PATIENT INFORMATION LEAFLET

Hidroclorotiazida Kern Pharma 50 mg tablets EFG

Hidroclorotiazida

Hidroclorotiazida Kern Pharma tablets is a medicine that contains hydrochlorothiazide as the active ingredient. Hydrochlorothiazide is a diuretic (a medicine 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 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 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 Kern Pharma tablets

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

Be especially careful with Hidroclorotiazida Kern Pharma tablets

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

If you have any of the following conditions:

• Liver insufficiency,
• Metabolic and endocrine problems (such as diabetes, gout, high cholesterol levels),
• Kidney insufficiency,
• 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 (chronic autoimmune disease),
• History of allergy or bronchial asthma,
• Previous history of pancreatitis (pancreas inflammation).
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its 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 exposure and UV rays while taking Hidroclorotiazida Kern Pharma.
• 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 a week after taking Hidroclorotiazida 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 Hidroclorotiazida Kern Pharma, seek medical attention immediately.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

• Antidiabetic medications,
• Muscle relaxants (such as baclofen, tubocurarine),
• Antihypertensive medications,
• Cholestyramine and cholestipol resins (used to reduce cholesterol levels),
• Pressor amines (such as adrenaline),
• Anfotericin B (injectable antibiotic), carbenoxolone (used to treat mouth sores), corticosteroids, hormones (such as corticotropin, adrenaline), laxatives (help with bowel evacuation),
• Lithium (antidepressant),
• Anti-inflammatory medications (such as indomethacin),
• Calcium salts,
• Digitals (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),
• Ciclosporin (immunosuppressive medication used in transplant patients),
• Tetracyclines (antibiotic),
• Anticholinergic agents (such as atropine),
• Medications 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 medications (such as barbiturates or narcotics).

Hidroclorotiazida may cause interference in the analysis of some tests, such as: bentiramide test (gastric test), or parathyroid function test, decrease the concentrations of iodine bound to proteins, modify the results of blood tests and urine tests.

Pregnancy and Lactation

Consult your doctor or pharmacist before using any medication.

You should inform your doctor if you are pregnant or suspect you are pregnant.Generally, your doctor will advise you to take another medication 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.

Hidroclorotiazida is excreted in human milk, so it is not recommended for breastfeeding mothers.

Driving and operating machinery

At the beginning of treatment, when the dosage is changed, or in combination with alcohol consumption, Hidroclorotiazida Kern Pharma tablets may cause dizziness, vertigo, or headache. If you experience dizziness, vertigo, or headache, you should avoid driving and operating machinery.

Important information about some components of Hidroclorotiazida Kern Pharma tablets

• This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.
• It is reported to athletes that this medication contains a component that may result in a positive analytical result in doping control as positive.

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

The usual 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 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.

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 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 Kern Pharma tablets than you should

If you have taken more Hidroclorotiazida Kern Pharma than you should, severe hypotension (drastic reduction in blood pressure), unconsciousness, nausea, drowsiness, drowsiness, 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.

If you forgot to take Hidroclorotiazida Kern Pharma tablets

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

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

Like all medications, Hidroclorotiazida Kern Pharma tablets may cause side effects, although not everyone will experience them.

Among these side effects are:

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

Skin alterations:photosensitivity reactions, urticaria, skin rash, salivary gland inflammation, allergic reactions.

Renal and urinary alterations:kidney inflammation, increased urine output, frequent urination.

Reproductive and mammary alterations:impotence.

Psychiatric alterations:agitation, depression, sleep disorders.

Ocular alterations:decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma.

Vascular alterations:inflammation of blood vessels.

Respiratory alterations:pneumonia, fluid accumulation in the lung, acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

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

Hepatic and biliary alterations:yellow skin discoloration.

Nervous system alterations:loss of appetite, movement difficulties, dizziness, vertigo, headache, weakness, restlessness.

Auditory alterations:vertigo.

Cardiac alterations:low blood pressure, arrhythmias, allergic inflammation of the heart muscle, inflammation of blood vessels.

Musculoskeletal alterations:muscle spasms.

General alterations:fever.

Immune system alterations:allergy.

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

Skin and lip cancer (non-melanoma skin cancer):Frequency «unknown».

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

No requires special conditions for conservation.

Keep out of sight and reach of children.

Do not use Kern Pharma Hydrochlorothiazide tablets 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 thrown down the drains or in the trash. Dispose of the packaging and medicines you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you do not need. In this way, you will help protect the environment.

Composition of Kern Pharma Hydrochlorothiazide Tablets

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

Appearance of the Product and Contents of the Package

It is presented in the form of white, round, and scored tablets on both sides.

The tablet can be divided into two equal halves.

Kern Pharma 50 mg Hydrochlorothiazide Tablets are presented in blister-type packages of 20 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

Kern Pharma S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was approved in December 2021

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