ACETENSIL 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Acetensil20 mg Tablets EFG

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 Package Leaflet

1. What is Acetensil and what is it used for
2. What you need to know before you take Acetensil
3. How to take Acetensil
4. Possible side effects
5. Storing Acetensil
6. Package Contents and Further Information

1. What is Acetensil and what is it used for

Acetensil contains the active substance enalapril maleate, which belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Acetensil is used to:

• treat high blood pressure (hypertension)
• treat heart failure (weakening of the heart's function). It can reduce the need for hospitalization and may help some patients live longer, preventing signs of heart failure. These 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. The medicine usually starts working 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 Acetensil

Do not takeAcetensil

• 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 similar medicine, 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 best to avoid Acetensil at the start of pregnancy – see section Pregnancy);
• if you have taken or are currently 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;

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Acetensil:

• 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 kidney problems (including kidney transplant), follow a low-salt diet, are taking potassium supplements, potassium-sparing diuretics, salt substitutes that contain potassium, or other medicines that may increase potassium levels in the blood (such as heparin, a medicine used to prevent blood clots; 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). This may cause high levels of potassium in your blood, which can be serious. Your doctor may need to adjust your dose of Acetensil or monitor your potassium levels in the blood. See also the information under the heading “Other medicines and Acetensil”;
• if you have liver problems;
• if you are undergoing dialysis;
• if you have recently had excessive vomiting or severe diarrhea;
• 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 the 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 dizziness or fainting, especially when standing up);
• if you have a disease of the collagen vascular system (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, are taking the medicines allopurinol or procainamide, or any combination of these;
• 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;
• if you are taking any of the following medicines used to treat high blood pressure:
• • an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Acetensil” and “Warnings and Precautions”);
  • Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Acetensil”.

You should inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking Acetensil before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Acetensil. 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 Acetensil lowers 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 starting to take 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 Acetensil:

• 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.

Other medicines and Acetensil

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes herbal treatments. This is because Acetensil may affect the way other medicines work. Other medicines may also affect how Acetensil 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 Acetensil” and “Warnings and Precautions”);
• other medicines to lower blood pressure, such as beta-blockers or water tablets (diuretics);
• potassium supplements (including dietary salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as 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). See also the information in the section “Warnings and Precautions”;
• medicines for diabetes (including oral antidiabetics and insulin);
• lithium (a medicine used to treat certain types of depression);
• medicines for depression called “tricyclic antidepressants”;
• medicines for mental problems called “antipsychotics”;
• certain medicines for cough and cold and weight loss medicines that contain a substance called “sympathomimetic medicine”;
• certain medicines for pain or arthritis, including gold treatment
• 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 in the section “Warnings and Precautions”;
• a medicine that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), racecadotril, or vildagliptin. 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 Acetensil” and “Warnings and Precautions”;
• non-steroidal anti-inflammatory medicines (NSAIDs), 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 starting to take Acetensil.

Taking Acetensil with food and drink

Acetensil can be taken with or without food. Most people take Acetensil 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. Your doctor will normally advise you to stop taking Acetensil before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Acetensil. 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 Acetensil, 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.

Acetensil contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Acetensil

Follow exactly the instructions of administration of this medicine given to you 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.
• The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

High Blood Pressure

• The usual initial dose is between 5 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 undergoing dialysis - 2.5 mg per day. On the days when you are not undergoing dialysis, your dose may change depending on how low your blood pressure is.

Patients over 65 years

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
• over 50 kg - 5 mg per day.

The dose may be changed according to the child's needs:

• up to 20 mg per day can be used in children who weigh between 20 kg and 50 kg
• up to 40 mg per day can be used in children who weigh over 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 Acetensil than you should

If you take more Acetensil than you should, consult your doctor or go to the hospital immediately. Take the medicine package with you. The following effects may occur: dizziness or lightheadedness. This is due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, you can also contact your pharmacist or the Toxicology Information Service. Phone: 91 562 04 20, indicating the medicine or the amount taken.

If you forget to take Acetensil

• 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 make up for missed doses.

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 Acetensil and talk to your doctor immediately:

• swelling of the face, lips, tongue, or throat that may 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 Acetensil and talk to your doctor immediately.

When you start taking this medicine, you may feel loss of consciousness or dizziness. If this occurs, lying down may 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 chest tightness;
• headache, depression, fainting (syncope), taste disorder;
• difficulty breathing;
• diarrhea, abdominal pain;
• fatigue;
• 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 (both usually detected in a blood test).

Uncommon(may affect up to 1 in 100 people)

• flushing;
• sudden drop in blood pressure;
• rapid and irregular heartbeats (palpitations);
• heart attack (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 itching or numbness in the skin;
• vertigo (feeling of dizziness);
• ringing in the ears (tinnitus);
• runny nose, sore throat, or hoarseness;
• chest tightness-associated asthma;
• 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;
• general discomfort (malaise), elevated temperature (fever);
• impotence;
• high levels of protein in the urine (determined in a 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 may 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;
• bone marrow depression;
• inflamed glands in the neck, armpits, or groin;
• autoimmune diseases;
• sleep disturbances or sleep problems;
• 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;
• target-shaped rash (erythema multiforme);
• "Stevens-Johnson syndrome" and "toxic epidermal necrolysis" (a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling), pemphigus (small fluid-filled blisters on the skin);
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzyme or bilirubin levels (determined in a test);
• breast enlargement 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 symptom complex has been reported that may include all or some of the following symptoms: 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 Acetensil

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. 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 ofAcetensil

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other ingredients (excipients) are pregelatinized cornstarch, microcrystalline cellulose, anhydrous colloidal silica (E551), sodium hydrogen carbonate, and magnesium stearate.

Appearance of the Product and Package Contents

Acetensil is presented in tablet form. Each package contains 28 tablets.

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 – Torrejón de Ardoz (Madrid)

Spain

Manufacturer

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Date of Last Revision of this Prospectus:11/2023.

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.