens-Johnson syndrome (a severe skin condition involving redness and peeling of the skin, blisters or sores, or separation of the top layer of skin from underlying layers), reduced urine output, breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people):
Intestinal swelling (intestinal angioedema).

Lercanidipine
Rare (may affect up to 1 in 1,000 people):
Angina pectoris (chest pain due to reduced blood flow to the heart), vomiting, heartburn, muscle pain.
Very rare (may affect up to 1 in 10,000 people):
Chest pain.
Patients with pre-existing angina pectoris may experience an increase in frequency, duration, and severity of attacks with the group of medicines to which lercanidipine belongs. Isolated cases of myocardial infarction may occur.

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. You can ask your doctor or pharmacist for further information about side effects. Both have a more complete list of possible side effects.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enalapril and 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 pack after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enalapril and Lercanidipine Krka contains

• 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, lactose monohydrate and sodium stearyl fumarate in the tablet core; hypromellose, titanium dioxide (E171), talc, macrogol 6000, yellow iron oxide (E172) and quinoline yellow (E104) in the coating film. See section 2 "Enalapril and Lercanidipine Krka contains lactose and sodium".

Description of the appearance of Enalapril and Lercanidipine Krka and package contents
The film-coated tablets are yellow, round, slightly biconvex with bevelled edges, and have a diameter of 10 mm.
Enalapril and Lercanidipine Krka is available in packages with blisters containing 10, 14, 15, 28, 30,
50, 56, 60, 84, 90, 98 or 100 film-coated tablets in a box.
Enalapril and Lercanidipine Krka is also available in calendar blister packs: 14, 28, 56 or 98 film-coated
tablets in a box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA d.d., Novo mesto, Šmarješka cesta 6, Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Local representative for Italy
KRKA Farmaceutici Milano S.r.l. – Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names: