SITAGLIPTIN PCOR sitagliptin 100 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sitagliptin hydrochloride monohydrate, Quantity: 109 mg (Equivalent: sitagliptin, Qty 100 mg)

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; povidone; sodium stearylfumarate; magnesium stearate; calcium hydrogen phosphate dihydrate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sitagliptin PCOR 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: Beige, round, biconvex film-coated tablets, debossed with S 100 on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-07-11

Patient Information leaflet

Sitagliptin PCOR
1
SITAGLIPTIN PCOR
_Sitagliptin (as hydrochloride) _
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or
pharmacist.
1.
WHY AM I TAKING SITAGLIPTIN PCOR?
Sitagliptin PCOR film-coated tablets contain the active ingredient
sitagliptin hydrochloride. Sitagliptin PCOR is used to
lower blood sugar levels in adults with type 2 diabetes mellitus.
For more information, see Section 1. Why am I using Sitagliptin PCOR ?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE SITAGLIPTIN PCOR?
Do not use if you have ever had an allergic reaction to Sitagliptin
PCOR 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 PCOR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sitagliptin PCOR 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.
4.
HOW DO I USE SITAGLIPTIN PCOR?
The dose of Sitagliptin PCOR is related to body weight for all
patients. Your doctor will calculate the dose you need and
tell you how many tablets to take each day. More instructions can be
found in Section 4. How do I use Sitagliptin PCOR?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SITAGLIPTIN PCOR ?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are using
Sitagliptin PCOR.

Call your doctor straight away if you become pregnant while taking
Sitagliptin PCOR.
THINGS YOU
SHOULD NOT DO

Do not stop taking this medicine suddenly.

Do not give Sitagliptin PCOR to anyone else, even if they have the
same condition as you.
LOOKING AFTER
YOUR MEDICINE

Keep your tablets in the blister pack until it is time to take them.

Store Sitagliptin

Summary of Product characteristics

Sitagliptin PCOR
Ver: 00
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AUSTRALIAN PRODUCT INFORMATION
SITAGLIPTIN PCOR (SITAGLIPTIN) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Sitagliptin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Sitagliptin PCOR contains sitagliptin hydrochloride. The
reference product contains sitagliptin
phosphate monohydrate. All clinical data in this product information
(including pharmacokinetic,
pharmacodynamic and clinical trial data) are based on the reference
product. Bioequivalence with
respect to sitagliptin has been established between the two salt
forms.
Each film-coated tablet of Sitagliptin PCOR contains 25 mg, 50 mg and
100 mg of sitagliptin (as
hydrochloride).
For the full list of excipients, see Section 6.1 List of excipients
3. PHARMACEUTICAL FORM
Sitagliptin PCOR 25 mg are pink, round, biconvex film-coated tablets,
debossed with “S 25” on one side
and plain on other side.
Sitagliptin PCOR 50 mg are light beige, round, biconvex film-coated
tablets, debossed with “S 50” on
one side and plain on other side.
Sitagliptin PCOR 100 mg are beige, round, biconvex film-coated
tablets, debossed with “S 100” on one
side and plain on other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Sitagliptin PCOR 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
The recommended dose of Sitagliptin PCOR 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
thiazolidinedione
(clinical
experience
is
with
pioglitazone
as
dua