HYDROCHLOROTHIAZIDE ARISTO 25 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Hydrochlorothiazide Aristo 25 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Hydrochlorothiazide Aristo and what is it used for
2. What you need to know before taking Hydrochlorothiazide Aristo
3. How to take Hydrochlorothiazide Aristo
4. Possible side effects
5. Storage of Hydrochlorothiazide Aristo
6. Package contents and additional information

1. What is Hydrochlorothiazide Aristo and what is it used for

Hydrochlorothiazide Aristo 25 mg is a medication that contains hydrochlorothiazide as the active ingredient. Hydrochlorothiazide is a diuretic (a medication that increases urine production) that belongs to the thiazide group. Hydrochlorothiazide increases urine production (diuretic) and helps reduce blood pressure (antihypertensive).

This medication is indicated for the treatment of the following diseases:

• arterial hypertension (high blood pressure) alone or in combination with other antihypertensive medications,
• edema (excessive fluid retention in tissues) due to heart, kidney, or liver disease,
• prevention of urinary stone formation (kidney stones) in patients with high calcium levels in the urine,
• nephrogenic diabetes insipidus (a disorder in which a defect in the small tubes (tubules) of the kidney causes a person to produce a large amount of urine) when treatment with antidiuretic hormone is not indicated.

2. What you need to know before taking Hydrochlorothiazide Aristo

• if you are allergic to hydrochlorothiazide or any of the other components of this medication (listed in section 6),
• if you have problems eliminating urine (anuria),
• if you are pregnant and have high blood pressure,

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication.

Be particularly careful in the following situations:

• if you have kidney problems,
• if you have liver problems,
• if you have electrolyte imbalance, such as high calcium levels in the blood,
• if you have metabolic and endocrine disorders,
• if you have an autoimmune disease called systemic lupus erythematosus,
• 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 pressure in the eye, and can occur within a few hours to a week after taking Hydrochlorothiazide Aristo. If left untreated, it can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it,
• if you have allergies or asthma.
• if you have had respiratory problems or pulmonary issues (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Hydrochlorothiazide Aristo, seek medical attention immediately.
• if you have had skin cancer or if you 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 skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV radiation while taking hydrochlorothiazide.

Taking Hydrochlorothiazide Aristo with Other Medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

The following medications may interact with hydrochlorothiazide when used at the same time:

• lithium (antidepressant),
• other antihypertensive medications,
• muscle relaxants,
• medications used to decrease potassium levels,
• antipsychotic, antidepressant, and antiepileptic medications,
• medications used to treat diabetes,
• digitalis (digoxin),
• anti-inflammatory medications (salicylic acid derivatives, indomethacin),
• medications used to treat gout, such as allopurinol,
• amantadine (antiviral medication),
• medications used to treat cancer (such as methotrexate, cyclophosphamide),
• anticholinergic agents (such as atropine),
• resins used to decrease cholesterol levels (such as cholestyramine, colestipol),
• vitamin D,
• cyclosporine (medication used in transplant patients),
• calcium salts,
• medications used to treat hypoglycemia (diazoxide),
• methyldopa, used to treat hypertension,
• alcohol, sleep-inducing medications (such as barbiturates and narcotics),
• pressor amines (such as norepinephrine).

Taking Hydrochlorothiazide Aristo with Food, Drinks, and Alcohol

In combination with alcohol consumption, this medication may cause dizziness, drowsiness, or headache.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Generally, your doctor will advise you to take a different medication instead of Hydrochlorothiazide Aristo 25 mg, as hydrochlorothiazide 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.

No human data are available. Animal studies do not show effects on fertility.

Driving and Using Machines

It is unlikely that hydrochlorothiazide will affect your ability to drive or use machines.

Hydrochlorothiazide Aristo Contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Use in Athletes

Athletes are informed that this medication contains a component that may result in a positive doping test

3. How to Take Hydrochlorothiazide Aristo

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The usual doses are:

• Treatment of arterial hypertension (high blood pressure): initially, a dose of 12.5 to 25 mg once daily is recommended, which can be increased to 50 mg/day divided into one or two doses.
• Treatment of edema (excessive fluid retention in tissues): the dose should not exceed 50 mg/day.
• Prevention of urinary stone formation (kidney stones): the recommended daily dose is 25 to 50 mg.
• Treatment of nephrogenic diabetes insipidus: initial doses of up to 100 mg/day are used.

Method of Administration

The tablets should be taken orally, with or without food.

The tablet can be divided into two equal halves.

If You Take More Hydrochlorothiazide Aristo Than You Should

If you have taken more Hydrochlorothiazide Aristo 25 mg than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The following signs and symptoms may occur in the event of an overdose: dizziness, nausea, drowsiness, decreased blood volume (hypovolemia), low blood pressure (hypotension), and electrolyte disorders associated with cardiac arrhythmias and muscle spasms.

If You Forget to Take Hydrochlorothiazide Aristo

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

If You Stop Taking Hydrochlorothiazide Aristo

Treatment of hypertension is a long-term treatment, and stopping this treatment should be consulted with your doctor.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Very Common Side Effects (may affect more than 1 in 10 patients):

• decrease in potassium levels in the blood, increase in lipid levels in the blood.

Common Side Effects (may affect up to 1 in 10 patients):

• decrease in sodium and magnesium levels in the blood, increase in uric acid levels,
• urticaria, skin rash,
• decreased appetite, nausea, vomiting,
• orthostatic hypotension (sudden drop in blood pressure),
• impotence.

Rare Side Effects (may affect up to 1 in 1,000 patients):

• decrease in platelet count in the blood, which can trigger a disease called purpura,
• increase in calcium and sugar levels in the blood, sugar in the urine, worsening of diabetes,
• headache, dizziness, sleep disturbances, depression, tingling sensation,
• vision disorders,
• skin disorders due to photosensitivity reactions,
• abdominal pain, constipation, diarrhea,
• yellowing of the skin,
• cardiac rhythm disorders.

Very Rare Side Effects (may affect up to 1 in 10,000 patients):

• decrease in white blood cell count, hemolytic anemia, disorders of bone marrow function,
• allergic reactions, difficulty breathing,
• acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).
• decrease in chloride levels in the blood,
• inflammation of blood vessels, appearance of blisters on the skin, cutaneous lupus erythematosus reactions,
• pancreatitis.

Side Effects with Unknown Frequency (cannot be estimated from available data):

• skin cancer and lip cancer (non-melanoma skin cancer).

Post-Marketing Experience

The following adverse reactions have been identified during post-marketing experience. Since these reactions have been reported voluntarily from a population of unknown size, it is not possible to estimate their frequency.

Unknown frequency: acute renal failure, renal disorder, aplastic anemia, erythema multiforme, pyrexia, muscle spasms, asthenia, decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or angle-closure glaucoma].

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hydrochlorothiazide Aristo

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

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of in wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Hydrochlorothiazide Aristo

• The active ingredient is hydrochlorothiazide. Each tablet contains 25 mg of hydrochlorothiazide.
• The other components (excipients) are lactose monohydrate, cornstarch, talc, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

Hydrochlorothiazide Aristo 25 mg tablets EFG are white, round, flat tablets with beveled edges, one side with a score line, and the other side without a score line.

Hydrochlorothiazide Aristo 25 mg tablets EFG are packaged in blisters and are available in packages containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Manufacturer

Date of the Last Revision of this Package Leaflet: November 2021

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