PHARMACOR SITAGLIPTIN sitagliptin 100 mg film-coated tablet blister pack

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: calcium hydrogen phosphate dihydrate; sodium stearylfumarate; povidone; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; 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:

Pharmacor Sitagliptin 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: Blister Pack; Container Material: PVC/PE/PVDC/Al; 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:

2022-07-11

Patient Information leaflet

Pharmacor Sitagliptin
1
PHARMACOR SITAGLIPTIN
_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 PHARMACOR SITAGLIPTIN?
Pharmacor Sitagliptin film-coated tablets contain the active
ingredient sitagliptin hydrochloride. Pharmacor Sitagliptin is
used to lower blood sugar levels in adults with type 2 diabetes
mellitus.
For more information, see Section 1. Why am I using Pharmacor
Sitagliptin ? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE PHARMACOR SITAGLIPTIN?
Do not use if you have ever had an allergic reaction to Pharmacor
Sitagliptin 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
Pharmacor Sitagliptin? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Pharmacor Sitagliptin 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 PHARMACOR SITAGLIPTIN?
The dose of Pharmacor Sitagliptin 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 Pharmacor
Sitagliptin? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PHARMACOR SITAGLIPTIN ?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are using
Pharmacor Sitagliptin.

Call your doctor straight away if you become pregnant while taking
Pharmacor Sitagliptin.
THINGS YOU
SHOULD NOT DO

Do not stop taking this medicine suddenly.

Do not give Pharmacor Sitagliptin to anyone else, even if they have
the same condition as you.
LOOKING AFTER
YOUR MEDICINE

Keep y

Summary of Product characteristics

Pharmacor Sitagliptin
Ver: 00
1 | P a g e
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR SITAGLIPTIN (SITAGLIPTIN) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Sitagliptin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pharmacor Sitagliptin 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 Pharmacor Sitagliptin 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
Pharmacor Sitagliptin 25 mg are pink, round, biconvex film-coated
tablets, debossed with “S 25” on one
side and plain on other side.
Pharmacor Sitagliptin 50 mg are light beige, round, biconvex
film-coated tablets, debossed with “S 50”
on one side and plain on other side.
Pharmacor Sitagliptin 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
Pharmacor Sitagliptin 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 Pharmacor Sitagliptin 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
(cl