Hydrochlorothiazide aurovitas

Package leaflet: Information for the user

Hydrochlorothiazide Aurovitas, 12.5 mg, tablets
Hydrochlorothiazide Aurovitas, 25 mg, tablets
Hydrochlorothiazidum
Please read all of this leaflet carefully before 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Hydrochlorothiazide Aurovitas belongs to a group of medicines called diuretics. Diuretics increase the amount of water eliminated from the body in the urine.
Hydrochlorothiazide Aurovitas is used in adults to treat:

• Fluid retention in tissues causing swelling (oedema), resulting from heart, liver or kidney disease;
• High blood pressure (hypertension). In this case, it may be prescribed alone or together with another medicine.

2. Important information before using Hydrochlorothiazide Aurovitas

When not to use 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 pass urine (anuria);
• if the patient has severe kidney function impairment.

Warnings and precautions
Before starting treatment with Hydrochlorothiazide Aurovitas, inform your doctor or
pharmacist:

• if the patient previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or difficulty breathing occurs after taking Hydrochlorothiazide Aurovitas, seek immediate medical help;
• if the patient has severe kidney or liver disease;
• if the patient has renal artery stenosis (narrowing of the blood vessels supplying the kidneys or the only remaining kidney);
• if the patient has diabetes (high blood sugar levels);
• if the patient has high cholesterol or triglyceride levels;
• if the patient has a disease called "lupus erythematosus" (also known as "lupus" or "SLE");
• if the patient has low potassium levels in the blood (with or without symptoms such as muscle weakness, muscle cramps, or irregular heartbeat);
• if the patient has low sodium levels in the blood (with symptoms such as fatigue, confusion, muscle cramps or seizures, or without them);
• if the patient has been diagnosed with elevated calcium levels in the blood (with symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness or cramps);
• if the patient experiences gout attacks (deposits of uric acid crystals in the joints);
• if blurred vision or eye pain occurs. These may be symptoms of fluid accumulation in the uvea (the vascular layer surrounding the eye) or increased intraocular pressure – they may occur from several hours to a week after taking Hydrochlorothiazide Aurovitas. If untreated, this may lead to permanent vision disturbances. Patients previously allergic to penicillin or sulfonamides may be more prone to developing this condition;
• if the patient has allergies or asthma;
• if the patient experiences skin reactions such as rash after sun exposure;
• if the patient is taking any other medicines;
• if the patient is pregnant or planning to become pregnant;
• if the patient has had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially long-term use of high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). The skin should be protected from sunlight and UV radiation while taking Hydrochlorothiazide Aurovitas.

In patients chronically abusing diuretics, a pseudo-Bartter syndrome with fluid retention (edema) may occur.
During treatment with this medicine, an adequate amount of fluids should be consumed. Due to increased potassium loss, a potassium-rich diet (e.g. bananas, vegetables, nuts) is recommended.
Exposure to sunlight or solarium
If photosensitivity reactions occur due to taking this medicine and the doctor decides to continue treatment, the skin should be protected from sunlight and UV tanning beds must not be used (see also section 4 for instructions on what to do if these adverse effects occur).
Blood tests
The doctor may recommend regular blood tests during treatment to monitor kidney function and especially to check blood levels of sodium, potassium, calcium, glucose (sugar), and uric acid.
Elderly patients (aged 65 years and older)
When treating elderly patients (65 years and older), possible kidney function limitations should be taken into account (see section 3).
Hydrochlorothiazide Aurovitas and other medicines
Inform your doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines.
The doctor may need to adjust the dose and/or take additional precautions if the patient is taking other medicines, especially if taking any of the following:

• lithium (a medicine used in psychiatric disorders), because its combination with hydrochlorothiazide may lead to lithium toxicity;
• blood pressure-lowering medicines or medicines used in heart conditions [e.g. diuretics, ACE inhibitors such as ramipril, angiotensin II antagonists (such as valsartan), digoxin, nitrates, and similar];
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. antidepressants, anxiolytics, antipsychotics, neuroleptics);
• medicines used to treat heart rhythm disorders (e.g. hydroquinidine, 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 in the treatment of epilepsy);
• stimulant laxatives and other laxatives;
• corticosteroids;
• desmopressin (used in diabetes or urological disorders);
• chelating resins (substances mainly used in treating high blood lipid levels);
• domperidone (to prevent nausea and vomiting);
• medicines used to treat malaria (e.g. halofantrine, lumefantrine);
• medicines used for allergic reactions (e.g. mizolastine, mequitazine);
• antibiotics used to treat infections (e.g. amphotericin B, erythromycin, levofloxacin, moxifloxacin, spiramycin);
• iodinated contrast agents (used in imaging procedures);
• medicines used to treat prostate disorders (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin);
• medicines used to treat erectile dysfunction;
• medicines used in 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 in the treatment of addiction to certain active substances);
• medicines used to treat certain cancers (vandetanib, toremifene);
• vinpocetine (used to treat age-related neurological disorders);
• cyclosporine (used after organ transplantation, in autoimmune diseases, or severe rheumatic or dermatological conditions).

Hydrochlorothiazide Aurovitas with food and drink
Do not drink alcohol while taking this medicine, as it may cause orthostatic hypotension (a sudden drop in blood pressure causing dizziness upon changing position, e.g. standing up).
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, consult a doctor before taking this medicine.
Pregnancy
Generally, the doctor will recommend using another medicine instead of Hydrochlorothiazide Aurovitas, as it is not recommended during pregnancy, except in rare cases where no alternative treatment is possible.
This medicine crosses the placenta, and its use after the third month of pregnancy may seriously harm the unborn child.
Breastfeeding
Hydrochlorothiazide passes into breast milk. This medicine should not be taken during breastfeeding unless advised by a doctor.
Driving and operating machinery
Hydrochlorothiazide Aurovitas has a minor or moderate effect on the ability to drive and operate machinery.
Even when used as directed, this medicine may affect the patient's reactions. Therefore, the ability to drive and operate machinery or work in locations without solid support may be reduced.
This is particularly important at the beginning of treatment, when the dose is increased, when the medicine is changed, or when taken together with alcohol.
Anti-doping test
Hydrochlorothiazide may give a positive analytical result in an anti-doping test.
Hydrochlorothiazide Aurovitas contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to take Hydrochlorothiazide Aurovitas
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Hydrochlorothiazide Aurovitas tablets are 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.
High blood pressure (hypertension):
The currently recommended doses in hypertension are 12.5 mg or 25 mg per day.
Elderly patients:
When treating elderly patients (65 years and older), possible kidney function limitations should be considered.
Use in children and adolescents
There is no experience with use in children and adolescents. Therefore, hydrochlorothiazide should not be given to children and adolescents.
Method of administration
Oral administration.
Tablets should be swallowed with sufficient fluid.
This medicine can be taken independently of meals.
Tablets may be divided into equal doses.
Frequency of administration
This medicine has a diuretic effect (the patient passes urine more frequently). Taking this into account, it is best not to take the last dose late in the day to avoid waking up at night.
If the patient takes the tablets once daily, they should be taken in the morning.
Duration of treatment
The doctor will inform the patient how long to take this medicine.
The doctor will perform regular check-ups to ensure the treatment is effective.
If there are any questions regarding the duration of treatment, speak with the doctor or pharmacist.
Taking more Hydrochlorothiazide Aurovitas than prescribed
If nausea, drowsiness, muscle cramps, heart rhythm disturbances (irregular heartbeat), low blood pressure (recognized by dizziness), confusion, or urinary disturbances occur, contact a doctor immediately.
Missing a dose of Hydrochlorothiazide Aurovitas
If a dose is missed, take it as soon as possible. Do not take a double dose to make up for the missed dose, but continue treatment as prescribed.
Stopping Hydrochlorothiazide Aurovitas
Do not stop treatment with Hydrochlorothiazide Aurovitas unless instructed by a doctor. If the patient stops treatment, their blood pressure will rise above normal levels (see also "Duration of treatment").
If there are any further questions about using this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Effects requiring discontinuation of treatment:
In case of a reaction to sunlight (skin reaction), treatment must be stopped and the patient should see a doctor
or go to a hospital emergency department.
Very common (may affect more than 1 in 10 people):

• increased blood lipid levels (hyperlipidaemia)
• decreased blood potassium levels (hypokalaemia)

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

• itchy rash (urticaria) and other skin eruptions
• loss of appetite, nausea, vomiting, diarrhoea
• drop in blood pressure when standing up from a lying position
• difficulty in achieving or maintaining an erection (impotence)
• decreased blood magnesium levels (hypomagnesaemia)
• decreased blood sodium levels (hyponatraemia)
• increased blood uric acid levels (hyperuricaemia)

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

• acute kidney failure (marked reduction in urine output)

Rare (may affect up to 1 in 1,000 people):

• worsening of diabetes
• increased sensitivity to sunlight
• abdominal discomfort, constipation
• liver function disorders, sometimes accompanied by yellowing of the eyes and skin (jaundice)
• irregular heartbeat
• headache
• dizziness with a sensation of spinning
• sleep disturbances
• sadness (depression)
• tingling or numbness in hands or feet (paraesthesia)
• visual disturbances
• elevated blood glucose levels
• glucose in urine
• increased blood calcium levels (hypercalcaemia)
• low number of blood platelets, sometimes with bleeding or bruising under the skin (thrombocytopenia)

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

• facial rash, joint pain, muscle complaints, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, purple-red skin spots, fever (necrotising vasculitis)
• severe skin reaction causing rash, redness of the skin, formation of blisters on lips, eyes or inside the 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)
• suppression of bone marrow function leading to reduced numbers of red blood cells and/or low numbers of white blood cells and platelets
• damage to red blood cells causing paleness, fatigue, shortness of breath, dark urine (haemolytic anaemia)
• absence or low number of white blood cells, which may cause fever, sore throat or mouth ulcers, more frequent infections (leucopenia or possible symptoms of agranulocytosis)
• acid-base imbalance causing disorientation, fatigue, muscle cramps and spasms, rapid breathing (hypochloraemic alkalosis)

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

• inadequate production of various blood cells by the bone marrow (bone marrow suppression)
• marked reduction in urine output (possible symptoms of kidney disorders)
• severe skin disease causing rash, redness of the skin, formation of blisters on lips, eyes or inside the mouth, skin peeling, fever (erythema multiforme)
• fever
• muscle cramps
• weakness (asthenia)
• sudden loss of distance vision (acute myopia), blurred vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive fluid buildup between choroid and sclera – or acute angle-closure glaucoma)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in
this leaflet, please inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Hydrochlorothiazide Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging following the word EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Keep the blister in the outer packaging in order to protect from light.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Hydrochlorothiazide Aurovitas contains

• The active substance 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.

• The other ingredients are: Tablet core: monohydrate lactose, dicalcium hydrogen phosphate dihydrate, pregelatinized corn starch, corn starch, 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, uncoated tablets with bevelled edges, embossed with the mark “HC 12.5” on one side and a division line on the other side. The tablet can be divided into equal doses.
Hydrochlorothiazide Aurovitas, 25 mg, tablets:
White or almost white, round, flat, uncoated tablets with bevelled edges, embossed with the mark “HC 25” on one side and a division line on the other side. The tablet can be divided into equal doses.
Hydrochlorothiazide Aurovitas tablets are available in blister packs and HDPE containers.
Blister packs:
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 Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
Poland

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 authorised in the European Economic Area countries 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 EFG