Hidrohlorothiazide Aurovitas

Leaflet accompanying the packaging: information for the user

Hydrochlorothiazide Aurovitas, 12.5 mg, tablets

Hydrochlorothiazide Aurovitas, 25 mg, tablets

Hydrochlorothiazide

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Hydrochlorothiazide Aurovitas and what is it used for
• 2. Important information before taking Hydrochlorothiazide Aurovitas
• 3. How to take Hydrochlorothiazide Aurovitas
• 4. Possible side effects
• 5. How to store Hydrochlorothiazide Aurovitas
• 6. Contents of the packaging and other information

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

Hydrochlorothiazide Aurovitas belongs to a group of medicines called diuretics. Diuretics increase the amount of water excreted in the urine.

Hydrochlorothiazide Aurovitas is used in adults to treat:

• fluid retention in tissues causing swelling (edema) due to heart, liver, or kidney disease;
• high blood pressure (hypertension). In this case, it can be prescribed alone or with another medicine.

2. Important information before taking Hydrochlorothiazide Aurovitas

When not to take Hydrochlorothiazide Aurovitas

• if the patient is allergic to hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6);
• if the patient is unable to urinate (anuria);
• if the patient has severe kidney dysfunction.

Warnings and precautions

Before starting treatment with Hydrochlorothiazide Aurovitas, the patient should inform their doctor or pharmacist:

• if they have had breathing or lung problems after taking hydrochlorothiazide in the past (including pneumonia or fluid accumulation in the lungs). If the patient experiences severe shortness of breath or difficulty breathing after taking Hydrochlorothiazide Aurovitas, they should seek medical attention immediately;
• if they have severe kidney or liver disease;
• if they have narrowing of the renal artery (narrowing of the blood vessels supplying the kidneys or a single kidney);
• if they have diabetes (high blood sugar levels);
• if they have high cholesterol or triglyceride levels;
• if they have a disease called systemic lupus erythematosus (also known as lupus or SLE);
• if they have low potassium levels in the blood (with or without symptoms such as muscle weakness, muscle cramps, or irregular heartbeat);
• if they have low sodium levels in the blood (with symptoms such as fatigue, confusion, muscle cramps, or without them);
• if they have high calcium levels in the blood (with symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness, or cramps);
• if they have gout attacks (uric acid crystal deposits in the joints);
• if they experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - these can occur within a few hours to a week after taking Hydrochlorothiazide Aurovitas. If left untreated, this can lead to permanent vision disturbances. If the patient has previously been allergic to penicillin or sulfonamides, they may be more prone to developing this condition;
• if they have allergies or asthma;
• if they have skin reactions, such as sun-induced rashes;
• if they are taking any other medicines;
• if they are pregnant or planning to become pregnant;
• if they have been diagnosed with skin cancer or if unexpected skin changes occur during treatment. Long-term treatment with hydrochlorothiazide, especially at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). The patient should protect their skin from sunlight and UV radiation while taking Hydrochlorothiazide Aurovitas.

In people who chronically abuse diuretics, pseudo-Bartter syndrome may occur, along with fluid retention in the body (edema).
During treatment with this medicine, the patient should drink sufficient fluids. Due to increased potassium loss, a potassium-rich diet should be followed (e.g., bananas, vegetables, nuts).

Exposure to sunlight or sunlamps

If the patient experiences sun-induced reactions while taking this medicine and the doctor decides to continue treatment, they should protect their skin from the sun and avoid using UV tanning beds (see also section 4 to find out what to do if these side effects occur).

Blood tests

The doctor may recommend regular blood tests during treatment to monitor kidney function, especially to control sodium, potassium, calcium, sugar (glucose), and uric acid levels in the blood.

Elderly patients (65 years and older)

In the treatment of elderly patients, attention should be paid to possible kidney function limitations (see section 3).

Hydrochlorothiazide Aurovitas and other medicines

The patient should inform their doctor or pharmacist if they are taking, have recently taken, or might take any other medicines.
It may be necessary for the doctor to change the dose and/or take other precautions if the patient is taking other medicines, especially if they are taking any of the following:

• lithium (a medicine used in psychiatric disorders), as its combination with hydrochlorothiazide may cause lithium overdose;
• blood pressure-lowering medicines or those used in heart diseases [e.g., diuretics, ACE inhibitors such as ramipril, angiotensin II antagonists (like valsartan), digoxin, nitrates, and similar];
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., antidepressants, anxiolytics, antipsychotics, neuroleptics);
• medicines used to treat heart rhythm disorders (e.g., quinidine, disopyramide, amiodarone, dronedarone, sotalol, digoxin);
• medicines used to treat pain or inflammatory conditions, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), and aspirin;
• carbamazepine or oxcarbazepine (used to treat epilepsy);
• laxatives and other laxative agents;
• corticosteroids;
• desmopressin (used in diabetes or urological disorders);
• ion-exchange resins (substances used mainly to treat high lipid levels in the blood);
• domperidone (used to prevent nausea and vomiting);
• medicines used to treat malaria (e.g., halofantrine, lumefantrine);
• medicines used to treat allergic reactions (e.g., mizolastine, mequitazine);
• antibiotics used to treat infections (e.g., amphotericin B, erythromycin, levofloxacin, moxifloxacin, spiramycin);
• iodine-based contrast agents (used in imaging studies);
• medicines used to treat prostate disorders (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin);
• medicines used to treat erectile dysfunction;
• medicines used to treat Parkinson's disease (dopamine agonists, levodopa);
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• calcium-containing tablets or other calcium supplements;
• methadone (used to treat addiction to certain substances);
• medicines used to treat certain cancers (vandetanib, toremifene);
• vinpocetine (used to treat neurological disorders related to aging);
• cyclosporine (used after organ transplantation, to treat autoimmune diseases, or severe rheumatologic or dermatologic conditions).

Hydrochlorothiazide Aurovitas with food and drink

Alcohol should not be consumed while taking this medicine, as it may cause orthostatic hypotension (a sudden drop in blood pressure that causes dizziness when changing positions, e.g., standing up).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Generally, the doctor will recommend taking a different medicine instead of Hydrochlorothiazide Aurovitas, as it is not recommended during pregnancy, except in rare cases where no other treatment can be used.
This medicine passes through the placenta, and its use after the third month of pregnancy may seriously harm the fetus.
Breastfeeding
Hydrochlorothiazide passes into breast milk. This medicine should not be taken while breastfeeding, unless the doctor recommends it.

Driving and using machines

Hydrochlorothiazide Aurovitas has a minor to moderate influence on the ability to drive and use machines.
Even when used as recommended, this medicine may affect the patient's reactions. Therefore, the ability to drive and use machines or work in locations without solid support may be limited.
This is especially important at the beginning of treatment, when the dose is increased, the medicine is changed, or taken in combination with alcohol.

Doping test

Hydrochlorothiazide may give a positive result in a doping test.

Hydrochlorothiazide Aurovitas contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Hydrochlorothiazide Aurovitas

The medicine should always be taken as recommended by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Hydrochlorothiazide Aurovitas, tablets, is available in two strengths: 12.5 mg and 25 mg.
Edema:
The usual initial dose is 50 mg to 100 mg of hydrochlorothiazide per day.
The maintenance dose is usually 25 mg to 50 mg of hydrochlorothiazide per day.
Hypertension:
The currently recommended doses for hypertension are 12.5 mg or 25 mg per day.
Elderly patients:
In the treatment of elderly patients (65 years and older), attention should be paid to possible kidney function limitations.

Use in children and adolescents

There is no experience with the use of hydrochlorothiazide in children and adolescents. Therefore, hydrochlorothiazide should not be given to children and adolescents.

Method of administration

Oral administration.
Tablets should be swallowed with a sufficient amount of fluid.
This medicine can be taken independently of meals.
Tablets can be divided into equal doses.

Frequency of administration

This medicine has a diuretic effect (the patient urinates more frequently). Considering this, it is best not to take the last dose late in the day to avoid waking up at night.
If the patient takes tablets once a day, they should take them in the morning.

Duration of treatment

The doctor will inform the patient how long they should take this medicine.
The doctor will perform regular check-ups to ensure that the treatment has the desired effect.
In case of any questions about the duration of treatment, the patient should talk to their doctor or pharmacist.

Taking a higher dose of Hydrochlorothiazide Aurovitas than recommended

If nausea, drowsiness, muscle cramps, irregular heartbeat, low blood pressure (recognized by dizziness), confusion, or urinary disorders occur, the patient should contact their doctor immediately.

Missing a dose of Hydrochlorothiazide Aurovitas

In case of a missed dose, the patient should take it as soon as possible. They should not take a double dose to make up for the missed dose but continue treatment as recommended.

Stopping treatment with Hydrochlorothiazide Aurovitas

The patient should not stop treatment with Hydrochlorothiazide Aurovitas unless their doctor recommends it. If the patient stops treatment, their blood pressure may increase above normal (see also "Duration of treatment").
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects requiring treatment discontinuation:

In case of sun-induced reactions (skin reaction), treatment should be discontinued, and the patient should consult their doctor or go to the emergency department.

Very common (may affect more than 1 in 10 people):

• increased lipid levels in the blood (hyperlipidemia)
• decreased potassium levels in the blood (hypokalemia)

Common (may affect less than 1 in 10 people):

• itching rash (hives) and other skin rashes
• loss of appetite, nausea, vomiting, diarrhea
• low blood pressure when standing up from a lying position
• difficulty achieving or maintaining an erection (impotence)
• low magnesium levels in the blood (hypomagnesemia)
• low sodium levels in the blood (hyponatremia)
• increased uric acid levels in the blood (hyperuricemia)

Uncommon (may affect less than 1 in 100 people):

• acute kidney failure (significant decrease in urine excretion)

Rare (may affect up to 1 in 1000 people):

• worsening of diabetes
• increased sensitivity to sunlight
• abdominal discomfort, constipation
• liver function disorders, which may be accompanied by yellowing of the eyes and skin
• irregular heartbeat
• headache
• dizziness with a feeling of spinning
• sleep disorders
• depression
• tingling or numbness of the hands or feet (paresthesia)
• vision disturbances
• high blood sugar levels
• sugar in the urine
• high calcium levels in the blood (hypercalcemia)
• low platelet count in the blood, sometimes with bleeding or bruising under the skin (thrombocytopenia)

Very rare (may affect up to 1 in 10,000 people):

• facial rash, joint pain, muscle symptoms, fever (systemic lupus erythematosus)
• vasculitis with symptoms such as rash, purplish-red spots on the skin, fever (necrotizing vasculitis)
• severe skin reaction causing rash, skin redness, blistering of the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)
• allergic reaction (hypersensitivity reaction)
• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion)
• severe abdominal pain (pancreatitis)
• bone marrow suppression causing a decrease in red blood cells and/or white blood cells and platelets
• red blood cell damage causing pallor, fatigue, shortness of breath, dark urine color (hemolytic anemia)
• low white blood cell count, which may cause fever, sore throat, or mouth sores, more frequent infections (leukopenia or possible symptoms of agranulocytosis).
• acid-base balance disorder causing disorientation, fatigue, muscle cramps, and spasms, rapid breathing (hypochloremic alkalosis).

Unknown frequency (cannot be estimated from the available data):

• insufficient production of various blood cells by the bone marrow (bone marrow suppression)
• significant decrease in urine excretion (possible symptoms of kidney disorders)
• severe skin disease causing rash, skin redness, blistering of the lips, eyes, or mouth, skin peeling, fever (erythema multiforme)
• fever
• muscle cramps
• weakness (asthenia)
• sudden vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - these can occur within a few hours to a week after taking Hydrochlorothiazide Aurovitas.
• skin cancer and lip cancer (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Hydrochlorothiazide Aurovitas

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
The blister should be stored in the outer packaging to protect it from light.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Hydrochlorothiazide Aurovitas contains

• The active substance of the medicine is hydrochlorothiazide.

Hydrochlorothiazide Aurovitas, 12.5 mg, tablets
Each tablet contains 12.5 mg of hydrochlorothiazide.
Hydrochlorothiazide Aurovitas, 25 mg, tablets
Each tablet contains 25 mg of hydrochlorothiazide.

• Other ingredients are: Tablet core:lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch, cornstarch, colloidal anhydrous silica, and magnesium stearate.

What Hydrochlorothiazide Aurovitas looks like and contents of the pack

Tablet.
Hydrochlorothiazide Aurovitas, 12.5 mg, tablets:
White or almost white, round, flat tablets with beveled edges, with the inscription "HC 12.5" on one side and a dividing line on the other. The tablet can be divided into equal doses.
Hydrochlorothiazide Aurovitas, 25 mg, tablets:
White or almost white, round, flat tablets with beveled edges, with the inscription "HC 25" on one side and a dividing line on the other. The tablet can be divided into equal doses.
Hydrochlorothiazide Aurovitas tablets are available in blister packs and HDPE containers.
Blister pack:
12.5 mg: 20, 30, 50, 60, 90, and 100 tablets
25 mg: 20, 30, 40, 50, 60, 90, and 100 tablets
HDPE container for all strengths: 500 tablets
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer

APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua Joao De Deus 19
Amadora 2700-487
Portugal
Arrow Generiques
26 Avenue Tony Garnier
Lyon 69007
France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Hydrochlorothiazide Aurovitas
France:
Hydrochlorothiazide Arrow 12.5 mg, comprimé
Hydrochlorothiazide Arrow 25 mg, comprimé sécable
Germany:
HCT PUREN 12.5 mg/ 25 mg/50 mg Tabletten
Italy:
Idroclorotiazide Aurobindo
Netherlands:
Hydrochloorthiazide Aurobindo 12.5 mg, /25 mg, /50 mg, tabletten
Poland:
Hydrochlorothiazide Aurovitas
Portugal:
Hidroclorotiazida Generis
Spain:
Hidroclorotiazida Aurovitas 25 mg comprimidos EFG
Hidroclorotiazida Aurovitas 50 mg comprimidos

Date of last revision of the leaflet: 03/2024