Glyxambi Film-Coated Tablets 25mg5mg

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

LINAGLIPTIN; Empagliflozin

Доступна з:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

ІПН (Міжнародна Ім'я):

LINAGLIPTIN; Empagliflozin

Одиниць в упаковці:

3 x 10tablet Tablets

Виробник:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
GLYXAMBI
® FILM-COATED TABLETS
Empagliflozin/ linagliptin (10mg/5mg and 25mg/5mg)
1
WHAT IS IN THIS LEAFLET
1.
What
_GLYXAMBI_
is used for
2.
How
_GLYXAMBI_
works
3.
Before you use
_GLYXAMBI_
4.
How to use
_GLYXAMBI_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_GLYXAMBI_
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
1. WHAT _GLYXAMBI_ IS USED FOR
_Glyxambi_
is used to lower blood sugar
level in diabetes patients.
_Glyxambi_
can be used when diet,
exercise and treatment with one of the
mono-component of
_Glyxambi_
with/without metformin do not provide
adequate glycaemic control.
_Glyxambi_
can also be used as a
replacement to taking both empagliflozin
and linagliptin as single tablets. In this
case, do not continue taking any one of
those tablets separately if you are taking
this medicine.
It is important that you continue with
your diet and exercise plan as
recommended by your doctor,
pharmacist or nurse.
2. HOW _GLYXAMBI_
WORKS
_Glyxambi_
is an anti-diabetic medicine
that contains two active substances called
empagliflozin and linagliptin:
•
Empagliflozin works by blocking a
protein in the kidneys called sodium
glucose co-transporter 2 (SGLT2).
SGLT2 prevents glucose from being
excreted in urine by absorbing
glucose back into the bloodstream as
blood is being filtered in the
kidneys. By blocking this protein,
the medicine causes glucose (blood
sugar), sodium (salt) and water to be
removed via the urine. This helps to
lower blood glucose levels, which
are too high because of your type 2
diabetes.
•
Linagliptin works in a different way,
namely by enabling the pancreas to
produce more insulin to lower blood
glucose levels. It does this by
blocking a protein called DPP-4.
3. BEFORE YOU USE _GLYXAMBI_
-
_When you must not use it _
Do not take
_Glyxambi_
if you are allergic
to empagliflozin, linagliptin, any other
SGLT2 inhibitor (e.g. dapagliflozin,
canagliflozin), any other DPP-4 inhibitor
(e

Характеристики продукта

1
Date
: 9 Sep 2021
Country
: Malaysia
Drug substance
: Empagliflozin/ Linagliptin
References
: CCDS 0285-16
Remarks
: Inclusion of new Adverse reaction “Constipation”
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 is indicated to improve glycaemic control in adults with type
2 diabetes mellitus:
•
instead of empagliflozin, when diet, exercise and treatment with
empagliflozin ± metformin
do not provide adequate glycaemic control
•
instead of linagliptin, when diet, exercise and treatment with
linagliptin ± metformin do not
provide adequate glycaemic control
GLYXAMBI can be used to replace the free combination of empagliflozin
and linagliptin in adult
patients with type 2 diabetes mellitus who are already being treated
with this combination.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose is 1 film-coated tablet of GLYXAMBI 10
mg/5 mg (10 mg
empagliflozin plus 5 mg linagliptin) once daily.
2
In patients who tolerate this starting dose and require additional
glycaemic control, the dose can be
increased to 1 film-coated tablet of GLYXAMBI 25 mg/5 mg (25 mg
empagliflozin plus 5 mg
linagliptin) once daily.
When GLYXAMBI is used in combination with a sulphonylurea or with
insulin, a lower dose of the
sulphonylurea or insulin may be considered to reduc