Hydrochlorothiazide Kern Pharma 50 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hydrochlorothiazide Kern Pharma 50 mg tablets EFG

Hydrochlorothiazide

Package leaflet contents:

1. What Hidroclorotiazida KERN PHARMA 50 mg tablets are and what they are used for
2. Before taking Hidroclorotiazida KERN PHARMA 50 mg tablets
3. How to take Hidroclorotiazida KERN PHARMA 50 mg tablets
4. Possible side effects
5. How to store Hidroclorotiazida KERN PHARMA 50 mg tablets
6. Further information

1. What Hidroclorotiazida Kern Pharma 50 mg tablets are and what they are used for

Hidroclorotiazida Kern Pharma tablets 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 urine output (diuretic effect), 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)
• nephrogenic diabetes insipidus (a disorder in which a defect in the kidney tubules causes a person to excrete large amounts of urine), when treatment with antidiuretic hormone is not indicated
• idiopathic hypercalciuria (elevated calcium levels in urine), as preventive treatment for urinary calculi (urinary tract stones).

2. Before taking Hidroclorotiazida Kern Pharma 50 mg tablets

Do not take Hidroclorotiazida Kern Pharma tablets

• If you are allergic to hydrochlorothiazide or any of the other ingredients of Hidroclorotiazida Kern Pharma.
• If you have any of the following conditions: anuria (absence of urine excretion), hepatic insufficiency, severe renal insufficiency, electrolyte depletion (abnormal loss of electrolytes from the body), decompensated diabetes, Addison's disease (hormonal deficiency).
• If you are pregnant.
• If you are breastfeeding, since hydrochlorothiazide is excreted in breast milk.

Take special care with Hidroclorotiazida Kern Pharma tablets

Consult your doctor, pharmacist, or nurse before starting treatment with Hidroclorotiazida Kern Pharma.

If you suffer from any of the following conditions:

• hepatic insufficiency,
• metabolic and endocrine disorders (such as diabetes, gout, elevated cholesterol levels),
• renal insufficiency,
• electrolyte imbalance (warning signs of electrolyte imbalance include: dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle cramps, muscle fatigue, low blood pressure, decreased urine output, tachycardia, nausea or vomiting),
• elevated calcium levels in the blood,
• systemic lupus erythematosus (chronic autoimmune disease),
• history of allergy or bronchial asthma,
• previous history of pancreatitis (inflammation of the pancreas),
• 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 Hidroclorotiazida Kern Pharma.
• If you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, occurring within hours to one week after taking Hidroclorotiazida Kern Pharma.
• If you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking Hidroclorotiazida Kern Pharma, seek medical attention immediately.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

The following medicines may interact with Hidroclorotiazida Kern Pharma tablets when used simultaneously:

• antidiabetic medications,
• muscle relaxants (such as baclofen, tubocurarine),
• 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),
• anti-inflammatory drugs (such as indomethacin),
• calcium salts,
• digitalis glycosides (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),
• cyclosporine (an immunosuppressant used in transplant patients),
• tetracyclines (antibiotic),
• anticholinergic agents (such as atropine),
• medicines used to treat gout (such as probenecid, allopurinol),
• diazoxide (medications used to treat hypoglycemia),
• amantadine (antiviral medication),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• salicylates,
• alcohol, sleep-inducing drugs (such as barbiturates or narcotics).

Hydrochlorothiazide may interfere analytically with certain diagnostic tests, such as the bentrimide test (gastric test) or parathyroid function tests, reduce concentrations of protein-bound iodine, and alter blood and urine test results.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medicine.

You must inform your doctor if you are pregnant or suspect you may be pregnant. Generally, your doctor will advise you to take an alternative medicine instead of Hidroclorotiazida Kern Pharma, as Hidroclorotiazida Kern Pharma 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

At the beginning of treatment, when the dosage is changed, or in combination with alcohol intake, Hidroclorotiazida Kern Pharma tablets may cause dizziness, vertigo, or headache. If dizziness, vertigo, or headache occur, driving and operating machinery should be avoided.

Important information about some of the components of Hidroclorotiazida Kern Pharma tablets

• 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.
• Athletes are advised that this medicine contains a component that may lead to a positive result in doping control tests.

3. How to take Hydrochlorothiazide Kern Pharma 50 mg tablets

Follow exactly the administration instructions for Hydrochlorothiazide Kern Pharma tablets provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual doses are:

• Treatment of hypertension (high blood pressure): initially a dose of 12.5 to 25 mg once daily is recommended, which may be increased up to 50 mg/day in one or two 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 swelling 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.

Use in children

The 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 doses.

If you take more Hydrochlorothiazide Kern Pharma tablets than you should

If you have taken more Hydrochlorothiazide Kern Pharma tablets than you should, you may experience severe hypotension (drastic reduction in blood pressure), unconsciousness, nausea, drowsiness, thirst, muscle pain, difficulty walking, cardiac arrhythmias, reduced heart rate, and renal failure.

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 medication and the amount ingested.

If you forget to take Hydrochlorothiazide Kern Pharma tablets

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

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

4. Possible adverse effects

Like all medicines, Hidroclorotiazida Kern Pharma tablets can cause adverse effects, although not everyone experiences them.

These adverse effects include:

Metabolism and nutrition disorders: loss of appetite, sugar and/or uric acid in urine, increased blood sugar, cholesterol and triglycerides, imbalance of salts (potassium, sodium, chloride and calcium).

Skin disorders: photosensitivity reactions, urticaria, skin rash, inflammation of the salivary glands, allergic reactions.

Renal and urinary disorders: inflammation of the kidney, increased urine volume, frequent urination.

Reproductive and breast disorders: impotence.

Psychiatric disorders: agitation, depression, sleep disorders.

Eye disorders: decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closet glaucoma].

Vascular disorders: inflammation of blood vessels.

Respiratory disorders: pneumonia, fluid accumulation in the lung, acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Gastrointestinal disorders: inflammation of the pancreas, gastric irritation, diarrhea, constipation, loss of appetite, nausea and vomiting, abdominal pain and cramps.

Hepatic and biliary disorders: yellowing of the skin.

Nervous system disorders: loss of appetite, difficulty in movement, dizziness, vertigo, headache, weakness, restlessness.

Ear disorders: vertigo.

Cardiac disorders: low blood pressure levels, arrhythmias, inflammation of the heart muscle due to allergy, inflammation of blood vessels.

Musculoskeletal disorders: muscle spasms.

General disorders: fever.

Immune system disorders: allergy.

Blood disorders: low blood levels of red blood cells, white blood cells and platelets.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Hydrochlorothiazide Kern Pharma 50 mg Tablets

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use Hydrochlorothiazide Kern Pharma tablets 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Additional Information

Composition of Hidroclorotiazida Kern Pharma tablets

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

Appearance of the medicinal product and contents of the container

It is presented as white, round, biconvex tablets, scored on both sides.

The tablet can be divided into equal halves.

Hidroclorotiazida Kern Pharma 50 mg tablets are available in blister packs containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain

This leaflet was approved in December 2021

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