Package Insert: Information for the User

ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 20 mg/12.5 mg Tablets EFG

Read this package insert carefully before starting to take this medication

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms, 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.

Contents of the package and additional information

This medicine contains two active principles, enalapril and hidroclorotiazida, which belong to the group of anti-hypertensives and, by different mechanisms, reduce elevated blood pressure.

The enalapril component of ENALAPRIL/HIDROCLOROTIAZIDA ABABOR is a medicine that belongs to a group of medicines 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 hidroclorotiazida component of ENALAPRIL/HIDROCLOROTIAZIDA ABABOR belongs to the group of medicines known as thiazide diuretics (medicines that increase the elimination of urine). Together, enalapril and hidroclorotiazida help to reduce elevated blood pressure.

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

Do not take ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 20 mg/12,5 mg tablets

• If you are allergic to enalapril, to hydrochlorothiazide or to any of the other components of this medicine (listed in section 6)
• If you are allergic to sulfonamide derivatives. Ask your doctor if you are unsure what sulfonamide derivatives are.
• If you have previously been treated with a medicine from the same group of medicines as ENALAPRIL/HIDROCLOROTIAZIDA ABABOR (ACE inhibitors), and have had allergic reactions with swelling of the face, lips, tongue and/or throat with 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 (a disease of the immune system that causes inflammation in the face and airways, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have anuria (do not urinate).
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure lowering medicine that contains aliskiren.
• If you are more than 3 months pregnant (It is also best to avoid ENALAPRIL/HIDROCLOROTIAZIDA ABABOR at the beginning of pregnancy - see Pregnancy section).
• 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.

If you are unsure whether you should start taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ENALAPRIL/HIDROCLOROTIAZIDA ABABOR

In the following situations, your doctor may need to adjust your dose of ENALAPRIL/HIDROCLOROTIAZIDA ABABOR or monitor your potassium level in the blood:

• If you have a heart disease that is associated with narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce the flow of the left heart chamber (hypertrophic obstructive cardiomyopathy).
• If you have conditions that reduce the volume of fluids or the level of sodium in the body (for example: intense vomiting, diarrhea or if you are being treated with high doses of medicines that increase urine production).
• If you have any blood abnormalities.
• If you have diabetes and are taking medicines to treat diabetes, including insulin, as it may be necessary to adjust the dose of the medicines used to treat diabetes. Diabetes can cause high levels of potassium in the blood that can be serious.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as these can cause high levels of potassium in the blood that can be serious.
• If you are undergoing dialysis.
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medicines or salt substitutes that contain potassium or other medicines that may increase potassium levels, such as heparin (a medicine used to prevent blood clots), trimethoprim or cotrimoxazole (medicines used to treat infections).

• (medicines that increase potassium levels) or substitutes for salt that contain potassium or other medicines that may increase potassium levels, such as heparin (a medicine used to prevent blood clots), trimethoprim or cotrimoxazole (medicines used to treat infections).

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• If during treatment you experience an allergic reaction with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing. You should be aware that patients of black race are more sensitive to this type of medicine.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis, to remove from the blood the LDL particles or bad cholesterol in cases where it is excessively elevated).
• If you are about to undergo a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure, as the use of ENALAPRIL/HIDROCLOROTIAZIDA ABABOR, especially in the first doses, can cause a sudden drop in blood pressure (you may notice it as dizziness or dizziness, especially when standing up).

Consult your doctor before starting to take ENALAPRIL/HIDROCLOROTIAZIDA ABABOR if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, especially its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR, go to the doctor immediately.

• If you are taking any of the following medicines, the risk of angioedema may increase (rapid swelling under the skin in areas such as the throat):

• 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 (hypertension):
• • an angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren

• If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within a few hours to a week after taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR.

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

See also the information under the heading “Do not take ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 20 mg/12,5 mg tablets”

Before undergoing surgery or anesthesia (including dental consultation), inform your doctor or dentist that you are taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR, 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 pregnant). Normally, your doctor will advise you to stop taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medicine instead of ENALAPRIL/HIDROCLOROTIAZIDA ABABOR. ENALAPRIL/HIDROCLOROTIAZIDA ABABOR is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious damage to your baby if used from the third month of pregnancy.

Children and adolescents

ENALAPRIL/HIDROCLOROTIAZIDA ABABOR has not been established as safe and effective 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 medicines and tolerability were similar in young adult and elderly patients with high blood pressure

Taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR with other medicines

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

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

• The simultaneous administration of mTOR inhibitors (e.g. temsirolimus, sirolimus, everolimus) could increase the risk of an allergic reaction called angioedema.

Taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 20 mg/12,5 mg tablets with food and drinks

ENALAPRIL/HIDROCLOROTIAZIDA ABABOR can be taken with or without foodThe majority of people take ENALAPRIL/HIDROCLOROTIAZIDA ABABOR with a glass of water.

Alcohol may increase the blood pressure lowering effect of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

If you are pregnant (or in the lactation period, think you may be pregnant or intend to become pregnant, consult your doctor before using this medicine.). Normally, your doctor will advise you to stop taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR before becoming pregnant or as soon as you know you are pregnant and advise you to take a different medicine instead of ENALAPRIL/HIDROCLOROTIAZIDA ABABOR. ENALAPRIL/HIDROCLOROTIAZIDA ABABOR is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious damage to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are in the lactation period or are about to start breastfeeding. ENALAPRIL/HIDROCLOROTIAZIDA ABABOR is not recommended for mothers who are breastfeeding.

The two active ingredients of ENALAPRIL/HIDROCLOROTIAZIDA ABABOR, enalapril and hydrochlorothiazide, pass into breast milk. If you are breastfeeding your baby or plan to do so, consult your doctor

Use in athletes

Inform athletes that this medicine contains a component that may produce a positive result in doping control tests.

Driving and operating machinery

It is unlikely that ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 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 performing these activities.

ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 20 mg/12,5 mg tablets contain lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Interference with diagnostic tests

If you are to undergo any diagnostic test to assess the function of the parathyroid gland, inform your doctor that you are taking ENALAPRIL/HIDROCLOROTIAZIDA ABABOR, as it may alter the results.

Follow exactly the administration instructions for ENALAPRIL/HIDROCLOROTIAZIDA ABABOR indicated by your doctor.

Consult your doctor or pharmacist if you have doubts.

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 normal dose is one or two tablets administered once a day. Take ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 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 what 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 ENALAPRIL/HIDROCLOROTIAZIDA ABABOR tablets with the help of a glass of water.

ENALAPRIL/HIDROCLOROTIAZIDA ABABOR can be taken before or after meals.

If you take more ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 20 mg/12.5 mg than you should

If you have taken more ENALAPRIL/HIDROCLOROTIAZIDA ABABOR than you should, consult your doctor or pharmacist immediately 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 ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 20 mg/12.5 mg

You should take ENALAPRIL/HIDROCLOROTIAZIDA ABABOR as prescribed.

Do not take a double dose to compensate for the missed doses. Limit yourself to taking the next dose in the usual manner.

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If you interrupt the treatment with ENALAPRIL/HIDROCLOROTIAZIDA ABABOR tablets

Your doctor will indicate the duration of your treatment with ENALAPRIL/HIDROCLOROTIAZIDA ABABOR. Do not stop treatment before, even if you feel better.

Do not stop taking your medication unless your doctor tells you to.

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

This medication contains sodium

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

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

The recorded side effects are listed 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, bone marrow depression (decrease in the body's ability to form blood cells), lymph node inflammation, 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 not known: decrease in vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

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 (irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive hypotension in high-risk patients (see Adverse reactions and precautions)

Rare: changes in skin color of fingers, hands, feet, 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 (difficulty breathing) and asthma

Rare: pulmonary infiltrates, respiratory distress (including pneumonia and pulmonary edema), nasal mucosa inflammation, 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 difficulty breathing, 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 mucous membrane of the mouth, 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, gallbladder inflammation (particularly in patients with pre-existing formation of stones in the bile ducts).

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)

Hypersensitivity/angioneurotic edema: facial swelling, extremities, lips, tongue, glottis, and/or larynx

Uncommon: excessive sweating, itching, urticaria, hair loss

Rare: skin redness, severe blistering or hemorrhaging 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 alteration, skin redness, vesicles on the skin, Stevens-Johnson syndrome.

A complex symptom syndrome has been reported that may include any or all of the following symptoms: fever, serositis, vasculitis, muscle and joint inflammation, positive antinuclear antibodies, 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: oliguria, renal cell inflammation.

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.

Investigations:

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.

* Only observed with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in ENALAPRIL/HIDROCLOROTIAZIDA ABABOR

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

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 Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required. Store in the original packaging.

Keep out of the sight and reach of children.

Do not use ENALAPRIL/HIDROCLOROTIAZIDA ABABOR after the expiration date shown 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. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of ENALAPRIL/HIDROCLOROTIAZIDA ABABOR 20 mg/12.5 mg tablets:

− 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, sodium bicarbonate, yellow iron oxide, cornstarch, pregelatinized cornstarch, magnesium stearate.

Appearance of the product and contents of the packaging:

It is presented in packs of 28 tablets, in aluminum-aluminum blisters. The tablets are yellow, round, and scored on one face.

The score serves to break and facilitate swallowing, but not to divide into equal doses.

Holder of the marketing authorization:

ABABOR PHARMACEUTICALS, S.L.,
C/ Chile nº4,Edif 1,Ofic 1,
Las Matas,Las Rozas(28290)Madrid- Spain.

Responsible for manufacturing:

TOLL MANUFACTURING SERVICES, S.L. Aragoneses, 2nd

28108 – Alcobendas (Madrid) 28108 Spain

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INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

Address: Laguna, 66-68-70. Industrial Polygon

Urtinsa II - Alcorcón (Madrid) - 28923 - Spain

Last review date of this leaflet: December 2021

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