Hidroclorotiazida aristo 25 mg comprimidos efg

Patient Information Leaflet: Package Insert

Hidroclorotiazida Aristo 25 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Aristo Hydrochlorothiazide 25 mg 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:

- high blood pressure (elevated blood pressure) alone or in combination with other antihypertensive medications,

- edema (excessive retention of fluid in tissues) due to heart, kidney or liver disease,

- prevention of the formation of urinary stones (stones in the urinary system) in patients with elevated levels of calcium in urine,

- nephrogenic diabetes insipidus (a disorder in which a defect in the small tubes (tubules) of the kidney causes a person to eliminate a large amount of urine) when treatment with antidiuretic hormone is not indicated.

- 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 especially careful in the following situations:

- If you have kidney problems,

- If you have liver problems,

- If you have electrolyte imbalances, such as high levels of calcium in the blood,

- If you have metabolic and endocrine problems,

- If you have a systemic autoimmune disease called systemic lupus erythematosus,

- If you experience a decrease in vision or eye pain, it could be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, 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 had a previous allergy to penicillin or sulfonamide, you may be at higher risk of developing it,

- If you have allergies or asthma.

- 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 Aristo, seek medical attention immediately.

- If you have had skin cancer or if an unexpected skin lesion appears during treatment. The treatment with hydrochlorothiazide, particularly 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 hydrochlorothiazide.

Hydrochlorothiazide Aristo with other medications

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

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

- Lithium (antidepressant),

- Other antihypertensives,

- Muscle relaxants,

- Medications used to lower potassium levels,

- Antipsychotics, antidepressants, and antiepileptic medications,

- Medications used to treat diabetes,

- Digitalis (digoxin),

- Anti-inflammatory medications (salicylate 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 lower cholesterol levels (such as cholestyramine, cholestipol),

- Vitamin D,

- Cyclosporine (medication used in transplant patients),

- Calcium salts,

- Medications used to treat hypoglycemia (diazoxide),

- Metildopa, used to treat hypertension,

- Alcohol, sleep-inducing medications (such as barbiturates and narcotics),

- Pressor amines (such as noradrenaline).

Hydrochlorothiazide Aristo with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Generally, your doctor will advise you to take another 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 it is not recommended for lactating mothers.

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

Driving and operating machinery

It is unlikely that hydrochlorothiazide will affect your ability to drive or operate machinery.

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

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 this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Usual doses are:

- Treatment of high blood pressure (hypertension): an initial dose of 12.5 to 25 mg once a day is recommended, which can be increased up to 50 mg/day divided into one or two doses.

- Treatment of edema (excessive fluid retention under the tissues): the dose should not exceed 50 mg/day.

- Prevention of urinary stone formation (stones in the urinary system): the recommended daily dose is 25 to 50 mg.

- Treatment of diabetic nephropathy: initial doses of up to 100 mg/day are used.

Administration Form

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

The tablet can be split into equal halves.

If you take more Hidroclorotiazida Aristo than you should

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

The following signs and symptoms may occur in cases of poisoning caused by an overdose: dizziness, nausea, drowsiness, decreased circulating blood volume (hypovolemia), low blood pressure (hypotension), and electrolyte disturbances associated with arrhythmias and muscle spasms.

If you forget to take Hidroclorotiazida Aristo

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

If you interrupt treatment with Hidroclorotiazida Aristo

Hypertension treatment is long-term, and interrupting this treatment should be discussed with your doctor.

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

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

Very common side effects (may affect more than 1 in 10 patients):

- Decrease in blood potassium levels, increase in blood lipids.

Common side effects (may affect up to 1 in 10 patients):

- Decrease in blood sodium and magnesium levels, 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 the number of platelets in the blood that may trigger a disease called purpura,

- Increase in calcium and blood sugar levels, sugar in urine, worsening of diabetes,

- Headache, dizziness, sleep disturbances, depression, tingling sensation,

- Vision disturbances,

- Skin alterations due to photosensitivity reactions,

- Abdominal pain, constipation, diarrhea,

- Yellow discoloration of the skin,

- Alterations in heart rhythm.

Very rare side effects (may affect up to 1 in 10,000 patients):

- Decrease in the number of white blood cells, hemolytic anemia, bone marrow function disorders,

- Allergic reactions, difficulty breathing,

- Acute respiratory distress (symptoms include severe breathing difficulty, fever, weakness, and confusion).

- Decrease in blood chloride levels,

- Inflammation of blood vessels, appearance of blisters on the skin, lupus erythematosus-like skin reactions,

- Pancreatitis.

Side effects of unknown frequency (cannot be estimated from available data):

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

Post-marketing experience of adverse reactions

The following adverse reactions have been identified through post-marketing experiences. Since these reactions have been voluntarily reported by an uncertain population size, it is not possible to estimate the reliability of their frequency.

Unknown frequency: acute renal failure, renal disorder, aplastic anemia, erythema multiforme, fever, muscle spasms, asthenia, decrease in 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 of adverse effects

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

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofHidroclorotiazida Aristo

- The active ingredient is hidroclorotiazida. Each tablet contains 25 mg of hidroclorotiazida.

- The other components (excipients) are lactose monohydrate, cornstarch, talc, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the container

Hidroclorotiazida Aristo 25 mg tablets EFG are white, round, flat tablets with beveled edges, with one face having a groove, and the other face without a groove.

Hidroclorotiazida Aristo 25 mg tablets EFG are packaged in a blister and is available in containers containing 20 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

Responsible for Manufacturing

Last review date of this leaflet: November 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/.