Hydrochlorothiazide Stada 50 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Hydrochlorothiazide Stada 50 mg tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

Hidroclorotiazida Stada is a medicine containing hydrochlorothiazide as the active substance. Hydrochlorothiazide is a diuretic (a medicine that increases urine elimination) belonging to the thiazide group. Hydrochlorothiazide increases the amount of urine produced (diuretic effect), thereby helping to reduce blood pressure (antihypertensive effect).

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

• arterial hypertension (high blood pressure)
• edema (excess fluid in the tissue beneath the skin) due to heart, kidney, or liver failure; premenstrual and idiopathic edema (of unknown cause)
• renal diabetes insipidus (a disorder in which a defect in the small renal tubules causes a person to excrete large amounts of urine), when treatment with antidiuretic hormone is not indicated
• idiopathic hypercalciuria (elevated levels of calcium in urine) for the preventive treatment of urinary calculi (stones in the urinary tract).

2. What you need to know before taking Hidroclorotiazida Stada

Do not take Hidroclorotiazida 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 conditions: anuria (absence of urine excretion).
• If you are pregnant.
• If you are breastfeeding, as the drug is excreted in breast milk.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidroclorotiazida Stada.

Take special care with hydrochlorothiazide if you have any of the following conditions:

• 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 disorders

• if you have an autoimmune disease called systemic lupus erythematosus

• 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 intraocular pressure, which may occur within hours to weeks after taking hydrochlorothiazide. This may lead to permanent vision loss if not treated. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides

• if you develop vision problems or eye pain (such as acute transient myopia or acute angle-closure glaucoma)

• if you have allergies or asthma

• if you have had skin cancer or 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 cancer. Protect your skin from exposure to sunlight and UV rays 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 develop shortness of breath or severe difficulty breathing after taking hydrochlorothiazide, seek medical attention immediately.

Taking Hidroclorotiazida Stada 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:

• muscle relaxants (such as baclofen, tubocurarine),
• other antihypertensives,
• cholestyramine and colestipol resins (used to reduce cholesterol levels),
• pressor amines (such as adrenaline),
• amphotericin B (injectable antibiotic), carbenoxolone (used to treat mouth ulcers), corticosteroids, hormones (such as corticotropin, adrenaline), stimulant laxatives (which help intestinal evacuation),
• lithium (antidepressant),
• calcium salts,
• digitalis agents (digoxin),
• antiarrhythmic drugs (such as sotalol, amiodarone) or drugs 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,
• cyclosporine (a medicine used in transplant patients),
• medicines used to lower potassium levels,
• amantadine (antiviral medicine),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• medicines used to treat diabetes,
• anti-inflammatory medicines (salicylic acid derivatives, indomethacin),
• alcohol, sleep-inducing drugs (such as barbiturates or narcotics).

Hydrochlorothiazide may interfere with laboratory tests, such as the bentiramide test (gastric test), parathyroid function tests, decrease concentrations of protein-bound iodine, and alter results of blood and urine tests.

Use of Hidroclorotiazida Stada 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.

You must inform your doctor if you are pregnant or suspect you are pregnant. Your doctor will generally advise you to take another medicine 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; therefore, its use is not recommended in breastfeeding mothers.

Driving and use of machines

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

Use in athletes

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

Hidroclorotiazida Stada contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Hydrochlorothiazide Stada

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

The recommended 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 in one or two divided doses.

• Treatment of edema (excess fluid in the tissue beneath 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 nephrogenic 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 may be taken whole, split, or crushed, with a small amount of water or another non-alcoholic drink. The tablet may be divided into equal doses.

Use in children

Usual doses in children are:

• Treatment of hypertension (high blood pressure): 1 to 2 mg/kg body weight (which may be increased up to 3 mg/kg) once daily, administered in one or two doses.

• Treatment of edema (excess fluid in the tissue beneath the skin): 2 mg/kg/day administered in two divided 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 renal failure may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common adverse effects (may affect more than 1 in 10 people):

• decrease in blood potassium levels, increase in blood lipids

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

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

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

• decrease in the number of platelets in the blood, which may trigger a disease called purpura
• increase in blood calcium and blood sugar levels, 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
• disturbances in heart rhythm

Rare adverse effects (may affect up to 1 in 10,000 people):

• decrease in the number of white blood cells, haemolytic anaemia, disorders of bone marrow function
• allergic-type reactions, difficulty breathing
• pneumonia, accumulation of fluid in the lung
• decrease in blood chloride levels
• inflammation of blood vessels, appearance of blisters on the skin, cutaneous lupus erythematosus-like reactions
• severe skin reactions (toxic epidermal necrolysis, TEN)
• inflammation of the pancreas
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

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

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

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

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 not known: acute renal failure, renal disorder, aplastic anaemia, erythema multiforme, pyrexia, muscle spasms, asthenia, angle-closure glaucomma.

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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hydrochlorothiazide Stada

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. 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 components are: monohydrate lactose (32.50 mg), calcium hydrogen phosphate, pregelatinized gluten-free corn starch, anhydrous colloidal silica, and magnesium stearate (E-470b).

Appearance of the product and contents of the pack

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

They are presented 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 the most recent review of this leaflet: December 2021

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