JANUMET 50 mg/850 mg sitagliptin phosphate monohydrate/metformin HCI 50 mg/850 mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

metformin hydrochloride, Quantity: 850 mg; sitagliptin phosphate monohydrate, Quantity: 64.25 mg

제공처:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Metformin hydrochloride,sitagliptin phosphate monohydrate

약제 형태:

Tablet

구성:

Excipient Ingredients: microcrystalline cellulose; sodium stearylfumarate; povidone; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

관리 경로:

Oral

패키지 단위:

Carton - 14 tablets, Carton - 56 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

JANUMET (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].

제품 요약:

Visual Identification: Pink, film coated tablet with "515" on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2009-04-30

환자 정보 전단

JANUMET®
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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 USING JANUMET?
JANUMET contains the active ingredients sitagliptin (as phosphate
monohydrate) and metformin (as hydrochloride). JANUMET is
used to lower blood sugar levels in adults with diabetes mellitus.
For more information, see Section 1. Why am I taking JANUMET? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE JANUMET?
Do not take if you have ever had an allergic reaction to JANUMET 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? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with JANUMET 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?
•
Your doctor will tell you how many JANUMET tablets to take and how
often to take them.
•
Take JANUMET with meals to lower your chance of an upset stomach.
More instructions can be found in Section 4. How do I take JANUMET? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING JANUMET?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
JANUMET.
•
Call your doctor straight away if you if you become pregnant while
taking JANUMET.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly.
•
Do not give JANUMET to anyone else, even if they have the same
condition as you.
DRIVING
OR USING
MACHINES
•
There is no information to suggest that JANUMET affects your ability
to drive a car or operate machinery.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol.
LOOKING AFTER
YOUR MEDICINE
•
Keep your tablets in the blister pack u

제품 특성 요약

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