Package Insert: Information for the User

Acetensil20 mg Tablets EFG

Enalapril Maleate

Read this package insert carefully before starting to take the medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Acetensilcontains an active ingredient called enalapril maleate, which belongs to a group of medications called angiotensin-converting enzyme (ACE) inhibitors.

Acetensilis indicated for:

• treatment of high blood pressure (hypertension)
• treatment of heart failure (weakening of the heart function). It may reduce the need for hospitalization and may help some patients live longerprevention of heart failure symptoms. Symptoms include: difficulty breathing, fatigue after light physical activity such as walking, or swelling of the ankles and feet.

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

Do not takeAcetensil

• if you are allergic to enalapril maleate or any of the other ingredients 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 avoidAcetensilat the beginning of pregnancy–see the 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;

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 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 white blood cell count (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia);
• if you have kidney problems (including kidney transplant), follow a low-sodium diet, are 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 co-trimoxazole (medications used to treat infections). This can cause high levels of potassium in the blood that can be serious. Your doctor may need to adjust your Acetensil dose or monitor your potassium levels in the blood. See also the information under the heading “Other medications and Acetensil”;
• if you have liver problems;
• if you are undergoing dialysis;
• if you have had many vomiting episodes (excessive vomiting) or have had intense diarrhea recently;
• 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 with difficulty swallowing or breathing. You should be aware that patients of black race have a higher risk of suffering 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 called vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking allopurinol or procainamide, or any combination of these;
• 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;
• if you are taking any of the following medications used to treat high blood pressure:
• • an angiotensin II receptor antagonist (ARA) (also known as “sartanes” - for example, valsartan, telmisartan, irbesartan, etc.), particularly if you have kidney problems related to diabetes;
  • Aliskirén.

Your doctor may need to 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 Acetensil”.

You should inform your doctor if you think you may be pregnant (or could be). This medication is not recommendedat the beginning of pregnancyand should not be taken if you are more than 3 months pregnant, as it may causeserious harm to your baby if used in this stage (see the Pregnancy section).

You should be aware that Acetensil reduces blood pressure in black patients less effectively than in patients who are not black.

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

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 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.

Other medications and Acetensil

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

You should 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 Acetensil” 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 co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to prevent blood clots). See also the information in the section “Warnings and precautions”;
• medications for diabetes (including oral antidiabetic medications and insulin);
• litium (a medication used to treat a certain type of depression);
• antidepressant medications called “tricyclic antidepressants”;
• antipsychotic medications;
• certain medications for coughs and colds and weight loss medications that contain a substance called “sympathomimetic”;
• 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 an organ transplant). See also the information in the section “Warnings and precautions”;
• a medication 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”;
• nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medications that reduce inflammation and may be used to help you relieve 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 Acetensil.

Taking Acetensil with food and drinks

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 could be), or intend to become pregnant, consult your doctor before using this medication. Your doctor will usually advise you to stop taking Acetensil before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medication instead of Acetensil. This medication is not recommendedat the beginning of pregnancyand should not be taken if you are more than 3 months pregnant, as it may causeserious harm to your baby if used in this stage (see the Pregnancy section).

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking this medication, it is not recommended to breastfeed 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 Acetensil 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.

Acetensil contains lactose

This medication contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Acetensil contains sodium

This medication contains less than 1 mmolof sodium (23 mg) per tablet; this is, essentially “sodium-free”.

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.
• The groove is only for breaking the tablet if it is difficult for you to swallow it whole.

Hypertension

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

Older patients

Your doctor will decide 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 moreAcetensilthan you should

If you take moreAcetensilthan you should, consult your doctor or go to the hospital immediately. Bring the medication packaging with you. The following effects may occur: dizziness or vertigo. This is due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, you may also consult your pharmacist or the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication or the amount taken.

If you forgot to takeAcetensil

• 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.

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 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 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 previous reactions, stop taking Acetensil 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)

• feeling dizzy, 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 discomfort;
• headache, depression, fainting (syncope), taste disorder;
• difficulty breathing;
• diarrhea, abdominal pain;
• fatigue;
• eruption, 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)

• rubor;
• sudden drop in blood pressure;
• rapid and arrhythmic heartbeats (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);
• 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;
• sensation of itching or numbness in the skin;
• vertigo (dizziness);
• ringing in the ears (tinnitus);
• runny nose, sore throat, or hoarseness;
• asthma-related chest tightness;
• slow movement of food through the 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;
• general feeling of being unwell, elevated temperature (fever);
• impotence;
• elevated protein levels in the 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;
• bone marrow depression;
• inflamed glands in the neck, armpits, or groin;
• autoimmune diseases;
• sleep disturbances or sleep problems;
• fluid accumulation or other substances in the lungs (as seen in X-rays);
• inflamed nose;
• inflamed lungs causing difficulty breathing (pneumonia);
• inflamed cheeks, gums, tongue, lips, throat;
• reduced urine production;
• eruption in the shape of a target (erythema multiforme);
• Stevens-Johnson syndrome and toxic epidermal necrolysis (a severe skin disorder in which you have red, peeling skin, blisters, or open ulcers), dermatitis exfoliativa/erythroderma (severe skin eruption with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin);
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellow skin or eyes), elevated liver enzymes or bilirubin levels (determined in a blood test);
• enlarged breasts in men (gynecomastia).

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

• swelling in the intestine (intestinal angioedema).

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

• excessive production of the antidiuretic hormone, causing fluid retention, leading to weakness, fatigue, or confusion;
• a complex symptom syndrome that may include any or all of the following symptoms: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), 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 Vigilance 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 usethis medicationafter the expiration date that appears on the blister 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 through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofAcetensil

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other components (excipients) are pregelatinized cornstarch, microcrystalline cellulose, silicon dioxide, sodium bicarbonate, and magnesium stearate.

Appearance of the product and content of the packaging

Acetensilis presented in the form of tablets. Each package contains 28 tablets.

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 – Torrejón de Ardoz (Madrid)

Spain

Responsible for manufacturing

Laboratorios Medicamentos Internacionales, S.A.

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Last review date of this leaflet:11/2023.

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.