HIDROSALURETIL 25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Hidrosaluretil 25 mg tablets EFG

Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Hidrosaluretil 25 mg tablets are and what they are used for
2. What you need to know before you take Hidrosaluretil 25 mg tablets
3. How to take Hidrosaluretil 25 mg tablets
4. Possible side effects
5. Storage of Hidrosaluretil 25 mg tablets

1. Contents of the pack and further information

1. What Hidrosaluretil 25 mg tablets are and what they are used for

Hidrosaluretil 25 mg tablets are a medicine that contains hydrochlorothiazide as the active substance. Hydrochlorothiazide is a diuretic (a medicine that increases urine production) that belongs to the group of thiazides. Hydrochlorothiazide increases urine production (diuretic) helping to reduce blood pressure (antihypertensive).

This medicine 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 failure)
• nephrogenic diabetes insipidus (a disorder in which a defect in the small renal tubules makes a person produce a large amount of urine) when treatment with antidiuretic hormone is not indicated

• prevention of the formation of urinary stones (kidney stones) in patients with high levels of calcium in the urine.

2. Before taking Hidrosaluretil 25 mg tablets

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 diseases: anuria (absence of urine production).
• 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 diseases:

• if you have kidney problems,
• if you have liver problems,
• if you have electrolyte imbalance, such as high calcium levels in the blood,
• if you have metabolic and endocrine disorders,
• if you have an autoimmune disease called systemic lupus erythematosus,
• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and 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 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. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV radiation 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 shortness of breath or severe difficulty breathing after taking Hidrosaluretil, seek medical attention immediately.

Using Hidrosaluretil 25 mg tablets with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

The following medicines may interact with Hidrosaluretil 25 mg tablets when used at the same time:

• muscle relaxants (such as baclofen, tubocurarine),
• other antihypertensives,
• cholestyramine and colestipol resins (used to reduce cholesterol levels),
• pressor amines (such as adrenaline),
• amphotericin B (intravenous antibiotic), carbenoxolone (used to treat mouth ulcers), corticosteroids, hormones (such as corticotropin, adrenaline), stimulant laxatives (aiding bowel evacuation),
• lithium (antidepressant),
• calcium salts,
• digitalis (digoxin),
• antiarrhythmic drugs (such as sotalol, amiodarone) or capable of inducing Torsades de Pointes (a type of arrhythmia) such as intravenous erythromycin, mizolastine,
• antipsychotic drugs (such as haloperidol),
• carbamazepine (for epilepsy),
• tetracyclines (antibiotic),
• anticholinergic agents (such as atropine),
• medicines used to treat gout (such as probenecid, allopurinol),
• diazoxide (medicines used to treat hypoglycemia),
• vitamin D,
• cyclosporine (medication used in transplant patients),
• medicines used to decrease potassium levels,
• amantadine (antiviral medication),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• medicines used to treat diabetes,
• anti-inflammatory drugs (salicylic acid derivatives, indomethacin),
• alcohol, sleep-inducing drugs (such as barbiturics or narcotics).

Hydrochlorothiazide may interfere with the analysis of some tests, such as: bentiramida test (gastric test), or parathyroid function test, decrease the levels of protein-bound iodine, modify the results of blood and urine tests.

Using Hidrosaluretil with food and drinks

In combination with alcohol consumption, this medicine may cause dizziness, drowsiness, or headache.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medicine.

You should inform your doctor if you are pregnant or think you may be pregnant. Your doctor will normally advise you to take a different medicine 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.

Hydrochlorothiazide is excreted in human milk, so its use is not recommended in breastfeeding mothers.

Driving and using machines

It is unlikely that hydrochlorothiazide will affect your ability to drive or use machines.

Hidrosaluretil 25 mg tabletscontain lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

3. How to take Hidrosaluretil 25 mg tablets

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

The usual doses are:

• Treatment of arterial hypertension (high blood pressure): initially, a dose of 12.5 to 25 mg once a day is recommended, which can be increased to 50 mg/day divided into one or two doses.
• Treatment of edema (excessive fluid retention in tissues): the dose should not exceed 50 mg/day.
• Prevention of the formation of urinary stones (kidney stones): the recommended daily dose is 25 to 50 mg.
• Treatment of nephrogenic diabetes insipidus: initial doses of up to 100 mg/day are used.

Method of administration

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

The tablets can be taken whole, broken, or crushed, with the help of a little water or another 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, severe hypotension (drastic reduction in blood pressure), unconsciousness, nausea, drowsiness, thirst, muscle pain, difficulty walking, cardiac arrhythmias, reduced heart rate, and renal failure may occur.

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

If you forget to take Hidrosaluretil 25 mg tablets

Do not take a double dose to make up for forgotten doses.

If you stop taking Hidrosaluretil

Treatment of hypertension is long-term treatment, and stopping 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.

4. Possible side effects

Like all medicines, Hidrosaluretil 25 mg tablets can cause side effects, although not everybody gets them.

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

• decrease in potassium levels in the blood, increase in blood lipids.

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

• decrease in sodium and magnesium levels in the blood, increase in uric acid levels,
• 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 people):

• decrease in platelet count in the blood that can trigger a disease called purpura,
• increase in calcium and sugar levels in the blood, sugar in urine, worsening of diabetes,
• headache, dizziness, sleep disturbances, depression, tingling sensation,
• vision disorders,
• skin alterations due to photosensitivity reactions,
• abdominal pain, constipation, diarrhea,
• yellowing of the skin,
• heart rhythm disorders.

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

• decrease in white blood cell count, hemolytic anemia, bone marrow disorders,
• allergic reactions, breathing difficulties,
• decrease in chloride levels in the blood,
• inflammation of blood vessels, appearance of blisters on the skin, lupus erythematosus-like reactions,
• pancreatitis,
• acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known:

• skin and lip cancer (non-melanoma skin cancer),
• decrease in vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Post-marketing experience

The following adverse reactions have been identified during post-marketing experience. Since these reactions have been reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hidrosaluretil 25 mg tablets

Keep out of the sight and reach of children.

Store in the outer packaging to protect from light.

Do not use Hidrosaluretil 25 mg tablets after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Hidrosaluretil 25 mg tablets

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

Appearance and packaging

They are presented in the form of white, round tablets.

The pack contains 20 tablets.

Marketing authorization holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat - Barcelona (Spain)

Manufacturer

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Date of last revision of this leaflet: November 2023.

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