Enalapril and lercanidipine Mylan Pharma

Italy
Brand name Enalapril and lercanidipine Mylan Pharma
Form tablets, film-coated
Active substance / Dosage
ENALAPRIL MALEATE
LERCANIDIPINE HYDROCHLORIDE
Prescription type Prescription only
ATC code
C09BB02
Registration number 045342
Manufacturer MYLAN S.P.A.

Table of Contents

Package leaflet: Information for the patient

Enalapril and Lercanidipine Mylan Pharma 20 mg/10 mg film-coated tablets

enalapril maleate and lercanidipine hydrochloride
Generic medicine
Please read this leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

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

Enalapril and Lercanidipine Mylan Pharma is a fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two medicines that reduce blood pressure.
Enalapril and Lercanidipine Mylan Pharma is indicated for the treatment of high blood pressure (hypertension) in adult patients who are currently taking enalapril and lercanidipine as separate tablets.
Enalapril and Lercanidipine Mylan Pharma is not indicated for the initial treatment of hypertension.

2. What you need to know before taking Enalapril and Lercanidipine Mylan Pharma

Do not take Enalapril and Lercanidipine Mylan Pharma:

  • 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 previously had an allergic reaction to a medicine similar to Enalapril and Lercanidipine Mylan Pharma, e.g. drugs called ACE inhibitors (such as quinapril, ramipril) or calcium antagonists (amlodipine, diltiazem).
  • If you have previously had 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 known cause or due to hereditary causes.
  • If you are being treated with sacubitril/valsartan (a medicine used to treat heart failure), as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased in adults.
  • 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 (Enalapril and Lercanidipine Mylan Pharma should also be avoided during the first months of pregnancy – see pregnancy section).
  • If you suffer from certain heart conditions such as:
    • obstruction of blood flow from the heart, including narrowing of the heart's aortic valve
    • untreated heart failure
    • chest pain occurring at rest, worsening progressively, or occurring more frequently (unstable angina)
    • heart attack occurred less than one month ago.
  • If you have severe kidney problems, or if you are on dialysis.
  • If you have severe liver problems.
  • If you are taking medicines that may affect how this medicine is removed from the bloodstream, such as:
    • antifungal medicines (e.g. ketoconazole, itraconazole)
    • macrolide antibiotics (e.g. erythromycin, troleandomycin)
    • antiviral medicines (e.g. 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 Pharma:

  • if you have low blood pressure (you may feel weak or dizzy, especially when standing up)
  • if you have been very ill recently (excessive vomiting) or have 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 may lead to higher levels of potassium in the blood, which can 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 number of red blood cells (anaemia)
  • if you have vascular collagen diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)
  • if you are receiving immunosuppressive therapy, or are taking allopurinol, procainamide, or any combination of these medicines
  • if you are of Black race, 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 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 rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus)
  • vildagliptin, a medicine used to treat diabetes

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 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 Pharma”.
Inform your doctor if you are planning to undergo medical treatment
Inform your doctor that you are taking this medicine if you are about to:

  • undergo surgery or anaesthesia (including dental anaesthesia)
  • receive a cholesterol-lowering treatment 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
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 and Lercanidipine Mylan Pharma
Enalapril and Lercanidipine Mylan Pharma should 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 Pharma is taken with certain other medicines, their effects may change, or unwanted side effects may occur more frequently.

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

  • neprilysin inhibitors (NEP) such as sacubitril (available in fixed-dose combination with valsartan for treating heart conditions): the risk of angioedema (rapid swelling under the skin in areas such as the throat) may be increased
  • potassium-containing medicines (including dietary supplements or salt substitutes)
  • potassium-sparing diuretics (a type of diuretic, e.g. spironolactone, triamterene, or amiloride)
  • other medicines that may increase potassium levels in the body, such as heparin (used to thin the blood and prevent clotting), trimethoprim, or trimethoprim/sulfamethoxazole (also known as co-trimoxazole)
  • beta-blockers (medicines used to treat high blood pressure and heart problems, e.g. bisoprolol, metoprolol)
  • other medicines that lower blood pressure, such as angiotensin II receptor blockers, diuretics (medicines that increase urine production), nitrates (e.g. glyceryl trinitrate), or a medicine called aliskiren
  • lithium (used to treat a certain type of depression)
  • estramustine or amifostine (used to treat certain types of cancer)
  • medicines to reduce the immune response (immunosuppressants, e.g. tacrolimus, mycophenolate)
  • allopurinol (used to treat gout)
  • procainamide (used to treat abnormal heart rhythm)
  • baclofen (a muscle relaxant)
  • medicines for depression called "tricyclic antidepressants" (e.g. clomipramine, lofepramine)
  • medicines for mental disorders called "antipsychotics" (e.g. olanzapine, amisulpride)
  • medicines called "corticosteroids" (used to reduce inflammation, e.g. prednisolone, hydrocortisone)
  • non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain, e.g. ibuprofen, diclofenac, celecoxib)
  • certain medicines for pain or arthritis, including gold therapy
  • certain cough and cold medicines and weight-reducing medicines containing a substance called a "sympathomimetic agent" (e.g. ephedrine, phenylephrine)
  • medicines for diabetes (including oral antidiabetic medicines and insulin)
  • astemizole or terfenadine (medicines for allergies)
  • amiodarone or quinidine (medicines for treating fast heart rate)
  • phenytoin or carbamazepine (medicines for epilepsy)
  • rifampicin (a medicine for treating tuberculosis)
  • digoxin (a medicine for treating heart problems)
  • midazolam (a medicine to help sleep)
  • cimetidine (a medicine for ulcers and heartburn) taken at daily doses exceeding 800 mg
  • other medicines for treating excess stomach acid or indigestion

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 rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.
  • vildagliptin, a medicine used to treat diabetes

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

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

Enalapril and Lercanidipine Mylan Pharma with food, drinks and alcohol

  • Take Enalapril and Lercanidipine Mylan Pharma at least 15 minutes before a meal.
  • Alcohol may enhance the effects of Enalapril and Lercanidipine Mylan Pharma. Therefore, you are advised not to drink alcohol or to keep alcohol consumption to a minimum.
  • Do not take Enalapril and Lercanidipine Mylan Pharma with grapefruit or grapefruit juice, as these may increase its blood pressure-lowering effect.

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking Enalapril and Lercanidipine Mylan Pharma before starting a pregnancy or as soon as you find out you are pregnant, and will recommend an alternative medicine. Enalapril and Lercanidipine Mylan Pharma is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your unborn baby if used beyond the third month of pregnancy.

Breastfeeding
Enalapril and Lercanidipine Mylan Pharma must not be used during breastfeeding.

Driving and using machines
Avoid driving or operating machinery if you experience dizziness, weakness, fatigue, or drowsiness while taking this medicine.

Enalapril and Lercanidipine Mylan Pharma contains sodium
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 Pharma

Take this medicine exactly as your doctor has told you. If you are not sure, 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.
Patients with kidney problems or elderly patients
Your doctor will decide the dose of the medicine according to how well your kidneys are working.
If you take more Enalapril and Lercanidipine Mylan Pharma than you should
If you have taken more medicine than you should, consult your doctor or go to hospital immediately. Take the pack with you. Taking too high a dose of the 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 Pharma
If you forget to take your tablet, skip the missed dose. Take your next dose as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Enalapril and Lercanidipine Mylan Pharma
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, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious.
If any of the following occur, contact your doctor immediately:
Allergic reaction with swelling of the face, lips, tongue or throat which may cause
difficulty swallowing or breathing
Weak heartbeat with cold or sweaty hands and feet, pale or bluish skin, shallow breathing,
dizziness or fainting. These may be signs of serious circulatory problems.
Severe chest pain or tightness, which may spread to the back and jaw, with sweating,
shortness of breath and feeling unwell. These may be signs of serious heart problems.
Sudden migraine with vision problems, difficulty speaking or moving, with tingling or numbness. These may be signs of a serious problem with blood vessels in the brain.
Severe pain or swelling in the abdomen, spreading to the back, which may be signs of
serious problems with the pancreas or intestine.
Reduced amount of urine produced, with feeling unwell, drowsiness or confusion, swelling of the legs, ankles or feet and shortness of breath. These may be signs of serious kidney problems.
Severe skin reactions causing widespread rashes with blisters, sores or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
At the beginning of treatment with Enalapril and Lercanidipine Mylan Pharma you may feel weak or dizzy or have blurred vision; this is caused by a sudden drop in blood pressure and lying down may help. If this concerns you, speak to your doctor.
Patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of attacks with the group of medicines to which lercanidipine belongs. Isolated cases of myocardial infarction may occur.

Side effects observed with enalapril and lercanidipine taken together
Common (may affect up to 1 in 10 people)

  • cough
  • dizziness, headache

Uncommon (may affect up to 1 in 100 people)

  • changes in blood values such as reduced number of blood platelets (which causes bruising or bleeding more easily or for longer than usual), or reduced number of red blood cells (which causes pale skin and tiredness)
  • increased level of potassium in the blood
  • nervousness (anxiety)
  • dizziness when standing up
  • sensation of spinning (vertigo)
  • fast or irregular heartbeat (palpitations)
  • redness of the face, neck or upper chest (flushing)
  • low blood pressure
  • abdominal pain
  • feeling unwell (nausea)
  • constipation
  • skin redness
  • increased levels of liver enzymes or fats in the blood, detectable by a blood test
  • joint pain
  • feeling of weakness
  • tiredness
  • swelling of the ankles
  • feeling of warmth
  • swollen ankles
  • increased frequency of urination

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

  • anaemia
  • ringing in the ears (tinnitus)
  • fainting
  • dry throat or sore throat
  • indigestion, salty taste in the mouth, diarrhoea, dry mouth, swollen gums
  • allergic reaction with swelling of face, lips, tongue or throat and difficulty swallowing or breathing, skin rash, hives
  • getting up at night to urinate
  • production of large amounts of urine
  • inability to get or maintain an erection

The following side effects have been observed more frequently or additionally when enalapril or
lercanidipine are taken separately

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

  • cough
  • dizziness, feeling unwell or weak
  • blurred vision

Common (may affect up to 1 in 10 people)

  • depression
  • headache, feeling of tiredness
  • chest pain
  • changes in heart rhythm
  • increased heart rate
  • angina
  • shortness of breath
  • low blood pressure, fainting
  • change in taste sensation
  • diarrhoea, abdominal pain
  • skin rash
  • increased levels of potassium or creatinine in the blood (usually detected by a blood test)
  • allergic reaction with swelling of face, lips, tongue or throat and difficulty swallowing or breathing

Uncommon (may affect up to 1 in 100 people)

  • reduced number of red blood cells
  • sudden drop in blood pressure
  • loss of appetite
  • confusion, drowsiness, difficulty sleeping
  • nervousness
  • tingling sensation, pins and needles or numbness of the skin
  • heart attack (probably due to very low blood pressure in some high-risk patients, including those with problems in blood flow to the heart or brain)
  • stroke (probably due to very low blood pressure in high-risk patients)
  • ringing in the ears
  • runny nose, sore throat and hoarseness
  • slow movement of food through the intestine (ileus)
  • severe constipation, dry mouth, indigestion, feeling unwell, irritated stomach (gastric irritation), ulcer
  • increased sweating, itching or hives, hair loss
  • inflammation of the pancreas
  • anorexia
  • itching or hives
  • reduced kidney function
  • muscle cramps
  • inability to get or maintain an erection
  • general feeling of being unwell, high temperature (fever)
  • hair loss
  • redness, fast or irregular heartbeat (palpitations)
  • dizziness (sensation of spinning)
  • high level of protein in urine (measured with a test)
  • low level of sugar or sodium in blood, high level of urea in blood (all detected with a blood test)

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

  • breathing difficulties, which may be caused by fluid in the lungs
  • liver problems such as reduced liver function or inflammation of the liver, which may cause jaundice (yellowing of the skin or eyes), fever, pale stools, dark urine or elevated bilirubin levels (measured with a blood test)
  • reduced number of white blood cells, causing more frequent infections with sore throat, fever and mouth ulcers
  • swollen lymph glands
  • bone marrow depression
  • swollen or painful mouth
  • inflammation of the nose
  • autoimmune diseases
  • altered dreams or sleep disturbances
  • Raynaud's phenomenon (in which hands and feet may become very cold and pale due to reduced blood flow)
  • Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin condition causing redness and peeling of the skin, blisters or sores)
  • pneumonia
  • red spots of various shapes on the skin (erythema multiforme)
  • peeling or small blisters on the skin (dermatitis, pemphigus)
  • reduced amount of urine produced
  • enlargement of the breast gland in men

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

  • Intestinal swelling (intestinal angioedema)

Not known (frequency cannot be estimated from the available data)

  • Excessive production of antidiuretic hormone causing fluid retention, leading to weakness, tiredness 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
Common (may affect up to 1 in 10 people):

  • headache
  • increased heart rate
  • sensation of rapid or irregular heartbeat (palpitations)
  • sudden redness of face, neck or upper chest (hot flushes)
  • swollen ankles

Uncommon (may affect up to 1 in 100 people):

  • dizziness
  • drop in blood pressure
  • heartburn
  • nausea
  • stomach ache
  • skin rash
  • itching
  • muscle pain
  • production of large amounts of urine
  • feeling of weakness or tiredness

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

  • drowsiness
  • vomiting
  • diarrhoea
  • hives
  • increased frequency of urination
  • chest pain

Not known (frequency cannot be estimated from the available data):

  • swollen gums
  • changes in liver function (detected by blood tests)
  • cloudy fluid (during dialysis through a tube in the abdomen)
  • swelling of face, lips, tongue or throat which may cause difficulty breathing or swallowing

Talk 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 http://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 Mylan Pharma

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 carton after the word
EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Enalapril and Lercanidipine Mylan Pharma contains
Each tablet of Enalapril and Lercanidipine Mylan Pharma 20 mg/10 mg contains 20 mg of enalapril maleate and 10 mg of lercanidipine hydrochloride.
The other ingredients are:
Tablet core: sodium hydrogen carbonate, microcrystalline cellulose, pregelatinized corn starch, sodium starch glycolate, anhydrous colloidal silica, and magnesium stearate.
Coating: hypromellose, macrogol, talc, and titanium dioxide (E171). The 20 mg/10 mg tablets also contain yellow iron oxide (E172).

Description of the appearance of Enalapril and Lercanidipine Mylan Pharma and package contents
Enalapril and Lercanidipine Mylan Pharma 20 mg/10 mg tablets are film-coated, pale yellow to yellowish, round, biconvex tablets.
Enalapril and Lercanidipine Mylan Pharma is available in blisters containing 14, 28, 30, 56, or 90 film-coated tablets for the 20 mg/10 mg strength.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy

Manufacturers
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
TEVA PHARMA S.L.U., C/C, n. 4, Polígono Industrial Malpica, 50016 Zaragoza, Spain
TEVA Pharmaceutical Works, Private Limited Company (TEVA Gyógyszergyár Zrt.), Pallagi út 13, 4042 Debrecen, Hungary

This medicinal product is authorized in the European Economic Area countries under the following names:
Spain Enalapril/Lercanidipino Mylan 20 mg/10 mg film-coated tablets
Enalapril/Lercanidipino Mylan 10 mg/10 mg film-coated tablets
France Enalapril / Lercanidipine Viatris 20 mg / 10 mg, film-coated tablet
Italy Enalapril e Lercanidipina Mylan Pharma
Portugal Enalapril + Lercanidipina Mylan