Natrilix SR 1.5 mg, prolonged-release film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-01-2022
Summary of Product characteristics
(SPC)
25-01-2022
Active ingredient:
Indapamide
Available from:
Les Laboratoires Servier
ATC code:
C03BA; C03BA11
INN (International Name):
Indapamide
Dosage:
1.5 milligram(s)
Pharmaceutical form:
Prolonged-release tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Sulfonamides, plain; indapamide
Authorization status:
Marketed
Authorization date:
1996-05-01
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 medicines (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
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
24 January 2022
CRN00CRWQ
Page 1 of 9
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 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 orsevere impairment of liver function.
- Hypokalaemia.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
24 January 2022
CRN00CRWQ
Page 2 of 9
_S
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