Hydrochlorothiazide Vir 25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hydrochlorothiazide Vir 25 mg tablets EFG

Read the entire leaflet carefully before you start taking 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, 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 Hydrochlorothiazide Vir is and what it is used for
2. What you need to know before taking Hydrochlorothiazide Vir
3. How to take Hydrochlorothiazide Vir
4. Possible side effects
5. How to store Hydrochlorothiazide Vir
6. Contents of the pack and other information

1. What Hidroclorotiazida Vir is and what it is used for

This medicine contains hydrochlorothiazide as the active substance.

Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase urine output and help reduce blood pressure.

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

• oedema due to heart or kidney disease
• hepatic oedema, usually in combination with potassium-sparing diuretics, in adults
• arterial hypertension in adults

2. What you need to know before taking Hidroclorotiazida Vir

Do not take Hidroclorotiazida Vir:

• if you are allergic to hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6),
• if you have problems passing urine (anuria),
• if you are pregnant

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Take special care in the following situations:

• 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 vision problems or eye pain (such as acute transient myopia and acute angle-closure glaucoma),
• if you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to one week after taking Hidroclorotiazida Vir. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.
• 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 non-melanoma skin and lip cancers. Protect your skin from exposure to sunlight and UV rays while taking Hidroclorotiazida Vir.
• if you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Hidroclorotiazida Vir, seek medical attention immediately.

Taking Hidroclorotiazida Vir with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may interact with hydrochlorothiazide when used at the same time:

• lithium (antidepressant),
• other antihypertensives,
• muscle relaxants such as tubocurarine,
• medicines that may reduce potassium levels in the blood, such as corticosteroids and some laxatives,
• antipsychotic, antidepressant, and antiepileptic medicines,
• medicines used to treat diabetes,
• digitalis (digoxin),
• anti-inflammatory medicines (salicylic acid derivatives, indomethacin),
• medicines used to treat gout, such as allopurinol,
• amantadine (antiviral medicine),
• medicines used to treat cancer (such as methotrexate, cyclophosphamide),
• anticholinergic agents (such as atropine),
• resins used to lower cholesterol levels (such as cholestyramine, colestipol),
• vitamin D,
• cyclosporine (a medicine used in transplant patients),
• calcium salts,
• medicines used to treat hypoglycemia (diazoxide),
• methyldopa, used to treat hypertension,
• alcohol, sleeping medicines (such as barbiturates and narcotics),
• pressor amines (such as noradrenaline).

Taking Hidroclorotiazida Vir with food, drinks, and alcohol

In combination with alcohol intake, this medicine may cause dizziness, lightheadedness, or headache.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Generally, your doctor will advise you to stop taking Hidroclorotiazida Vir before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine.

Hidroclorotiazida Vir 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.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed.

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

Fertility

There are no human data available. Animal studies do not show effects on fertility.

Driving and using machines

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

Hidroclorotiazida Vir contains lactose

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

Use in athletes

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

3. How to take Hydrochlorothiazide Vir

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual doses are:

• Treatment of hypertension (high blood pressure): initially a dose of 12.5 to 25 mg once daily is recommended; this dose may be increased up to 50 mg/day, given in one or two doses.
• Treatment of edema (excessive fluid retention under the tissues): the dose should not exceed 50 mg/day.

Method of administration

The tablets are taken orally, with or without food.

The tablet may be divided into equal halves.

If you take more Hydrochlorothiazide Vir than you should

If you have taken more Hydrochlorothiazide Vir than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately, telephone: 91 562 04 20, indicating the medicine and the amount taken.

The following signs and symptoms may occur in poisoning due to overdose: dizziness, nausea, sleepiness (somnolence), decreased circulating blood volume (hypovolemia), low blood pressure (hypotension), and electrolyte disturbances associated with irregularities in the normal rhythm of heartbeats (cardiac arrhythmias) and muscle spasms.

If you forget to take Hydrochlorothiazide Vir

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

If you stop taking Hydrochlorothiazide Vir

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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause 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 blood uric acid levels,
• urticaria, skin rash,
• loss of appetite, nausea, vomiting,
• orthostatic hypotension (sudden drop in blood pressure),
• inability to achieve or maintain an erection (impotence).

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

• decrease in the number of platelets in the blood which may trigger a condition 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, diarrhoea,
• yellowing of the skin,
• disturbances in heart rhythm.

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, reactions resembling cutaneous lupus erythematosus,
• 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).

Adverse reactions reported after 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: weakness, frequent infections and bruising (aplastic anaemia), acute kidney failure, kidney disorder, skin rash, blisters on lips, eyes or mouth; skin peeling, fever (possible signs of erythema multiforme), pyrexia, muscle spasms, asthenia, 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].

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 Hydrochlorothiazide Vir

Keep this medicine out of the sight and reach of children.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidroclorotiazida Vir

• The active substance is hydrochlorothiazide. Each tablet contains 25 mg of hydrochlorothiazide.
• The other components (excipients) are monohydrate lactose, maize starch, talc, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

Hidroclorotiazida Vir 25 mg tablets are white, round, flat tablets with a score line.

Hidroclorotiazida Vir is packaged in blisters and available in packs containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

Pharmaceuticals Works Polpharma S.A

19 Pelplinska Street, Starogard, Gdanski, Poland

or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

This product is authorized in other European Economic Area (EEA) Member States under the following names:

• Portugal: Hidroclorotiazida Vir

Date of the most recent revision of this leaflet: June 2024

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