ENALAPRIL AUROVITAS 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril Aurovitas 10 mg Tablets

Enalapril Maleate

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Enalapril Aurovitas and what is it used for
2. What you need to know before you take Enalapril Aurovitas
3. How to take Enalapril Aurovitas
4. Possible side effects
5. Storage of Enalapril Aurovitas

Contents of the pack and further information

1. What is Enalapril Aurovitas and what is it used for

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

Enalapril is used to:

• Treat high blood pressure (hypertension)
• Treat heart failure (weakening of the heart's function). It may reduce the need for hospitalization and may help some patients live longer
• Prevent signs of heart failure. Signs include: difficulty breathing, tiredness after light physical activity such as walking or 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 an hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before the full effect on blood pressure is seen.

2. What you need to know before you take Enalapril Aurovitas

Do not takeEnalapril Aurovitas

• If you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6).
• If you have ever been treated for an allergic reaction to a medicine similar to this one, called an ACE inhibitor.
• If you have ever had swelling of the face, lips, tongue or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary.
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.
• If you are more than 3 months pregnant. (It is also recommended to avoid enalapril at the start of pregnancy - see section Pregnancy).
• If you have taken or are taking sacubitril/valsartan, a medicine 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 medicines, the risk of angioedema may increase:
• • Racecadotril, a medicine used to treat diarrhea.
  • Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking 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 or absent white blood cells (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, which can be serious. Your doctor may need to adjust your dose of enalapril or monitor your potassium levels in your blood.
• If you are on dialysis.
• If you have recently had severe vomiting or diarrhea.
• If you are on a low-salt diet, are taking potassium supplements, potassium-sparing diuretics, or other medicines that may increase potassium levels in your blood, such as heparin (a medicine used to prevent blood clots), trimethoprim, or cotrimoxazole (medicines used to treat bacterial infections).
• If you are over 70 years old.
• If you have diabetes. You should monitor your blood for low blood sugar levels, especially during the first month of treatment. Your potassium level in your blood may also be higher.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing. You should be aware that black patients have a higher risk of these reactions to ACE inhibitors.
• If you have low blood pressure (you may notice this as fainting or dizziness, especially when standing up).
• If you have a disease of the blood vessels in the skin (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, or are taking allopurinol or procainamide, or any 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 the immune system from rejecting a transplanted organ) or a medicine that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan) and racecadotril. You may have a higher risk of an allergic reaction called angioedema.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (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 are pregnant (or might be). Your doctor will normally advise you to stop taking enalapril before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of enalapril. This medicine is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

You should be aware that this medicine reduces blood pressure in black patients less effectively than in non-black patients.

If you are not sure if any of the above applies 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:

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

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

Taking Enalapril Aurovitas with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal treatments. This is because enalapril may affect the way other medicines work. Other medicines may also affect how enalapril works. Your doctor may need to change your 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 (ARA) or aliskiren (see also the information under the headings "Do not take Enalapril Aurovitas" and "Warnings and precautions").
• Other medicines to reduce blood pressure, such as beta-blockers or water tablets (diuretics).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in your blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Medicines for diabetes (including oral antidiabetic medicines and insulin).
• Lithium (a medicine used to treat a certain type of depression).
• Medicines for depression called "tricyclic antidepressants".
• Medicines for mental problems called "antipsychotics".
• Certain medicines for coughs and colds and weight-reducing medicines that contain a substance called "sympathomimetic agent".
• Certain medicines for pain or arthritis, including treatment with gold.
• An mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medicines 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 medicine 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".
• Non-steroidal anti-inflammatory medicines, 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 not sure if any of the above applies to you, consult your doctor or pharmacist before taking enalapril.

Taking Enalapril Aurovitas with food and drink

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 are planning to have a baby, ask your doctor for advice before taking this medicine. Normally, your doctor will advise you to stop taking enalapril before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of enalapril. This medicine is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. While taking this medicine, breastfeeding is not recommended in newborns (first few 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 medicine, compared to other treatments, while breastfeeding.

Driving and using machines

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

Enalapril Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Enalapril Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• It is very important that you continue taking this medicine for the time your doctor has prescribed it.
• Do not take more tablets than you have been prescribed.

High blood pressure

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

Heart failure

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

Patients with kidney problems

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

Patients over 70 years old

Your doctor will decide on the dose and will be based on how well your kidneys are working.

Use in children

Experience with the use of enalapril in children with high blood pressure 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 changed according to the child's needs:

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

This medicine is not recommended in newborn babies (first few weeks after birth) or in 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 Toxicology Information Service, telephone 91 562 04 20. Take the medicine pack with you. The following effects may occur: 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 forgotten dose.
• Take the next dose as usual.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Enalapril Aurovitas

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 can cause difficulty swallowing or breathing.
• Swelling of your hands, feet, or ankles.
• If you develop a red rash on the skin with swelling (hives).

You should be aware that black patients have a higher risk of suffering from 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 faint or dizzy. If this happens, lying down can help. This is due to a decrease in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please talk to your doctor.

Other adverse effects include:

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

• Feeling of 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 heartbeats, chest pain, or angina.
• 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.
• High levels of potassium in the blood, high levels of creatinine in the blood (usually both are detected in a blood test).

Uncommon(may affect up to 1 in 100 people)

• Flush.
• Sudden drop in blood pressure.
• Rapid or irregular heartbeats (palpitations).
• Myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in heart or brain blood flow).
• Stroke (possibly due to very low blood pressure in high-risk patients).
• Anemia (including aplastic and hemolytic anemia).
• Confusion, drowsiness, or inability to sleep, nervousness.
• Feeling of tingling or numbness in the skin.
• Vertigo (feeling of dizziness).
• Ringing in the ears (tinnitus).
• Runny nose, sore throat, or hoarseness.
• Asthma - associated with chest tightness.
• Slow movement of food through the intestine (ileus), pancreatitis.
• Vomiting, indigestion, constipation, anorexia.
• Irritated stomach (gastric irritation), dry mouth, ulcer.
• Muscle cramps.
• Reduced kidney function, kidney failure.
• Increased sweating.
• Itching or hives.
• Hair loss.
• Malaise (general discomfort), elevated temperature (fever).
• Impotence.
• High levels of protein in the urine (determined in a urine test), low levels of sugar or sodium in the blood, high levels of urea 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 can become very cold and white due to low blood flow.
• Changes in blood values such as a lower number of white or red blood cells, lower hemoglobin, lower platelet count in the blood.
• Bone marrow depression.
• Inflamed glands in the neck, armpits, or groin.
• Autoimmune diseases.
• Sleep disturbances or problems sleeping.
• Fluid or substance accumulation in the lungs (as seen on X-rays).
• Nasal inflammation.
• Lung inflammation causing difficulty breathing (pneumonia).
• Inflammation of the cheeks, gums, tongue, lips, throat.
• Reduced amount of urine produced.
• Rash with a target-like shape (erythema multiforme).
• "Stevens-Johnson syndrome" and "toxic epidermal necrolysis" (a severe skin disorder in which you have red and scaly skin, with blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling of the skin), pemphigus (small blisters filled with fluid on the skin).
• Liver or bile duct problems such as decreased liver function, liver inflammation, jaundice (yellowish color of the skin or eyes), elevated liver enzyme or bilirubin levels (determined in a blood test).
• Increased breast size in men (gynecomastia).

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

• Swelling in your intestine (intestinal angioedema).

Frequency Not Known(frequency cannot be estimated from available data)

• Overproduction of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue, or confusion.
• A set of symptoms has been reported that may include one or more of the following: fever, blood vessel inflammation (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Rash, photosensitivity, or other skin manifestations may occur.

Reporting Adverse Effects

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

5. Storage of Enalapril Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enalapril Aurovitas

• The active ingredient is enalapril maleate. Each tablet contains 10 mg of enalapril maleate.
• The other ingredients are: lactose monohydrate, pregelatinized corn starch, and glycerol distearate (Type I).

Appearance of the Product and Package Contents

Uncoated tablets, white to off-white, round (6.5 mm in diameter), with flat faces and a beveled edge, engraved on one face with "1" and "0" separated by a score line and "E" on the other face. The tablet can be divided into equal doses.

Enalapril Aurovitas is available in aluminum blister packs with a triple-layer cold seal (Alu-Alu) and transparent PVC - aluminum foil.

Package Sizes:28, 30, 50, 56, 90, and 100 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

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 under the following names:

Spain: Enalapril Aurovitas 10 mg tablets

Italy: Enalapril Aurobindo Pharma Italia

Netherlands: Enalapril maleate Aurobindo 10 mg, tablets

Portugal: Enalapril Generis Phar

Date of Last Revision of this Prospectus: May 2021

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