Package Leaflet: Information for the User

Hidroclorotiazida Vir 25 mg Tablets EFG

Read 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medication contains hydrochlorothiazide as the active substance.

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

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

• edema due to heart or kidney disease
• hepatic edema, usually in combination with vasodilating diuretics, in adults

arterial hypertension in adults

Do not take Hidroclorotiazida Vir:

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

Warnings and precautions

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

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 levels of calcium in the blood,
• if you have metabolic and endocrine problems,
• 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, it could be a symptom of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or an increase in eye pressure, which can occur within a few hours to a week after taking Hidroclorotiazida Vir. If left untreated, this can lead to permanent vision loss. You may be at higher risk of developing this if you have had an allergy to penicillin or sulfonamides in the past.

• -if you have allergies or asthma.
• -if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The 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 exposure and UV rays while taking Hidroclorotiazida 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 severe shortness of breath or difficulty breathing after taking Hidroclorotiazida Vir, seek medical attention immediately.

Taking Hidroclorotiazida Vir with other medications

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

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

• lithium (antidepressant),
• other antihypertensives,
• muscle relaxants, such as tubocurarine
• medications that may decrease potassium levels in the blood, such as corticosteroids and some laxatives
• antipsychotics, antidepressants, and antiepileptics,
• medications used to treat diabetes,
• digitalis (digoxin),
• anti-inflammatory medications (salicylate derivatives, indomethacin),
• medications used to treat gout, such as allopurinol,
• amantadine (antiviral medication),
• medications used to treat cancer (such as methotrexate, cyclophosphamide),
• anticholinergic agents (such as atropine),
• resins used to lower cholesterol levels (such as cholestyramine, cholestipol),
• vitamin D,
• ciclosporin (medication used in transplant patients),
• calcium salts,
• medications used to treat hypoglycemia (diazoxide),
• metildopa, used to treat hypertension,
• alcohol, sleep-inducing medications (such as barbiturates and narcotics),
• aminergic pressors (such as noradrenaline).

Taking Hidroclorotiazida Vir with food, drinks, and alcohol

When combined with alcohol consumption, this medication may cause dizziness, vertigo, or headache.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 advise you to take another medication instead of Hidroclorotiazida Vir.

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.

Hidroclorotiazida is excreted in breast milk, so it is not recommended for lactating mothers.

Fertility

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

Driving and operating machinery

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

Hidroclorotiazida Vir contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical control test for doping.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual doses are:

• Treatment of high blood pressure (hypertension): initially, a dose of 12.5 to 25 mg once a day is recommended, which can be increased up 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.

Administration Form

The tablets should be taken orally, with or without food.

The tablet can be split into 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 medication and the amount used.

The following signs and symptoms may occur in poisoning caused by an overdose: dizziness, nausea, drowsiness, decreased circulating blood volume (hypovolemia), low blood pressure (hypotension), and electrolyte disturbances associated with abnormal heart rhythm (cardiac arrhythmias) and muscle spasms.

If you forgot to take Hydrochlorothiazide Vir

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Hydrochlorothiazide Vir

Hypertension treatment is long-term, and interrupting this treatment should be discussed with your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

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

• 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),
• Inability to obtain or maintain an erection (impotence).

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

• Decrease in the number of platelets in the blood that may trigger a condition called purpura,
• Increased levels of calcium and sugar in the blood, sugar in urine, worsening of diabetes,
• Headache, dizziness, sleep disturbances, depression, tingling sensation,
• Vision disturbances,
• Skin alterations due to photosensitivity reactions,
• Abdominal pain, constipation, diarrhea,
• Yellow discoloration of the skin,
• Cardiac rhythm disturbances.

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

• Decrease in the number of white blood cells, hemolytic anemia, bone marrow function disorders,
• Allergic reactions, difficulty breathing,
• Decrease in chloride levels in the blood,
• Vascular inflammation, appearance of blisters on the skin, lupus erythematosus-like skin reactions,
• Pancreatitis inflammation.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Frequency «unknown»: Skin and lip cancer (non-melanoma skin cancer).

Post-marketing reaction experiences

The following adverse reactions have been identified through post-marketing experiences. Because these reactions have been voluntarily reported from an uncertain population size, it is not possible to estimate the reliability of their frequency.

Unknown frequency: weakness, frequent infections, and hematomas (aplastic anemia), acute renal failure, renal 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 hemorrhage) 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hydrochlorothiazide Vir

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

Appearance of the product and contents of the packaging

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

Hydrochlorothiazide Vir is packaged in a blister and is available in packaging containing 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing

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 Member States of the European Economic Area (EEA) with the following names:

• Portugal: Hydrochlorothiazide Vir

Last review date of this leaflet:June 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.