Enalapril/hydrochlorothiazide Ababor 20 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine

• 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 others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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 taking 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. How to store ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets

Pack 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 the group of antihypertensive drugs and which, through different mechanisms, reduce elevated 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 works by dilating blood vessels to allow the heart to 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 lower high blood pressure.

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

2. What you need to know before taking 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 sulfonamide-derived substances. Ask your doctor if you are unsure what sulfonamide-derived medicines are.
• If you have previously been treated with a medicine from the same group as ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR (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 impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant (ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR should also be avoided in early pregnancy – see Pregnancy section).
• 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 beneath the skin, e.g., in the throat) is high.

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

Warnings and precautions

Consult your doctor or pharmacist before starting 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 a heart condition involving narrowing of heart valves (mitral or aortic valve stenosis) or other factors reducing blood flow from the left chamber of the heart (hypertrophic obstructive 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 diuretic medicines).

• If you have blood disorders.

• If you have diabetes and are taking antidiabetic medicines, including insulin, as your antidiabetic treatment may require dose adjustment. Diabetes may lead to elevated blood potassium levels, which can be serious.

• If you have liver problems.

• If you have kidney problems (including kidney transplant), as these may cause elevated blood potassium levels, which can 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 levels, 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, with difficulty swallowing or breathing. Note that patients of Black race are more susceptible to this type of reaction.

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

• If you are scheduled for desensitization therapy to reduce the effect of an allergy to bee or wasp stings.

• If you have low blood pressure, as taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR, especially with the first doses, may cause a sudden drop in blood pressure (you may feel faint or dizzy, particularly when standing up).

Consult your doctor before starting ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 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 cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR.

• If you have previously experienced respiratory or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR, seek medical attention immediately.

• If you are taking any of the following medicines, your risk of developing angioedema (rapid swelling beneath the skin, e.g., in the throat) 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 for high blood pressure (hypertension):

  • 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

• If you experience vision changes or eye pain, these could 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 ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR.

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

See also information under the heading “Do not take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets”

Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR, 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). ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR is not recommended in early pregnancy and must not be used after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Children and adolescents

The safety and efficacy of ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR have not been established in this population group, and therefore its use is not recommended in children.

Use in the elderly

In studies where enalapril and hydrochlorothiazide were taken together, the effects and tolerability of the medicines were similar in younger and older adult patients with high blood pressure.

Taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR with other medicines

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 to 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 ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets” and “Warnings and precautions”)

• Antihypertensive medicines (lower high blood pressure), such as vasodilators, beta-blockers, diuretics.

• Potassium supplements (including 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 and 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), including acetylsalicylic acid, and selective 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 (prevent blood clot formation).

• Calcium and vitamin D salts.

• Ion-exchange resins (used to lower blood cholesterol), such as cholestyramine and colestipol.

• Antiarrhythmics (used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.

• Anticholinergic medicines (reduce 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 to treat cancer), 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.

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

ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR may be taken with or without food. Most people take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 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 plan to become pregnant, consult your doctor before using this medicine. Your doctor will usually advise you to stop taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR before pregnancy or as soon as you know you are pregnant, and recommend an alternative medicine. ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR is not recommended during pregnancy and must not be taken after 3 months of pregnancy, 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. ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR is not recommended for breastfeeding mothers.

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

Use in athletes

Athletes should be aware that this medicine contains a component that may lead to a positive result in doping control tests.

Driving and using machines

It is unlikely that ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 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.

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

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Interference with diagnostic tests

If you are scheduled for diagnostic tests to assess parathyroid gland function, inform your doctor that you are being treated with ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR, as it may alter test results.

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

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

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

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

The usual dose is one or two tablets taken once daily. Take ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 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 occurs during continued treatment. You may feel faint or dizzy, and lying down may help. If you are concerned, consult your doctor.

Use in patients with impaired kidney function:

If you have any kidney disease, your doctor will determine the most appropriate dose for you.

Method of administration

This medicine is administered orally.

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

ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR may 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, contact your doctor or pharmacist immediately 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’s packaging and leaflet to healthcare personnel.

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

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 missed doses. Simply take the next dose as usual.

If you stop taking ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR tablets

Your doctor will advise you on how long your treatment with ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR should last. Do not stop treatment early, even if you feel better.

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

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

This medicine contains sodium.

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

4. Possible adverse effects

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

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

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

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

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

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

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

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

Benign and malignant 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 (protein in red blood cells that carries oxygen), decrease in platelet count in blood, decrease in hematocrit (proportion of red blood cells in 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: high potassium levels in blood, increased cholesterol, increased triglycerides, increased uric acid in blood.

Uncommon: low blood glucose and magnesium levels, gout

Rare: increased blood glucose

Very rare: high calcium levels in blood

Nervous system disorders:

Common: headache, fainting, 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) 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, 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 color 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 (difficulty breathing) and asthma

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

Very rare: Acute respiratory difficulty (symptoms include severe breathing difficulty, fever, weakness, and confusion)

Gastrointestinal disorders:

Very common: nausea

Common: diarrhea, abdominal pain

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

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

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

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)

Hypersensitivity/angioneurotic edema: 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 rash with loss of skin and hair, skin peeling, appearance of red spots on the skin, skin disorder, skin redness, blister formation on the skin, Stevens-Johnson syndrome.

A symptomatic complex has been reported that may include all or some 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: general malaise, fever

Investigations:

Common: elevated potassium levels in blood, increased serum creatinine

Uncommon: increased blood urea, low sodium levels in blood

Rare: increased liver enzymes, increased serum bilirubin.

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

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

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 through 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 ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR 20 mg/12.5 mg tablets

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

Keep out of the sight and reach of children.

Do not use ENALAPRIL/HYDROCHLOROTHIAZIDE ABABOR after the expiry date stated on the packaging 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. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

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

• The active substances are enalapril (as 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, corn starch, pregelatinized corn starch, magnesium stearate.

Appearance of the medicinal product and contents of the pack:

Presented in packs of 28 tablets, in aluminum-aluminum blisters. The tablets are yellow, round, and scored on one side.

The score line is intended to facilitate breaking and swallowing, but not for dividing the tablet 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 most recent review of this leaflet: December 2021

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