HYDROCHLOROTHIAZIDE VIR 25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Hydrochlorothiazide Vir 25 mg Tablets EFG

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Hydrochlorothiazide Vir and what is it used for
2. What you need to know before taking Hydrochlorothiazide Vir
3. How to take Hydrochlorothiazide Vir
4. Possible side effects
5. Storage of Hydrochlorothiazide Vir
6. Contents of the pack and further information

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

This medicine contains hydrochlorothiazide as the active substance.

Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increases the amount of urine, helping to reduce blood pressure.

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

• edema due to heart or kidney disease
• edema of hepatic origin, usually in combination with potassium-sparing diuretics, in adults

arterial hypertension in adults

2. What you need to know before taking Hydrochlorothiazide Vir

Do not take Hydrochlorothiazide Vir:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Be especially careful in the following situations:

• 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 have vision problems or eye pain (such as transient myopia and acute angle-closure glaucoma,

• 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 Hydrochlorothiazide Vir. If left untreated, this can lead to permanent vision loss. You may be more likely to develop it if you have previously suffered 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV radiation while taking Hydrochlorothiazide Vir.
• 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 Hydrochlorothiazide Vir, seek medical attention immediately.

Taking Hydrochlorothiazide Vir with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 decrease 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,
• cyclosporin (medicine used in transplant patients),
• calcium salts,
• medicines used to treat hypoglycemia (diazoxide),
• methyldopa, used to treat hypertension,
• alcohol, sleep-inducing medicines (such as barbiturates and narcotics),
• pressor amines (such as noradrenaline).

Taking Hydrochlorothiazide Vir with food, drinks, and alcohol

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

Usually, your doctor will advise you to stop taking Hydrochlorothiazide Vir before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Hydrochlorothiazide Vir.

Hydrochlorothiazide 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

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

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

Fertility

No data are available in humans. Animal studies do not show effects on fertility.

Driving and using machines

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

Hydrochlorothiazide Vir contains 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 Hydrochlorothiazide Vir

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 can be increased to 50 mg/day divided into 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 should be taken orally, with or without food.

The tablet can be divided into two equal halves.

If you take more Hydrochlorothiazide Vir than you should

If you have taken more Hydrochlorothiazide Vir than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

The following signs and symptoms may occur in the event of overdose: dizziness, nausea, drowsiness, decreased blood circulation (hypovolemia), low blood pressure (hypotension), and electrolyte disorders associated with 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 a long-term treatment, and stopping this treatment should be consulted with your doctor.

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

4. Possible side effects

Like all medicines, this medicine 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 (inability to obtain or maintain an erection).

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 disorders 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, difficulty breathing,
• decrease in chloride levels in the blood,
• inflammation of blood vessels, appearance of blisters on the skin, lupus-like reactions,
• pancreatitis.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

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

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

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 package leaflet. You can also report side effects directly through the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side 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 which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Hydrochlorothiazide Vir

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

Appearance of the product and packaging

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

Hydrochlorothiazide Vir is packaged in blisters and is 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) countries with the following names:

• Portugal: Hydrochlorothiazide Vir

Date of last revision of this package leaflet:June 2024

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/.