HYDROCHLOROTHIAZIDE KERN PHARMA 25 mg TABLETS

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Hydrochlorothiazide Kern Pharma is a medicine that contains hydrochlorothiazide as the active substance. Hydrochlorothiazide is a diuretic (a medicine that increases urine production) 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 failure; premenstrual and idiopathic edema (of unknown cause)
• nephrogenic diabetes insipidus (a disorder in which a defect in the small tubes (tubules) of the kidneys makes a person produce a large amount of urine) when treatment with antidiuretic hormone is not indicated
• idiopathic hypercalciuria (high levels of calcium in the urine) as preventive treatment for urinary calcium stones (stones in the urinary system).

2. What you need to know before you take Hydrochlorothiazide Kern Pharma

Do not take Hydrochlorothiazide Kern Pharma

• If you are allergic to hydrochlorothiazide or any of the other components 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 electrolytes from the body), uncontrolled diabetes, Addison's disease (hormonal deficiency).
• If you are pregnant.
• If you are breastfeeding, as it is excreted in breast milk.

Warnings and precautions

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

Be especially careful if you have 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 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 Hydrochlorothiazide Kern Pharma with other medicines

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

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

• 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 (intravenous antibiotic), carbenoxolone (used to treat mouth ulcers), corticosteroids, hormones (such as corticotropin, adrenaline), stimulant laxatives (help with 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 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 barbiturics or narcotics).

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

Pregnancy, breastfeeding, and fertility

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 taking 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 human 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 may cause dizziness, drowsiness, or headache. If you experience dizziness, drowsiness, or headache, you should avoid driving and using machines.

Hydrochlorothiazide Kern Pharma contains lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Hydrochlorothiazide Kern Pharma

Follow the administration instructions of Hydrochlorothiazide Kern Pharma 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 nephrogenic 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 and adolescents

The usual doses in children are:

• Treatment of arterial hypertension (high blood pressure): 1 to 2 mg/kg body weight (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, 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

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

If you stop taking Hydrochlorothiazide Kern Pharma

Treatment of hypertension is long-term treatment, and stopping this treatment should be consulted with your doctor. Stopping or suspending your treatment could lead to an increase in blood pressure.

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

4. Possible side effects

Like all medicines, this medicine 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 sugar, cholesterol, and triglycerides in blood, 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: inflammation of blood vessels.

Respiratory disorders: pneumonia, fluid accumulation in the lungs, acute respiratory distress (signs include severe respiratory distress, 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, inflammation of blood vessels.

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".

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

If you consider that any of the side effects you are suffering from is serious or if you notice any side 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 expiration date stated on the packaging after EXP. The expiration 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 SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hydrochlorothiazide Kern Pharma

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

Appearance of the product and packaging

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

It is available in blister packs of 20 tablets.

Marketing authorization holder and manufacturer

Kern Pharma S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Spain

Date of the last revision of this leaflet: December 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es/