IDROCLOROTIAZIDE 25 mg Tablet

Зміст інструкції

1. Idroclorotiazide Aurobindo 25 mg tablets
   1. What is Idroclorotiazide Aurobindo 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

Idroclorotiazide Aurobindo 25 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is Idroclorotiazide Aurobindo and what it is used for
• 2. What you need to know before you take 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 is Idroclorotiazide Aurobindo 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 the tissues that leads to swelling (edema) caused by problems of the heart, liver or kidneys,
• 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 takeIdroclorotiazide 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 a severe kidney or liver disease
if you have stenosis of the renal artery (narrowing of the blood vessels that supply 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, spasms
muscle or abnormal heartbeat)
if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, spasms
muscle or cramps)
if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, pain
to the stomach, 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 have decreased vision or eye pain. These may be symptoms
1/7
of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase
in eye pressure and can occur within a period ranging from a few hours to weeks
after taking Idroclorotiazide Aurobindo. This can lead to permanent vision loss if
not treated. If you have previously had an allergy to penicillin or sulfonamides, you may
be at higher risk of developing this.
if you suffer from allergy or asthma
if you have skin reactions such as erythema after exposure to the sun
if you are taking any other medicine
if you are pregnant or intend to become pregnant
if you have had skin cancer or if you develop an unexpected skin lesion during treatment.
Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase
the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect
your skin from exposure to the sun and UV rays while taking Idroclorotiazide Aurobindo.

Exposure to sunlight or UV tanning booths
If you have had reactions to sunlight due to this medicine and your doctor has decided to continue the
treatment, you must protect your skin from the sun 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 undergo regular blood tests during treatment to
monitor kidney function and check in particular the levels of sodium, potassium, calcium, sugar
(glucose) and uric acid in the blood.

Elderly (65 years and over):
Caution should be exercised in the treatment of elderly patients regarding possible limitations of renal function (see section 3).

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

• lithium (a medicine used for mental health problems), because its combination with hydrochlorothiazide can cause a lithium overdose,
• medicines to lower blood pressure or treat heart disease (for example diuretics, ACE inhibitors such as ramipril, angiotensin II antagonists such as valsartan, digoxin, nitrates and similar),
• medicines for the treatment of mental health problems such as depression, anxiety, schizophrenia (e.g. antidepressants, anxiolytics, antipsychotics, neuroleptics),
• medicines for the treatment of heart rhythm problems (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 used mainly to treat high levels of lipids in the blood),
• domperidone (to stop nausea and vomiting),
• medicines to treat malaria (e.g. alofantrine, lumefantrine),
• medicines for the treatment of allergic reactions (e.g. mizolastine, mequitazine),
• antibiotics to treat infections (e.g. amphotericin B, erythromycin, levofloxacin, moxifloxacin, spiramycin),
• iodinated contrast agents (used in imaging studies),

2/7

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.

Pregnancy
In general, your doctor will advise you to take another medicine instead of Idroclorotiazide Aurobindo
because 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 can 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 operating machinery
Idroclorotiazide Aurobindo tablets have a mild or moderate effect on the ability to drive vehicles and
operate machinery.
Even when used as directed, this medicine may affect your reactions. Therefore, the ability to
drive or operate machinery or work in places without solid support may be impaired.
This is especially true at the beginning of treatment, when the dose is increased, the drug is changed or
taken in combination with alcohol.

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

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

3. How to take Idroclorotiazide Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Idroclorotiazide Aurobindo tablets are available in 3 dosages: 12.5 mg, 25 mg and 50 mg tablets.
Edema:
The usual starting dose is from 50 mg to 100 mg of hydrochlorothiazide per day.
3/7
The maintenance dose is usually from 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:
In the treatment of elderly patients (65 years and over), attention should be paid to possible limitations
of renal function.

Use in children and adolescents
There is no experience in children and adolescents. Therefore, hydrochlorothiazide should not be
administered to children and adolescents.

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

Frequency of administration
This drug has a diuretic effect (i.e. you will urinate more often). With that said, it is best not to take
the last dose at the end of the day to avoid waking up during the night.
If you take the tablets in one dose, take them in the morning.

Duration of treatment
The doctor will tell you how long you will have to take this medicine.
The doctor will perform regular checks to ensure that the treatment has the expected effects.
If you have questions about the duration of treatment, talk to 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 contractions, heart 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 a forgotten dose but continue the treatment as prescribed.

If you forget to take Idroclorotiazide Aurobindo
Do not stop the treatment with Idroclorotiazide Aurobindo unless your doctor tells you to do so. If
you stop the treatment, your blood pressure will not be controlled (see also "Duration of
treatment”).
If you have further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Side effects that require stopping treatment:
You should stop treatment and consult a doctor or emergency room in case of a reaction to
sunlight (skin reaction).

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

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

4/7

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

• itchy rash (urticaria) and other forms of skin rash
• decreased appetite, nausea, vomiting, diarrhoea
• lowering of blood pressure when moving from a lying to an upright position
• inability to achieve or maintain an erection (impotence)
• lowering of blood magnesium levels (hypomagnesaemia)
• lowering of blood sodium levels (hyponatraemia)
• increased levels of uric acid in the blood (hyperuricaemia)

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

• acute kidney failure (severely reduced urine flow)

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 a sensation of spinning
• sleep disorders
• feeling sad (depression)
• tingling or numbness in the hands or feet (paraesthesia)
• vision problems
• increased blood sugar levels
• presence of sugar in the urine
• increased levels of calcium in the blood (hypercalcaemia)
• low level of platelets in the blood, sometimes with bleeding or bruising under the skin (thrombocytopenia)

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

• rash on the face, joint pain, muscle problems, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, purplish-red spots on the skin, fever (necrotizing vasculitis)
• severe skin reactions causing rash, redness of the skin, blisters on the lips, eyes or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
• allergic reaction (hypersensitivity reaction)
• severe abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, dyspnoea (difficulty breathing including pneumonia and pulmonary oedema)
• depression of the bone marrow with resulting reduction in the number of red blood cells and/or an abnormally low level of white blood cells and platelets
• destruction of red blood cells causing pallor, fatigue, shortness of breath, dark urine (haemolytic anaemia)
• lack or low level of white blood cells which can cause fever, sore throat or mouth ulcers, more frequent infections (leucopenia or possible signs of agranulocytosis).
• disturbances of the acid-base balance causing confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloraemic alkalosis).

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack or blister 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 in the original pack to protect it from light.
Store in the original packaging to protect from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Idroclorotiazide Aurobindo contains

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

Description of the appearance of Idroclorotiazide Aurobindo and contents of the pack
Uncoated tablets of colour from white to almost white, round, flat with bevelled edges, with
"HC 25" imprinted on one side and a breakline on the other side. The tablet can be divided into equal doses.
Idroclorotiazide Aurobindo tablets is available in blister packs and HDPE bottle.
Blister packs:

25 mg:20, 30, 40, 50, 60, 90 and 100 tablets.
HDPE bottle packs:
500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102

• 21047 – Saronno (VA)

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 authorised in the Member States of the European Economic Area with the following
denominations:
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 Tablets
Italy Idroclorotiazide Aurobindo
Netherlands Hydrochloorthiazide Aurobindo 12.5 mg/25 mg/50 mg, tablets
Poland Hydrochlorothiazide Aurovitas
Portugal Hidroclorotiazida Generis
Spain Hidroclorotiazida Aurovitas 25 mg comprimidos EFG
Hidroclorotiazida Aurovitas 50 mg comprimidos
7/7