Package Leaflet: Information for the User

Enalapril Aurovitas 20 mg Tablets EFG

Enalapril Maleate

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Enalapril Aurovitas contains an active ingredient called enalapril maleate. It belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Enalapril is used for:

• Treating high blood pressure (hypertension)
• Treating heart failure (weakening of the heart function). It may reduce the need for hospital visits and may help some patients live longer
• Preventing signs of heart failure. These signs include: difficulty breathing, fatigue after light physical activity such as walking, and swelling of the ankles and feet.

This medicine works by widening your blood vessels. This reduces your blood pressure. Normally, the medicine starts to work within one hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before they notice the greatest effect on their blood pressure.

Do not takeEnalapril Aurovitas

• If you are allergic to enalapril maleate or any of the other components of this medication (listed in section 6).
• If you have ever been treated for an allergic reaction to a similar medication to this one, called an ACE inhibitor.
• If you have ever had swelling of the face, lips, mouth, tongue, or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are more than 3 months pregnant. (It is also best to avoid enalapril at the beginning of pregnancy - see Pregnancy section).
• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high. If you are taking any of the following medications, the risk of angioedema may increase:
• • Racecadotril, a medication used to treat diarrhea.
  • Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medication used to treat diabetes.

Do not take this medication if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril Aurovitas:

• If you have a heart problem.
• If you have a disease that affects the blood vessels in the brain.
• If you have blood disorders such as low white blood cell count (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have a liver problem.
• If you have a kidney problem (including kidney transplant). This may cause high levels of potassium in your blood that can be serious. Your doctor may need to adjust your enalapril dose or monitor your potassium levels in the blood.
• If you are undergoing dialysis.
• If you have had many vomiting episodes (excessive vomiting) or have had intense diarrhea recently.
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medications, salt substitutes containing potassium, or other medications that may increase potassium levels in the blood, such as heparin (a medication used to prevent blood clots), trimethoprim, or cotrimoxazole (medications used to treat infections).
• If you are over 70 years old.
• If you have diabetes. You should monitor your blood sugar levels to see if you have low blood sugar levels, especially during the first month of treatment. Your potassium levels in the blood may also be higher.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat that caused difficulty swallowing or breathing. You should be aware that patients of African descent have a higher risk of experiencing this type of reaction to ACE inhibitors.
• If you have low blood pressure (you may feel dizzy or lightheaded, especially when standing up).
• If you have a disease that affects the blood vessels, such as lupus erythematosus, rheumatoid arthritis, or scleroderma, are being treated with immunosuppressive medications, are taking alopurinol or procainamide, or any combination of these.
• If you are taking an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medications used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ) or a medication that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), used in patients with heart failure, and racecadotril, used in patients with acute diarrhea. You may have a higher risk of experiencing an allergic reaction called angioedema.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):

• An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, 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 in the blood (e.g., potassium) at regular intervals.

See also the information under the heading "Do not take Enalapril Aurovitas".

You should inform your doctor if you think you may be pregnant (or could be). This medication is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

You should be aware that this medication reduces blood pressure in patients of African descent less effectively than in patients who are not of African descent.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medication.

Before undergoing a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking enalapril:

• Any surgery or if you are to receive anesthetics (even at the dentist's office).
• A treatment to remove cholesterol from your blood called "apheresis of LDL".
• A desensitization treatment to reduce the effect of an allergy to a bee or wasp sting.

If any of the above situations apply to you, consult your doctor or dentist before starting the procedure.

Taking Enalapril Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes herbal remedies. This is because enalapril may affect how other medications work. Other medications may also affect how enalapril works. Your doctor may need to adjust your dose and/or take other precautions.

Especially, inform your doctor or pharmacist if you are taking any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Enalapril Aurovitas" and "Warnings and precautions").
• Other medications to lower blood pressure, such as beta-blockers or diuretics.
• Potassium supplements (including salt substitutes), diuretics that spare potassium, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to prevent blood clots).
• Medications for diabetes (including oral antidiabetic medications and insulin).
• Lithium (a medication used to treat certain types of depression).
• Antidepressant medications called "tricyclic antidepressants".
• Psychotic medications.
• Certain medications for coughs and colds and weight loss medications that contain a substance called "sympathomimetic agent".
• Certain medications for pain or arthritis, including gold treatment.
• An mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medications used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ). See also the information under the heading "Warnings and precautions".
• A medication that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan) and racecadotril. This may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also the information in the sections "Do not take Enalapril Aurovitas" and "Warnings and precautions".
• Nonsteroidal anti-inflammatory medications, including COX-2 inhibitors (medications that reduce inflammation and may be used to help alleviate pain).
• Aspirin (acetylsalicylic acid).
• Medications used to dissolve blood clots (thrombolytics).
• Alcohol.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take enalapril.

Taking Enalapril Aurovitas with food and drinks

Enalapril can be taken with or without food. Most people take enalapril with a little water.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will usually advise you to stop taking enalapril before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of enalapril. This medication is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. While taking this medication, breastfeeding is not recommended in newborns (first weeks after birth) and especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking this medication compared to other treatments while breastfeeding.

Driving and operating machinery

You may feel dizzy or drowsy while taking this medication. If this happens, do not drive or use tools or machinery.

Enalapril Aurovitas contains lactose

If your doctor has told you that you have a certain type of sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• It is very important that you continue taking this medication for the time your doctor prescribes.
• Do not take more tablets than those prescribed to you.

Hypertension

• The usual initial dose varies between 5 mg and 20 mg, administered once a day.
• Some patients may need a lower initial dose.
• The usual long-term dose is 20 mg, administered once a day.
• The maximum long-term dose is 40 mg, administered once a day.

Heart failure

• The usual initial dose is 2.5 mg, administered once a day.
• Your doctor will gradually increase this amount until the appropriate dose for you is reached.
• The usual long-term dose is 20 mg per day, administered in one or two doses.
• The maximum long-term dose is 40 mg per day, divided into two doses.

Patients with kidney problems

• Your medication dose will change depending on how well your kidneys are functioning:
• Moderate kidney problems - 5 mg to 10 mg per day.
• Severe kidney problems - 2.5 mg per day.
• If undergoing dialysis - 2.5 mg per day. On days when you are not undergoing dialysis, your dose may change depending on how low your blood pressure is.

Older patients

Your doctor will decide on the dose and will base it on how well your kidneys are functioning.

Use in children

The experience with the use of enalapril in children with hypertension is limited. If the child can swallow tablets, the dose will be calculated based on the child's weight and blood pressure. The usual initial doses are:

• Between 20 kg and 50 kg - 2.5 mg per day.
• More than 50 kg - 5 mg per day.

The dose may be adjusted as needed:

• A maximum of 20 mg per day may be used in children weighing between 20 kg and 50 kg.
• A maximum of 40 mg per day may be used in children weighing more than 50 kg.

This medication is not recommended for newborns (first weeks after birth) or children with kidney problems.

If you take more Enalapril Aurovitas than you should

If you take more enalapril than you should, consult your doctor or go to the hospital immediately. In case of overdose or accidental ingestion, call the Toxicological Information Service, phone 91 562 04 20. Bring the medication packaging with you. The following effects may occur: a feeling of dizziness or vertigo. This is due to a sudden or excessive drop in blood pressure.

If you forget to take Enalapril Aurovitas

• If you forget to take a tablet, do not take the missed dose.
• Take the next dose as usual.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Enalapril Aurovitas

Do not stop taking your medication unless your doctor tells you to.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following symptoms, stop taking enalapril and talk to your doctor immediately:

• Swelling of your face, lips, tongue, or throat that may cause difficulty swallowing or breathing.
• Swelling of your hands, feet, or ankles.
• Developing a red rash on your skin with swelling (hives).

You should be aware that patients of black race have a higher risk of experiencing this type of reaction. If you experience any of the above reactions, stop taking enalapril and talk to your doctor immediately.

When you start taking this medicine, you may feel a loss of consciousness or feel dizzy. If this happens, lying down may help. This is due to a decrease in your blood pressure. This will improve as you continue to take the medicine. If you are concerned, please talk to your doctor.

Other side effects include:

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

• Dizziness, weakness, or vomiting.
• Blurred vision.
• Cough.

Common(may affect up to 1 in 10 people)

• Dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeat, chest pain, or chest tightness.
• Headache, depression, fainting (syncope), taste disorder.
• Difficulty breathing.
• Diarrhea, abdominal pain.
• Fatigue (tiredness).
• Rash, allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing.
• Elevated potassium levels in the blood, elevated creatinine levels in the blood (usually both are detected in a blood test).

Uncommon(may affect up to 1 in 100 people)

• Redness.
• Sudden drop in blood pressure.
• Rapid or irregular heartbeat (palpitations).
• Myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in blood flow to the heart or brain).
• Cerebrovascular accident (possibly due to very low blood pressure in high-risk patients).
• Anemia (including aplastic and hemolytic anemia).
• Confusion, drowsiness, or inability to sleep, nervousness.
• Sensation of numbness or tingling in your skin.
• Dizziness (sensation of spinning).
• Ringing in the ears (tinnitus).
• Cough, sore throat, or hoarseness.
• Asma - associated with chest tightness.
• Slow movement of food through your intestine (ileus), pancreatitis.
• Vomiting, indigestion, constipation, anorexia.
• Irritated stomach (gastritis), dry mouth, ulcers.
• Muscle cramps.
• Reduced kidney function, kidney failure.
• Increased sweating.
• Itching or urticaria.
• Hair loss.
• Indisposition (general feeling of being unwell), elevated temperature (fever).
• Impotence
• Elevated protein levels in your urine (determined in a blood test).
• Low blood sugar or sodium levels, elevated urea levels in the blood (all determined in a blood test).

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

• “Raynaud’s phenomenon” in which your hands and feet may become very cold and white due to low blood flow.
• Changes in blood values such as a lower number of white blood cells or red blood cells, lower hemoglobin levels, lower platelet count in the blood.
• Depression of the bone marrow.
• Swollen glands in the neck, armpits, or groin.
• Autoimmune diseases.
• Alterations in sleep or difficulty sleeping.
• Accumulation of fluids or other substances in the lungs (as seen in X-rays).
• Inflammation of the nose.
• Inflammation of the lungs causing difficulty breathing (pneumonia).
• Inflammation of the cheeks, gums, tongue, lips, throat.
• Reduced urine production.
• Rash with target-shaped lesions (erythema multiforme).
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red, peeling skin with blisters or open ulcers), dermatitis exfoliativa/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small blisters filled with fluid on the skin).
• Problems with the liver or bile ducts such as decreased liver function, inflammation of the liver, jaundice (yellow discoloration of the skin or eyes), elevated liver enzymes or bilirubin levels (determined in a blood test).
• Enlargement of the breasts in men (gynecomastia).

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

• Swelling in your intestine (intestinal angioedema).

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

• Overproduction of the antidiuretic hormone, which causes fluid retention, leading to weakness, fatigue, or confusion.
• A set of symptoms that may include one or more of the following: fever, inflammation of the blood vessels (serositis/vasculitis), muscle pain (myalgia/miositis), joint pain (arthralgia/arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and carton after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Enalapril Aurovitas

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other components are: lactose monohydrate, pregelatinized cornstarch and glycerol diestearate (Type I).

Appearance of the product and contents of the package

Uncoated tablets, white to off-white in color, round (8.5 mm in diameter), with flat faces and beveled edges, engraved on one face with “2” and “0” separated by a groove and “E” on the other face. The tablet can be divided into equal doses.

Enalapril Aurovitas is available in aluminum foil blister packs (Alu-Alu) and transparent PVC with aluminum foil.

Package sizes:14, 28, 30, 50, 56, 84, 90 & 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Enalapril Aurovitas 20 mg tablets EFG

France:Enalapril Arrow Lab 20 mg scored tablet

Italy:Enalapril Aurobindo Pharma Italia

Netherlands:Enalaprilmaleaat Aurobindo 20 mg, tablets

Portugal:Enalapril Generis Phar

Last review date of this leaflet: May 2021

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