HIDROSALURETIL 50 mg TABLETS

Introduction

Leaflet: information for the user

Hydrosaluretil 50 mg tablets EFG

Hydrochlorothiazide

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

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medicine 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Hydrosaluretil 50 mg tablets and what is it used for
2. What you need to know before taking Hydrosaluretil 50 mg tablets
3. How to take Hydrosaluretil 50 mg tablets
4. Possible side effects
5. Storage of Hydrosaluretil 50 mg tablets
6. Package contents and additional information

1. What is Hydrosaluretil 50 mg tablets and what is it used for

Hydrosaluretil 50 mg tablets is a medicine that contains hydrochlorothiazide as the active ingredient. Hydrochlorothiazide is a diuretic (a medicine that increases urine production) that belongs to the thiazide group. Hydrochlorothiazide increases the amount of urine (diuretic) helping to reduce blood pressure (antihypertensive).

This medicine 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 edema (of unknown cause)
• renal diabetes insipidus (a 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
• idiopathic hypercalciuria (high levels of calcium in the urine) as preventive treatment for urinary calcium concretions (kidney stones).

2. Before taking Hydrosaluretil 50 mg tablets

Do not take Hydrosaluretil 50 mg tablets

• If you are allergic to hydrochlorothiazide or any of the other components of Hydrosaluretil 50 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 Hydrosaluretil 50 mg tablets.

Be particularly careful with Hydrosaluretil 50 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, which 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 Hydrosaluretil 50 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, particularly 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 Hydrosaluretil,
• 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 Hydrosaluretil, seek medical attention immediately.

Using Hydrosaluretil 50 mg tablets with other medicines

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

The following medicines may interact with Hydrosaluretil 50 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),
• vasopressor 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 (medicines used in transplant patients),
• medicines used to decrease potassium levels,
• amantadine (antiviral medicine),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• medicines used to treat diabetes,
• anti-inflammatory medicines (salicylate derivatives, indomethacin),
• alcohol, sleep-inducing drugs (such as barbiturates or narcotics).

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

Using Hydrosaluretil 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 usually advise you to take a different medicine instead of Hydrosaluretil 50 mg, as Hydrosaluretil 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 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.

Hydrosaluretil 50 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 Hydrosaluretil 50 mg tablets

Follow the administration instructions of Hydrosaluretil 50 mg tablets exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 may be increased to 50 mg/day in one or two doses.
• Treatment of edema (excess fluid in the tissue under the skin): 25 to 100 mg/day administered in one or two doses.
• Treatment of swelling and weight gain associated with premenstrual syndrome: 25 to 50 mg administered in one or two doses.
• Treatment of renal diabetes insipidus: 50 to 100 mg/day.
• Treatment of hypercalciuria (high levels of calcium in the 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 the help of a little water or another non-alcoholic drink.

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 notch with your index fingers. Do not use sharp objects to break the tablets.

Use in children

The usual doses in children are:

• Treatment of arterial hypertension (high blood pressure): 1 to 2 mg/kg of body weight (which can 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 moreHydrosaluretil50 mg tablets than you should

If you have taken more Hydrosaluretil 50 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 kidney 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 takeHydrosaluretil50 mg tablets

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

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

4. Possible side effects

Like all medicines, Hydrosaluretil 50 mg tablets can cause side effects, although not everyone gets them.

These side effects include:

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

Skin disorders: photosensitivity reactions, urticaria, rash, inflammation of the salivary glands, allergic reactions.

Frequency not known: skin and lip cancer (non-melanoma skin cancer).

Kidney and urinary disorders: kidney inflammation, increased urine production, frequent urination.

Reproductive system and breast disorders: impotence.

Psychiatric disorders: agitation, depression, sleep disorders.

Eye disorders: blurred vision, yellow vision.

Frequency not known: decreased 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].

Vascular disorders: blood vessel inflammation.

Respiratory disorders: pneumonia, fluid accumulation in the lungs, and very rarely: acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

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

Hepatobiliary disorders: yellowing of the skin.

Nervous system disorders: loss of appetite, difficulty moving, dizziness, headache, weakness, restlessness.

Ear disorders: dizziness.

Cardiac disorders: low blood pressure, arrhythmias, allergic inflammation of the heart muscle, blood vessel inflammation.

Musculoskeletal disorders: muscle spasms.

General disorders: fever.

Immune system disorders: allergy.

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

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Hydrosaluretil 50 mg tablets

Keep in the outer packaging to protect from light.

Keep out of the reach and sight of children.

Do not use Hydrosaluretil 50 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. Package contents and additional information

Composition of Hydrosaluretil 50 mg tablets

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

Appearance of the product and package contents

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

The package contents are 20 tablets.

Marketing authorization holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, Planta 10

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: September 2023.

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