SITAGLIPTIN SUN sitagliptin 25 mg (as fumarate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sitagliptin fumarate, Quantity: 32.124 mg

Available from:

Sun Pharma ANZ Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: calcium hydrogen phosphate; crospovidone; hydrogenated castor oil; glycerol dibehenate; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000; iron oxide red

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sitagliptin SUN (sitagliptin fumarate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as: - monotherapy when metformin is considered inappropriate due to intolerance; or - in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on different add-on combination therapies].

Product summary:

Visual Identification: Light pink colour, round film-coated tablets debossed with F1 on one side and plain on the other side; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-11-23

Patient Information leaflet

SITAGLIPTIN SUN v1.1
SITAGLIPTIN SUN
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
Sitagliptin SUN contains the active ingredient sitagliptin fumarate.
Sitagliptin SUN is used to lower blood sugar levels in
patients with type 2 diabetes mellitus alone or in combination with
certain other medicines, when diet plus exercise or the
other medicine(s) do not provide adequate blood sugar level control.
For more information, see Section 1. Why am I using Sitagliptin SUN?
in the full CMI.
Do not use if you have ever had an allergic reaction to Sitagliptin
SUN or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Sitagliptin SUN? in the full CMI.
Some medicines may interfere with Sitagliptin SUN and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
•
Take Sitagliptin SUN only when prescribed by your doctor.
•
The recommended dose is to take one 100 mg tablet once a day, by
mouth, with or without food.
More instructions can be found in Section 4. How do I use Sitagliptin
SUN? in the full CMI.
THINGS YOU
SHOULD DO
•
If you become pregnant while taking Sitagliptin SUN, tell your doctor
immediately.
•
If you are about to be started on any new medicine, tell your doctor
and pharmacist that you are
taking Sitagliptin SUN.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not give Sitagliptin SUN to anyone else, even if they have the same
condition as you.
DRIVING OR USING
MACHINES
•
Sitagliptin SUN is not expected to affect the ability to drive and use
machines.
LOOKING AFTER
YOUR MEDICINE
•
Keep Sitagliptin SUN in a cool dry place where the temperature stays
below 25°C. Do not store it or
any other medicine in the bat

Summary of Product characteristics

1
SITAGLIPTRIN SUN v2.0
AUSTRALIAN PRODUCT INFORMATION –
SITAGLIPTIN SUN
(SITAGLIPTIN FUMARATE)
1
NAME OF THE MEDICINE
sitagliptin fumarate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin SUN is available for oral use as film coated tablets
containing sitagliptin fumarate
equivalent to 25, 50 or 100 mg of free base.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Sitagliptin SUN Tablet 25 mg - Light pink colour, round film coated
tablets debossed with F1
on one side and plain on the other side.
Sitagliptin SUN Tablet 50 mg - Light beige colour, round film coated
tablets debossed with
F2 on one side and plain on the other side.
Sitagliptin SUN Tablet 100 mg - Beige colour, round film coated
tablets debossed with F3 on
one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sitagliptin SUN (sitagliptin fumarate) is indicated as an adjunct to
diet and exercise to improve
glycaemic control in adults with type 2 diabetes mellitus as:
- monotherapy when metformin is considered inappropriate due to
intolerance; or
- in combination with other anti-hyperglycaemic agents, including
insulin
[see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, 4.5 INTERACTIONS
WITH
OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on
different add-on combination therapies].
4.2
DOSE AND METHOD OF ADMINISTRATION
_Each SITAGLIPTIN SUN tablet contains sitagliptin fumarate. The
innovator product _
_contains sitagliptin phosphate monohydrate. All clinical data in this
product _
_information (including pharmacokinetic, pharmacodynamic and clinical
trial data) are _
_based on sitagliptin phosphate monohydrate. Bioequivalence with
respect to _
_sitagliptin has been established between the two salt forms. _
The recommended dose of Sitagliptin SUN is 100 mg once daily as
monotherapy, or as
combination therapy with metformin, or a sulfonylurea (clinical
experience is with glimepiride
as dual therapy), insulin (with or without metformin), a
thiazolidin