Enalapril and lercanidipine Mylan

Italy
Brand name Enalapril and lercanidipine Mylan
Form tablets, film-coated
Active substance / Dosage
ENALAPRIL
LERCANIDIPINE
Prescription type Prescription only
ATC code
C09BB02
Registration number 050209
Manufacturer MYLAN S.P.A.

Table of Contents

PACKAGE LEAFLET

Package leaflet: information for the user

Enalapril and Lercanidipine Mylan 20 mg/20 mg

Film-coated tablets
enalapril maleate/lercanidipine hydrochloride
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because 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 Mylan is and what it is used for
  2. What you need to know before taking Enalapril and Lercanidipine Mylan
  3. How to take Enalapril and Lercanidipine Mylan
  4. Possible side effects
  5. How to store Enalapril and Lercanidipine Mylan
  6. Contents of the pack and other information

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

Enalapril and Lercanidipine Mylan is a fixed-dose combination of an ACE inhibitor (enalapril maleate) and a calcium antagonist (lercanidipine hydrochloride), two medicines that reduce blood pressure.
Enalapril and Lercanidipine Mylan is indicated for the treatment of high blood pressure (hypertension) in adult patients who are currently taking enalapril and lercanidipine as separate tablets.

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

Do not take Enalapril and Lercanidipine Mylan

  • If you are allergic (hypersensitive) to enalapril maleate or lercanidipine hydrochloride or to any of the other components of this medicine (listed in section 6).
  • If you have previously had an allergic reaction to a medicine similar to those contained in Enalapril and Lercanidipine Mylan, e.g. drugs called ACE inhibitors or calcium antagonists.
  • If you have previously experienced swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing (angioedema) after taking a medicine called an ACE inhibitor, or if such swelling occurred without a known cause or due to hereditary factors.
  • 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 in the throat) is increased.
  • If you have diabetes or kidney problems and are taking medicines containing aliskiren to lower blood pressure.
  • If you are more than three months pregnant (it is also advisable to avoid Enalapril and Lercanidipine Mylan during the first months of pregnancy – see Pregnancy section).
  • If you suffer from certain heart conditions such as:
    • obstruction to blood flow from the heart
    • untreated heart failure
  • unstable angina (chest discomfort occurring at rest or progressively worsening)
  • heart attack occurred less than one month ago.
    • If you have severe liver problems.
    • If you have severe kidney problems or are on dialysis.
    • If you are taking medicines that are inhibitors of hepatic metabolism, such as:
  • antifungal medicines (such as ketoconazole or itraconazole)
  • macrolide antibiotics (such as erythromycin, troleandomycin, clarithromycin)
  • antiviral medicines (such as ritonavir).
    • If you are concurrently taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
    • Together with grapefruit or grapefruit juice.

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

  • If you have low blood pressure (you may experience weakness or dizziness, especially when standing up).
  • If you have been seriously ill (excessive vomiting) or have recently had diarrhoea.
  • If you are on a low-sodium 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). This could lead to higher potassium levels in the blood, which may have serious consequences. Your doctor may decide to adjust your enalapril dose or monitor your blood potassium levels.
  • If you have liver problems.
  • If you have blood disorders, such as reduced or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced red blood cells (anaemia).
  • If you have vascular collagen diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), if you are on immunosuppressive therapy, or if you are taking allopurinol, procainamide, or any combination of these medicines.
  • If you are of Black origin, you should be aware that Black patients have a higher risk of allergic reactions with swelling of the face, lips, tongue, and throat, causing difficulty in swallowing and breathing, while taking ACE inhibitors.
  • If you have diabetes. You should monitor for possible drops in blood glucose levels, especially during the first month of treatment. Blood potassium levels may also be higher.
  • If you are taking potassium supplements, potassium-sparing medicines, or salt substitutes containing 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, the risk of angioedema may be increased:

  • racecadotril, a medicine used to treat diarrhoea;
  • medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus);
  • vildagliptin, a medicine used to treat diabetes.

If you are taking any of the following medicines for 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 monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section “Do not take Enalapril and Lercanidipine Mylan”.
Inform your doctor if you are planning to undergo a medical procedure
Inform your doctor that you are taking Enalapril and Lercanidipine Mylan if you are about to:

  • undergo surgery or anaesthesia (including dental anaesthesia);
  • receive a treatment to remove cholesterol from the blood called “LDL apheresis”;
  • undergo desensitisation therapy to reduce the effects of allergies to bee or wasp stings.

Inform your doctor if you think you are (or might become) pregnant or if you are breastfeeding
(see section Pregnancy, breastfeeding and fertility).
Children and adolescents
The safety and efficacy of Enalapril and Lercanidipine Mylan in children and adolescents under 18 years of age have not been established.
Other medicines and Enalapril and Lercanidipine Mylan
Enalapril and Lercanidipine Mylan must not be taken together with certain medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because when Enalapril and Lercanidipine Mylan is taken together with certain medicines, its effect or that of the other medicines may change, or certain side effects may occur more frequently.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

  • other medicines to lower blood pressure;
  • potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines;
  • medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting). See “Do not take Enalapril and Lercanidipine Mylan”;
  • lithium (used to treat a certain type 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 and may be used to relieve pain);
  • certain medicines for pain or arthritis, including gold therapy;
  • certain medicines for cough and colds and weight-reducing medicines containing a substance called “sympathomimetic agent”;
  • medicines for diabetes (including oral antidiabetic medicines and insulin);
  • astemizole or terfenadine (medicines for allergies);
  • amiodarone, quinidine, or sotalol (medicines to treat rapid heartbeat);
  • 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 that helps with sleep);
  • beta-blockers, e.g. metoprolol (a medicine used to treat high blood pressure, heart failure, and abnormal heart rhythm);
  • cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn).

Do not take Enalapril and Lercanidipine Mylan 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 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 diarrhoea;
  • medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus);
  • vildagliptin, a medicine used to treat diabetes.

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

  • if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also “Do not take Enalapril and Lercanidipine Mylan” and “Warnings and precautions”).

Enalapril and Lercanidipine Mylan with food, drinks and alcohol

  • Enalapril and Lercanidipine Mylan should be taken at least 15 minutes before a meal.
  • A high-fat meal significantly increases the levels of the medicine in the blood.
  • Alcohol consumption may enhance the effects of Enalapril and Lercanidipine Mylan. Do not consume alcohol during treatment with Enalapril and Lercanidipine Mylan.
  • Enalapril and Lercanidipine Mylan must not be taken with grapefruit or grapefruit juice, as they may increase its hypotensive effect (see “Do not take Enalapril and Lercanidipine Mylan”).

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Inform your doctor if you think you are (or might become) pregnant. Enalapril and Lercanidipine Mylan is not recommended for women who may become pregnant and during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause severe harm to your unborn baby if used after the third month of pregnancy.
Breastfeeding
Enalapril and Lercanidipine Mylan must not be used during breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
If you experience dizziness, weakness, or drowsiness with this medicine, avoid driving or operating machinery.
Enalapril and Lercanidipine Mylan contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 Mylan

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Adults: The recommended dose is one tablet daily, taken at the same time each day, unless otherwise prescribed by your doctor. The tablet should preferably be taken in the morning, at least 15 minutes before breakfast. Swallow the tablet whole with water. See “Enalapril and Lercanidipine Mylan with food, drinks and alcohol”.
Patients with kidney problems/elderly patients: Your doctor will decide the dose of medicine you should take, based on how well your kidneys are functioning.
If you take more Enalapril and Lercanidipine Mylan than you should
Do not exceed the prescribed dose. If you have taken more medicine than prescribed, consult your doctor or go to hospital immediately. Take the medicine pack with you. Taking too much medicine may cause excessive lowering of blood pressure and may lead to irregular heartbeat or tachycardia.
If you forget to take Enalapril and Lercanidipine Mylan

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

If you stop taking Enalapril and Lercanidipine Mylan
Do not stop taking this medicine unless your doctor tells you to.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Enalapril and Lercanidipine Mylan may cause side effects, although not everyone experiences them. The following side effects may occur with this medicine:
Some side effects may be serious.
If any of the following occur, inform your doctor immediately:
Allergic reaction with swelling of the face, lips, tongue or throat, which may cause difficulty swallowing or breathing.
At the beginning of treatment with Enalapril and Lercanidipine Mylan, 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 this occurs. If this concerns you, discuss it with your doctor.

Side effects observed with Enalapril and Lercanidipine Mylan
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);
  • sensation of dizziness when standing up, vertigo;
  • fast heartbeat, fast or irregular heartbeat (palpitations);
  • sudden redness of the face, neck or upper chest (hot flushes), low blood pressure;
  • abdominal pain, constipation, feeling unwell (nausea);
  • elevated liver enzyme levels;
  • skin redness;
  • joint pain;
  • increased frequency of urination;
  • feeling of weakness, fatigue, feeling hot, 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 or sore throat;
  • indigestion, salty taste sensation, diarrhoea, dry mouth, gum swelling;
  • allergic reaction with swelling of the face, lips, tongue or throat and difficulty swallowing or breathing, skin rash, urticaria;
  • getting up at night to urinate, producing large amounts of urine;
  • impotence.

Additional side effects observed with enalapril or lercanidipine taken alone
Enalapril
Very common (may affect more than 1 in 10 people)
Blurred vision, dizziness, weakness or malaise, and cough.
Common (may affect up to 1 in 10 people)
Depression, headache, fainting (syncope), chest pain, mild mental confusion due to low blood pressure, changes in heart rhythm, rapid heartbeat, angina, shortness of breath, altered sense of taste, increased creatinine levels in blood (usually detected by a test), elevated potassium levels in blood, diarrhoea, abdominal pain, fatigue, skin rash, allergic reaction with swelling of face, lips, tongue or throat with 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, nervousness, 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 (likely due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, chest tightness associated with asthma, slow passage of food through the intestine (ileus), pancreatitis, malaise (vomiting), indigestion, constipation, irritated stomach (gastric irritation), dry mouth, ulcer, anorexia, itching or urticaria, hair loss, impaired kidney function, kidney failure, increased sweating, high protein levels in urine (measured by a test), muscle cramps, general feeling of unwellness (malaise), high temperature (fever), low blood sugar or sodium levels, high urea levels in blood (all measured by blood tests), flushing, rapid or irregular heartbeat (palpitations), dizziness (sensation of spinning), ringing in the ears (tinnitus), impotence.
Rare (may affect up to 1 in 1,000 people)
Changes in blood test values such as reduced white blood cell count, bone marrow depression, autoimmune diseases, unusual dreams or sleep disturbances, “Raynaud’s phenomenon” (causing hands and feet to become very cold and pale due to reduced blood flow), nasal inflammation, pneumonia, liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of skin or eyes), elevated liver enzymes or bilirubin (measured by blood test), erythema multiforme (red spots of various shapes on the skin), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition involving redness, skin peeling, blisters or sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or small blisters), pemphigus (small fluid-filled blisters on the skin), reduced urine output, breast enlargement in men (gynaecomastia), swelling of glands in the neck, armpits or groin, fluid or other substance accumulation in the lungs (as seen on X-rays), inflammation of cheeks, gums, tongue, lips or throat.
Very rare (may affect up to 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).
Not known (frequency cannot be estimated from available data)
Excessive production of antidiuretic hormone causing fluid retention, leading to weakness, fatigue or confusion.
A symptomatic complex has been reported which may include some or all of the following symptoms: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity or other dermatological manifestations may also occur.

Lercanidipine
Some side effects may be serious.
If any of the following occur, inform your doctor immediately:
Rare (may affect up to 1 in 1,000 people)
Angina pectoris (chest pain due to reduced blood supply to the heart), allergic reactions (symptoms include itching, skin rash, urticaria), fainting.
Patients with pre-existing angina pectoris may experience increased frequency, duration or severity of attacks with medicines in the same class as lercanidipine. Isolated cases of heart attack have been 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 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 unwell, stomach discomfort, skin rash, itching, muscle pain, increased urine production, feeling of weakness or fatigue.
Rare (may affect up to 1 in 1,000 people): drowsiness, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Gum swelling, changes in liver function (detected by blood tests), cloudy fluid (during peritoneal dialysis), swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing.

If any of the side effects worsen, or if you notice a side effect not listed in this leaflet, consult your doctor or pharmacist. Speak to 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Enalapril and Lercanidipine Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton, following the word
"Exp."
The expiry date refers to the last day of that month.
Do not store above 25 °C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of medicines 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 Mylan 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
20.28 mg of lercanidipine hydrochloride hemihydrate (equivalent to 18.88 mg of lercanidipine).
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium hydroxide in pellets, purified water,
povidone, crospovidone, talc, anhydrous colloidal silica, magnesium stearate. See section 2,
"Enalapril and Lercanidipine Mylan contains lactose and sodium".
Film coating: hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Enalapril and Lercanidipine Mylan and contents of the pack
Enalapril and Lercanidipine Mylan 20 mg/20 mg film-coated tablets are orange-coloured, circular, biconvex tablets, with "LE3" engraved on one side and the other side smooth, with a diameter of approximately 12.10 mm and a thickness of 4.80 mm.
Enalapril and Lercanidipine Mylan 20 mg/20 mg is available in packs of 14, 28 and 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A. - Via Vittor Pisani, 20 - 20124 Milan, Italy

Manufacturer
Micro Labs GmbH
Lyoner Straße 20, 60528 Frankfurt
Germany