HYDROCHLOROTHIAZIDE KERN PHARMA 50 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hydrochlorothiazide Kern Pharma 50 mg tablets EFG

Hydrochlorothiazide

Contents of the package leaflet:

1. What Hydrochlorothiazide Kern Pharma 50 mg tablets are and what they are used for
2. Before taking Hydrochlorothiazide Kern Pharma 50 mg tablets
3. How to take Hydrochlorothiazide Kern Pharma 50 mg tablets
4. Possible side effects
5. Storage of Hydrochlorothiazide Kern Pharma 50 mg tablets
6. Further information

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

Hydrochlorothiazide Kern Pharma tablets are a medicine that contains hydrochlorothiazide as the active ingredient. Hydrochlorothiazide is a diuretic (a medicine that increases urine production) belonging to the thiazide group. Hydrochlorothiazide increases urine production (diuretic effect) helping to reduce blood pressure (antihypertensive effect).

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, 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 eliminate a large amount of urine) when treatment with antidiuretic hormone is not indicated
• idiopathic hypercalciuria (high levels of calcium in the urine) as a preventive treatment for urinary calcium stones.

2. Before taking Hydrochlorothiazide Kern Pharma 50 mg tablets

Do not take Hydrochlorothiazide Kern Pharma tablets

• If you are allergic to hydrochlorothiazide or any of the other ingredients of Hydrochlorothiazide Kern Pharma.
• If you have any of the following diseases: anuria (absence of urine production), liver failure, severe kidney failure, electrolyte depletion (abnormal consumption of the body's own electrolytes), uncontrolled diabetes, Addison's disease (hormonal deficiency).
• If you are pregnant.
• If you are breastfeeding, as it is excreted in breast milk.

Special warnings and precautions for use

Consult your doctor, pharmacist, or nurse before starting to take Hydrochlorothiazide Kern Pharma.

If you suffer from any of the following diseases:

• liver failure,
• metabolic and endocrine problems (such as diabetes, gout, high cholesterol levels),
• kidney failure,
• electrolyte imbalance (warning signs of electrolyte imbalance are: dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle cramps, muscle fatigue, low blood pressure, decreased urine production, tachycardia, nausea or vomiting),
• high blood calcium levels,
• systemic lupus erythematosus (a chronic autoimmune disease),
• history of allergy or bronchial asthma,
• previous history of pancreatitis (inflammation of the pancreas).
• 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 week after taking Hydrochlorothiazide Kern Pharma.
• 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 Kern Pharma, seek medical attention immediately.

Using other medicines

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

The following medicines may interact with Hydrochlorothiazide Kern Pharma tablets when used at the same time:

• antidiabetic medicines,
• muscle relaxants (such as baclofen, tubocurarine),
• antihypertensive medicines,
• 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 (helping bowel evacuation),
• lithium (antidepressant),
• anti-inflammatory medicines (such as indomethacin),
• calcium salts,
• digitalis (digoxin),
• antiarrhythmic medicines (such as sotalol, amiodarone) or capable of inducing Torsades de Pointes (a type of arrhythmia) such as intravenous erythromycin, mizolastine,
• antipsychotic medicines (such as haloperidol),
• carbamazepine (for epilepsy),
• cyclosporin (immunosuppressive medicine used in transplant patients),
• tetracyclines (antibiotic),
• anticholinergic agents (such as atropine),
• medicines used for the treatment of gout (such as probenecid, allopurinol),
• diazoxide (medicines used to treat hypoglycemia),
• amantadine (antiviral medicine),
• cytotoxic agents (such as methotrexate, cyclophosphamide),
• salicylates,
• alcohol, sleep-inducing medicines (such as barbiturates or narcotics).

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

You should inform your doctor if you are pregnant or think you may be pregnant. Your doctor will usually advise you to take a different medicine instead of Hydrochlorothiazide Kern Pharma, as Hydrochlorothiazide 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 breast milk, so its use is not recommended in breastfeeding mothers.

Driving and using machines

At the start of treatment, when the dosage is changed, or in combination with alcohol consumption, Hydrochlorothiazide Kern Pharma tablets may cause dizziness, drowsiness, or headache. If you experience dizziness, drowsiness, or headache, you should avoid driving and using machines.

Important information about some of the ingredients of Hydrochlorothiazide Kern Pharma tablets

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

3. How to take Hydrochlorothiazide Kern Pharma 50 mg tablets

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

The usual 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 beverage.

Use in children

The usual doses in children are:

• Treatment of arterial hypertension (high blood pressure): 1 to 2 mg/kg 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 Kern Pharma tablets than you should

If you have taken more Hydrochlorothiazide Kern Pharma 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.

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 side effects

Like all medicines, Hydrochlorothiazide Kern Pharma tablets can cause side effects, although not everybody gets them.

These side effects include:

Metabolic and nutritional disorders: loss of appetite, sugar and/or uric acid in urine, increased blood sugar, cholesterol, and triglyceride levels, electrolyte imbalance (potassium, sodium, chloride, and calcium).

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

Renal and urinary disorders: kidney inflammation, increased urine production, frequent urination.

Reproductive system and breast disorders: impotence.

Psychiatric disorders: agitation, depression, sleep disorders.

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

Vascular disorders: blood vessel inflammation.

Respiratory disorders: pneumonia, fluid accumulation in the lungs, acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

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

Hepatobiliary disorders: yellowing of the skin.

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

Ear disorders: vertigo.

Cardiac disorders: low blood pressure, arrhythmias, allergic inflammation of the heart muscle, blood vessel inflammation.

Musculoskeletal disorders: muscle spasms.

General disorders: fever.

Immune system disorders: allergy.

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

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

If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Hydrochlorothiazide Kern Pharma tablets

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

Appearance of the product and packaging content

They are presented in the form of white, round, and scored tablets on both sides.

The tablet can be divided into two equal halves.

Hydrochlorothiazide Kern Pharma 50 mg tablets are presented in blister packs of 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 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/