XELEVIA sitagliptin (as phosphate monohydrate) 100 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sitagliptin phosphate monohydrate, Quantity: 128.5 mg (Equivalent: sitagliptin, Qty 100 mg)

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

sitagliptin phosphate monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

7 tablets (starter pack), 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

XELEVIA (sitagliptin phosphate monohydrate) 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 tablet with "277" on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-11-19

Patient Information leaflet

XELEVIA
®
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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 XELEVIA?
XELEVIA contains the active ingredient sitagliptin (as phosphate
monohydrate). XELEVIA is used to lower blood sugar levels in
adults with type 2 diabetes mellitus.
For more information, see Section 1. Why am I taking XELEVIA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE XELEVIA?
Do not use if you have ever had an allergic reaction to XELEVIA 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 take
XELEVIA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with XELEVIA 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 TAKE XELEVIA?
•
Take XELEVIA once a day by mouth, with or without food
More instructions can be found in Section 4. How do I take XELEVIA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING XELEVIA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
XELEVIA.
•
Call your doctor straight away if you become pregnant while taking
XELEVIA.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly.
•
Do not give XELEVIA 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 XELEVIA in a cool dry place away from moisture, heat or
sunlight.
For more information, see Section 5. What should I know while taking
XELEVIA? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Serious side effects in particular that need to be noted are:
•
Allergic reactions including ras

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
XELEVIA
®
(SITAGLIPTIN PHOSPHATE MONOHYDRATE)
1
NAME OF THE MEDICINE
sitagliptin phosphate monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
XELEVIA is available for oral use as film coated tablets containing
sitagliptin phosphate
monohydrate 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
XELEVIA 25 mg - a pink, round, film coated tablet with ”221” on
one side and plain on the
other.
XELEVIA 50 mg - a light beige, round, film coated tablet with
”112” on one side and plain on
the other.
XELEVIA 100 mg - a beige, round, film coated tablet with ”277” on
one side and plain on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
XELEVIA (sitagliptin phosphate monohydrate) 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 XELEVIA 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 experience is with addition of sitagliptin to
glimepiride or gliclazide and
metformin as triple therapy). XELEVIA can be taken with or without
food.
When XELEVIA is used in combination with a sulfonylurea or with
insulin, reduction in the
dose of sulfonylurea or insulin may be considered to reduce the risk
of sulfonylurea- or
insulin-induced hyp