Hidrosaluretil 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hidrosaluretil 50 mg tablets EFG

Hydrochlorothiazide

Read the entire 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.

Leaflet contents

1. What Hidrosaluretil 50 mg tablets are and what they are used for
2. What you need to know before taking Hidrosaluretil 50 mg tablets
3. How to take Hidrosaluretil 50 mg tablets
4. Possible side effects
5. How to store Hidrosaluretil 50 mg tablets
6. Contents of the pack and other information

1. What Hidrosaluretil 50 mg tablets are and what they are used for

Hidrosaluretil 50 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 (excess fluid in the tissue beneath the skin) due to cardiac, renal, or hepatic insufficiency; premenstrual and idiopathic edema (of unknown cause)
• renal 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
• idiopathic hypercalciuria (elevated calcium levels in urine), as preventive treatment for urinary calculi (stones in the urinary tract).

2. Before taking Hidrosaluretil 50 mg tablets

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 output).
• 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 50 mg tablets.

Take special care with Hidrosaluretil 50 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 or 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; these may occur within hours to one 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 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 non-melanoma skin and lip 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 inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking Hidrosaluretil, seek medical attention immediately.

Use of Hidrosaluretil 50 mg tablets with other medicines

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

The following medicines may interact with Hidrosaluretil 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),
• 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 intestinal evacuation),
• lithium (antidepressant),
• calcium salts,
• digitalis glycosides (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 for the treatment of diabetes,
• anti-inflammatory medicines (salicylic acid derivatives, indomethacin),
• alcohol, sleep-inducing medicines (such as barbiturates or narcotics).

Hydrochlorothiazide may interfere analytically with certain 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 combined with alcohol intake, 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 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 newborn.

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

Driving and using machines

Hydrochlorothiazide is unlikely to affect your ability to drive or operate machinery.

Hidrosaluretil 50 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 finding in doping control tests.

3. How to take Hidrosaluretil 50 mg tablets

Follow exactly the instructions for use of Hidrosaluretil 50 mg tablets provided 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 daily is recommended, which may be increased up to 50 mg/day in one or two doses.
• Treatment of edema (excess fluid in the tissue beneath 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 nephrogenic diabetes insipidus: 50 to 100 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 may be taken whole, split, or crushed, with 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 score line facing upwards, and press on both sides of the groove with your index fingers. Do not use sharp objects to split the tablets.

Use in children

The usual doses in children are:

• Treatment of arterial hypertension (high blood pressure): 1 to 2 mg/kg body weight (which may be increased up to 3 mg/kg) once daily, administered in one or two doses.
• Treatment of edema (excess fluid in the tissue beneath the skin): 2 mg/kg/day administered in two doses.

If you take more Hidrosaluretil 50 mg tablets than you should

If you have taken more Hidrosaluretil 50 mg tablets 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Hidrosaluretil 50 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 adverse effects

Like all medicines, Hidrosaluretil 50 mg tablets can cause adverse effects, although not everyone will experience them.

These adverse effects include:

Metabolism and nutrition disorders: Loss of appetite, sugar and/or uric acid in urine, increased blood sugar, cholesterol and triglycerides, imbalance of electrolytes (potassium, sodium, chloride and calcium).

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

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

Renal and urinary disorders: Kidney inflammation, increased urine volume, frequent urination.

Reproductive system and breast disorders: Impotence.

Psychiatric disorders: Restlessness, depression, sleep disorders.

Eye disorders: Transient blurred vision, yellow vision of objects.

Frequency not known: 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].

Vascular disorders: Inflammation of blood vessels.

Respiratory disorders: Pneumonia, pulmonary fluid accumulation, and very rare cases: acute breathing difficulty (signs 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.

Hepatic and biliary disorders: Yellowing of the skin.

Nervous system disorders: Loss of appetite, movement difficulties, dizziness, vertigo, headache, weakness, restlessness.

Ear disorders: Vertigo.

Cardiac disorders: Low blood pressure, arrhythmias, allergic inflammation of the heart muscle, inflammation of blood vessels.

Musculoskeletal disorders: Muscle spasms.

General disorders: Fever.

Immune system disorders: Allergic reactions.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Hidrosaluretil 50 mg tablets

Keep in the outer packaging to protect from light.

Keep out of the reach and sight of children.

Do not use Hidrosaluretil 50 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. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidrosaluretil 50 mg tablets

• The active substance is hydrochlorothiazide. Each tablet contains 50 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, scored 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 for production

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

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

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