Package Insert: Information for the User

Hidroclorotiazida Stada 50 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Hidroclorotiazida Stada is a medication that contains hydrochlorothiazide as the active ingredient. Hydrochlorothiazide is a diuretic (a medication that increases the elimination of urine) that belongs to the group of thiazides. Hydrochlorothiazide increases the amount of urine (diuretic) helping to reduce blood pressure (antihypertensive).

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

• arterial hypertension (high blood pressure)
• edema (excess fluid in the tissue under the skin) due to heart, kidney, and liver insufficiency; premenstrual and idiopathic edemas (of unknown cause)
• renal diabetes insipidus (a disorder in which a defect in the small renal tubules causes a person to eliminate a large amount of urine) when treatment with antidiuretic hormone is not indicated

• idiopathic hypercalciuria (elevated levels of calcium in urine) as a preventive treatment of urinary tract stones (kidney stones).

Do not take Hidroclorotiazida Stada

• If you are allergic to hydrochlorothiazide or any of the other components of this medication (listed in section 6).
• If you have any of the following conditions: anuria (absence of urine elimination).
• If you are pregnant.
• If you are breastfeeding, as it is excreted in breast milk.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidroclorotiazida Stada

Be especially careful with hydrochlorothiazide if you have 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 a systemic autoimmune disease called systemic lupus erythematosus

• If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to several weeks after taking hydrochlorothiazide. This can lead to permanent vision loss if not treated. You may be at higher risk of developing this if you have previously had an allergy to penicillin or sulfonamides
• If you have vision problems or eye pain (such as acute myopia and acute angle-closure glaucoma)
• If you have allergies or asthma
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, especially at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from the sun and UV rays while taking hydrochlorothiazide
• 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 hydrochlorothiazide, seek medical attention immediately

Taking Hidroclorotiazida Stada 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:

• muscle relaxants (such as baclofen, tubocurarine),
• other antihypertensives,
• cholestyramine and cholestipol resins (used to reduce cholesterol levels),
• vasopressors (such as adrenaline),
• amphotericin B (injectable antibiotic), carbenoxolone (used to treat mouth sores), corticosteroids, hormones (such as corticotropin, adrenaline), laxatives (help with bowel evacuation),
• lithium (antidepressant),
• calcium salts,
• digitalis (digoxin),
• antiarrhythmic medications (such as sotalol, amiodarone) or capable of inducing Torsades de Pointes (a type of arrhythmia) such as intravenous erythromycin, mizolastine,
• antipsychotic medications (such as haloperidol),
• carbamazepine (for epilepsy),
• tetracyclines (antibiotic),
• anticholinergic agents (such as atropine),
• medications used to treat gout (such as probenecid, allopurinol),
• diazoxide (medications used to treat hypoglycemia),
• vitamin D,
• ciclosporin (medication used in transplant patients),
• medications used to reduce potassium levels,
• amantadine (antiviral medication),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• medications used to treat diabetes,
• anti-inflammatory medications (salicylate derivatives, indomethacin)
• alcohol, sleep-inducing medications (such as barbiturates or narcotics).

Hydrochlorothiazide may interfere with analytical diagnosis in some tests, such as: bentiramide test (gastric test), or parathyroid function test, decrease yodine-bound protein concentrations, modify blood and urine test results.

Use of Hidroclorotiazida Stada 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 suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

You should inform your doctor if you are pregnant or suspect you may be pregnant. Your doctor will usually advise you to take another medication instead of Hidroclorotiazida Stada, as hydrochlorothiazide 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, so it is not recommended for breastfeeding mothers.

Driving and operating machinery

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

Use in athletes

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

Hidroclorotiazida Stada contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended doses are:

• Treatment of high blood pressure (elevated blood pressure): initially, a dose of 12.5 to 25 mg once a day is recommended, which can be increased up to 50 mg/day in one or two doses.
• Treatment of edema (excess fluid in the tissue under the skin): 25 to 100 mg/day administered in one or two doses.
• Treatment of bloating and weight gain associated with premenstrual syndrome: 25 to 50 mg administered in one or two doses.

• Treatment of renal 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 can be taken whole, broken, or crushed, with a little water or other non-alcoholic beverage. The tablet can be divided into equal doses.

Use in children

The usual doses in children are:

-Treatment of high blood pressure (elevated blood pressure): 1 to 2 mg/kg of body weight (which can be increased up to 3 mg/kg) once a day administered in one or two doses.

• Treatment of edema (excess fluid in the tissue under the skin): 2 mg/kg/day administered in two doses.

If you take more Hidroclorotiazida Stada than you should

If you have taken more Hidroclorotiazida Stada 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 appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Hidroclorotiazida Stada

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

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 people):

• decreased levels of potassium in the blood, increased levels of lipids in the blood

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

• decreased levels of sodium and magnesium in the blood, increased levels of uric acid
• urticaria, skin rash
• decreased appetite, nausea, vomiting
• orthostatic hypotension (sudden drop in blood pressure)
• impotence

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

• decreased platelet count 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 people)

• decreased white blood cell count, hemolytic anemia, bone marrow function disorders
• allergic reactions, difficulty breathing
• pneumonia, fluid accumulation in the lung
• decreased levels of chloride in the blood
• inflammation of blood vessels, appearance of blisters on the skin, lupus erythematosus-like skin reactions
• severe skin reactions (toxic epidermal necrolysis, NET)
• pancreatitis inflammation
• acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency (frequency cannot be estimated from available data)

• skin and lip cancer (non-melanoma skin cancer)

• decreased vision or eye pain due to high pressure - possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or closed-angle glaucoma.

Post-marketing experience of adverse reactions

The following adverse reactions have been identified through post-marketing experience. 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: acute renal failure, renal disorder, aplastic anemia, erythema multiforme, fever, muscle spasms, asthenia, closed-angle 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 out of the sight and reach of children.

No special storage conditions are required.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Hidroclorotiazida Stada

• The active ingredient is hidroclorotiazida. Each tablet contains 50 mg of hidroclorotiazida.
• The other components are: lactose monohydrate (32.50 mg), calcium hydrogen phosphate, pregelatinized cornstarch without gluten, anhydrous colloidal silica, and magnesium stearate (E-470b).

Appearance of the product and content of the packaging

The tablets of Hidroclorotiazida Stada are white, round, and scored on both faces. The tablet can be divided into equal doses.

They are presented in blister packaging that contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing:

Kern Pharma, S.L.

Polígono Ind. Colón II Venus, 72

08228 Terrassa (Barcelona) Spain

Date of the last review of this leaflet:December 2021

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