Hydrochlorothiazide Kern Pharma 25 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Hydrochlorothiazide Kern Pharma 25 mg tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Hidroclorotiazida Kern Pharma is and what it is used for

Hidroclorotiazida Kern Pharma 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)
• renal 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. What you need to know before taking Hidroclorotiazida Kern Pharma

Do not take Hidroclorotiazida Kern Pharma

• 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, as the drug is excreted in breast milk.

Warnings and precautions

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

Exercise particular caution 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 (a 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 a decrease in vision or eye pain, which 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 one week after taking Hidroclorotiazida.
• If you have previously experienced respiratory or pulmonary problems (such as lung 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 Hidroclorotiazida Kern Pharma with other medicines

Inform 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 Hidroclorotiazida Kern Pharma when used simultaneously:

• antidiabetic medicines,
• 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 aid intestinal evacuation),
• lithium (antidepressant),
• anti-inflammatory medicines (such as indomethacin),
• calcium salts,
• digitalis (digoxin),
• antiarrhythmic medicines (such as sotalol, amiodarone) or those capable of inducing Torsades de Pointes (a type of arrhythmia), such as intravenous erythromycin, mizolastine,
• antipsychotic medicines (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 (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 laboratory diagnostic tests, such as the bentrimide test (gastric test), parathyroid function tests, decrease concentrations of protein-bound iodine, and alter results of blood and urine tests.

Pregnancy, breastfeeding, and fertility

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 it 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 operating machinery

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

Hidroclorotiazida Kern Pharma contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult 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

Follow exactly the instructions for use of Hydrochlorothiazide Kern Pharma as given 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; 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 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 levels of calcium 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 little water or another non-alcoholic drink.

Use in children and adolescents

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 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, 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

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

If you stop taking Hydrochlorothiazide Kern Pharma

Treatment of hypertension is long-term, and stopping this treatment should be discussed with your doctor. Interrupting or stopping your treatment may result in increased blood pressure.

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

4. Possible adverse effects

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

Reproductive system and breast disorders: impotence.

Psychiatric disorders: restlessness, 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-closure glaucoma].

Vascular disorders: inflammation of blood vessels.

Respiratory disorders: pneumonia, pulmonary fluid accumulation, acute breathing difficulty (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.

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, arrhythmias, allergic inflammation of the heart muscle (myocarditis), 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".

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

5. Storage of Hydrochlorothiazide Kern Pharma

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use Hydrochlorothiazide Kern Pharma after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Hydrochlorothiazide Kern Pharma

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

Appearance of the medicine and contents of the pack

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

It is available in blister packs containing 20 tablets.

Marketing Authorization Holder and 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http:// www.aemps.gob.es/