INDAPAMIDE 2.5 mg Coated tablets

Зміст інструкції

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

INDAPAMIDE SANDOZ 2,5 mg coated tablets

Equivalent Medicinal Product

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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is INDAPAMIDE SANDOZ and what it is used for

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

2. What you need to know before you take INDAPAMIDE SANDOZ

Do not take INDAPAMIDE SANDOZ

• 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 insufficiency) and if you have a reduced urge to urinate (anuria);
• if you have liver disease (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 blood circulation in the brain (cerebrovascular accidents);
• if you have been diagnosed with a 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 SANDOZ.

• If you suffer from 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 blood salt levels (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 light.
• If you have a decrease in 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 few hours to weeks after taking Indapamide Sandoz. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may be at greater risk of developing this condition.

During treatment with this medicine, a decrease in thyroid gland activity may occur without symptoms.
Pay particular attention to the use of the medicine and inform your doctor:

• if you have high levels of uric acid in your blood (hyperuricemia) and are prone to joint inflammation (gout); if you are an elderly person and if you have kidney problems (persistent renal insufficiency); if you experience a decrease in 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 few hours or weeks of taking INDAPAMIDE SANDOZ. 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 greater risk of developing it.

During treatment with this medicine, a slight decrease in blood acidity
(hypochloraemic alkalosis) may occur, which requires specific treatments if you suffer from liver or kidney disorders.
During the use of this medicine, your doctor may periodically prescribe blood tests for
checking the levels of:

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

This medicine is more effective if kidney function is normal or only slightly impaired. In elderly subjects, creatinine levels should be monitored in relation to age, weight and sex. This medicine can
cause a decrease in blood volume (hypovolaemia) inducing a decrease in kidney activity and
an increase in urea and creatinine in the blood.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and can
still result in positive doping tests.

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

Other medicines and INDAPAMIDE SANDOZ
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Pay particular attention and tell your doctor if you are taking:

• medicines containing lithium, used to treat depression. The association with this medicine, if necessary, requires monitoring of lithium levels in the blood and an adjustment of the dose;
• 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;
• allopurinol, used in gout; concomitant treatment with indapamide may increase the incidence of hypersensitivity reactions to allopurinol;
• amphotericin B (when administered 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 pathologies (rheumatoid arthritis, terminal stages of some tumors, Crohn's disease and other autoimmune diseases);
• stimulant laxatives, used to promote bowel motility;
• potassium-sparing diuretics, such as amiloride, spironolactone, triamterene;
• metformin, a medicine used to treat diabetes;
• 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 SANDOZ 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, ciamezazine, 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 administered 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 administered intravenously, antibiotics used to treat bacterial infections;
• vincamine administered intravenously, used to treat some nervous system disorders.

The association of this medicine with those listed above may increase the risk of heart
problems (torsades de pointes), especially if you have low levels of potassium in your blood. Before starting treatment with
this medicine, your doctor will prescribe tests to check your blood salt levels and heart activity
(electrocardiogram).

Pregnancy and breastfeeding
If you are pregnant, suspect you are 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 damage to fetal growth.
The use of this medicine is not recommended if you are breastfeeding.

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

INDAPAMIDE SANDOZ contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with intolerance to
some sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take INDAPAMIDE SANDOZ

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult 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 section 2).
Do not use this medicine if you suffer from severe renal insufficiency (See section 2 Do not take Indapamide
Sandoz).

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 section 2 Do not take Indapamide
Sandoz).

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 section 2 Warnings and precautions).

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

If you take more INDAPAMIDE SANDOZ than you should
This medicine has not shown toxicity for doses much higher than the therapeutic dose. The signs
of intoxication manifest especially with alterations of the levels of sodium and potassium 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 SANDOZ
Do not take a double dose to compensate for the missed tablet.
If you have any doubts 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 everybody gets them.
The following side effects may occur:

Common:

• skin irritations (maculopapular rashes).
• low levels of potassium in the blood

Uncommon(may affect up to 1 in 100 people)

• vomiting;
• skin disease associated with bleeding (purpura).
• low levels of sodium in the blood which can lead to dehydration and low blood pressure
• impotence (inability to get or maintain an erection).

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

• dizziness;
• feeling tired and sleepy;
• headache
• tingling in the hands and feet (paresthesia);
• stomach and intestinal disorders (gastrointestinal intolerance), nausea and constipation;
• dry mouth;
• muscle pain (cramps).
• low levels of chlorine in the blood
• low levels of magnesium in the blood

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);
• heartbeat irregularities (arrhythmias);
• lowering of 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 reactions (Stevens-Johnson syndrome);
• kidney problems (renal failure);
• increased levels of calcium in the blood.

Not known(frequency cannot be estimated from available data)

• loss of consciousness (syncope);
• confusional state;
• heart disorders such as torsade de pointes, potentially fatal (See section 2 “Warnings and precautions” and “Other medicines and INDAPAMIDE SANDOZ”);
• feeling dizzy 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) (see section 2 “Do not take INDAPAMIDE SANDOZ” and “Warnings and precautions”);
• inflammation of the liver (hepatitis);
• skin disorders such as itching, irritations (rash, photosensitivity);
• worsening of a skin disease called lupus erythematosus;
• kidney problems (acute renal failure);
• excessive fatigue (asthenia)
• falls;
• altered heartbeat (prolongation of the QT interval See section 2 “Warnings and precautions” and “Other medicines and INDAPAMIDE SANDOZ”);
• increased levels of uric acid and blood sugar levels (hyperglycemia), pay particular attention if you suffer from diabetes or gout;
• slight increase in blood urea;
• Slight increase in liver enzymes;
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion).
• excessive loss of chlorides with urine (which may determine a mild metabolic alkalosis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 SANDOZ

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 after “Expiry”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 SANDOZ contains

• The active ingredient is indapamide. Each tablet contains 2.5 mg of indapamide.
• The other ingredients are corn starch; glycerol; lactose monohydrate; hypromellose; magnesium stearate; polyethylene glycol 6000; povidone; sodium lauryl sulfate; talc; titanium dioxide.

Description of the appearance of INDAPAMIDE Sandoz and contents of the pack
Pack of 30 coated tablets.

Marketing Authorisation Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (Va), Italy

Manufacturer
Edmond Pharma S.r.l. – Strada Statale Dei Giovi, 131 - 20037 Paderno Dugnano (MI), Italy