GLYXAMBI FILM-COATED TABLETS 10 MG5 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Empagliflozin; Linagliptin

Available from:

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.

ATC code:

A10BD19

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Empagliflozin 10.00 mg; Linagliptin 5.00 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2017-06-16

Summary of Product characteristics

1
Abcd
Glyxambi
®
1.
NAME OF THE MEDICINAL PRODUCT
Glyxambi Film-Coated Tablets 10mg/5mg
Glyxambi Film-Coated Tablets 25mg/5mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 25mg empagliflozin and 5mg linagliptin
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Glyxambi 10mg/5mg: Pale yellow, arc triangular, flat-faced,
bevel-edged, film-coated tablets. One side
is debossed with the Boehringer Ingelheim company symbol, the other
side is debossed with "10/5".
Glyxambi 25mg/5mg: Pale pink, arc triangular, flat-faced, bevel-edged,
film-coated tablets. One side
is debossed with the Boehringer Ingelheim company symbol, the other
side is debossed with "25/5".
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GLYXAMBI tablets are indicated as an adjunct to diet and exercise to
improve glycemic control in
adults with type 2 diabetes mellitus when treatment with both
empagliflozin and linagliptin is
appropriate. (See Clinical Trials)
_ _
_ _
LIMITATIONS OF USE
GLYXAMBI is not recommended for patients with type 1 diabetes or for
the treatment of diabetic
ketoacidosis.
GLYXAMBI has not been studied in patients with a history of
pancreatitis. It is unknown whether
patients with a history of pancreatitis are at an increased risk for
the development of pancreatitis while
using GLYXAMBI.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Recommended Dosage
The recommended dose of GLYXAMBI is 10 mg empagliflozin/5 mg
linagliptin once daily in the
morning, taken with or without food. In patients tolerating GLYXAMBI,
the dose may be increased to
25 mg empagliflozin/5 mg linagliptin once daily.
In patients with volume depletion, correcting this condition prior to
initiation of GLYXAMBI is
recommended.
No studies have been performed specifically examining the safety and
efficacy of GLYXAMBI in
patients previously treated with other oral antihyperglycemic agents
and switched to GLYXAMBI. Any
2
change in therapy of type 2 diabetes should be undertaken with care
and approp