NATRIXAM MODIFIED RELEASE TABLET 1.5 mg10 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Amlodipine besilate 13.87 mg eqv amlodipine; Indapamide

Available from:

SERVIER (S) PTE LTD

ATC code:

C08GA02

Pharmaceutical form:

TABLET, MULTILAYER, EXTENDED RELEASE

Composition:

Amlodipine besilate 13.87 mg eqv amlodipine 10 mg; Indapamide 1.5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

LES LABORATOIRES SERVIER INDUSTRIE

Authorization status:

ACTIVE

Authorization date:

2015-12-03

Summary of Product characteristics

Natrixam common package insert
NATRIXAM
®
1.
NAME OF THE MEDICINAL PRODUCT
Natrixam 1.5 mg / 5 mg modified-release tablets
Natrixam 1.5 mg / 10 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 1.5 mg indapamide and 6.935 mg amlodipine besilate
equivalent to 5 mg amlodipine.
One tablet contains 1.5 mg indapamide and 13.87 mg amlodipine besilate
equivalent to 10 mg amlodipine.
Excipient with known effect: 104.5 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet.
_Natrixam 1.5 mg / 5 mg _
White, round, film-coated, bilayered, modified-release tablet of 9 mm
diameter engraved with
on one
face.
_Natrixam 1.5 mg / 10 mg _
Pink, round, film-coated, bilayered, modified-release tablet of 9 mm
diameter engraved with
on one
face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Natrixam is indicated as substitution therapy for treatment of
essential hypertension in patients already
controlled with indapamide and amlodipine given concurrently at the
same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet per day as single dose, preferably to be taken in the
morning, to be swallowed whole with water
and not chewed.
The fixed dose combination is not suitable for initiation therapy.
If a change of the posology is required, titration should be done with
the individual components.
Special populations
Natrixam common package insert
_Paediatric population _
The safety and efficacy of Natrixam in children and adolescents have
not been established.
_ _
No data are available.
_ _
_Patients with renal impairment (see sections 4.3 and 4.4): _
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contraindicated.
In patients with mild to moderate renal impairment, no dose adjustment
is needed.
_Older people (see section 4.4 and 5.2): _
Older people can be treated with Natrixam according to renal function.
_ _
_Patients with hepatic impairment (see sections 4.3 and 4.4): _
In