Acetensil Plus 20 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetensil Plus 20 mg/12.5 mg tablets EFG

enalapril maleate/hydrochlorothiazide

Read all of this 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 you should not give it to other people, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet

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

1. What Acetensil Plus is and what it is used for

This medicine contains two active substances, enalapril and hydrochlorothiazide, which belong to the antihypertensive group and reduce elevated blood pressure through different mechanisms.

The enalapril component of Acetensil Plus is a medicine that belongs to a class of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which works by dilating blood vessels to allow the heart to pump blood more easily to all parts of the body. The hydrochlorothiazide component of Acetensil Plus belongs to a group of medicines known as thiazide diuretics (medicines that increase urine elimination). Together, enalapril and hydrochlorothiazide help lower high blood pressure.

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

2. What you need to know before taking Acetensil Plus

Do not take Acetensil Plus

• If you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure about what sulfonamide-derived medicines are.
• If you have previously been treated with a medicine from the same group as Acetensil Plus (ACE inhibitors), and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing.
• If you have had such allergic reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema (an immune system disorder causing swelling in the face and airways, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you suffer from anuria (you do not urinate).
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. (Acetensil Plus should also be avoided in early pregnancy – see section “Pregnancy”).
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, for example in the throat) is high.

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

Warnings and precautions

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

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

• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking Acetensil Plus, seek medical attention immediately.

• If you have a heart condition involving narrowing of heart valves (mitral or aortic valve stenosis) or other factors that reduce blood flow from the left chamber of the heart (obstructive hypertrophic cardiomyopathy).

• If you have conditions that reduce fluid volume or sodium levels in the body (e.g., severe vomiting, diarrhea, or if you are on high doses of medicines that increase urine output).

• If you have blood disorders.

• If you have diabetes and are taking medicines for diabetes, including insulin, as dosage adjustments of your diabetes medicines may be needed. Diabetes can cause high blood potassium levels, which may be serious.

• If you have liver problems.

• If you have kidney problems (including kidney transplant), as these may lead to high blood potassium levels that could be serious.

• If you are undergoing dialysis.

• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines (medicines that increase potassium levels), potassium-containing salt substitutes, or other medicines that may increase blood potassium, such as heparin (a medicine used to prevent blood clots), trimethoprim, or cotrimoxazole (also known as trimethoprim/sulfamethoxazole, used to treat infections).

• If you develop an allergic reaction during treatment, with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing. Note that black patients may be more sensitive to this type of medicine.

• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis, used to remove LDL particles or "bad cholesterol" from the blood when levels are excessively high).

• If you are scheduled to undergo desensitization treatment to reduce the effects of an allergy to bee or wasp stings.

• If you have low blood pressure, as use of Acetensil Plus, especially with the first doses, may cause a sudden drop in blood pressure (you may experience fainting or dizziness, particularly when standing up).

• Consult your doctor before starting Acetensil Plus if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Acetensil Plus.

• If you are taking any of the following medicines, your 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.

• Inform your doctor if you are taking any of the following medicines used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes,

• Aliskiren.

• Inform your doctor if you experience vision changes or eye pain, as these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking Acetensil Plus. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamide.

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

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

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

Inform your doctor if you think you are pregnant (or could be). Acetensil Plus is not recommended in early pregnancy and must not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this stage (see section “Pregnancy”).

Children and adolescents

The safety and efficacy of Acetensil Plus have not been established in this population group, and therefore its use is not recommended in children.

Use in elderly patients

In studies combining enalapril and hydrochlorothiazide, the effect and tolerability of the medicines were similar in younger and elderly adult patients with high blood pressure.

Other medicines and Acetensil Plus

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust your dose and/or take other precautions.

It is especially important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Acetensil Plus” and “Warnings and precautions”).
• Antihypertensive medicines (lower high blood pressure), such as vasodilators, beta-blockers, diuretics.
• Potassium supplements (including dietary salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (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 the information in the section "Warnings and precautions".
• Medicines used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioids (medicines used to treat severe pain).
• Medicines used to treat diabetes, such as insulin or oral antidiabetics (e.g., metformin).
• Medicines used to treat pain or certain inflammations, such as non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, and selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (used to treat certain heart and blood vessel disorders and some cold remedies).
• Pressor amines, such as noradrenaline.
• Muscle relaxants such as tubocurarine.
• Thrombolytic medicines (which prevent blood clot formation).
• Calcium salts and vitamin D.
• Ion-exchange resins (medicines used to lower blood cholesterol), such as cholestyramine and colestipol.
• Antiarrhythmics (used for prevention and control of heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medicines (which slow gastric emptying), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medicines for gout treatment, such as probenecid, sulfinpyrazone, and allopurinol.
• Antivirals (used to treat viral infections), such as amantadine.
• Cytotoxic medicines (used in cancer treatment), such as cyclophosphamide and methotrexate.
• Immunosuppressants (used to prevent transplant rejection), such as cyclosporine.
• Antibiotics (used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).
• Concomitant use of mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) may increase the risk of an allergic reaction called angioedema.
• A medicine containing 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 information in 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 enhance the blood pressure-lowering (hypotensive) effect of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. 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 recommend an alternative medicine. Acetensil Plus is not recommended during 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 onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Acetensil Plus is not recommended for breastfeeding mothers.

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

Driving and using machines

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

Acetensil Plus contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him/her before taking this medicine.

Acetensil Plus contains sodium

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

Use in athletes

This medicine contains hydrochlorothiazide, which may lead to a positive result in doping control tests.

Interference with diagnostic tests

If you are scheduled for any diagnostic test to assess parathyroid gland function, inform your doctor that you are being treated with Acetensil Plus, as it may alter test results.

3. How to take Acetensil Plus

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

Remember to take your medicine.

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

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

The initial dose may cause a greater drop in blood pressure than that seen during continued treatment. You may feel faint or dizzy, and lying down could help. If you are concerned, consult your doctor.

Use in patients with impaired kidney function:

If you have any kidney disease, your doctor will advise you on the most appropriate dose.

Method of administration

This medicine is administered orally.

Take the tablets with a glass of water.

Acetensil Plus may 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine pack and leaflet to the healthcare professional.

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

If you forget to take Acetensil Plus

You should take Acetensil Plus as directed by your doctor. Do not take a double dose to make up for forgotten doses. Simply take the next dose as usual.

If you stop taking Acetensil Plus

Your doctor will tell you how long you should take Acetensil Plus. Do not stop treatment early, even if you feel better.

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

4. Possible adverse effects

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

The adverse effects reported are listed below according to the following frequency categories:

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

Common: (occurs in at least 1 in every 100 but less than 1 in 10 treated patients)

Uncommon: (occurs in at least 1 in every 1,000 but less than 1 in 100 treated patients)

Rare: (occurs in at least 1 in every 10,000 but less than 1 in 1,000 treated patients)

Very rare: (occurs in less than 1 in 10,000 treated patients)

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

Benign, malignant 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 (blood cells that carry oxygen)

Rare: reduction in a type of white blood cells (neutrophils), decrease in hemoglobin (the oxygen-carrying protein in red blood cells), decrease in platelet count, decrease in hematocrit (proportion of red blood cells in the blood), decrease in white blood cell count, bone marrow depression (reduced ability of the body to produce blood cells), lymph node inflammation, immune system disorders.

Endocrine disorders:

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

Metabolism and nutrition disorders:

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

Uncommon: low blood glucose and magnesium levels, gout

Rare: increased blood glucose

Very rare: elevated calcium levels in blood

Nervous system disorders:

Common: headache, syncope, taste disturbance

Uncommon: confusion, drowsiness, insomnia, tingling sensation, dizziness

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 not known: decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)].

Ear and labyrinth disorders:

Uncommon: tinnitus (ringing in the ears)

Cardiac and vascular disorders:

Very common: dizziness

Common: low blood pressure associated with fainting, cardiac rhythm disorders, angina pectoris, tachycardia (rapid heartbeat)

Uncommon: flushing, palpitations (rapid or irregular heartbeat sensation), myocardial infarction or stroke, possibly secondary to excessive drop in blood pressure in high-risk patients (see section “Warnings and precautions”)

Rare: changes in skin coloration of fingers, toes, nose or ears (Raynaud's phenomenon)

Respiratory, thoracic and mediastinal disorders:

Very common: cough

Common: difficulty breathing

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

Rare: pulmonary infiltrates, respiratory discomfort (including pneumonia and pulmonary edema), inflammation of nasal mucosa, allergic alveolitis/eosinophilic pneumonia (a condition in which a type of white blood cells called eosinophils accumulate in the lungs)

Very rare: acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion)

Gastrointestinal disorders:

Very common: nausea

Common: diarrhea, abdominal pain

Uncommon: intestinal obstruction with severe 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 failure, hepatic necrosis (which may be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes (jaundice), gallbladder inflammation (particularly in patients with pre-existing gallstones)

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)

Hypersensitivity/angioedema: swelling of the face, limbs, lips, tongue, glottis and/or larynx

Uncommon: excessive sweating, itching, urticaria, hair loss

Rare: skin redness, severe blistering or bleeding in the skin (Stevens-Johnson syndrome), severe skin redness/rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin disorders, skin redness, blister formation on the skin

A symptomatic complex has been observed that may include one or more of the following symptoms: fever, serositis, vasculitis, muscle inflammation/pain, joint inflammation/pain, positive antinuclear antibody test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. Skin rash, photosensitivity, or other skin manifestations may also occur.

Musculoskeletal, connective tissue and bone disorders:

Common: muscle cramps †

Uncommon: joint pain *

Renal and urinary disorders:

Uncommon: renal dysfunction (impaired kidney function), renal failure, presence of protein in urine

Rare: reduced urine output, inflammation of kidney cells

Reproductive system and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men

General disorders and administration site conditions:

Very common: fatigue

Common: chest pain, tiredness

Uncommon: malaise, fever

Investigations:

Common: elevated potassium levels in blood, increased serum creatinine

Uncommon: increased blood urea, low blood sodium levels

Rare: increased liver enzymes, increased serum bilirubin

• Observed only with hydrochlorothiazide doses of 12.5 mg and 25 mg, as contained in Acetensil Plus.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Plus

Keep out of the sight and reach of children.

Do not store above 25°C.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetensil Plus

• The active substances 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 monohydrate lactose, sodium hydrogen carbonate (E-500), corn starch, pregelatinized corn starch, magnesium stearate (E-572), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

It is presented in packs of 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.

Solana, 26

28850 – Torrejón de Ardoz (Madrid)

Spain

Date of the most recent revision of this leaflet: 12/2023

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