INDAPAMIDE 1.5 мг Таблетки с пролонгированным высвобождением

Содержание инструкции

1. Indapamide Aurobindo 1,5 mg prolonged-release tablets
   1. What is Indapamide Aurobindo and what is it 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

Indapamide Aurobindo 1,5 mg prolonged-release tablets

Generic medicine
Read this leaflet carefully before 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. Never give it to others. Even if they have the same symptoms as you, this medicine may be dangerous for others.
• 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 Indapamide Aurobindo is and what it is used for
• 2. What you need to know before you take 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 is Indapamide Aurobindo and what is it 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 a severe kidney disease;
• if you have a severe liver disease or suffer from a disease called hepatic encephalopathy (a degenerative brain disease);
• if you have low potassium levels in the 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 disturbances or kidney problems;
• if you need to undergo a test to check the function of the parathyroid gland;
• if you have decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to a few weeks after taking Indapamide Aurobindo. This can lead to permanent vision loss if not

treated. If you have had an allergy to penicillin or sulfonamide, the risk of this symptom occurring
may be higher.
You should inform your doctor if you have had photosensitivity reactions.
Your doctor may have you undergo blood tests to check if you have low levels of
sodium or potassium, or high levels of calcium in the blood.
If you think you fall into any of the above conditions or have any questions or doubts about how to take
this medicine, consult your doctor or pharmacist.
For those who play sports: be aware that the use of the drug without a therapeutic need
constitutes doping and may still result in a positive doping test.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The use of this medicine is not recommended during pregnancy. If a pregnancy is planned or
confirmed, a switch to alternative treatment should be undertaken as soon as possible. Tell your
doctor if you are pregnant or planning a pregnancy.
The active ingredient is excreted in breast milk. Breastfeeding is not recommended during the intake of
the drug.

Driving and operating machinery
This medicine can cause side effects related to lowering blood pressure such as
dizziness or fatigue (see section 4). These side effects are more likely to occur
at the beginning of treatment and following an increase in dose. If this happens, you should refrain from driving or from
other activities that require attention. However, these side effects are unlikely to occur
under good medical control.

Indapamide Aurobindo contains lactose
This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take Indapamide Aurobindo

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is one tablet a day, preferably in the morning. The tablets can be
taken independently of meals. They must be swallowed whole, with water. They must not be
crushed or chewed. Treatment for hypertension is usually for life.

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 the usual time. Do not take
a double dose to make up for a missed dose.

If you stop taking Indapamide Aurobindo
Since treatment for hypertension is usually for life, talk to your doctor before
stopping treatment with this medicine.
If you have any 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.
manifest.

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, which causes shortness of breath or difficulty swallowing. If this happens, 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, intense itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare) (may affect up to 1 in 10,000 people).
• Irregular heartbeat that can be life-threatening (not known).
• Inflammation of the pancreas that can cause severe pain in the abdomen and back, combined with a feeling of severe malaise (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, side effects may include:

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

• red, raised rash;
• allergic reactions, predominantly dermatological, in subjects with a predisposition 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 tired, headache, tingling (paresthesia), 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), leukopenia (reduction in white blood cells which can cause unexplained fever, sore throat or other flu-like symptoms - if this happens, contact your doctor) and anemia (reduction in red blood cells);
• increased levels of calcium in the blood;
• irregular heartbeat, low blood pressure;
• kidney disease;
• abnormal liver function. Not known(the frequency cannot be estimated from the available data)
• fainting;
• if you suffer from systemic lupus erythematosus (a type of collagen disease), it may worsen;
• cases of photosensitivity reactions (changes in skin appearance) have also been reported after exposure to the sun or artificial UVA rays;
• myopia;
• blurred vision;
• impaired vision;
• 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);
• changes in laboratory parameters (blood tests) may occur and your doctor may ask you to undergo blood tests to monitor your health condition. Laboratory parameters may change as follows:
• low levels of potassium in the blood;
• low levels of sodium in the blood, which can lead to dehydration and low blood pressure;
• increased uric acid, a substance that can cause or worsen gout (joint pain, especially in the feet);
• increased glucose levels in the blood in diabetic patients;
• increased calcium levels in the blood;
• increased levels of liver enzymes;
• abnormal ECG tracing.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please 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 Indapamide Aurobindo

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

• The active ingredient is indapamide. Each prolonged-release tablet contains 1.5 mg of indapamide.
• The other ingredients are: Tablet core: lactose monohydrate, 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
Prolonged-release, film-coated, round, biconvex tablets, from white to off-white in colour.
Indapamide Aurobindo is available in packs containing 10, 14, 15, 20, 30, 50, 60, 90, 100 prolonged-release tablets in blister packs (PVC/aluminium).

Marketing authorisation holder and manufacturer
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 - 21047 Saronno (VA)

Manufacturer responsible for batch release
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000,
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: