JANORIX sitagliptin 25 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sitagliptin hydrochloride monohydrate, Quantity: 27.25 mg (Equivalent: sitagliptin, Qty 25 mg)

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Janorix 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: Pink, round, biconvex film-coated tablets, debossed with S 25 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

Janorix
1
JANORIX
_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 JANORIX?
Janorix film-coated tablets contain the active ingredient sitagliptin
hydrochloride. Janorix is used to lower blood sugar
levels in adults with type 2 diabetes mellitus.
For more information, see Section 1. Why am I using Janorix ? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE JANORIX?
Do not use if you have ever had an allergic reaction to Janorix 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
Janorix? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Janorix 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 JANORIX?
The dose of Janorix 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 Janorix? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING JANORIX ?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are using
Janorix.

Call your doctor straight away if you become pregnant while taking
Janorix.
THINGS YOU
SHOULD NOT DO

Do not stop taking this medicine suddenly.

Do not give Janorix 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 Janorix it in a cool, dry place, below 25°C.
For more information, see Section 5. What should I know while using
Janorix ? in the full CMI.
6.
ARE THERE ANY SIDE EF

Summary of Product characteristics

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