Leaflet: information for the user

Acetensil Plus20 mg/12,5 mg EFG tablets

enalapril maleate/hydrochlorothiazide

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

This medication contains two active principles, enalapril and hydrochlorothiazide, which belong to the group of antihypertensives and, through different mechanisms, reduce elevated blood pressure.

The enalapril component of Acetensil Plus is a medication that belongs to a group of medications known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which acts by dilating blood vessels to make it easier for the heart to pump blood to all parts of the body. The hydrochlorothiazide component of Acetensil Plus belongs to the group of medications known as thiazide diuretics (medications that increase the elimination of urine). Together, enalapril and hydrochlorothiazide help to reduce elevated blood pressure.

Your doctor has prescribed Acetensil Plus to treat hypertension (high blood pressure) because it is not adequately controlled with enalapril or an ACE inhibitor alone.

Do not take Acetensil Plus

If you are unsure whether you should start taking Acetensil Plus, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acetensil Plus.

In the following situations, your doctor may need to adjust your Acetensil Plus dose or monitor your potassium levels in the blood:

Your doctor may monitor your renal 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 Plus”.

Before undergoing surgery or anesthesia (including dental consultation), inform your doctor or dentist that you are taking Acetensil Plus, as you may experience a sudden drop in blood pressure due to the anesthesia.

You should inform your doctor if you think you may be pregnant (or could be). Acetensil Plus is not recommended at the beginning of pregnancy and should not be used if you are more than 3 months pregnant, as it may cause severe damage to your baby if used during this period (see section “Pregnancy”).

Children and adolescents

The safety and efficacy of Acetensil Plus have not been established in this age group, so it is not recommended for use in children.

Use in the elderly

In studies where enalapril and hydrochlorothiazide were taken together, the effect of the medications and tolerability were similar in young adult and elderly patients with high blood pressure.

Other medications and Acetensil Plus

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. Your doctor may need to adjust your dose and/or take other precautions.

It is especially important to inform your doctor if you are using or have used recently any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Acetensil Plus” and “Warnings and precautions”).
• Antihypertensive medications (reduce elevated blood pressure), e.g., vasodilators, beta-blockers, diuretics.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant 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 used to treat certain mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioids (medications used to treat intense pain).
• Medications used to treat diabetes, such as insulin or oral antidiabetic medications (e.g., metformin).
• Medications used to treat pain or certain inflammation, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, including selective COX-2 inhibitors.
• Sympathomimetic medications (medications used in the treatment of certain heart and blood vessel disorders and some medications for colds).
• Pressor amines, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medications (that prevent blood clot formation).
• Calcium salts and vitamin D.
• Ionic exchange resins (medications used to reduce cholesterol in the blood) such as cholestyramine and colestipol.
• Antiarrhythmic medications (medications used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medications (medications that decrease gastric emptying rate), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medications used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antiviral medications (medications used to treat viral infections), such as amantadine.
• Cytotoxic medications (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medications (used to prevent organ transplant rejection), such as ciclosporin.
• Antibiotics (medications used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).
• The simultaneous administration of mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) may increase the risk of an allergic reaction called angioedema.
• A medication containing an inhibitor of neprilysin, 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, difficulty swallowing or breathing). See also the information in the sections “Do not take Acetensil Plus” and “Warnings and precautions”.

Taking Acetensil Plus with food and drinks

Acetensil Plus can be taken with or without food. Most people take Acetensil Plus with a glass of water.

Alcohol may increase the blood pressure-lowering effect of this medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

If you are pregnant or think you may be pregnant (or could be), consult your doctor before using this medication. Your doctor will usually advise you to stop taking Acetensil Plus before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication. Acetensil Plus is not recommended during pregnancy and should not be used if you are more than 3 months pregnant, as it may cause severe damage to your baby if used during this period (see section “Pregnancy”).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Acetensil Plus is not recommended for mothers who are breastfeeding.

The two active ingredients in Acetensil Plus, enalapril and hydrochlorothiazide, pass into breast milk. If you are breastfeeding your baby or plan to do so, consult your doctor.

Driving and operating machinery

It is unlikely that Acetensil Plus will affect your ability to drive or operate machinery. However, you may occasionally experience dizziness or fatigue during the treatment of high blood pressure, especially at the beginning. If you experience these effects, consult your doctor before engaging in these activities.

Acetensil Plus contains lactose

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

Acetensil Plus contains sodium

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

Use in athletes

This medication contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Interference with diagnostic tests

If you need to undergo any diagnostic test to evaluate parathyroid gland function, inform your doctor that you are taking Acetensil Plus, as it may alter the results.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will decide on the appropriate dose, depending on your condition and whether you are taking other medications.

The recommended dose is one or two tablets taken once a day. Take this medication every day, exactly as indicated by your doctor. It is very important to continue taking this medication for the recommended time by your doctor. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than will occur after continued treatment. You may notice dizziness or fainting and lying down may help. If you are concerned, consult your doctor.

Use in patients with altered kidney function:

If you have any kidney disease, your doctor will indicate the most suitable dose.

Administration Form

This medication is administered orally.

Take the tablets with the help of a glass of water.

Acetensil Plus can be taken before or after meals.

If you take more Acetensil Plus than you should

If you have taken more Acetensil Plus than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare staff.

The most likely symptoms would be a sensation of dizziness or vertigo due to a sudden or excessive drop in blood pressure and/or excessive thirst, disorientation, decreased urine production, and/or tachycardia.

If you forgot to take Acetensil Plus

You should take Acetensil Plus as indicated by your doctor. Do not take a double dose to compensate for the missed doses. Limit yourself to taking the next dose in the usual manner.

If you interrupt treatment with Acetensil Plus

Your doctor will indicate the duration of your treatment with Acetensil Plus. Do not stop treatment before, even if you feel better.

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

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

The recorded side effects are detailed below according to the following frequencies:

Very common: (occur in at least 1 in 10 patients treated)

Common: (occur in at least 1 in 100 and fewer than 1 in 10 patients treated)

Uncommon: (occur in at least 1 in 1,000 and fewer than 1 in 100 patients treated)

Rare: (occur in at least 1 in 10,000 and fewer than 1 in 1,000 patients treated)

Very rare: (occur in fewer than 1 in 10,000 patients treated)

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

Malignant, benign, and unspecified neoplasms (including cysts and polyps)

Frequency not known: skin and lip cancer (non-melanoma skin cancer).

Blood and lymphatic system disorders:

Uncommon: decrease in red blood cells (cells that transport oxygen)

Rare: reduction of a type of white blood cell (neutrophils), decrease in hemoglobin (protein in red blood cells that transports oxygen), decrease in platelets in the blood, decrease in hematocrit (proportion of red blood cells in the blood), decrease in white blood cells, depression of the bone marrow (decrease in the body's ability to form blood cells), inflammation of lymph nodes, immune system diseases.

Endocrine disorders:

Frequency not known: syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Metabolism and nutrition disorders:

Common: elevated potassium levels in the blood, increased cholesterol, increased triglycerides, increased uric acid in the blood

Uncommon: low glucose and magnesium levels in the blood, gout

Rare: increased glucose levels in the blood

Very rare: elevated calcium levels in the blood

Nervous system disorders:

Common: headache, dizziness, altered taste

Uncommon: confusion, drowsiness, insomnia, numbness, vertigo

Rare: paralysis (due to low potassium levels).

Psychiatric disorders:

Common: depression

Uncommon: nervousness, decreased libido*

Rare:abnormal dreams, sleep disorders.

Eye disorders:

Very common: blurred vision.

Frequency unknown: decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage)].

Ear and labyrinth disorders:

Uncommon: ringing in the ears.

Cardiac and vascular disorders:

Very common: dizziness

Common:hypotension associated with fainting, cardiac rhythm disorders, angina pectoris, tachycardia (rapid heartbeats)

Uncommon: flushing, palpitations (sensation of irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive hypotension in high-risk patients (see "Warnings and precautions")

Rare: changes in skin color of fingers, hands, and feet, nose, or ears (Raynaud's phenomenon).

Respiratory, thoracic, and mediastinal disorders:

Very common: cough

Common: shortness of breath

Uncommon: mucus secretion, sore throat, and hoarseness, bronchospasm (difficulty breathing) and asthma

Rare: pulmonary infiltrates, respiratory distress (including pneumonia and pulmonary edema), inflammation of nasal mucosa, allergic alveolitis (inflammation of the alveolar lung by allergy)/eosinophilic pneumonia (disease in which a type of white blood cell, called eosinophils, accumulates in the lungs).

Very rare:acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

Gastrointestinal disorders:

Very common: nausea

Common: diarrhea, abdominal pain

Uncommon: intestinal obstruction with intense pain, pancreatitis, vomiting, digestive discomfort, constipation, loss of appetite, gastric irritation, dry mouth, peptic ulcer, flatulence (gas)*

Rare: infection or inflammation of the oral mucosa, inflammation of the tongue

Very rare: intestinal angioedema (inflammation of the intestinal wall).

Hepatobiliary disorders:

Rare: liver insufficiency, liver necrosis (which can be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes, inflammation of the gallbladder (particularly in patients with pre-existing formation of stones in the bile ducts).

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)

Angioedema/urticaria: facial swelling, extremities, lips, tongue, glottis, and/orlarynx

Uncommon: excessive sweating, itching, urticaria, hair loss

Rare: skin redness, severe blistering or hemorrhaging in the skin (Stevens-Johnson syndrome), severe skin rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin alteration, skin redness, vesicles on the skin.

A complex of symptoms has been observed that may include some of the following symptoms: fever, serositis, vasculitis, muscle and joint inflammation, positive antinuclear antibodies test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. It may also cause skin rash, sensitivity to sunlight, or other skin manifestations.

Musculoskeletal, connective tissue, and bone disorders:

Common: muscle cramps †

Uncommon: joint pain *

Renal and urinary disorders:

Uncommon: renal dysfunction (alteration of kidney function), renal insufficiency, proteinuria

Rare:deficient urine secretion, inflammation of kidney cells.

Reproductive and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men.

General disorders and administration site conditions:

Very common: fatigue

Common: chest pain, fatigue

Uncommon: general malaise, fever.

Complementary examinations:

Common: elevated potassium levels in the blood, increased creatinine levels

Uncommon: increased urea levels in the blood,low sodium levels in the blood

Rare: increased liver enzymes, increased bilirubin levels in the blood.

* Only observed with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in Acetensil Plus.

† The frequency of muscle spasms as "common" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in Acetensil Plus, although the frequency of the event is "uncommon", and applies to the 6 mg dose of hydrochlorothiazide.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not store at a temperature above25°C.

Store in the original packaging.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines that you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of packaging and medicines that you no longer need. This will help protect the environment.

Composition of Acetensil Plus

• The active principles are enalapril in the form of maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.

• The other components are lactose monohydrate, sodium hydrogen carbonate (E-500), cornstarch, pregelatinized cornstarch, magnesium stearate (E-572), and yellow iron oxide (E-172).

Appearance of the product and content of the packaging

It is presented in packs of 28 tablets.

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 – Torrejón de Ardoz (Madrid)

Spain

Responsiblefor manufacturing

Laboratorios Medicamentos Internacionales S.A.

Solana, 26

28850 – Torrejón de Ardoz (Madrid)

Spain

Last review date of this leaflet:12/2023

The 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