Sitagliptin/Metformin Sandoz 50/500 sitagliptin (as hydrochloride monohydrate)/metformin hydrochloride 50 mg/500 mg film coated tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

sitagliptin hydrochloride monohydrate, Quantity: 56.69 mg (Equivalent: sitagliptin, Qty 50 mg); metformin hydrochloride, Quantity: 500 mg

Доступна с:

Sandoz Pty Ltd

Фармацевтическая форма:

Tablet, film coated

состав:

Excipient Ingredients: croscarmellose sodium; triethyl citrate; hyprolose; povidone; hypromellose; purified talc; titanium dioxide; microcrystalline cellulose; sodium lauryl sulfate; sodium stearylfumarate; iron oxide red

Администрация маршрут:

Oral

Штук в упаковке:

56

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Sitagliptin/Metformin Sandoz is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

Обзор продуктов:

Visual Identification: A pink, oval, film coated tablet debossed with "SM1" on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2021-09-13

тонкая брошюра

SITAGLIPTIN/METFORMIN SANDOZ
®
1
SITAGLIPTIN/
METFORMIN SANDOZ ®
_sitagliptin hydrochloride monohydrate/metformin hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
Sitagliptin/Metformin Sandoz. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Sitagliptin/Metformin Sandoz against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
SITAGLIPTIN/METFORMIN
SANDOZ IS USED FOR
Sitagliptin/Metformin Sandoz helps
to lower blood sugar levels in
patients with type 2 diabetes mellitus
along with diet and exercise.
Sitagliptin/Metformin Sandoz can be
used alone, or in combination with
ertugliflozin, insulin, or sulfonylurea
medicines such as glimepiride,
gliclazide and glibenclamide.
TYPE 2 DIABETES MELLITUS
Type 2 diabetes mellitus is a
condition in which your body does
not make enough insulin and 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 resulting in
high blood sugar (hyperglycaemia).
This can lead to serious medical
problems.
The main goal of treating diabetes is
to lower your blood sugar to a
normal level. Lowering and
controlling blood sugar may help
prevent or delay complications of
diabetes, such as heart disease,
kidney disease, blindness and foot
amputation.
High blood sugar can be lowered by
diet and exercise and by certain
medicines.
_HOW SITAGLIPTIN/METFORMIN _
_SANDOZ WORKS _
Sitagliptin/Metformin Sandoz
contains two active ingredients,
sitagliptin (as hydrochloride
monohydrate) and metformin
hydrochloride. Sitagliptin belongs to
a class of medicines called DPP-4
inhibitors (dipeptidyl peptidase-4
inhibitors), and

Характеристики продукта

210913-sitagliptin/metformin sandoz-pi
Page 1 of 42
AUSTRALIAN PRODUCT INFORMATION
SITAGLIPTIN/METFORMIN SANDOZ
® 50/500
SITAGLIPTIN/METFORMIN SANDOZ
® 50/850
SITAGLIPTIN/METFORMIN SANDOZ
® 50/1000
(SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE/METFORMIN
HYDROCHLORIDE) FILM COATED TABLET
1.
NAME OF THE MEDICINE
Sitagliptin hydrochloride monohydrate/metformin hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin/Metformin Sandoz is available for oral administration as
film-coated tablets
containing sitagliptin hydrochloride monohydrate and metformin
hydrochloride equivalent to:
50 mg sitagliptin as free base and 500 mg metformin hydrochloride
(Sitagliptin/Metformin
50/500),
850
mg
metformin
hydrochloride
(Sitagliptin/Metformin
50/850)
or
1000
mg
metformin hydrochloride (Sitagliptin/Metformin 50/1000).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Sitagliptin/Metformin Sandoz 50/500 - A pink, film coated tablet with
"SM 1" on one side and
plain on the other.
Sitagliptin/Metformin Sandoz 50/850 - A light orange, film coated
tablet with "SM 2" on one
side and plain on the other.
Sitagliptin/Metformin Sandoz 50/1000 - A light red, film coated tablet
with "SM 3" on one side
and plain on the other.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Sitagliptin/Metformin
Sandoz
(sitagliptin
hydrochloride
monohydrate
and
metformin
hydrochloride) is indicated as an adjunct to diet and exercise to
improve glycaemic control in
adults with type 2 diabetes mellitus when treatment with both
sitagliptin and metformin is
appropriate.
[see Section 5.1 Pharmacodynamic properties, Clinical trials and 4.2
Dose and method of
administration].
4.2.
D
OSE AND METHOD OF ADMINISTRATION
Life-threatening lactic acidosis can occur due to accumulation of
metformin. Risk factors
include renal impairment, old age and the use of high doses of
metformin above 2000 mg
per day.
210913-sitagliptin/metformin sandoz-pi
Page 2 of 42
_Sitagliptin/Metformin _
_Sandoz _
_50/500, _
_Sitagliptin/Met