Indapamide Aurobindo

Package leaflet: Information for the user

Indapamide Aurobindo 1.5 mg prolonged-release 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. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Indapamide Aurobindo 1.5 mg is a prolonged-release tablet containing indapamide as the active substance.
Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys.
However, unlike other diuretics, indapamide causes only a slight increase in the amount of urine produced.
This medicine is intended to reduce high blood pressure (hypertension) in adults.

2. What you need to know before taking Indapamide Aurobindo

Do not take Indapamide Aurobindo:

• if you are allergic to indapamide or to any other sulfonamide or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney disease;
• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disorder);
• if you have low levels of potassium in your blood.

Warnings and precautions:
Tell your doctor or pharmacist before taking Indapamide Aurobindo 1.5 mg prolonged-release tablets:

• if you have liver problems;
• if you have diabetes;
• if you suffer from gout;
• if you have heart rhythm disorders or kidney problems;
• if you are due to undergo a test to check the function of your parathyroid gland;
• if you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure inside the eye, and may occur from a few hours to several weeks after taking Indapamide Aurobindo. This may lead to permanent vision loss if not treated.
  If you have previously had an allergy to penicillin or sulfonamides, your risk of developing this symptom may be higher.
  You must inform your doctor if you have ever experienced photosensitivity reactions.
  Your doctor may carry out blood tests to check whether you have low levels of sodium or potassium, or high levels of calcium in your blood.
  If you think any of the above conditions apply to you, or if you have any questions or doubts about how to take this medicine, consult your doctor or pharmacist.
  For athletes: You should be aware that using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Other medicines and Indapamide Aurobindo
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
You must not take Indapamide Aurobindo 1.5 mg prolonged-release tablets with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.
Make sure you inform your doctor if you are taking any of the following medicines, as special attention may be required:

• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis);
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotic drugs, neuroleptics);
• bepridil (used to treat angina pectoris, a condition causing chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• sparfloxacin, moxifloxacin, injectable erythromycin (antibiotics used to treat infections);
• injectable vincamine (used in elderly patients for symptomatic treatment of cognitive disorders, including memory loss);
• halofantrine (an antiparasitic drug used to treat certain types of malaria);
• pentamidine (used to treat certain types of pneumonia);
• mizolastine (used to treat allergic reactions such as hay fever);
• non-steroidal anti-inflammatory drugs (NSAIDs) to relieve pain (e.g. ibuprofen) or high-dose acetylsalicylic acid;
• angiotensin-converting enzyme (ACE) inhibitors (used to treat hypertension and heart failure);
• injectable amphotericin B (an antifungal medicine);
• oral corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis;
• stimulant laxatives;
• baclofen (to treat muscle stiffness in diseases such as multiple sclerosis);
• allopurinol (for the treatment of gout);
• potassium-sparing diuretics (amiloride, spironolactone, triamterene);
• metformin (for the treatment of diabetes);
• iodinated contrast media (used in X-ray radiological examinations);
• calcium tablets or other calcium supplements;
• cyclosporine, tacrolimus, or other medicines that suppress the immune system after organ transplantation, to treat autoimmune diseases, or severe rheumatic or dermatological conditions;
• tetracosactide (for the treatment of Crohn's disease).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of this medicine during pregnancy is not recommended. If you plan to become pregnant or confirm a pregnancy, you should switch to an alternative treatment as soon as possible. Inform your doctor if you are pregnant or planning a pregnancy.
The active substance is excreted in breast milk. Breastfeeding is not recommended while taking this medicine.

Driving and using machines
This medicine may cause side effects related to low blood pressure such as dizziness or fatigue (see section 4). These side effects are more likely to occur at the beginning of treatment or after a dose increase. If this happens, you must refrain from driving or performing any other activities requiring alertness. However, such side effects are unlikely to occur under proper medical supervision.

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

3. How to take Indapamide Aurobindo

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily, preferably in the morning. The tablets may be
taken regardless of meals. They must be swallowed whole with water. They must not be
crushed or chewed. Treatment for hypertension is usually lifelong.
If you take more Indapamide Aurobindo than you should
If you have taken too many tablets, contact your doctor or pharmacist immediately.
At very high doses, Indapamide Aurobindo 1.5 mg prolonged-release tablets may cause nausea,
vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion, and changes in the amount of
urine produced by the kidneys.
If you forget to take Indapamide Aurobindo
If you forget to take a dose of the medicine, take the next dose at your usual time. Do not take
a double dose to make up for the forgotten dose.
If you stop taking Indapamide Aurobindo
Since treatment for hypertension is usually lifelong, speak with your doctor before stopping
treatment with this medicine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you notice any of the following side effects, stop taking the medicine and consult your doctor
immediately:

• Angioedema and/or urticaria. Angioedema is characterised by swelling of the skin of the extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or airways, causing shortness of breath or difficulty swallowing. If this occurs, contact your doctor immediately (very rare) (may affect up to 1 in 10,000 people).
• Severe skin reactions, including intense skin reaction, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare) (may affect up to 1 in 10,000 people).
• Irregular heartbeat that may be life-threatening (not known).
• Inflammation of the pancreas which may cause severe abdominal and back pain, accompanied by a strong feeling of illness (very rare) (may affect up to 1 in 10,000 people).
• Brain disease caused by liver disease (hepatic encephalopathy) (not known).
• Inflammation of the liver (hepatitis) (not known).

In order of decreasing frequency, the side effects may include:
Common (may affect up to 1 in 10 people) :

• red, raised rash;
• allergic reactions, mainly dermatological, in subjects predisposed to allergic and asthmatic reactions.

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

• vomiting;
• small red spots on the skin (purpura).
  Rare (may affect up to 1 in 1,000 people) :
• feeling of tiredness, headache, tingling (paraesthesia), dizziness;
• gastrointestinal disorders (such as nausea, constipation), dry mouth.

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

• changes in blood cells, such as thrombocytopenia (reduction in the number of platelets causing easy bruising and nosebleeds), leucopenia (reduction in white blood cells which may cause unexplained fever, sore throat or other flu-like symptoms – if this occurs, contact your doctor) and anaemia (reduction in red blood cells);
• increased levels of calcium in the blood;
• irregular heart rhythm, low blood pressure;
• kidney disease;
• abnormal liver function.
  Not known (frequency cannot be estimated from the available data)
• fainting;
• if you suffer from systemic lupus erythematosus (a type of collagen disease), your condition may worsen;
• cases of photosensitivity reactions (skin changes) have also been reported after exposure to sunlight or artificial UVA rays;
• myopia;
• blurred vision;
• visual impairment;
• decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma);
• laboratory test parameters (blood tests) may change, and your doctor may ask you to have blood tests to monitor your health status. Laboratory parameters may change as follows:
• low levels of potassium in the blood;
• low levels of sodium in the blood, which may lead to dehydration and reduced blood pressure;
• increased uric acid, a substance that may cause or worsen gout (joint pain, especially in the feet);
• increased blood glucose levels in diabetic patients;
• increased level of calcium in the blood;
• increased levels of liver enzymes;
• abnormal ECG tracing.

Reporting of side effects
If you get any side effects, 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 Indapamide Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
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 Indapamide Aurobindo contains

• The active substance is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
• The other components are:
  Tablet core: monohydrate lactose, pregelatinized starch, hypromellose, anhydrous colloidal silica, magnesium stearate (vegetable).
  Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E171).

Description of the appearance of Indapamide Aurobindo and contents of the pack
White to almost white, round, biconvex prolonged-release film-coated tablets.
Indapamide Aurobindo is available in packs containing 10, 14, 15, 20, 30, 50, 60, 90, 100 prolonged-release tablets in blister packs (PVC/aluminum).

Marketing Authorization Holder and Manufacturer
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 - 21047 Saronno (VA)

Responsible lot manufacturer
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000,
Malta

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