SITAGLIPTIN SANDOZ PHARMA sitagliptin (as hydrochloride monohydrate) 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sitagliptin hydrochloride monohydrate, Quantity: 113.38 mg (Equivalent: sitagliptin, Qty mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; calcium hydrogen phosphate; sodium starch glycollate type A; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SITAGLIPTIN SANDOZ PHARMA 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 Sections 5.1 Pharmacodynamic properties ? Clinical trials and 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 film-coated tablet with 100 engraved on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-12-23

Patient Information leaflet

Sitagliptin Sandoz Pharma® Tablets
1
SITAGLIPTIN SANDOZ PHARMA® TABLETS
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 USING SITAGLIPTIN SANDOZ PHARMA?
Sitagliptin Sandoz Pharma contains the active ingredient sitagliptin
(as hydrochloride monohydrate). Sitagliptin Sandoz Pharma
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 Sandoz Pharma?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SITAGLIPTIN SANDOZ PHARMA?
Do not use if you have ever had an allergic reaction to Sitagliptin
Sandoz Pharma 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
Sandoz Pharma? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sitagliptin Sandoz Pharma 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 SANDOZ PHARMA?
•
Your doctor will tell you how many tablets to take each day. The
standard recommended dose is one 100 mg tablet per
day. Your doctor may prescribe a lower dose for you.
•
Swallow the tablet whole by mouth, with or without food, with a glass
of water and take Sitagliptin Sandoz Pharma at
about the same time each day
More instructions can be found in Section 4. How do I use Sitagliptin
Sandoz Pharma?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SITAGLIPTIN SANDOZ PHARMA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that yo

Summary of Product characteristics

211223- sitagliptin sandoz pharma-pi
Page 1 of 37
AUSTRALIAN PRODUCT INFORMATION
SITAGLIPTIN SANDOZ PHARMA
® (SITAGLIPTIN) FILM-COATED
TABLET
1.
NAME OF THE MEDICINE
Sitagliptin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SITAGLIPTIN SANDOZ PHARMA film-coated tablet contains either 25
mg, 50 mg or
100 mg sitagliptin (as hydrochloride monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
SITAGLIPTIN SANDOZ PHARMA 25 mg film-coated tablet are pink, round,
with “25”
engraved on one side.
SITAGLIPTIN SANDOZ PHARMA 50 mg film-coated tablet are light beige,
round, with “50”
engraved on one side.
SITAGLIPTIN SANDOZ PHARMA 100 mg film-coated tablet are beige, round,
with “100”
engraved on one side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
SITAGLIPTIN SANDOZ PHARMA 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 Sections 5.1 Pharmacodynamic properties – Clinical trials and
4.5 Interactions with other
medicines and other forms of interactions for available data on
different add-on combination
therapies].
4.2.
D
OSE AND METHOD OF ADMINISTRATION
_Each SITAGLIPTIN SANDOZ PHARMA film-coated tablet contains
sitagliptin hydrochloride _
_monohydrate. 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 SANDOZ PHARMA 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