Package Insert: Information for the User

Hidrosaluretil 25 mg EFG Tablets

Hydrochlorothiazide

Read this entire package insert carefully before starting to take this 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 your doctor or pharmacist.
• This medication 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6.Contents of the Package and Additional Information

Hydrochlorothiazide 25 mg tablets is a medicinal product containing hydrochlorothiazide as active ingredient. Hydrochlorothiazide is a diuretic (medication that increases urine elimination) belonging to the thiazide group. Hydrochlorothiazide increases urine production (diuretic) helping to reduce blood pressure (antihypertensive).

This medicinal product is indicated for the treatment of the following diseases:

• arterial hypertension (high blood pressure)
• edema (excessive fluid retention in tissues due to heart, kidney, and liver insufficiency)
• renal diabetes insipidus (disorder in which a defect in the small renal tubules causes a person to eliminate a large amount of urine) when treatment with antidiuretic hormone is not indicated

-prevention of urinary stone formation (stones in the urinary system) in patients with elevated levels of calcium in urine.

Do not take Hidrosaluretil 25 mg tablets

• If you are allergic to hydrochlorothiazide or any of the other components of Hidrosaluretil 25 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 25 mg tablets.

Be especially careful with Hidrosaluretil 25 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 25 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 25 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 25 mg tablets when used at the same time:

• muscle relaxants (such as baclofen, tubocurarine),
• other antihypertensives,
• cholesterol-lowering resins (such as cholestyramine and colestipol),
• vasopressors (such as adrenaline),
• amphotericin B (injectable antibiotic), carbenoxolone (used to treat mouth sores), corticosteroids, hormones (such as corticotropin, adrenaline), laxatives (stimulants that help bowel evacuation),
• 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,
• ciclosporin (medication used in transplant patients),
• medications used to decrease 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 25 mg tablets may interfere with analytical diagnosis in some tests, such as: bentiramide test (gastric test), or parathyroid function test, decrease yodine-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 25 mg, as Hidrosaluretil 25 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 newborn.

Hidrosaluretil 25 mg is excreted in breast 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 25 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 for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Usual doses are:

-Hypertension (high blood pressure) treatment: an initial dose of 12.5 to 25 mg once a day is recommended, which can be increased up to 50 mg/day divided into one or two doses.

- Edema (excessive fluid retention under the tissues) treatment: the dose should not exceed 50 mg/day.

- Prevention of urinary stone formation (stones in the urinary system): the recommended daily dose is 25 to 50 mg.

- Treatment of diabetic nephropathy: initial doses of up to 100 mg/day are used.

Administration Form

The tablets should be taken orally, with or without food.

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

The tablet cannot be divided into equal doses.

If you take more Hidrosaluretil 25 mg tablets than you should

If you have taken more Hidrosaluretil 25 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 forget to take Hidrosaluretil 25 mg tablets

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

If you interrupt treatment with Hidrosaluretil

Hypertension treatment is a long-term treatment, and interrupting this treatment should be consulted with your doctor.

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

Like all medications,Hidrosaluretil25 mg tablets may cause side effects, although not everyone will experience them.

Very common side effects (may affect more than 1 in 10 patients):

- Decreased levels of potassium in the blood, increased levels of lipids in the blood.

Common side effects (may affect up to 1 in 10 patients):

- Decreased levels of sodium and magnesium in the blood, increased levels of uric acid,

- Urticaria, skin rash,

- Decreased appetite, nausea, vomiting,

- Orthostatic hypotension (sudden drop in blood pressure),

- Impotence.

Rare side effects (may affect up to 1 in 1,000 patients):

- Decreased platelet count in the blood that may trigger a condition called purpura,

- Increased levels of calcium and sugar in the blood, sugar in urine, worsening of diabetes,

- Headache, dizziness, sleep disturbances, depression, tingling sensation,

- Vision disturbances,

- Skin alterations due to photosensitivity reactions,

- Abdominal pain, constipation, diarrhea,

- Yellow discoloration of the skin,

- Cardiac rhythm disturbances.

Very rare side effects (may affect up to 1 in 10,000 patients):

- Decreased white blood cell count, hemolytic anemia, bone marrow function disorders,

- Allergic reactions, difficulty breathing,

- Decreased levels of chloride in the blood,

- Inflammation of blood vessels, appearance of blisters on the skin, lupus erythematosus-like skin reactions,

- Pancreatitis inflammation,

- Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency:

• Skin and lip cancer (non-melanoma skin cancer),
• Decreased 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].

Post-marketing adverse reactions

The following adverse reactions have been identified through post-marketing experiences. Because these reactions have been voluntarily reported from an uncertain population, it is not possible to estimate the reliability of their frequency.

Unknown frequency: acute renal failure, renal disorder, aplastic anemia, erythema multiforme, fever, muscle spasms, asthenia, angle-closure glaucoma.

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Store in the outer packaging to protect it from light.

Do not useHidrosaluretil25 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. By doing so, you will help protect the environment.

Composition of Hidrosaluretil 25 mg tablets

• The active ingredient is hydrochlorothiazide. Each tablet contains 25 mg of hydrochlorothiazide.
• The other components are lactose, cornstarch, microcrystalline cellulose, magnesium stearate, and hypromellose.

Appearance of the product and content of the packaging

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

The content of the packaging is 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 review date of this leaflet: November 2023.

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