Enalapril Aurobindo Pharma Italia

Package leaflet: Information for the user

Enalapril Aurobindo Pharma Italia 5 mg tablets, 20 mg tablets

Generic medicine
Please 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 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, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Enalapril Aurobindo Pharma Italia is and what it is used for

Enalapril Aurobindo Pharma Italia contains an active substance called enalapril maleate. This active
substance belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Enalapril Aurobindo Pharma Italia is used:

• to treat high blood pressure (hypertension);
• to treat heart failure (weakening of heart function). It can reduce the need for hospitalisation and may help some patients live longer;
• to prevent the signs of heart failure. Signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet.

This medicine works by dilating your blood vessels. This lowers your blood pressure. The medicine usually starts to work within one hour, and its effects last for at least 24 hours. Some people may need several weeks of treatment before the best effect on blood pressure can be seen.

2. What you need to know before taking Enalapril Aurobindo Pharma Italia

Do not take Enalapril Aurobindo Pharma Italia

• if you are allergic to enalapril maleate 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 of the same type as this medicine, called an ACE inhibitor;
• if you have previously experienced swelling of the face, lips, mouth, tongue or throat causing difficulty in swallowing or breathing (angioedema) of unknown or hereditary origin;
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you are more than 3 months pregnant (it is also preferable to avoid using Enalapril Aurobindo Pharma Italia in the early stages of pregnancy – see section Pregnancy);
• 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, for example in the throat);
• if you are currently taking any of the following medicines, the risk of angioedema may be increased: o racecadotril, a medicine used to treat diarrhoea; o medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus); o vildagliptin, a medicine used to treat diabetes.

Do not take this medicine if you have any of the conditions listed above. If you are unsure, speak with your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril Aurobindo Pharma Italia:

• if you have a heart condition;
• if you have a condition affecting the blood vessels in the brain;
• if you have a blood disorder such as low number or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia);
• if you have a liver problem;
• if you have a kidney problem (including kidney transplant). This may lead to increased levels of potassium in the blood, which can be serious. Your doctor may need to adjust your dose of Enalapril Aurobindo Pharma Italia or monitor your blood potassium levels;
• if you are undergoing dialysis;
• if you have recently been severely ill (excessive vomiting) or have had severe diarrhoea;
• if you are on a low-salt diet, taking potassium supplements, potassium-sparing agents, potassium-containing salt substitutes, or other medicines that may increase blood potassium levels (e.g. heparin);
• if you are over 70 years of age;
• if you have diabetes. Close monitoring for low blood glucose levels is necessary, especially during the first month of treatment. Blood potassium levels may also be higher;
• if you have previously had an allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing. Please note that black patients are at higher risk of such reactions to ACE inhibitors;
• if you have low blood pressure (which you may notice as fainting or dizziness, especially when standing up);
• if you have a collagen vascular disease (e.g. systemic lupus erythematosus, rheumatoid arthritis or scleroderma), if you are receiving immunosuppressive therapy, if you are taking allopurinol or procainamide, or a combination of these;
• if you are taking an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus: medicines used to treat certain types of cancer or to prevent rejection of a transplanted organ by the body’s immune system) or a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan), used in patients with heart failure, or racecadotril, used in patients with acute diarrhoea. You may have an increased risk of an allergic reaction called angioedema;
• if you are taking any of the following medicines for high blood pressure: o an angiotensin II receptor antagonist (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan, etc.), particularly if you have kidney problems related to diabetes; o 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 information under the heading “Do not take Enalapril Aurobindo Pharma Italia”.

You must inform your doctor if you think you are (or could be) pregnant. This medicine is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn baby if used during this period (see section Pregnancy).

Please be aware that in black patients, this medicine is less effective in lowering blood pressure compared to non-black patients.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking this medicine.

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 Aurobindo Pharma Italia:

• any type of surgery or anaesthesia (including dental procedures);

• a treatment to remove cholesterol from the blood called “LDL apheresis”;

• a desensitisation treatment to reduce the effect of an allergy to bee or wasp stings.

• If any of the above situations apply to you, speak with your doctor or dentist before the procedure.

Other medicines and Enalapril Aurobindo Pharma Italia

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines. This is because Enalapril Aurobindo Pharma Italia may interfere with the action of certain medicines, and some other medicines may interfere with the action of Enalapril Aurobindo Pharma Italia. Your doctor may need to adjust the dose and/or take other precautions.

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

• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information under “Do not take Enalapril Aurobindo Pharma Italia” and “Warnings and precautions”);
• other medicines to lower blood pressure, such as beta-blockers or diuretics;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene or amiloride), and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole used to treat bacterial infections; ciclosporin, an immunosuppressive medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting);
• medicines for diabetes (including oral antidiabetics and insulin);
• lithium (a medicine used to treat a certain type of depression);
• medicines for depression called “tricyclic antidepressants”;
• medicines for mental disorders called “antipsychotics”;
• some cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic”;
• some medicines for pain or arthritis, including gold salts therapy;
• an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus: medicines used to treat certain types of cancer or to prevent rejection of a transplanted organ by the body’s immune system). See also the information in the section “Warnings and precautions”;
• a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan) or racecadotril. The risk of angioedema (swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) may be increased. See also the information in the sections “Do not take Enalapril Aurobindo Pharma Italia” and “Warnings and precautions”;
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain);
• aspirin (acetylsalicylic acid);
• medicines used to dissolve blood clots (thrombolytics);
• alcohol.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking this medicine.

Enalapril Aurobindo Pharma Italia with food and drink

Enalapril Aurobindo Pharma Italia can be taken with or without food. Most people take Enalapril Aurobindo Pharma Italia with a glass of water.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine. Your doctor will usually advise you to stop taking Enalapril Aurobindo Pharma Italia before pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. This medicine is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn baby if taken beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding. Breastfeeding of newborns (first weeks after birth), especially premature infants, is not recommended during treatment with this medicine. For older infants, your doctor will advise you on the benefits and risks of taking this medicine while breastfeeding compared to other treatments.

Driving and using machines

While taking this medicine, you may experience dizziness or drowsiness. If this occurs, do not drive and do not operate tools or machinery.

Enalapril Aurobindo Pharma Italia contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Enalapril Aurobindo Pharma Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

• It is very important to continue taking this medicine for the entire duration prescribed by your doctor.
• Do not take more tablets than prescribed.

High blood pressure

• The usual starting dose ranges from 5 to 20 mg once daily.
• Some patients may require a lower starting dose.
• The usual maintenance dose is 20 mg once daily.
• The maximum maintenance dose is 40 mg once daily.

Heart failure

• The usual starting dose is 2.5 mg once daily.
• Your doctor will gradually increase this dose until the appropriate dose for you is reached.
• The usual maintenance dose is 20 mg daily, taken as either a single dose or in two divided doses.
• The maximum maintenance dose is 40 mg daily, divided into two doses.

Patients with kidney problems
The dose of the medicine will be adjusted according to how well your kidneys are functioning:

• Moderate kidney problems – 5 mg to 10 mg daily.
• Severe kidney problems – 2.5 mg daily.
• If you are undergoing dialysis – 2.5 mg daily. On days when you are not undergoing dialysis, the dose may be adjusted depending on how low your blood pressure is.

Elderly patients
The dose will be determined by your doctor and will be based on the degree of kidney function.
Use in children
Experience with the use of Enalapril Aurobindo Pharma Italia in children with high blood pressure is
limited. If the child is able to swallow tablets, the dose will be based on the child's weight and
blood pressure. Usual starting doses are:

• Body weight between 20 kg and 50 kg – 2.5 mg daily.
• Body weight above 50 kg – 5 mg daily. The dose may be adjusted according to the child's needs:
• A maximum dose of 20 mg daily may be used in children weighing between 20 kg and 50 kg.
• A maximum dose of 40 mg daily may be used in children weighing above 50 kg.

This medicine is not recommended for newborns (first weeks of life) and children with kidney
problems.
If you take more Enalapril Aurobindo Pharma Italia than you should
If you take more Enalapril Aurobindo Pharma Italia than prescribed, inform your doctor or go immediately
to hospital. Take the medicine pack with you. The following effects may occur: feeling dizzy or lightheaded. This is due to a sudden or excessive drop in blood pressure.
If you forget to take Enalapril Aurobindo Pharma Italia

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

If you stop taking Enalapril Aurobindo Pharma Italia
Do not stop treatment with 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. The following side effects may occur with this medicine:
Stop taking Enalapril Aurobindo Pharma Italia and contact a doctor immediately if you notice any of the
following symptoms:

• Swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing.
• Swelling of the hands, feet or ankles.
• If you develop a skin rash with red raised areas (urticaria). You should know that black patients have an increased risk of developing these types of reactions. If any of the above cases occur, stop taking Enalapril Aurobindo Pharma Italia and contact your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this happens, it may help to lie down. This is caused by a drop in blood pressure. This should improve as you continue taking the medicine. If you are concerned, contact your doctor.
Other side effects include:
Very common (may affect more than 1 in 10 people)

• Dizziness, weakness or feeling unwell.
• Blurred vision.
• Cough.

Common (may affect up to 1 in 10 people)

• Dizziness due to low blood pressure, changes in heart rate, rapid heartbeat, angina or chest pain.
• Headache, depression, fainting (syncope), altered taste sensation.
• Shortness of breath.
• Diarrhoea, abdominal pain.
• Tiredness (fatigue).
• Skin rash, allergic reactions with swelling of the face, lips, tongue or throat, causing difficulty in breathing or swallowing.
• High levels of potassium in the blood, increased levels of creatinine in the blood (both usually detected by laboratory tests).

Uncommon (may affect up to 1 in 100 people)

• Flushing.
• Sudden drop in blood pressure.
• Rapid or irregular heartbeat (palpitations).
• Heart attack (possibly 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).
• Anaemia (including aplastic and haemolytic anaemia).
• Confusion, insomnia or drowsiness, nervousness.
• Tingling or numbness of the skin.
• Dizziness (sensation of spinning).
• Ringing in the ears (tinnitus).
• Runny nose, sore throat or hoarseness.
• Chest tightness associated with asthma.
• Slowed movement of food through the intestine (ileus), inflammation of the pancreas.
• Feeling unwell (nausea, vomiting), indigestion, constipation, loss of appetite.
• Irritated stomach (gastric irritation), dry mouth, ulcer.
• Muscle cramps.
• Impaired kidney function, kidney failure.
• Increased sweating.
• Itching or urticaria.
• Hair loss.
• General feeling of being unwell (malaise), high body temperature (fever).
• Impotence.
• High levels of protein in the urine (detected by laboratory test).
• Low levels of sugar or sodium in the blood, high levels of urea in the blood (all measured by blood tests).

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

• “Raynaud’s phenomenon”, in which hands and feet may become very cold and white due to reduced blood flow.
• Changes in blood values such as decreased number of white blood cells and red blood cells, decreased haemoglobin, decreased platelet count.
• Bone marrow suppression.
• Swelling of the glands in the neck, armpits or groin.
• Autoimmune diseases.
• Strange dreams or sleep disturbances.
• Accumulation of fluid or other substances in the lungs (detected by X-ray).
• Inflammation of the nose.
• Inflammation of the lungs causing breathing difficulties (pneumonia).
• Inflammation of cheeks, gums, tongue, lips, throat.
• Decreased urine output.
• Target-like skin rash (erythema multiforme).
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (serious skin conditions characterized by redness, peeling of the skin, blistering or raw areas), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin).

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

• Swelling in the intestine (intestinal angioedema).

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

• Excessive production of antidiuretic hormone, leading to fluid retention, resulting in weakness, fatigue or confusion.
• A complex of symptoms has been reported, which may include some or all 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.

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: 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 Aurobindo Pharma Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after the word
"Exp.". The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Enalapril Aurobindo Pharma Italia contains

• The active substance is enalapril maleate. Each tablet contains 5 mg of enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other ingredients are monohydrate lactose, pregelatinized starch (corn starch), and glycerol distearate (type I).

Description of the appearance of Enalapril Aurobindo Pharma Italia and package contents
Enalapril Aurobindo Pharma Italia 5 mg tablets
Uncoated tablets, white to off-white in colour, round (diameter 5 mm), flat with bevelled edges, imprinted with "5" on one side and a break line on the other side. The tablet can be divided into equal doses.
Enalapril Aurobindo Pharma Italia 20 mg tablets
Uncoated tablets, white to off-white in colour, round (diameter 8.5 mm), flat with bevelled edges, imprinted with "20" on one side and a break line on the other side. The tablet can be divided into equal doses.
Enalapril Aurobindo Pharma Italia 5 mg and 20 mg tablets are available in triple-layer aluminium (Alu-Alu) blisters and transparent PVC-Al blisters.
Pack sizes:
Blister packs:
5 mg: 10, 20, 28, 30, 50, 60, 84, 90 and 100 tablets.
20 mg: 14, 28, 30, 50, 56, 84, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Manufacturers:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
France: Enalapril Arrow Lab 5 mg/20 mg comprimé sécable
Italy: Enalapril Aurobindo Pharma Italia
Netherlands: Enalaprilmaleaat Aurobindo 2,5 mg/5 mg/10 mg/20 mg, tabletten
Portugal: Enalapril Generis
Spain: Enalapril Aurovitas 5 mg comprimidos EFG
Enalapril Aurovitas 10 mg comprimidos
Enalapril Aurovitas 20 mg comprimidos EFG