Hidrosaluretil 25 mg tablets EFG

Package leaflet: Information for the user

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, 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 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.

Contents of the leaflet

1. What Hidrosaluretil 25 mg tablets are and what they are used for
2. What you need to know before taking Hidrosaluretil 25 mg tablets
3. How to take Hidrosaluretil 25 mg tablets
4. Possible side effects
5. How to store Hidrosaluretil 25 mg tablets
6. Contents of the pack and other information

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

Hidrosaluretil 25 mg tablets is a medicine containing hydrochlorothiazide as the active substance. Hydrochlorothiazide is a diuretic (a medicine that increases urine elimination) belonging to the thiazide group. Hydrochlorothiazide increases urine output (diuretic effect), helping to reduce blood pressure (antihypertensive effect).

This medicine is indicated for the treatment of the following conditions:

• arterial hypertension (high blood pressure)

• edema (excessive fluid retention in tissues due to cardiac, renal, or hepatic insufficiency)

• nephrogenic diabetes insipidus (a disorder in which a defect in the kidney tubules causes a person to excrete large amounts of urine), when treatment with antidiuretic hormone is not indicated

• prevention of urinary stone formation (stones in the urinary tract) in patients with high levels of calcium in 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 conditions: anuria (absence of urine excretion).
• If you are pregnant.
• If you are breastfeeding, as the drug is excreted in breast milk.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidrosaluretil 25 mg tablets.

Take special care with Hidrosaluretil 25 mg tablets if you suffer from 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 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 eye pressure, and may occur within hours to one 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 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 exposure to sunlight and UV rays while taking Hidrosaluretil,
• if you have previously experienced respiratory or pulmonary 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 Hidrosaluretil, seek medical attention immediately.

Use of Hidrosaluretil 25 mg tablets with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any 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 (injectable antibiotic), carbenoxolone (used to treat mouth ulcers), corticosteroids, hormones (such as corticotropin, adrenaline), stimulant laxatives (which help bowel evacuation),
• lithium (antidepressant),
• calcium salts,
• digitalis (digoxin),
• antiarrhythmic drugs (such as sotalol, amiodarone) or drugs 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 (a medicine used in transplant patients),
• medicines used to reduce potassium levels,
• amantadine (antiviral medicine),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• medicines used to treat diabetes,
• anti-inflammatory medicines (salicylic acid derivatives, indomethacin),
• alcohol, sleep-inducing drugs (such as barbiturates or narcotics).

Hydrochlorothiazide may interfere with laboratory diagnostic tests, such as the bentrimide test (gastric test) or parathyroid function tests, reduce concentrations of protein-bound iodine, and alter results of blood and urine tests.

Use of Hidrosaluretil with food and drinks

When taken together with alcohol, this medicine may cause dizziness, lightheadedness, or headache.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

You must inform your doctor if you are pregnant or suspect you may be pregnant. Generally, your doctor will advise you to take another 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, therefore its use is not recommended in nursing mothers.

Driving and use of machines

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

Hidrosaluretil 25 mg tablets contain lactose.

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Use in athletes

Athletes are advised that this medicine contains a component that may lead to a positive analytical result in doping controls.

3. How to take Hidrosaluretil 25 mg tablets

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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 daily is recommended, which may be increased up to 50 mg/day divided into one or two doses.
• Treatment of edema (excessive fluid retention beneath tissues): the dose should not exceed 50 mg/day.
• Prevention of urinary calculi formation (stones in the urinary tract): 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 may be taken whole, split, or crushed, with a small amount of water or other non-alcoholic drink.

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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

The treatment of hypertension is long-term, and stopping this treatment should be discussed with your doctor.

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

4. Possible adverse effects

Like all medicines, Hidrosaluretil 25 mg tablets may produce adverse effects, although not everyone experiences them.

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

• Decrease in blood potassium levels, increase in blood lipids.

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

• Decrease in blood sodium and magnesium levels, increase in uric acid levels,
• Urticaria, skin rash,
• Loss of appetite, nausea, vomiting,
• Orthostatic hypotension (sudden drop in blood pressure),
• Impotence.

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

• Decrease in the number of platelets in the blood, which may trigger a disease called purpura,
• Increase in blood calcium and blood sugar levels, sugar in urine, worsening of diabetes,
• Headache, dizziness, sleep disturbances, depression, tingling sensation,
• Visual disturbances,
• Skin disorders due to photosensitivity reactions,
• Abdominal pain, constipation, diarrhea,
• Yellowing of the skin,
• Heart rhythm disturbances.

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

• Decrease in the number of white blood cells, haemolytic anaemia, disorders of bone marrow function,
• Allergic-type reactions, difficulty breathing,
• Decrease in blood chloride levels,
• Inflammation of blood vessels, appearance of blisters on the skin, cutaneous lupus erythematosus-like reactions,
• Inflammation of the pancreas,
• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known:

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

Adverse reaction reports following marketing

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

Frequency unknown: acute renal failure, renal disorder, aplastic anaemia, erythema multiforme, pyrexia, 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hidrosaluretil 25 mg tablets

Keep out of sight and reach of children.

Store in the outer packaging to protect from light.

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidrosaluretil 25 mg tablets

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

Appearance of the product and contents of the pack

It is presented as 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 responsible

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Date of the most recent revision of this leaflet: November 2023.

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