HYDROCHLOROTHIAZIDE STADA 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Hydrochlorothiazide Stada 50 mg Tablets EFG

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

• Keep this 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 signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Hydrochlorothiazide Stada is a medicine that contains hydrochlorothiazide as the active substance. Hydrochlorothiazide is a diuretic (a medicine that increases urine production) that belongs to the group of thiazides. Hydrochlorothiazide increases the amount of urine (diuretic) helping to reduce blood pressure (antihypertensive).

This medicine 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 failure; premenstrual and idiopathic edema (of unknown cause)
• renal diabetes insipidus (a disorder in which a defect in the small tubes (tubules) of the kidneys makes a person produce a large amount of urine) when treatment with antidiuretic hormone is not indicated

• idiopathic hypercalciuria (high levels of calcium in the urine) as preventive treatment for urinary calcium stones.

2. What you need to know before you take Hydrochlorothiazide Stada

Do not take Hydrochlorothiazide Stada

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

Warnings and precautions

Consult your doctor or pharmacist before taking Hydrochlorothiazide Stada.

Be particularly careful with hydrochlorothiazide if you have any of the following diseases:

• 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 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 few weeks after taking hydrochlorothiazide. This can lead to permanent vision loss if left untreated. You may be more likely to develop this if you have previously had an allergy to penicillin or sulfonamides
• if you have vision problems or eye pain (such as transient 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. 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 exposure while taking hydrochlorothiazide
• if you have had respiratory or lung 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 Hydrochlorothiazide Stada 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:

• muscle relaxants (such as baclofen, tubocurarine),
• other antihypertensives,
• cholestyramine and colestipol resins (used to reduce cholesterol levels),
• vasopressors (such as adrenaline),
• amphotericin B (intravenous antibiotic), carbenoxolone (used to treat mouth ulcers), corticosteroids, hormones (such as corticotropin, adrenaline), stimulant laxatives (help with bowel evacuation),
• lithium (antidepressant),
• calcium salts,
• digitalis (digoxin),
• antiarrhythmic drugs (such as sotalol, amiodarone) or 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,
• cyclosporin (medicine used in transplant patients),
• medicines used to decrease potassium levels,
• amantadine (antiviral medicine),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• medicines used to treat diabetes,
• anti-inflammatory medicines (salicylate derivatives, indomethacin)
• alcohol, sleep-inducing drugs (such as barbiturics or narcotics).

Hydrochlorothiazide may interfere with the results of some tests, such as: bentiramida test (gastric test), parathyroid function test, decrease iodine-bound protein levels, modify blood and urine test results.

Taking Hydrochlorothiazide Stada 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.

You should inform your doctor if you are pregnant or suspect you are pregnant. Your doctor will usually advise you to take a different medicine instead of Hydrochlorothiazide 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 its use is not recommended in breastfeeding mothers.

Driving and using machines

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

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Hydrochlorothiazide Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Hydrochlorothiazide Stada

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended doses are:

• Treatment of arterial hypertension (high blood pressure): initially, a dose of 12.5 to 25 mg once a day is recommended, which may be increased 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 swelling 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 (high levels of calcium in the 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 the help of a little water or another non-alcoholic drink. The tablet can be divided into equal doses.

Use in children

The usual doses in children are:

• Treatment of arterial hypertension (high blood pressure): 1 to 2 mg/kg of body weight (which may be increased 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 Hydrochlorothiazide Stada than you should

If you have taken more Hydrochlorothiazide 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 kidney failure may occur.

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

If you forget to take Hydrochlorothiazide Stada

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

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

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, breathing difficulties
• pneumonia, fluid accumulation in the lungs
• decrease in chloride levels in the blood
• inflammation of blood vessels, appearance of blisters on the skin, lupus erythematosus-like reactions
• severe skin reactions (toxic epidermal necrolysis, TEN)
• pancreatitis
• acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (frequency cannot be estimated from the available data)

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

• decrease in vision or eye pain due to increased pressure - possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or angle-closure glaucoma-.

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 reliably.

Unknown frequency: acute kidney failure, renal disorder, aplastic anemia, erythema multiforme, pyrexia, muscle spasms, asthenia, angle-closure glaucoma.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Hydrochlorothiazide Stada

Keep out of the sight and reach of children.

No special storage conditions are required.

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 indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hydrochlorothiazide Stada

• The active substance is hydrochlorothiazide. Each tablet contains 50 mg of hydrochlorothiazide.
• The other ingredients are: lactose monohydrate (32.50 mg), calcium hydrogen phosphate, pregelatinized corn starch, anhydrous colloidal silica, and magnesium stearate (E-470b).

Appearance and packaging

Hydrochlorothiazide Stada tablets are white, round, and scored on both sides. The tablet can be divided into equal doses.

They are available in blister packs containing 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer:

Kern Pharma, S.L.

Polígono Ind. Colón II Venus, 72

08228 Terrassa (Barcelona) Spain

Date of last revision of this leaflet:December 2021

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/