Presentation and composition
Box of 30 sustained-release coated tablets dosed at 1.5 mg of Indapamide.
Indapamide is a diuretic acting at the cortical dilution segment. The
antihypertensive action is related to an improvement in arterial compliance
and a reduction in arteriolar and total peripheral resistance. Indapamide
also reduces left ventricular hypertrophy.
Natrilix SR is supplied in a sustained release dosage based on a matrix
system in which the active ingredient is dispersed in a support which allows
sustained release of indapamide.
The fraction of indapamide released is rapidly and totally absorbed via the
gastrointestinal digestive tract.
Eating slightly increases the rapidity of absorption but has no influence on
the amount of the drug absorbed.
Peak serum level following a single dose occurs about 12 hours after
ingestion, repeated administration reduces the variation in serum levels
between 2 doses.
Intra-individual variability exists.
Binding of indapamide to plasma proteins is 79 %. The plasma elimination
half-life is 14 to 24 hours (mean 18 hours).
Steady state is achieved after 7 days.
Repeated administration does not lead to accumulation.
Elimination is essentially urinary (70 % of the dose) and faecal (22 %) in
the form of inactive metabolites.
Population at risk
Pharmacokinetic parameters are unchanged in renal failure patients.
Treatment of essential hypertension.
The majority of adverse effects are dose dependent. Thiazide and related
diuretics including Indapamide may cause:
• Variations in certain blood parameters, in particular potassium depletion,
hyponatraemia with hypovolaemia responsible for dehydration
and orthostatic hypotension, increase in plasma uric acid and glucose.
• According to clinical parameters:
- in the presence of hepatic insufficiency, possible onset of hepatic
encephalopathy may occur;
- hypersensitive reactions essentially dermatological;
- maculopapular rashes, purpura, possible worsening of pre-existent acute
disseminated lupus erythematosus;
- nausea, constipation, dry mouth, vertigo, tiredness, paresthesiae,
headache, occurring rare ly and responding in most instances to a dose
- very rarely, pancreatitis.
Administration of the diuretic must be stopped immediately when liver
function is impaired.
This drug should be used cautiously in the following situations: disturbed
water/electrolyte balance (plasma sodium, plasma potassium), diabetes, gout,
The attention of athletes is drawn to the fact that this drug contains an
active ingredient that may induce a positive reaction during antidoping
• Hypersensitivity to sulphonamides.
• Severe renal failure.
• Hepatic encephalopathy or severe liver failure.
As a general rule, the administration of thiazide and related diuretics
should be avoided in pregnant women and should never be used to treat
physiological oedema of pregnancy. Diuretics can cause faetoplacental
ischemia, with a risk of foetal hypotrophy.
Breast-feeding is inadvisable (passage into breast milk).
Drug Interactions and Other Interactions
Lithium, non-antiarrhythmic drugs causing wave burst arrhythmias.
Combinations requiring precautions:
NSAID (systemic), high dose salicylate, other hypokalemic compounds,
baclofen, digitalis preparations.
Combinations which must be taken into account Hyperkalemic diuretics,
angiotensin converting enzyme inhibitors, antiarrhythmic agents causing wave
burst arrhythmias, metformin, iodinated contrast media, imipramine
antidepressants (tricyclics), neuroleptics, calcium salts, cyclosporin,
corticosteroids, tetracosaclide (systemic).
Drivers and use of machinery
Individual reactions in relation to the decrease in blood pressure may occur
in certain patients. Consequently, the ability to drive vehicles or to use
machinery may be decreased.
One tablet per 24 hours, preferably in the morning. Higher doses do not
improve the antihypertensive action of Indapamide, rather they increase the
Indapamide has not shown any toxicity at doses of up to 40 mg, i.e. 27 times
the therapeutic dose. Above all, signs of acute poisoning take the form of
water and electrolyte disturbances (hyponatraemia and hypokalemia).
Clinically, they include possible nausea, vomiting, hypotension, cramps,
vertigo, drowsiness, confusional states, polyuria or oliguria up to the
extent of anuria (due to hypovolaemia).
Initial measures taken involve the rapid elimination of the product(s)
ingested by means of gastric lavage and/or the administration of activated
charcoal, followed by restoration of the fluid and electrolyte balance to
normal in a specialised centre.
Do not exceed the expiry date clearly indicated on the outer packaging.
Store at room temperature, 15-25°C. Protect from humidity.