Acetensil 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetensil 20 mg tablets EFG

enalapril maleate

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Acetensil is and what it is used for

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

Acetensil is indicated for:

• treating high blood pressure (hypertension)
• treating heart failure (weakening of the heart's function). It may reduce the need for hospitalization and may help some patients live longer by preventing the signs of heart failure. These signs include: shortness of breath, fatigue after mild physical activity such as walking, and swelling of the ankles and feet.

This medicine works by widening your blood vessels. This lowers your blood pressure. The medicine usually starts to work within one 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 taking Acetensil

Do not take Acetensil

• if you are allergic to enalapril maleate or to 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, known as 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 blood pressure-lowering medicine containing aliskiren;
• if you are more than 3 months pregnant. (It is also advisable to avoid Acetensil in early pregnancy – see Pregnancy section);
• if you are currently taking or have recently taken sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, such as in the throat) is high;

Do not take this medicine if any of the above situations apply to you. If you are unsure, 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 condition;
• if you have a disease affecting the blood vessels in the brain;
• if you have blood disorders such as low levels or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia);
• if you have a kidney problem (including after kidney transplant), are on a salt-free diet, are taking potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), medicines containing trimethoprim or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections). This may lead to high potassium levels in your blood, which can be serious. Your doctor may need to adjust your Acetensil dose or monitor your blood potassium levels. See also information under the heading “Other medicines and Acetensil”;
• if you have liver problems;
• if you are undergoing dialysis;
• if you have recently experienced excessive vomiting or severe diarrhea;
• if you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. Your blood potassium level may also be higher;
• if you have ever had an allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty swallowing or breathing. Please note that patients of black race have a higher risk of such reactions to ACE inhibitors;
• if you have low blood pressure (you may experience fainting or dizziness, especially when standing up);
• if you have a vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis or scleroderma), are being treated with medicines that suppress your immune system, or are taking allopurinol, procainamide, or any combination of these;
• if you are taking any of the following medicines, the risk of developing 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 for high blood pressure:
  • an angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g., valsartan, telmisartan, irbesartan, etc.), particularly if you have kidney problems related to diabetes;
  • aliskiren.

Your doctor may 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 Acetensil”.

You should inform your doctor if you think you are pregnant (or could be). This medicine is not recommended in early 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 during this stage (see Pregnancy section).

Please note that Acetensil is less effective in lowering blood pressure in black patients compared to non-black patients.

If you are unsure whether any of the above situations apply 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 to receive anesthetics (including 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 situations apply to you, consult your doctor or dentist before starting the procedure.

Other medicines and Acetensil

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. This includes herbal remedies. This is because Acetensil may affect how other medicines work. Other medicines may also affect how Acetensil works. Your doctor may need to adjust 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 information under the headings “Do not take Acetensil” and “Warnings and precautions”);
• other blood pressure-lowering medicines such as beta-blockers or diuretics (“water pills”);
• potassium supplements (including dietary salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also 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);
• antidepressant medicines called “tricyclic antidepressants”;
• medicines for mental disorders called “antipsychotics”;
• certain cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic”;
• certain medicines for pain or arthritis, including gold therapy;
• 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 information in the section “Warnings and precautions”;
• a medicine containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), racecadotril, or vildagliptina. This may increase the risk of angioedema (swelling of the face, lips, tongue or throat with difficulty swallowing or breathing). See also information in the sections “Do not take Acetensil” and “Warnings and precautions”;
• non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain);
• aspirin (acetylsalicylic acid);
• medicines 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 drink

Acetensil may be taken with or without food. Most people take Acetensil with a glass of 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 medicine. Your doctor will usually advise you to stop taking Acetensil before becoming pregnant 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 if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

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

Driving and using machines

You may feel dizzy or drowsy while taking this medicine. If this occurs, do not drive or operate tools or machinery.

Acetensil contains sodium

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

3. How to take Acetensil

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• It is very important that you continue taking this medicine for as long as your doctor has prescribed it.
• Do not take more tablets than prescribed.
• The score line is intended only to facilitate splitting the tablet if you have difficulty swallowing it whole.

High blood pressure

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

Heart failure

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

Patients with kidney problems

Your dose will be adjusted 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 non-dialysis days, your dose may be adjusted depending on how low your blood pressure is.

Elderly patients

Your doctor will determine the dose based on how well your kidneys are functioning.

Use in children

Experience with enalapril use 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. 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 adjusted according to the child's needs:

• 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 over 50 kg.

This medicine is not recommended for newborn infants (first weeks after birth) or in children with kidney problems.

If you take more Acetensil than you should

If you take more Acetensil than prescribed, consult your doctor or go to the hospital immediately. Take the medicine packaging with you. The following effects may occur: dizziness or vertigo. These are due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, you may also contact your pharmacist or the Toxicology Information Service. Telephone: 91 562 04 20, stating the name of the medicine and 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 at the usual time.
• Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• swelling of the face, lips, tongue, or throat which may cause difficulty swallowing or breathing;
• swelling of your hands, feet, or ankles;
• if you develop a red rash on the skin with swelling (wheals).

Please note that patients of black race have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking Acetensil and speak to your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this occurs, lying down may help. This is due to a drop in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please speak to your doctor.

Other adverse effects include:

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

• feeling dizzy, weak, or nauseous;
• blurred vision;
• cough.

Common (may affect up to 1 in 10 people)

• dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeat, angina or chest pain;
• headache, depression, fainting (syncope), taste disturbances;
• difficulty breathing;
• diarrhoea, abdominal pain;
• tiredness (fatigue);
• rash, allergic reactions with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing;
• elevated potassium levels in the blood, elevated creatinine levels in the blood (both are usually detected in a blood test).

Uncommon (may affect up to 1 in 100 people)

• flushing;
• sudden drop in blood pressure;
• rapid and irregular heartbeat (palpitations);
• myocardial infarction (possibly due to very low blood pressure in certain 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, drowsiness or inability to sleep, restlessness;
• sensation of itching or numbness in the skin;
• vertigo (sensation of dizziness);
• ringing in the ears (tinnitus);
• runny nose, sore throat, or hoarseness;
• asthma-related chest tightness;
• slow movement of food through the intestine (ileus), inflammation of the pancreas;
• 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;
• elevated protein levels in urine (detected in a test);
• low blood sugar or sodium levels, elevated blood urea levels (all determined by blood tests).

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 reduced blood flow;
• changes in blood values such as reduced number of white or red blood cells, reduced haemoglobin, reduced platelet count;
• bone marrow depression;
• swollen glands in the neck, armpits, or groin;
• autoimmune diseases;
• sleep disturbances or sleep problems;
• accumulation of fluid or other substances in the lungs (as seen on X-rays);
• inflammation of the nose;
• lung inflammation causing difficulty breathing (pneumonitis);
• inflammation of the cheeks, gums, tongue, lips, or throat;
• reduced amount of urine produced;
• target-shaped rash (erythema multiforme);
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a serious skin disorder where you have red, peeling skin, blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin);
• liver or gallbladder problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in a blood test);
• breast enlargement in men (gynaecomastia).

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

• swelling in the intestine (intestinal angioedema).

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

• overproduction of antidiuretic hormone, causing fluid retention, leading to weakness, fatigue, or confusion;
• a symptomatic complex has been reported which may include all or some of the following symptoms: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity, or other skin manifestations may occur.

Reporting of adverse effects: If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetensil

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

Do not use this medicine after the expiry date stated on the blister and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetensil

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

Appearance of the product and contents of the pack

Acetensil is presented as tablets. Each pack 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 the most recent revision of this leaflet: 11/2023.

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