TRIPLIXAM FILM COATED TABLET 5 mg 1.25 mg 10 mg

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

Amlodipine besilate 13.87 mg eqv amlodipine; Indapamide; Perindopril 3.395 mg eqv perindopril arginine

Dostopno od:

SERVIER (S) PTE LTD

Koda artikla:

C09BX01

Farmacevtska oblika:

TABLET, FILM COATED

Sestava:

Amlodipine besilate 13.87 mg eqv amlodipine 10 mg; Indapamide 1.25 mg; Perindopril 3.395 mg eqv perindopril arginine 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

Servier (Ireland) Industries Ltd. [SII]

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2016-05-23

Lastnosti izdelka

Triplixam Singapore common package insert
1
1.
NAME OF THE MEDICINAL PRODUCT
Triplixam 5mg/1.25mg/5mg film-coated tablets
Triplixam 5mg/1.25mg/10mg film-coated tablets
Triplixam 10mg/2.5mg/5mg film-coated tablets
Triplixam 10mg/2.5mg/10mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 3.395 mg perindopril equivalent to 5
mg perindopril arginine, 1.25 mg
indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg of
amlodipine.
One film-coated tablet contains 3.395 mg perindopril equivalent to 5
mg perindopril arginine, 1.25 mg
indapamide and 13.870 mg amlodipine besilate equivalent to 10mg of
amlodipine.
One film-coated tablet contains 6.790 mg perindopril equivalent to 10
mg perindopril arginine, 2.5 mg
indapamide and 6.935 mg amlodipine besilate equivalent to 5 mg of
amlodipine.
One film-coated tablet contains 6.790 mg perindopril equivalent to 10
mg perindopril arginine, 2.5 mg
indapamide and 13.870 mg amlodipine besilate equivalent to 10 mg of
amlodipine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Triplixam 5/1.25/5 mg: white, oblong, film-coated tablet, 9.75 mm long
and 5.16 mm wide, engraved with
on one face and
on the other face.
Triplixam 5/1.25/10 mg: white, oblong, film-coated tablet, 10.7 mm
long and 5.66 mm wide, engraved with
on one face and
on the other face.
Triplixam 10/2.5/5 mg: white, oblong, film-coated tablet, 11.5 mm long
and 6.09 mm wide, engraved with
on one face and
on the other face.
Triplixam 10/2.5/10 mg: white, oblong, film-coated tablet, 12.2 mm
long and 6.46 mm wide, engraved with
on one face and
on the other face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Triplixam is indicated as substitution therapy for treatment of
essential hypertension, in patients already
controlled with perindopril/indapamide fixed dose combination and
amlodipine, taken at the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Triplixam film-coated tablet per day as a single dos