ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets

Introduction

Package Leaflet: Information for the User

ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets are and what they are used for
2. What you need to know before you take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets
3. How to take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets
4. Possible side effects
5. Storage of ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets

Package contents and additional information

1. What ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets are and what they are used for

This medicine contains two active substances, enalapril and hydrochlorothiazide, which belong to a group of antihypertensive medicines and, through different mechanisms, reduce high blood pressure.

The enalapril component of ENALAPRIL/HYDROCHLOROTHIAZIDE 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 the heart pump blood more easily to all parts of the body. The hydrochlorothiazide component of ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR belongs to a group of medicines known as thiazide diuretics (medicines that increase urine elimination). Together, enalapril and hydrochlorothiazide help to decrease high blood pressure.

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

2. What you need to know before you take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets

Do not take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets

• If you are allergic to enalapril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to sulphonamide-derived substances. Ask your doctor if you are not sure what sulphonamide-derived medicines are.
• If you have been previously treated with a medicine from the same group of medicines as ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR (ACE inhibitors), and you 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 respiratory tract, and abdominal colic).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have anuria (you do not urinate).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you are pregnant for more than 3 months (it is also best to avoid ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR at the beginning of pregnancy - see section Pregnancy).
• If you have taken or are 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 areas such as the throat) is high.

If you are not sure if you should start taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR, consult your doctor.

Warnings and precautions

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

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

• If you have heart disease with narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce left ventricular outflow (hypertrophic cardiomyopathy).
• If you have disorders that reduce fluid volume or sodium levels in the body (e.g., severe vomiting, diarrhea, or if you are being treated with high doses of diuretics).
• If you have any blood disorders.
• If you have diabetes and are taking medicines to treat diabetes, including insulin, as your doctor may need to adjust your dose of diabetes medicines. Diabetes can cause high potassium levels in the blood, which can be serious.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as they can cause high potassium levels in the blood, which can be serious.
• If you are undergoing dialysis.
• If you follow a low-salt diet, take potassium supplements, or take potassium-sparing medicines (medicines that increase potassium levels) or salt substitutes that contain potassium or other medicines that can increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), trimethoprim, or cotrimoxazole (also known as trimethoprim/sulfamethoxazole, medicines used to treat infections).

• If 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 black patients 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 bad cholesterol from the blood in cases where it is excessively high).
• If you are going to undergo 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/HYDROCHLOROTHIAZIDE ABABOR, especially in the first doses, can cause a sudden drop in blood pressure (you may notice it as fainting or dizziness, especially when standing up).

Tell your doctor before starting to take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking ENALAPRIL/HYDROCHLOROTHIAZIDE 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 shortness of breath or severe difficulty breathing after taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR, seek medical attention 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).

• Tell 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 "sartans" - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney problems.
  • Aliskiren

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

Your doctor may need to 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 ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets"

Before undergoing surgery or anesthesia (even at the dentist), inform your doctor or dentist that you are taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR, as you may experience a sudden drop in blood pressure due to anesthesia.

You must inform your doctor if you think you are pregnant (or might be). ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR is not recommended at the beginning of pregnancy and should not be used if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used at this stage (see section Pregnancy).

Children and adolescents

The safety and efficacy of ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR in this population have not been established, so its use is not recommended 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/HYDROCHLOROTHIAZIDE ABABOR with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken 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 the information under the headings "Do not take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets" and "Warnings and precautions").
• Blood pressure-lowering medicines (e.g., vasodilators, beta-blockers, diuretics).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that can increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• 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), such as acetylsalicylic acid, including selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (medicines used to treat certain heart and blood vessel disorders and some cold medicines).
• 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 cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmics (medicines used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medicines (medicines that decrease gastric emptying), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medicines used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antivirals (medicines used to treat viral infections), such as amantadine.
• Cytotoxic medicines (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medicines (used to prevent organ transplant rejection), such as cyclosporin.
• Antibiotics (medicines 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.

Taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets with food and drinks

ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR can be taken with or without food. Most people take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR with a glass of water.

Alcohol can increase the blood pressure-lowering effect of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Pregnancy

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

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR is not recommended in breastfeeding mothers.

The two active substances of ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR, enalapril and hydrochlorothiazide, pass into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor.

Use in athletes

Athletes are informed that this medicine contains a component that can produce a positive result in doping tests.

Driving and using machines

It is unlikely that ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR will affect your ability to drive or use machines. However, you may occasionally experience dizziness or fatigue during treatment for high blood pressure, especially at the beginning. If you notice these effects, you should consult your doctor before performing these activities.

ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets contain lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Interference with diagnostic tests

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

3. How to take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets

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

Consult your doctor or pharmacist if you have any 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/HYDROCHLOROTHIAZIDE ABABOR every day, exactly as indicated by your doctor. It is very important to continue taking this medication for the recommended time. Do not take more tablets than prescribed

The initial dose may cause a greater drop in blood pressure than what will occur after continued treatment. You may experience dizziness or lightheadedness, 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.

Method of administration

This medication is administered orally.

Take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR tablets with the help of a glass of water.

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

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

If you have taken more ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR than you should, consult your doctor or pharmacist immediately or call the Toxicology 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 personnel.

The most likely symptoms would be dizziness or lightheadedness due to a sudden or excessive drop in blood pressure and/or excessive thirst, disorientation, decreased urine production and/or rapid heartbeat

If you forget to take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg

You should take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR as prescribed

Do not take a double dose to make up for forgotten doses. Just take the next dose as usual

.

If you stop treatment with ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR tablets

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

Do not stop taking your medication unless your doctor tells you to do so

If you have any other questions 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"

.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The reported 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 less than 1 in 10 patients treated)

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

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

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

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 (cells that carry oxygen in the blood)

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

Endocrine disorders:

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

Metabolic and nutritional disorders:

Common: high 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 in the blood

Very rare: high calcium levels in the blood

Nervous system disorders:

Common: headache, syncope, altered taste

Uncommon: confusion, somnolence, 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 high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Ear and labyrinth disorders:

Uncommon: ringing in the ears

Cardiac and vascular disorders:

Very common: dizziness

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

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

Rare: changes in skin color of fingers, hands, 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 lung alveoli due to allergy)/eosinophilic pneumonia (disease in which a type of white blood cell, called eosinophils, accumulates in the lungs).

Very rare: Acute respiratory distress (symptoms include severe difficulty breathing, 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: oral mucosa infection or inflammation, tongue inflammation

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

Hepatobiliary disorders:

Rare: liver failure, 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 bile duct stones).

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 and shedding with hair loss, skin peeling, appearance of red spots on the skin, skin alteration, skin redness, blistering on the skin, Stevens-Johnson syndrome.

A symptomatic complex has been reported that may include any or all 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, sun sensitivity, or other skin manifestations may also occur.

Musculoskeletal and connective tissue disorders:

Common: muscle cramps†

Uncommon: joint pain*

Renal and urinary disorders:

Uncommon: renal dysfunction (kidney function alteration), renal failure, proteinuria

Rare: decreased urine production, kidney cell inflammation.

Reproductive system 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: high potassium levels in the blood, increased serum creatinine

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

Rare: increased liver enzymes, increased serum bilirubin.

• This is only observed with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR

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

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets

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

Keep out of sight and reach of children.

Do not use ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR after the expiration date shown on the packaging after Exp:. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

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

• The active ingredients 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 ingredients are lactose, sodium bicarbonate, yellow iron oxide, cornstarch, pregelatinized cornstarch, magnesium stearate.

Appearance of the product and packaging contents:

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

The score line is used to break the tablet and facilitate swallowing, but not to divide into equal doses.

Marketing authorization holder

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

Manufacturer

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

28108 – Alcobendas (Madrid) 28108 Spain

Or

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

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

Urtinsa II - Alcorcón (Madrid) - 28923 - Spain

Date of the last revision of this leaflet: December 2021

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