INDAPAMIDE 2.5 mg Коированные таблетки

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1. INDAPAMIDE MYLAN GENERICS 2,5 mg coated tablets
   1. What is INDAPAMIDE MYLAN GENERICS and what it is used for
   2. What you need to know before you take INDAPAMIDE MYLAN GENERICS
   3. How to take INDAPAMIDE MYLAN GENERICS
   4. Possible side effects
   5. How to store INDAPAMIDE MYLAN GENERICS
   6. Contents of the pack and other information

INDAPAMIDE MYLAN GENERICS 2,5 mg coated tablets

Indapamide

Equivalent Medicinal Product

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

1. What is INDAPAMIDE MYLAN GENERICS and what it is used for

This medicine contains the active ingredient indapamide, belonging to the group of medicines called
diuretics, which work by promoting the elimination of fluids from the body and therefore lowering blood
pressure.
INDAPAMIDE MYLAN GENERICS is used for the treatment of high blood pressure
(arterial hypertension).

2. What you need to know before you take INDAPAMIDE MYLAN GENERICS

Do not take INDAPAMIDE MYLAN GENERICS

• if you are allergic to indapamide or other similar medicines (sulphonamide derivatives) or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal failure) and if you have a reduced urge to urinate (anuria);
• if you have liver problems (hepatic encephalopathy or severe impairment of liver function);
• if you have low levels of potassium in your blood (hypokalaemia);
• if you have recently had problems with the circulation of the brain (cerebrovascular accidents);
• if you have been diagnosed with a type of tumor called pheochromocytoma;
• if you have been diagnosed with overactivity of the adrenal gland (Conn's syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before taking INDAPAMIDE MYLAN GENERICS.
If you have liver problems (impaired liver function), you may experience a condition called
hepatic encephalopathy, characterized by mental confusion and drowsiness, especially if there is a change
in the levels of salts in the blood (sodium, potassium). Stop taking this
medicine immediately if you experience these symptoms.
Stop taking this medicine if you experience skin irritation accompanied by itching in areas
that have been exposed to the sun (photosensitivity reactions). If it is necessary to resume treatment, protect
the irritated areas from the light.
If you are pregnant.
During treatment with this medicine, a decrease in thyroid activity may occur without
accompanying symptoms.
Take particular care with this medicine and tell your doctor:

• if you have high levels of uric acid in your blood (hyperuricemia) and are prone to inflammation of the joints (gout);
• if you are an elderly person and have kidney problems (persistent renal failure).

During the use of this medicine, your doctor may prescribe periodic blood tests to
check the levels of:

• sodium, both before starting and during treatment. If you are an elderly person or if you have liver problems (cirrhosis), these checks should be even more frequent.
• potassium, especially if you are an elderly person or malnourished, if you have liver problems (cirrhosis with edema and ascites), if you have heart problems (heart failure and coronary artery disease, prolonged QT interval). The first check should be performed during the first week of starting treatment. If the levels of potassium in the blood decrease (hypokalaemia), a dose adjustment is necessary.
• sugar (glycaemia), especially if you have diabetes and if your potassium levels in the blood are low (hypokalaemia);
• calcium, because an increase in calcium levels (hypercalcemia) may indicate an altered activity of the parathyroid gland (hyperparathyroidism). Stop treatment before checking the function of the parathyroid gland.
• uric acid, because gout attacks may increase.

For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Children and adolescents
The use of this medicine is not recommended in children and adolescents.

Other medicines and INDAPAMIDE MYLAN GENERICS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Take particular care and tell your doctor if you are taking:

• medicines containing lithium, used to treat depression. Association with this medicine, if necessary, requires monitoring of lithium levels in the blood and dose adjustment.
• non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain, especially if you are dehydrated;
• other medicines used to treat high blood pressure, such as ACE inhibitors, if you have low levels of sodium in your blood;
• baclofen, used to treat muscle disorders. Increase your fluid intake and check your kidney function before starting treatment.
• digoxin medicines, used to treat heart rhythm disorders;
• amphotericin B (when given intravenously), a medicine used for fungal infections;
• glucocorticoids and mineralocorticoids (systemic), used for various disorders such as asthma and rheumatoid arthritis;
• tetracosactide, a medicine used to treat various conditions (rheumatoid arthritis, late stages of some cancers, Crohn's disease and other autoimmune diseases);
• stimulant laxatives, used to promote bowel movements;
• potassium-sparing diuretics, such as amiloride, spironolactone, triamterene;
• metformin, a medicine used to treat diabetes;
• allopurinol, a medicine used to reduce uric acid levels in the blood.
• iodinated contrast agents;
• calcium salts;
• cyclosporine and tacrolimus, medicines used in case of transplants;
• imipramine-like antidepressants, used to treat depression;
• neuroleptics, used to treat mental disorders (psychoses).

Tell your doctor and avoid taking INDAPAMIDE MYLAN GENERICS if you have low levels of
potassium in your blood (hypokalaemia) and are taking the following medicines:

• medicines used to treat heart rhythm disorders such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide;
• medicines used to treat mental disorders (antipsychotics) such as chlorpromazine, ciamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, haloperidol;
• bepridil, used to treat heart problems;
• cisapride and difemanil, used for stomach and intestinal problems;
• erythromycin given intravenously
• halofantrine, used to treat a type of malaria;
• mizolastine, used to treat allergies;
• pentamidine, used to treat some types of pneumonia;
• sparfloxacin, moxifloxacin and erythromycin given intravenously, antibiotics used to treat bacterial infections;
• vincamine given intravenously, used to treat some nervous system disorders. The association of this medicine with those listed above may increase the risk of heart problems (torsade de pointes), especially if you have low levels of potassium in your blood. Before starting treatment with this medicine, it is necessary to check the levels of salts in the blood and heart activity (electrocardiogram). If you have low levels of potassium in your blood, they must be brought back to normal levels before taking INDAPAMIDE MYLAN GENERICS.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Avoid using this medicine if you are pregnant. Do not use this medicine if you are pregnant to treat physiological swelling (physiological edema). Diuretic medicines can cause
serious harm to the growth of the fetus.
It is not recommended to use this medicine if you are breastfeeding.
In men, no effects on fertility are expected.

Driving and using machines
This medicine does not alter concentration, but different reactions may occur due to
lowering of blood pressure, especially at the beginning of treatment or when this medicine is
combined with another antihypertensive agent. In this case, the ability to drive
vehicles or operate machinery may be impaired.

INDAPAMIDE MYLAN GENERICS contains lactose and sucrose
This medicine contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with a
intolerance to some sugars, contact him before taking this medicine.

3. How to take INDAPAMIDE MYLAN GENERICS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is 1 tablet a day to be taken in the morning.

Use in patients with kidney problems (renal insufficiency)
The doctor will adjust the dose based on kidney function.
This medicine is effective only if you have a correct functioning of the kidneys or if this is minimally
reduced (see paragraph 2).
Do not use this medicine if you suffer from severe renal insufficiency (see paragraph 2).

Use in patients with liver problems (hepatic insufficiency)
If you suffer from hepatic insufficiency, a dose reduction is necessary.
Do not use this medicine in case of severe hepatic insufficiency (see paragraph 2).

Use in elderly people
The doctor will adjust the dosage based on age, weight and sex.
Take this medicine only if you have normal kidney function or if this is minimally
compromised (see paragraph 2).

If you take more INDAPAMIDE MYLAN GENERICS than you should
This medicine has not shown toxicity for doses much higher than the therapeutic dose. Signs
of intoxication manifest mainly with alterations in sodium and potassium levels in the blood:
Symptoms include:

• nausea and vomiting;
• decreased blood pressure (hypotension);
• involuntary muscle contractions associated with pain (cramps);
• dizziness;
• drowsiness, confusion;
• increased or decreased urine production (polyuria and oliguria) up to a possible absent urine production (anuria). In case of ingestion/taking an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take INDAPAMIDE MYLAN GENERICS
Do not take a double dose to make up for the missed tablet.
If you have any doubts about 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.
The following side effects may occur:

Common:

• maculopapular rashes

Uncommon(may affect up to 1 in 100 people)

• vomiting;
• skin disease associated with bleeding (purpura).

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

• dizziness;
• feeling of fatigue and drowsiness;
• headache
• tingling in the hands and feet (paresthesia);
• stomach and intestinal disorders (gastrointestinal intolerance), nausea and constipation;
• dry mouth;
• muscle pain (cramps).

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

• decreased levels of platelets (thrombocytopenia), decreased levels of white blood cells (leukopenia, agranulocytosis), decreased levels of all blood components (aplastic anemia) and decreased red blood cells (hemolytic anemia);
• irregular heartbeats (arrhythmias);
• low blood pressure (hypotension);
• inflammation of the pancreas (pancreatitis);
• liver disorders;
• swelling around the eyes and mouth (angioedema);
• skin irritation (urticaria), severe skin disease (toxic epidermal necrolysis) and allergic-type manifestations (Stevens-Johnson syndrome);
• kidney problems (renal failure);
• increased levels of calcium in the blood.

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

• loss of consciousness (syncope);
• confusional state;
• vision disorders (myopia, blurred vision, impaired vision)
• heart disorders such as torsade de pointes (see section 2);
• rapid heartbeat (palpitations);
• feeling of dizziness when getting up due to a rapid drop in blood pressure (orthostatic hypotension);
• hepatic encephalopathy, characterized by mental confusion and drowsiness, if you have liver problems (liver failure);
• liver problems (hepatitis)
• skin disorders such as itching, irritation (erythema, rash, photosensitivity);
• worsening of a skin disease called lupus erythematosus;
• kidney problems (acute renal failure);
• asthenia
• falls;
• alteration of the heartbeat (prolongation of the QT interval);
• lowering of potassium and sodium levels in the blood (see section 2). If chloride ion levels are lowered at the same time, a condition called metabolic alkalosis may occur.
• increased levels of uric acid and blood sugar (hyperglycemia). Pay particular attention if you have diabetes or gout;
• slight increase in blood urea nitrogen;
• increased liver enzymes

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
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store INDAPAMIDE MYLAN GENERICS

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the 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 MYLAN GENERICS contains

• The active ingredient is indapamide. Each tablet contains 2.5 mg of indapamide.
• The other ingredients are lactose, sucrose, corn starch, talc, gum arabic, magnesium carbonate, magnesium stearate, titanium dioxide, erythrosine red (E127).

Description of the appearance of INDAPAMIDE MYLAN GENERICS and contents of the pack
Pack of 50 coated tablets.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturer
Mipharm S.p.A., Via B. Quaranta 12, 20141 Milan
ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10090 Ivrea (TO)