Enalapril/hydrochlorothiazide Tarbis 20 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril/Hydrochlorothiazide Tarbis 20 mg/12.5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents:

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

1. What Enalapril/Hydrochlorothiazide Tarbis is and what it is used for

Enalapril/Hydrochlorothiazide Tarbis is a medicine containing two active substances: enalapril and hydrochlorothiazide.

Enalapril belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors. It works by dilating blood vessels, thereby reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (medicines that increase urine production).

Together, enalapril and hydrochlorothiazide help lower high blood pressure.

Enalapril/Hydrochlorothiazide Tarbis is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled with an ACE inhibitor used alone.

2. What you need to know before taking Enalapril/Hydrochlorothiazide Tarbis

Do not take Enalapril/Hydrochlorothiazide Tarbis:

• If you are allergic to the active substances or hypersensitive to enalapril, hydrochlorothiazide, or any of the other components of this medicine (listed in section 6).
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure about what sulfonamide-derived medicines are.
• If you have previously been treated with a medicine from the same class as enalapril/hydrochlorothiazide (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 have anuria (you do not urinate).
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. (Enalapril/Hydrochlorothiazide Tarbis 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 taking any of the following medicines, the risk of developing angioedema may increase:
  • Racecadotril, a medicine used to treat diarrhoea.
  • Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.

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

Warnings and precautions:

Talk to your doctor or pharmacist before starting Enalapril/Hydrochlorothiazide Tarbis.

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

• If you have heart disease involving narrowing of heart valves (mitral or aortic stenosis) or other factors reducing blood flow from the left chamber of the heart (obstructive hypertrophic cardiomyopathy).

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

• If you have blood disorders.

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

• If you have liver problems.

• If you have kidney problems (including kidney transplant), as these may cause high blood potassium levels, which may 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), or salt substitutes containing potassium.

• 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 black patients are more susceptible to this type of reaction.

• If you are about to undergo LDL apheresis (a dialysis-like treatment to remove LDL or "bad" cholesterol particles from the blood when levels are extremely high).

• If you are scheduled for desensitization treatment to reduce the effects of bee or wasp sting allergy.

• If you have low blood pressure, as enalapril/hydrochlorothiazide, especially in the initial doses, may cause a sudden drop in blood pressure (you may experience fainting or dizziness, particularly when standing up).

• 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 have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancers. Protect your skin from sun exposure and UV rays while taking Enalapril/Hydrochlorothiazide Tarbis.

• If you experience vision loss or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to a week after taking Enalapril/Hydrochlorothiazide Tarbis.

• If you have previously had 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 Tarbis, seek medical attention immediately.

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

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

Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking this medicine, as anesthesia may cause a sudden drop in blood pressure.

Inform your doctor if you think you are pregnant (or could be). Enalapril/Hydrochlorothiazide Tarbis 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 at this stage (see pregnancy section).

Children

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

Use of Enalapril/Hydrochlorothiazide Tarbis with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including over-the-counter, homeopathic, herbal medicines, and other health-related products, as treatment interruption or dose adjustment may be necessary. Your doctor may need to adjust your dose and/or take additional precautions.

In particular, talk to your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under “Do not take Enalapril/Hydrochlorothiazide Tarbis” and “Take special care with Enalapril/Hydrochlorothiazide Tarbis”).
• Antihypertensive medicines (lower high blood pressure), e.g., 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 to prevent clots).
• Medicines used to treat certain mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Anaesthetics
• Opioids (medicines used to treat severe pain).
• Medicines used to treat diabetes such as insulin or oral antidiabetics (e.g., metformin).
• Medicines used to treat pain or certain inflammations, such as non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, and selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (used to treat certain heart and blood vessel disorders and some cold remedies).
• Pressor amines, such as noradrenaline.
• Muscle relaxants such as tubocurarine.
• Thrombolytic medicines (prevent blood clot formation).
• Calcium salts and vitamin D.
• 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 speed), such as atropine (used before general anaesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medicines for gout treatment, such as probenecid, sulfinpyrazone, and allopurinol.
• Antivirals (medicines for treating viral infections), such as amantadine.
• Cytotoxic medicines (used in cancer treatment), such as cyclophosphamide and methotrexate.
• Immunosuppressants (used to prevent transplant rejection), such as cyclosporine.
• Antibiotics (medicines for treating certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).

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

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

Alcohol may enhance the hypotensive effect (blood pressure-lowering 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 medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking Enalapril/Hydrochlorothiazide Tarbis before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine. Enalapril/Hydrochlorothiazide Tarbis 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 about to start breastfeeding. Enalapril/Hydrochlorothiazide Tarbis is not recommended for breastfeeding mothers.

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

Use in elderly

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

Use in athletes

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

Driving and using machines

It is unlikely that Enalapril/Hydrochlorothiazide Tarbis 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 engaging in such activities.

Enalapril/Hydrochlorothiazide Tarbis contains lactose

If your doctor has informed you that you have 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 Tarbis, as it may alter test results.

3. How to take Enalapril/Hydrochlorothiazide Tarbis

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

Remember to take your medicine.

Enalapril/Hydrochlorothiazide Tarbis are tablets for oral administration.

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

The tablets are scored on one side, which allows them to be split in half. The score line is provided only to facilitate breaking the tablet if you have difficulty swallowing it whole.

Your doctor will determine the appropriate dose based on your condition and whether you are taking other medications. The usual dose is one tablet once daily. If necessary, your doctor may increase the dose to two tablets taken once daily.

Symptomatic hypotension may occur after the initial dose of enalapril/hydrochlorothiazide, particularly in patients with volume or salt depletion. If you have previously taken diuretics before starting treatment, or follow a low-salt diet, your doctor will discontinue the diuretic 2 or 3 days prior to starting treatment.

Patients with renal impairment or elderly patients: Your doctor will advise you on the most appropriate dose. (See section “Do not take Enalapril/Hydrochlorothiazide Tarbis”).

Your doctor will inform you of the duration of your treatment with Enalapril/Hydrochlorothiazide Tarbis. Do not stop treatment prematurely or abruptly, as your condition may return or you may experience additional symptoms.

If you feel that the effect of Enalapril/Hydrochlorothiazide Tarbis is too strong or too weak, inform your doctor or pharmacist.

If you take more Enalapril/Hydrochlorothiazide Tarbis than you should

If you have taken more Enalapril/Hydrochlorothiazide Tarbis than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medication and the amount taken.

It is recommended to bring the medicine 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 Tarbis

You should take Enalapril/Hydrochlorothiazide Tarbis exactly as prescribed by your doctor. Do not take a double dose to make up for a missed dose. Simply take the next dose as usual.

If you stop taking Enalapril/Hydrochlorothiazide Tarbis

Your doctor will advise you on how long you should take Enalapril/Hydrochlorothiazide Tarbis. Do not stop treatment early, even if you feel better.

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

4. Possible adverse effects

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

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

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 the number of platelets 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: elevated potassium levels in blood, increased cholesterol, increased triglycerides, increased blood uric acid.
• Uncommon: low blood glucose and magnesium levels, gout.
• Rare: increased blood glucose.
• Very rare: elevated calcium levels in blood.

Nervous system disorders:

• Common: headache, 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 reduction in blood pressure in high-risk patients (see section Special warnings and precautions for Enalapril/Hydrochlorothiazide Tarbis).
• 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 distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

Gastrointestinal disorders:

• Very common: nausea.
• Common: diarrhea, abdominal pain.
• Uncommon: intestinal obstruction with severe pain, pancreatitis (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 mouth mucosa, inflammation of the tongue.
• Very rare: intestinal angioedema (inflammation of the intestinal wall).

Hepatobiliary disorders:

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

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 of the skin (Stevens-Johnson syndrome), severe skin redness/rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin disorders, skin redness, formation of blisters on the skin, Stevens-Johnson syndrome.

A symptomatic complex has been observed that may include some of the following reactions: fever, serositis, vasculitis, muscle pain or inflammation, joint pain or inflammation, 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.

Additional 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.

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

• Frequency not known.

* Observed only with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in Enalapril/Hydrochlorothiazide Tarbis.

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enalapril/Hydrochlorothiazide

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

Do not store above 25°C.

Keep in the original packaging.

Do not use this medicine 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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Pack contents and other information

Composition of Enalapril/Hydrochlorothiazide Tarbis

The active substances are enalapril in the form of maleate and hydrochlorothiazide.

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

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

Appearance of the product and pack contents

Enalapril/Hydrochlorothiazide Tarbis is presented as oval-shaped, ochre-coloured tablets, scored on one side. Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona, Spain

Manufacturer:

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 Vallès (Barcelona), Spain

Date of the most recent review of this leaflet: December 2021.

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