JANUMET XR 50/1000 sitagliptin (as phosphate monohydrate)/metformin hydrochloride 50 mg/1000 mg extended release tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metformin hydrochloride, Quantity: 1000 mg; sitagliptin phosphate monohydrate, Quantity: 64.25 mg (Equivalent: sitagliptin, Qty 50 mg)

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Metformin hydrochloride,sitagliptin phosphate monohydrate

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: povidone; hypromellose; colloidal anhydrous silica; sodium stearylfumarate; propyl gallate; macrogol 3350; kaolin; Carnauba Wax; titanium dioxide; hyprolose; iron oxide yellow; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

14 tablets - starter pack, 56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

JANUMET XR (sitagliptin phosphate monohydrate and metformin hydrochloride) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.,[see Sections 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION].

Product summary:

Visual Identification: Light green, bi-convex oval, film coated tablet, debossed "80" on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2013-11-01

Patient Information leaflet

JANUMET XR®
J
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®
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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 JANUMET XR?
JANUMET XR contains the active ingredients sitagliptin (as phosphate
monohydrate) and metformin (as hydrochloride). JANUMET
XR is used to lower blood sugar levels in adults with type 2 diabetes
mellitus.
For more information, see Section 1. Why am I taking JANUMET XR? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE JANUMET XR?
Do not use if you have ever had an allergic reaction to JANUMET XR 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
JANUMET XR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with JANUMET XR 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 JANUMET XR?
•
Take your JANUMET XR tablets once a day with a meal.
More instructions can be found in Section 4. How do I take JANUMET XR?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING JANUMET XR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
JANUMET XR.
•
Call your doctor straight away if you if you become pregnant while
taking JANUMET XR.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly.
•
Do not give JANUMET XR to anyone else, even if they have the same
condition as you.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol.
LOOKING AFTER
YOUR MEDICINE
•
Keep your tablets in the bottle until it is time to take them.
•
Store JANUMET XR in a cool dry place away from moisture, heat or
sunlight.
For more information, see Section 5. What should I know while using
JANUMET XR?

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
JANUMET
® (SITAGLIPTIN PHOSPHATE MONOHYDRATE/METFORMIN
HYDROCHLORIDE) 50 MG/500 MG, 50 MG/850 MG & 50 MG/1000 MG
JANUMET
® XR (SITAGLIPTIN PHOSPHATE MONOHYDRATE/METFORMIN
HYDROCHLORIDE MODIFIED RELEASE) 50 MG/500 MG, 50 MG/1000 MG &
100 MG/1000 MG
1
NAME OF THE MEDICINE
sitagliptin phosphate monohydrate/metformin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
JANUMET and JANUMET XR both contain sitagliptin phosphate and
metformin
hydrochloride. JANUMET tablets consist of sitagliptin and an
immediate-release formulation
of metformin, and JANUMET XR tablets consist of sitagliptin and a
modified release
formulation of metformin.
JANUMET is available for oral administration as film-coated tablets
containing sitagliptin
phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg
sitagliptin as free
base and 500 mg metformin hydrochloride (JANUMET 50 mg/500 mg), 850 mg
metformin
hydrochloride (JANUMET 50 mg/850 mg) or 1000 mg metformin
hydrochloride (JANUMET
50 mg/1000 mg).
JANUMET XR is available for oral administration as film-coated tablets
containing sitagliptin
phosphate monohydrate equivalent to 50 mg sitagliptin as free base and
either 500 mg
metformin hydrochloride modified release (JANUMET XR 50 mg/500 mg*),
or 1000 mg
metformin hydrochloride modified release (JANUMET XR 50 mg/1000 mg).
Additionally,
JANUMET XR is available for oral administration as tablets containing
sitagliptin phosphate
monohydrate equivalent to 100 mg sitagliptin as free base and 1000 mg
metformin
hydrochloride modified release (JANUMET XR 100 mg/1000 mg).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
JANUMET 50 mg/500 mg - a light pink, film coated tablet with "575" on
one side and plain
on the other.
JANUMET 50 mg/850 mg - a pink, film coated tablet with "515" on one
side and plain on the
other.
JANUMET 50 mg/1000 mg - a red, film coated tablet with "577" on one
side and plain on the
other.
JANUMET XR consists of a modified release m