Hydrochlorothiazide Aurobindo

Patient Information Leaflet: Information for the user

Hydrochlorothiazide Aurobindo 25 mg tablets

Generic medicine
Please read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Idroclorotiazide Aurobindo is and what it is used for

Idroclorotiazide Aurobindo belongs to a group of medicines called "diuretics". Diuretics increase the amount of water excreted in the urine.
Idroclorotiazide Aurobindo is used in adults to treat:

• fluid retention in tissues leading to swelling (edema) caused by heart, liver or kidney problems,
• high blood pressure (hypertension). In this case, it may be prescribed alone or in combination with other antihypertensive medicines.

2. What you need to know before taking Idroclorotiazide Aurobindo

Do not take Idroclorotiazide Aurobindo
if you are allergic to hydrochlorothiazide or any of the other ingredients of this medicine
(listed in section 6);
if you are unable to urinate (anuria);
if you have severe kidney impairment;

Warnings and precautions
Talk to your doctor or pharmacist before taking Idroclorotiazide Aurobindo
if you have severe kidney or liver disease;
if you have renal artery stenosis (narrowing of the blood vessels supplying both kidneys or a single kidney);
if you have diabetes (high blood sugar levels);
if your cholesterol or triglyceride levels are high;
if you have had a disease called "lupus erythematosus" (also known as "lupus" or "SLE");
if you have low levels of potassium in your blood (with or without symptoms such as muscle weakness, muscle cramps, or irregular heartbeat);
if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle cramps, or spasms);
if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent need to urinate, feeling thirsty, muscle weakness, or spasms);
if you suffer from gout attacks (deposits of uric acid crystals in the joints);
if you experience vision changes or eye pain. These could be symptoms
1/7
of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking Idroclorotiazide Aurobindo. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at increased risk of developing this condition.
if you suffer from allergies or asthma;
if you experience skin reactions such as redness after sun exposure;
if you are taking any other medicine;
if you are pregnant or planning to become pregnant;
if you have had skin cancer or 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 non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Idroclorotiazide Aurobindo.

Exposure to sunlight or UV tanning booths
If you have experienced sun-related reactions due to this medicine and your doctor has decided to continue treatment, you must protect your skin from sunlight and must not use UV tanning booths (see also section 4 on what to do if these side effects occur).

Blood tests
Your doctor may ask you to have regular blood tests during treatment to monitor kidney function and particularly to check levels of sodium, potassium, calcium, blood sugar (glucose), and uric acid in your blood.

Elderly (65 years and over):
When treating elderly patients, possible limitations in kidney function should be taken into account (see section 3).

Other medicines and Idroclorotiazide Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust the dose and/or take other precautions if you are taking other medicines, especially if you are taking any of the following:

• lithium (a medicine used for mental health conditions), because its combination with hydrochlorothiazide may cause lithium overdose;
• medicines to lower blood pressure or treat heart conditions (e.g. diuretics, ACE inhibitors such as ramipril, angiotensin II antagonists such as valsartan, digoxin, nitrates, and similar);
• medicines for mental health conditions such as depression, anxiety, schizophrenia (e.g. antidepressants, anxiolytics, antipsychotics, neuroleptics);
• medicines for heart rhythm disorders (e.g. quinidine, disopyramide, amiodarone, dronedarone, sotalol, digoxin);
• medicines used for pain or inflammation, non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) and aspirin;
• carbamazepine or oxcarbazepine (for the treatment of epilepsy);
• stimulant laxatives and other laxatives;
• corticosteroids;
• desmopressin (for diabetes or urinary problems);
• chelating resins (substances mainly used to treat high lipid levels in the blood);
• domperidone (to stop nausea and vomiting);
• medicines for treating malaria (e.g. halofantrine, lumefantrine);
• medicines for treating allergic reactions (e.g. mizolastine, mequitazine);
• antibiotics for treating infections (e.g. amphotericin B, erythromycin, levofloxacin, moxifloxacin, spiramycin);
• iodinated contrast agents (used in imaging studies);

2/7

• medicines for treating prostate disorders (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin);
• medicines for erectile dysfunction;
• medicines used in Parkinson’s disease (dopamine agonists, levodopa);
• baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis);
• calcium tablets or other calcium supplements;
• methadone (to treat dependence on certain active substances);
• medicines for treating certain cancers (vandetanib, toremifene);
• vincamine (used to treat neurological disorders related to aging);
• cyclosporine (used after organ transplantation, or for treating autoimmune diseases or severe rheumatic or dermatological conditions).

Idroclorotiazide Aurobindo with food and alcohol
Do not consume alcohol while taking this medicine, as it may cause orthostatic hypotension (a sudden drop in blood pressure causing dizziness due to a change in position, e.g. when standing up).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
In general, your doctor will advise you to take another medicine instead of Idroclorotiazide Aurobindo, as it is not recommended during pregnancy except in rare cases where no other treatment can be used.
This medicine crosses the placenta and its use after the third month of pregnancy may cause serious harm to the baby.
Breastfeeding
Hydrochlorothiazide is excreted in breast milk. Do not take this medicine while breastfeeding unless advised by your doctor.

Driving and using machines
Idroclorotiazide Aurobindo tablets have a minor or moderate effect on the ability to drive and use machines.
Even when used as directed, this medicine may affect your reaction time. Therefore, your ability to drive, operate machinery, or work at heights without secure support may be impaired.
This is particularly true at the beginning of treatment, when the dose is increased, when the medicine is changed, or when taken together with alcohol.

Anti-doping tests
Hydrochlorothiazide may produce a positive analytical result in an anti-doping test.

Idroclorotiazide Aurobindo contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Idroclorotiazide Aurobindo

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Idroclorotiazide Aurobindo tablets are available in 3 strengths: 12.5 mg, 25 mg, and 50 mg tablets.

Edema:
The usual starting dose is 50 mg to 100 mg of hydrochlorothiazide per day.
3/7
The maintenance dose is usually 25 mg to 50 mg of hydrochlorothiazide per day.

High blood pressure (hypertension):
The currently recommended doses in arterial hypertension are 12.5 mg or 25 mg per day.

Elderly patients:
When treating elderly patients (65 years and older), caution should be exercised due to possible reduced
kidney function.

Use in children and adolescents
There is no experience with this medicine in children and adolescents. Therefore, hydrochlorothiazide must not be
administered to children and adolescents.

Method of administration
For oral use.
Swallow the tablets with a sufficient amount of liquid.
This medicine may be taken with or without food.
The 25 mg and 50 mg tablets may be divided into equal doses.

Frequency of administration
This medicine has a diuretic effect (i.e., you will urinate more frequently). Therefore, it is best not to take
the last dose late in the day to avoid waking up during the night.
If you take the tablets once daily, take them in the morning.

Duration of treatment
Your doctor will tell you how long you should take this medicine.
Your doctor will perform regular checks to ensure the treatment is having the intended effects.
If you have any questions about the duration of treatment, speak with your doctor or pharmacist.

If you take more Idroclorotiazide Aurobindo than you should
Contact your doctor or go immediately to the emergency room if you experience nausea, drowsiness,
muscle cramps, cardiac arrhythmias (irregular heartbeat), low blood pressure (recognizable by dizziness), confusion, or urinary problems.

If you forget to take Idroclorotiazide Aurobindo
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for
the missed dose, but continue treatment as prescribed.

If you stop taking Idroclorotiazide Aurobindo
Do not stop treatment with Idroclorotiazide Aurobindo unless your doctor tells you to. If
you stop treatment, your blood pressure will not be controlled (see also "Duration of treatment").

If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Effects requiring discontinuation of treatment:
Treatment must be stopped and a doctor or emergency department consulted if a reaction to sunlight occurs (skin reaction).

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

• an increase in blood lipids (hyperlipidemia)
• a decrease in blood potassium levels (hypokalemia)

4/7

Common (may affect up to 1 in 10 people):

• itchy red rash (urticaria) and other forms of skin rash
• loss of appetite, nausea, vomiting, diarrhea
• drop in blood pressure when changing from a lying to a standing position
• inability to achieve or maintain an erection (impotence)
• decrease in blood magnesium levels (hypomagnesemia)
• decrease in blood sodium levels (hyponatremia)
• increase in blood uric acid levels (hyperuricemia)

Uncommon (may affect up to 1 in 100 people):

• acute kidney failure (severely reduced urine output)

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

• worsening of diabetes
• increased sensitivity to sunlight
• abdominal discomfort, constipation
• liver disorders which may be accompanied by yellowing of the eyes and skin
• irregular heartbeat
• headache
• dizziness with spinning sensation
• sleep disorders
• feeling sad (depression)
• tingling or numbness in the hands or feet (paresthesia)
• vision problems
• increased blood sugar levels
• presence of sugars in urine
• increased blood calcium levels (hypercalcemia)
• low platelet count in 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 problems, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, purple-red skin lesions, fever (necrotizing vasculitis)
• severe skin reactions causing rash, skin redness, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• allergic reaction (hypersensitivity reaction)
• severe abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory difficulty including pneumonia and pulmonary edema)
• bone marrow suppression leading to reduced number of red blood cells and/or abnormally low levels of white blood cells and platelets
• destruction of red blood cells causing paleness, fatigue, shortness of breath, dark urine (hemolytic anemia)
• absence or low levels of white blood cells which may cause fever, sore throat or mouth ulcers, more frequent infections (leukopenia or possible signs of agranulocytosis)
• disturbances in acid-base balance causing confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloremic alkalosis)

Not known (frequency cannot be estimated from the available data):

• inadequate production of various blood cells by the bone marrow (myelosuppression)
• markedly decreased urine production (possible signs of kidney problems)
• severe skin disease causing rash, skin redness, blisters on lips, eyes or mouth, skin peeling, fever (erythema multiforme)
• fever
• muscle spasms

5/7

• weakness (asthenia)
• decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• skin and lip cancer (non-melanoma skin tumor)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Idroclorotiazide Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Keep the blister pack in the original carton to protect it from light.
Store in the original packaging to protect from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Idroclorotiazide Aurobindo contains

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

Description of the appearance of Idroclorotiazide Aurobindo and package contents
Uncoated tablets, white to almost white, round, flat with bevelled edges, imprinted with "HC 25" on one side and a break line on the other side. The tablet can be divided into equal doses.
Idroclorotiazide Aurobindo tablets are available in blister packs and HDPE bottles.
Blister packs:
25 mg: 20, 30, 40, 50, 60, 90 and 100 tablets.
HDPE bottles:
500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 – Saronno (VA)
Italy

Manufacturers
6/7
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
Arrow Generiques
26 Avenue Tony Garnier
Lyon, Rhone, 69007
France

This medicinal product is authorized 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
7/7