Package Insert: Information for the User

Hidrosaluretil50 mg EFG Tablets

Hydrochlorothiazide

Read this entire package insert carefully before starting totakethis medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
  If you have any questions, consult yourdoctororpharmacist.
• This medication has been prescribed for you only, 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 adverse effects, consult your doctor orpharmacist, even if they are not listed in this package insert.See section 4.

Hydrochlorothiazide 50 mgtabletsis a medication that containshydrochlorothiazideas the active ingredient. Hydrochlorothiazide is a diuretic (a medication that increases urine production)that belongs to the group of thiazides.Hydrochlorothiazide increases urine production (diuretic) and helps to reduce blood pressure (antihypertensive).

This medication is indicated for the treatment of the following diseases:

• arterial hypertension (high blood pressure)
• edema (excess fluid in the tissue under the skin)due to heart, kidney, and liver failure; premenstrual and idiopathic edemas (of unknown cause)
• renal diabetes insipidus(a disorder in which a defect in the small tubes (tubules) of the kidneys causes a person to eliminate a large amount of urine) when treatment with antidiuretic hormone is not indicated
• idiopathic hypercalciuria (elevated levels of calcium in urine)as a preventive treatment for urinary tract stones (kidney stones).

Do not take Hidrosaluretil 50 mg tablets

• If you are allergic to hydrochlorothiazide or any of the other components of Hidrosaluretil 50 mg tablets.
• If you have any of the following conditions: anuria (absence of urine elimination)
• If you are pregnant.
• If you are breastfeeding, as it is excreted in breast milk.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidrosaluretil 50 mg tablets.

Be especially careful with Hidrosaluretil 50 mg tablets if you have any of the following conditions:

• If you have kidney problems,
• If you have liver problems,
• If you have electrolyte imbalances, such as high levels of calcium in the blood,
• If you have metabolic and endocrine disorders,
• If you have a systemic autoimmune disease called systemic lupus erythematosus,
• If you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Hidrosaluretil 50 mg tablets,
• If you have vision problems or eye pain (such as acute transient myopia and acute angle-closure glaucoma,
• If you have allergies or asthma,
• 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 Hidrosaluretil,
• 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 Hidrosaluretil, seek medical attention immediately.

Use of Hidrosaluretil 50 mg tablets with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

The following medications may interact with Hidrosaluretil 50 mg tablets when used at the same time:

• muscle relaxants (such as baclofen, tubocurarine),
• other antihypertensive medications
• cholestyramine and cholestipol resins (used to reduce cholesterol levels),
• pressor amines (such as adrenaline),
• amphotericin B (injectable antibiotic), carbenoxolone (used to treat mouth sores), corticosteroids, hormones (such as corticotropin, adrenaline), laxatives (stimulants that help evacuate the intestine),
• lithium (antidepressant),
• calcium salts,
• digitalis (digoxin),
• antiarrhythmic medications (such as sotalol, amiodarone) or capable of inducing Torsades de Pointes (a type of arrhythmia) such as intravenous erythromycin, mizolastine,
• antipsychotic medications (such as haloperidol),
• carbamazepine (for epilepsy),
• tetracyclines (antibiotic),
• anticholinergic agents (such as atropine),
• medications used to treat gout (such as probenecid, allopurinol),
• diazoxide (medications used to treat hypoglycemia),
• vitamin D,
• cyclosporine (medication used in transplant patients),
• medications used to reduce potassium levels,
• amantadine (antiviral medication),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• medications used to treat diabetes,
• anti-inflammatory medications (salicylate derivatives, indomethacin),
• alcohol, sleep-inducing medications (such as barbiturates or narcotics).

Hidrosaluretil may interfere with analytical interference in the diagnosis of certain tests, such as: bentiramide test (gastric test), or parathyroid function test, decrease yodo-bound protein concentrations, modify blood test results and urine test results.

Use of Hidrosaluretil with food, beverages

In combination with alcohol consumption, this medication may cause dizziness, vertigo, or headache.

Pregnancy and Lactation

Consult your doctor or pharmacist before using any medication.

You should inform your doctor if you are pregnant or suspect you are pregnant..Generally, your doctor will advise you to take another medication instead of Hidrosaluretil 50 mg, as Hidrosaluretil 50 mg is not recommended during pregnancy. This is because hydrochlorothiazide crosses the placenta and its use after the first trimester of pregnancy may cause potentially harmful effects on the fetus and neonate..

Hidrosaluretil is excreted in human milk, so it is not recommended for breastfeeding mothers.

Driving and operating machinery

It is unlikely that hydrochlorothiazide will affect your ability to drive or operate machinery.

Hidrosaluretil 50 mg tabletscontain lactose.

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

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical result for doping control.

Follow exactly the administration instructions forHidrosaluretil50 mg tablets indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual doses are:

• Treatment of high blood pressure (elevated blood pressure): Initially, a dose of12.5 to25 mg once a day, which may be increased to 50 mg/day in one or two doses.
• Treatment of edema (excess fluid in the tissue under the skin):25 to100 mg/day administered in one or two doses.
• Treatment of bloating and weight gain associated with premenstrual syndrome:25 to50 mg administered in one or two doses.
• Treatment of diabetic nephropathy:50 to100 mg/day.
• Treatment of hypercalciuria (elevated calcium levels in urine): 50 mg administered in one or two doses.

The tablets should be taken orally.

The tablets can be taken whole, broken, or crushed, with a little water or other non-alcoholic beverage.

The tablet can be divided into equal doses. To do this, place it on a hard surface, with the break line facing up, and press on both sides of the groove with your index fingers. Do not use sharp objects to break the tablets.

Use in children

The usual doses in children are:

• Treatment of high blood pressure (elevated blood pressure):1 to2 mg/kg of body weight (which may be increased to 3 mg/kg) once a day administered in one or two doses.
• Treatment of edema (excess fluid in the tissue under the skin): 2 mg/kg/day administered in two doses.

If you take moreHidrosaluretil50 mg tablets than you should

If you have taken moreHidrosaluretil50 mg than you should, you may experience severe hypotension (drastic reduction in blood pressure), unconsciousness, nausea, drowsiness, thirst, muscle pain, difficulty walking, cardiac arrhythmias, reduced heart rate, and renal failure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeHidrosaluretil50 mg tablets

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Hidrosaluretil 50 mg tablets may cause side effects, although not everyone will experience them.

These side effects include:

Metabolic and nutritional alterations: loss of appetite, sugar and/or uric acid in urine, increased blood sugar, cholesterol, and triglycerides, electrolyte imbalance (potassium, sodium, chloride, and calcium).

Skin alterations: photosensitivity reactions, urticaria, skin rash, salivary gland inflammation, allergic reactions.

Unknown frequency: skin and lip cancer (non-melanoma skin cancer).

Renal and urinary alterations: kidney inflammation, increased urine output, frequent urination.

Reproductive and mammary gland alterations: impotence.

Psychiatric alterations: agitation, depression, sleep disorders.

Ocular alterations: transient blurred vision, yellow vision of objects.

Unknown frequency: decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

Vascular alterations: blood vessel inflammation.

Respiratory alterations:pneumonia, fluid accumulation in the lung, and very rare frequency: acute respiratory distress (symptoms include severe respiratory difficulty, fever, weakness, and confusion).

Gastrointestinal alterations:pancreatitis, gastric irritation, diarrhea, constipation, loss of appetite, nausea, and vomiting, abdominal pain and cramps.

Hepatic and biliary alterations:yellow skin discoloration.

Nervous system alterations:loss of appetite, movement difficulty, dizziness, vertigo, headache, weakness, restlessness.

Auditory alterations:vertigo.

Cardiac alterations:low blood pressure, arrhythmias, allergic myocarditis, blood vessel inflammation.

Musculoskeletal alterations:muscle spasms.

General alterations:fever.

Immune system alterations:allergy.

Blood alterations:low levels of red blood cells, white blood cells, and platelets in the blood.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Store in the outer packaging to protect it from light.

Keep out of the reach and sight of children.

Do not useHidrosaluretil50 mg tablets after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines 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 medicines you no longer need. In this way, you will help protect the environment.

Composition of Hidrosaluretil 50 mg tablets

• The active ingredient is hydrochlorothiazide. Each tablet contains 50 mg of hydrochlorothiazide.
• The other components are lactose, cornstarch, microcrystalline cellulose, magnesium stearate, and hypromellose.

Appearance of the product and contents of the packaging

It is presented in the form of white, round, and scored tablets.

The contents of the packaging are 20 tablets.

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

Responsible for manufacturing

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Last reviewed date of this leaflet: September 2023.

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