Hidroclorotiazida kern pharma 25 mg comprimidos

Prospect: Information for the User

Hidroclorotiazida Kern Pharma 25 mg Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Hidroclorotiazida Kern Pharma is a medication that contains hydrochlorothiazide as the active ingredient. Hydrochlorothiazide is a diuretic (a medication 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 medication 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 for urinary tract stones (kidney stones).

Do not take Hidroclorotiazida Kern Pharma

• 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 in the lactation period, as it is excreted in breast milk.

Warnings and precautions

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

Be especially careful 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, drowsiness, restlessness, muscle cramps, muscle fatigue, low blood pressure, decreased urine production, 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 (pancreas inflammation),
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, particularly at high doses, may increase the risk of certain types of skin cancer 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, it may be a symptom 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 this hydrochlorothiazide.
• 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 Hidroclorotiazida Kern Pharma with 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 when used simultaneously:

• Antidiabetic medications,
• Muscle relaxants (such as baclofen, tubocurarine),
• Antihypertensive medications,
• Cholestyramine and colestipol 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 (stimulants that help 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 interfere with analytical diagnosis in some tests, such as: bentiramide test (gastric test), or parathyroid function test, decrease yodine-bound protein concentrations, modify blood and urine test results.

Pregnancy, lactation, and fertility

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 Pharmais 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 neonate.

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

Driving and operating machinery

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

Hidroclorotiazida Kern Pharma contains lactose.If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

It is reported to athletes that this medication contains a component that may result in a positive analytical result for doping control.

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

Usual doses are:

• Treatment of high blood pressure (elevated blood pressure): initially, a dose of 12.5 to 25 mg once a day, 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 bloating and weight gain associated with premenstrual syndrome: 25 to 50 mg administered in one or two doses.
• Treatment of diabetic 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 can be taken whole, broken, or crushed, with a little water or other non-alcoholic beverage.

Use in children and adolescents

Usual doses in children are:

• Treatment of high blood pressure (elevated 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 Kern Pharma than you should

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

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 forget to take Hydrochlorothiazide Kern Pharma

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

If you interrupt treatment with Hydrochlorothiazide Kern Pharma

Hypertension treatment is a long-term treatment, and interrupting this treatment should be consulted with your doctor. Stopping or suspending your treatment may cause an increase in blood pressure.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Among these side effects are:

Metabolism and nutrition 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 breast alterations: impotence.

Psychiatric alterations: agitation, depression, sleep disorders.

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

Vascular alterations: blood vessel inflammation.

Respiratory alterations:pneumonia, fluid accumulation in the lung, acute respiratory distress (symptoms include severe respiratory difficulty, 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 difficulty, dizziness, vertigo, headache, weakness, restlessness.

Auditory alterations:vertigo.

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

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):Unknown frequency.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this prospectus. You can also report them directly to the Spanish System of Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

If you consider that any of the side effects you are experiencing is 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 this medication out of the sight and reach of children.

Do not use Hydrochlorothiazide Kern Pharma 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 medications you no longer need at the SIGRE collection pointof the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hidroclorotiazida Kern Pharma

• The active ingredient is hydrochlorothiazide. Each tablet contains 25 mg of hydrochlorothiazide.
• The other components are:lactose monohydrate, calcium hydrogen phosphate anhydrous, pregelatinized cornstarch, anhydrous colloidal silica and magnesium stearate (E-470b).

Appearance of the product and contents of the packaging

Hidroclorotiazida Kern Pharma are white, round, and scored tablets on one side. The tablet can be divided into two equal halves.

It is presented in blister-type packaging of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma S.L.

Colón II Industrial Estate

Venus, 72

08228 Terrassa (Barcelona)

Spain

Last review date of this leaflet: 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/