Natrilix SR 1.5 mg, prolonged-release film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

INDAPAMIDE

Available from:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

ATC code:

C03BA11

INN (International Name):

INDAPAMIDE 1.5 mg

Pharmaceutical form:

FILM-COATED TABLET PROLONGED-RELEASE TABLET

Composition:

INDAPAMIDE 1.5 mg

Prescription type:

POM

Therapeutic area:

DIURETICS

Authorization status:

Authorised

Authorization date:

2005-09-01

Patient Information leaflet

1/7
PACKAGE LEAFLET: INFORMATION FOR THE USER
NATRILIX SR 1.5 MG PROLONGED-RELEASE FILM-COATED TABLETS
Indapamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Natrilix SR 1.5 mg is and what it is used for
2.
What you need to know before you take Natrilix SR 1.5 mg
3.
How to take Natrilix SR 1.5 mg
4.
Possible side effects
5.
How to store Natrilix SR 1.5 mg
6.
Contents of the pack and other information
1.
WHAT NATRILIX SR 1.5 MG IS AND WHAT IT IS USED FOR
Natrilix SR 1.5 mg is a prolonged-release film-coated tablet
containing indapamide as active ingredient.
This medicine is intended to reduce high blood pressure (hypertension)
in adults.
Indapamide is a diuretic. Most diuretics increase the amount of urine
produced by the kidneys. However,
indapamide is different from other diuretics, as it only causes a
slight increase in the amount of urine
produced.
In addition, indapamide widens blood vessels so that blood passes
through more easily. This helps to
lower blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NATRILIX SR 1.5 MG
DO NOT TAKE NATRILIX SR 1.5 MG:
-
if you are allergic to indapamide or any other sulphonamide 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
(degenerative disease of the brain),
-
if you have low potassium levels in your blood.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before taking Natrilix

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Natrilix SR 1.5 mg, prolonged-release film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release film-coated tablet contains 1.5 mg indapamide.
Excipient with known effect: 124.5 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
White, round, film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Natrilix SR 1.5 mg is indicated in essential hypertension in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet per 24 hours, preferably in the morning, to be swallowed
whole with water and not chewed.
_ _
At higher doses the antihypertensive action of indapamide is not
enhanced but the saluretic effect is increased.
Special populations
_ _
_Renal impairment (see sections 4.3 and 4.4): _
In severe renal failure (creatinine clearance below 30 ml/min),
treatment is contraindicated.
Thiazide and related diuretics are fully effective only when renal
function is normal or only minimally
impaired.
_ _
_Hepatic impairment (see sections 4.3 and 4.4): _
In severe hepatic impairment, treatment is contraindicated.
_ _
_Elderly (see section 4.4): _
In the elderly, the plasma creatinine must be adjusted in relation to
age, weight and gender. Elderly patients
can be treated with Natrilix SR 1.5 mg when renal function is normal
or only minimally impaired.
Paediatric population:
The safety and efficacy of Natrilix SR 1.5 mg in children and
adolescents have not been established. No data
are available.
Method of administration
Oral use
_ _
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance, to other sulfonamides or to
any of the excipients listed in section
6.1.
-
Severe renal failure.
-
Hepatic encephalopathy or
_ _
severe impairment of liver function.
-
Hypokalaemia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Special warnings _
When liver function is impaired, thiazide-related diuretics may cause,
particularly in case o