Steglujan (Ertugliflozin 15mg/Sitagliptin 100mg) Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Ertuglifozin L-pyroglutamic acid; Sitagliptin Phosphate Monohydrate

Boleh didapati daripada:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

Ertuglifozin L-pyroglutamic acid; Sitagliptin Phosphate Monohydrate

Unit dalam pakej:

7 Tablets; 28 Tablets

Dikeluarkan oleh:

SCHERING-PLOUGH LABO N.V.

Risalah maklumat

STEGLUJAN
®
FILM-COATED TABLET
Ertugliflozin/sitagliptin phosphate (5mg/100mg, 15mg/100mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What STEGLUJAN is used for
2.
How STEGLUJAN works
3.
Before you use STEGLUJAN
4.
How to use STEGLUJAN
5.
While you are using STEGLUJAN
6.
Side effects
7.
Storage and Disposal of
STEGLUJAN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT STEGLUJAN IS USED FOR
•
STEGLUJAN lowers blood sugar
levels in adult patients (aged 18
years and older) with type 2
diabetes.
•
STEGLUJAN can be used instead of
taking both ertugliflozin and
sitagliptin as separate tablets.
•
STEGLUJAN can be used alone or
with some other medicines that
lower blood sugar.
•
You need to keep following your
food and exercise plan while taking
STEGLUJAN.
HOW STEGLUJAN WORKS
STEGLUJAN contains two active
substances, ertugliflozin and sitagliptin.
•
Ertugliflozin belongs to a group of
medicines called sodium glucose co-
transporter-2 (SGLT2) inhibitors. It
works by blocking the SGLT2
protein in your kidneys. This causes
blood sugar to be removed in your
urine.
•
Sitagliptin belongs to a group of
medicines called DPP-4 (dipeptidyl
peptidase-4) inhibitors. It helps to
increase the levels of insulin
produced when blood sugar is high,
especially after a meal. Sitagliptin
also lowers blood sugar between
meals. It also lowers the amount of
sugar made by your body.
WHAT IS TYPE 2 DIABETES?
Type 2 diabetes is a condition in which
your body does not make enough insulin
or the insulin that your body produces
does not work as well as it should. Your
body can also make too much sugar.
When this happens, sugar (glucose)
builds up in the blood. This can lead to
serious medical problems like heart
disease, kidney disease, blindness and
poor circulation.
BEFORE YOU USE STEGLUJAN
_ _
_WHEN YOU MUST NOT USE IT _
Do not take STEGLUJAN:
•
if you are allergic to ertugliflozin or
sitagliptin or any of the ingredients
of this me

Ciri produk

LPC -MK8835A -T-102018
1. NAME OF THE MEDICINAL PRODUCT
Steglujan (Ertugliflozin 5mg/Sitagliptin 100mg) F ilm -Coated Tablets
Steglujan (Ertugliflozin 15mg/Sitagliptin 100mg) F ilm -Coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Steglujan 5 mg/100 mg film -coated tablets
Each tablet contains 5 mg ertugliflozin (as ertugliflozin L -pyroglutamic acid) and 100 mg
sitagliptin (as sitagliptin phosphate monohydrate).
Steglujan 15 mg/100 mg film -coated tablets
Each tablet contains 15 mg ertugliflozin (as ertugliflozin L -pyroglutamic acid) and 100 mg
sitagliptin (as sitagliptin phosphate monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film -coated tablet (tablet).
Steglujan 5 mg/100 mg film -coated tablets
Beige, 12.0 x 7.4 mm, almond -shaped, film -coated tablets debossed with “554” on one side
and plain on the other side.
Steglujan 15 mg/100 mg film -coated tablets
Brown, 12.0 x 7.4 mm, almon d-shaped, film -coated tablets debossed with “555” on one side
and plain on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an
adjunct to diet and exercise to improve glycaemic control:
• when metformin and one of the monocomponents of Steglujan do not provide
adequate glycaemic control.
• in patients already being treated with the combination of ertugliflozin and sitagliptin as
separate tablets.
(For study results with respect to combinations and effects on glycaemic control, see
sections 4.4, 4.5, and 5.1)
4.2 Posology and method of administration
Posology
The recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily. In
patients tolerating the starting dose, the dose may be increased to 15 mg ertugliflozin/100
mg sitagliptin, once daily, if additional glycaemic control is needed .
For patients treated with ertugliflozin who are being switched to Steglujan, the dose of