Label: Information for the User

Enalapril/Hidroclorotiazida Tarbis 20 mg/12.5 mg Tablets EFG

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Enalapril/Hidroclorotiazida Tarbis is a medication with two components: enalapril and hidroclorotiazida.

Enalapril belongs to a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by dilating blood vessels, which reduces blood pressure.

Hidroclorotiazida belongs to a group of medications called thiazide diuretics (urine-producing medications).

Together, enalapril and hidroclorotiazida help to lower elevated blood pressure.

Enalapril/Hidroclorotiazida Tarbis is indicated for the treatment of hypertension in patients not adequately controlled with an ACE inhibitor as monotherapy.

Do not take Enalapril/Hidroclorotiazida Tarbis:

• If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure what sulfonamide-derived medications are.
• If you have previously been treated with a medication from the same group as enalapril/hidroclorotiazida (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat, 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 condition of the immune system that causes inflammation in the face and respiratory tracts, 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 medication to lower blood pressure that contains aliskirén.
• If you are more than 3 months pregnant (It is also recommended to avoid Enalapril/Hidroclorotiazida Tarbis at the beginning of pregnancy - see pregnancy section).
• If you have taken or are currently taking sacubitril/valsartán, a medication used to treat a type of 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 taking any of the following medications, the risk of angioedema may increase:
• Racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medication used to treat diabetes.

If you are unsure whether you should start taking Enalapril/Hidroclorotiazida Tarbis, consult your doctor.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Enalapril/Hidroclorotiazida Tarbis.

In the following situations, your doctor may need to adjust your Enalapril/Hidroclorotiazida Tarbis dose or monitor your blood potassium levels:

• If you have a heart disease that involves narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce left heart chamber flow (hypertrophic obstructive cardiomyopathy).
• If you have conditions that reduce fluid volume or sodium levels in the body (e.g., intense vomiting, diarrhea, or if you are taking high doses of medications that increase urine production).
• If you have any blood abnormalities.
• If you have diabetes and are taking medications to treat diabetes, including insulin, as you may need to adjust your diabetes medication dose. Diabetes can cause high potassium levels in the blood that can be severe.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as these can cause high potassium levels in the blood that can be severe.
• If you are undergoing dialysis.
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medications (medications that increase potassium levels), or salt substitutes that contain potassium.
• If you experience an allergic reaction with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing. Note that patients of black race are more sensitive to this type of medication.
• If you are about to undergo a treatment called LDL apheresis (a treatment similar to dialysis, to remove LDL particles or bad cholesterol from the blood in cases where it is excessively elevated).
• If you are about 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/hidroclorotiazida, especially in the first doses, can cause a sudden drop in blood pressure (you may feel dizzy or lightheaded, especially when standing up).
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• • An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
  • Aliskirén

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of hydrochlorothiazide, particularly 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 sun exposure and UV rays while taking Enalapril/Hidroclorotiazida Tarbis.
• If you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Enalapril/Hidroclorotiazida Tarbis.
• 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 Tarbis, seek medical attention immediately.

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Enalapril/Hidroclorotiazida Tarbis”.

Before undergoing surgery or anesthesia (even at the dentist's office), inform your doctor or dentist that you are taking this medication, as there may be a sudden drop in blood pressure associated with anesthesia.

Inform your doctor if you think you may be pregnant (or could be). Enalapril/Hidroclorotiazida Tarbis is not recommended at the beginning of pregnancy and should not be used if you are more than 3 months pregnant, as it may cause severe damage to your baby if used from the third month of pregnancy.

Children

The safety and efficacy of enalapril/hidroclorotiazida have not been established in this population, so it is not recommended for use in children.

Use of Enalapril/Hidroclorotiazida Tarbis with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more of them. Your doctor may need to modify your dose and/or take other precautions.

Particularly, discuss with your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Enalapril/Hidroclorotiazida Tarbis” and “Be careful with Enalapril/Hidroclorotiazida Tarbis”).
• Anti-hypertensive medications (reduce elevated blood pressure), e.g., vasodilators, beta-blockers, diuretics.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to thin the blood to prevent clots).
• Medications used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics
• Opioids (medications used to treat intense pain).
• Medications used to treat diabetes, such as insulin or oral antidiabetic medications (e.g., metformin).
• Medications used to treat pain or certain inflammation, such as nonsteroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, including selective COX-2 inhibitors.
• Sympathomimetic medications (medications used to treat certain heart and blood vessel disorders and some medications for colds).
• Amines, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medications (medications that prevent blood clot formation).
• Calcium salts and vitamin D.
• Ionic exchange resins (medications used to lower cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmic medications (medications used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medications (medications that decrease gastric emptying rate), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medications used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antiviral medications (medications used to treat viral infections), such as amantadine.
• Cytotoxic medications (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medications (used to prevent organ transplant rejection), such as ciclosporin.
• Antibiotics (medications used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).

Taking Enalapril/Hidroclorotiazida Tarbis with food, drinks, and alcohol

Enalapril/Hidroclorotiazida Tarbis can be taken before or after meals.

Alcohol may potentiate the hypotensive effect of enalapril.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Inform your doctor if you think you may be pregnant (or could be). Normally, your doctor will advise you to stop taking Enalapril/Hidroclorotiazida Tarbis before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Enalapril/Hidroclorotiazida Tarbis. Enalapril/Hidroclorotiazida Tarbis is not recommended during pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause severe damage to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Enalapril/Hidroclorotiazida Tarbis is not recommended for mothers who are breastfeeding.

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

Use in the elderly

Studies in which enalapril and hydrochlorothiazide were taken together showed similar effects of the medications and tolerability in young adult patients and elderly patients with high blood pressure.

Use in athletes

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

Driving and operating machinery

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

Enalapril/Hidroclorotiazida Tarbis contains lactose

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

Interference with diagnostic tests

If you need to undergo a diagnostic test to evaluate parathyroid gland function, inform your doctor that you are taking Enalapril/Hidroclorotiazida Tarbis, as it may alter the test results.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Enalapril/Hidroclorotiazida Tarbis are tablets for oral administration.

You can take the tablets with a glass of water; before, during or after meals.

The tablets are scored on one side, which allows you to break them in half. The score is only for breaking the tablet if it is difficult for you to swallow it whole.

Your doctor will decide on the appropriate dose depending on your condition and if you are taking other medications. The usual dose is one tablet once a day. If necessary, your doctor may increase the dose to two tablets administered once a day.

You may experience symptomatic hypotension after the initial dose of enalapril/hidroclorotiazida, which is more likely to occur in patients with volume or salt depletion. If you have taken diuretics before starting treatment, or are following a low-sodium diet, your doctor will discontinue the diuretic 2 or 3 days before starting treatment.

Patients with renal insufficiency or advanced age:Your doctor will indicate the most suitable dose. (See section “Do not take Enalapril/Hidroclorotiazida Tarbis”).

Your doctor will indicate the duration of your treatment with Enalapril/Hidroclorotiazida Tarbis. Do not discontinue treatment before or abruptly, as your condition may recur or you may experience other symptoms.

If you estimate that the action of Enalapril/Hidroclorotiazida Tarbis is too strong or weak, inform your doctor or pharmacist.

If you take more Enalapril/Hidroclorotiazida Tarbis than you should

If you have taken more Enalapril/Hidroclorotiazida Tarbis than you should, consult your doctor, 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 feeling 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 forget to take Enalapril/Hidroclorotiazida Tarbis

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

If you interrupt treatment with Enalapril/Hidroclorotiazida Tarbis

Your doctor will indicate the duration of your treatment with Enalapril/Hidroclorotiazida Tarbis. Do not discontinue treatment before, even if you feel better.

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

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

Side effects have been classified according to the following definitions of frequencies: very common (may affect more than 1 in 10 patients); common (may affect between 1 and 10 in 100 patients); uncommon (may affect between 1 and 10 in 1,000 patients); rare (may affect between 1 and 10 in 10,000 patients); very rare (may affect less than 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

Blood and lymphatic system disorders:

uncommon: decrease in red blood cells (cells that carry oxygen in the blood).

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

Endocrine disorders:

frequency not known: syndrome of inadequate antidiuretic hormone secretion (SIADH).

Metabolism and nutrition disorders:

common: high levels of potassium in the blood, increased cholesterol, increased triglycerides, increased uric acid in the blood uncommon: low levels of glucose and magnesium in the blood, gout.

very rare: high levels of glucose in the blood.

Nervous system disorders:

common: headache, dizziness, altered taste.

uncommon: confusion, drowsiness, insomnia, numbness, vertigo.

very rare: paralysis (due to low levels of potassium).

Psychiatric disorders:

common: depression

uncommon: nervousness, decreased libido*

very rare: abnormal dreams, sleep disorders.

Eye disorders:

very common: blurred vision.

frequency not known: decrease in vision or eye pain due to high 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: low blood pressure associated with fainting, cardiac rhythm disorders, angina pectoris, tachycardia (rapid heartbeats).

uncommon: flushing, palpitations (rapid and irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive decrease in blood pressure in high-risk patients (see sectionBe careful with Enalapril/Hidroclorotiazida Tarbis).

very 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.

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

very rare: acute respiratory distress (symptoms 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)*.

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

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

common: skin rash (exanthema).

hypersensitivity/angioneurotic edema: facial swelling, extremities, lips, tongue, glottis, and/or larynx uncommon: excessive sweating, itching, urticaria, hair loss.

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

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

Musculoskeletal, connective tissue, and bone disorders:

common: muscle cramps †.

uncommon: joint pain *.

Renal and urinary disorders:

uncommon: renal dysfunction (alteration of kidney function), renal insufficiency, presence of proteins in the urine.

very rare: inadequate urine secretion, inflammation of kidney cells.

Reproductive and breast disorders:

uncommon: impotence.

very rare: breast enlargement in men.

General disorders and administration site conditions:

very common: fatigue.

common: chest pain, fatigue.

uncommon: general malaise, fever.

Complementary examinations:

common: high levels of potassium in the blood, increases in serum creatinine.

uncommon: increases in blood urea, low levels of sodium in the blood.

very rare: increases in liver enzymes, increases in serum bilirubin.

Skin cancer and lip cancer (non-melanoma skin cancer):

frequency not known.

* Only observed with doses of 12.5 mg and 25 mg of hydrochlorothiazide, as found in Enalapril/Hidroclorotiazida Tarbis,

† The frequency of muscle spasms as "common" applies to the doses of hydrochlorothiazide of 12.5 mg and 25 mg, as found in Enalapril/Hidroclorotiazida Tarbis, although the frequency of the event is "uncommon", and applies to the dose of 6 mg 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 Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C.

Store in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Enalapril/Hidroclorotiazida Tarbis

The active principles are enalapril in the form of maleate and hidroclorotiazida.

Each tablet contains 20 mg of maleate of enalapril and 12.5 mg of hidroclorotiazida.

The other components (excipients) are: lactose monohydrate, sodium hydrogen carbonate, cornstarch, pregelatinized cornstarch, magnesium stearate, yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Enalapril/Hidroclorotiazida Tarbis is presented in the form of oblong tablets, of ocre color and scored on one face. Each packaging contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona, Spain

Responsible for manufacturing:

Laboratorios Medicamentos Internacionales, S.A.

Solana, 26

28850 Torrejón de Ardoz (Madrid), Spain.

or

FERRER INTERNACIONAL, S.A.

Joan Buscallá, 1-9

08173 Sant Cugat del Valles (Barcelona), Spain

Last review date of this leaflet:December 2021.

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/