Janumet

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Metformin hydrochloride 500mg; Sitagliptin phosphate monohydrate 64.25mg equivalent to Sitagliptin 50 mg;  ;  

Tilgængelig fra:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Metformin hydrochloride 500 mg

Dosering:

50mg/500mg

Lægemiddelform:

Film coated tablet

Sammensætning:

Active: Metformin hydrochloride 500mg Sitagliptin phosphate monohydrate 64.25mg equivalent to Sitagliptin 50 mg     Excipient: Microcrystalline cellulose Opadry pink 85F94203 Povidone Sodium laurilsulfate Sodium stearyl fumarate

Enheder i pakken:

Blister pack, Al/Al or PVDC/Al, 14 tablets

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Farmhispania SA

Terapeutiske indikationer:

JANUMET is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus inadequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin. JANUMET is indicated as part of triple combination therapy with a sulfonylurea as an adjunct to diet and exercise in patients with type 2 diabetes mellitus inadequately controlled with any two of the three agents: metformin, sitagliptin, or a sulfonylurea. JANUMET is indicated in patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in combination with premixed or long/intermediate acting insulin.

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, Al/Al or PVDC/Al - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Al/Al or PVDC/Al - 56 tablets - 36 months from date of manufacture stored at or below 25°C

Autorisation dato:

2006-06-23

Indlægsseddel

1
JANUMET
®
_sitagliptin phosphate/metformin HCl_
50 mg/500 mg, 50 mg/850 mg, 50 mg/1000 mg tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about JANUMET. It does not
contain all the
available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
JANUMET against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
WHAT JANUMET IS USED FOR
JANUMET (_sitagliptin phosphate/metformin HCl_) is a tablet that
contains sitagliptin
phosphate and metformin hydrochloride as active ingredients:
JANUMET 50 mg sitagliptin phosphate/500 mg metformin hydrochloride
JANUMET 50 mg sitagliptin phosphate/850 mg metformin hydrochloride
JANUMET 50 mg sitagliptin phosphate/1000 mg metformin hydrochloride
JANUMET is a tablet that contains two prescription medicines,
sitagliptin phosphate
(JANUVIA
®
) and metformin, which lower blood sugar. Sitagliptin, a member of a
class of
medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors),
and metformin, a
member of the biguanide class of medicines, work together to control
blood sugar levels in
patients with type 2 diabetes mellitus. Type 2 diabetes is also called
non-insulin-dependent
diabetes mellitus, or NIDDM.

JANUMET lowers blood sugar levels in patients with type 2 diabetes.

JANUMET helps to improve the levels of insulin after a meal.

JANUMET helps the body respond better to the insulin it makes
naturally.

JANUMET decreases the amount of sugar made by the body.

JANUMET is unlikely to cause low blood sugar (hypoglycaemia).
Your doctor has prescribed JANUMET to help lower your blood sugar,
which is too high
because of your type 2 diabetes, along with a recommended diet and
exercise
programme.
WHAT IS TYPE 2 DIABETES?
Type 2 diabetes is a condition in which your body does not

Produktets egenskaber

Page
1
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DATA SHEET
1.
PRODUCT NAME
JANUMET
®
50/500 mg film-coated tablets
JANUMET
®
50/850 mg film-coated tablets
JANUMET
®
50/1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each JANUMET 50/500 mg tablet contains sitagliptin phosphate
monohydrate equivalent to 50 mg of
sitagliptin and 500 mg of metformin hydrochloride.
Each JANUMET 50/850 mg tablet contains sitagliptin phosphate
monohydrate equivalent to 50 mg of
sitagliptin and 850 mg of metformin hydrochloride.
Each JANUMET 50/1000 mg tablet contains sitagliptin phosphate
monohydrate equivalent to 50 mg
of sitagliptin and 1000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
50/500 mg tablets: Light pink, film coated tablet, debossed "575" on
one side and plain on the other.
50/850 mg tablets: Pink, film coated tablet, debossed "515" on one
side and plain on the other.
50/1000 mg tablets: Red, film coated tablet, debossed "577" on one
side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
JANUMET is indicated as an adjunct to diet and exercise to improve
glycaemic control in adult
patients with type 2 diabetes mellitus inadequately controlled on
metformin or sitagliptin alone or in
patients already being treated with the combination of sitagliptin and
metformin.
JANUMET is indicated as part of triple combination therapy with a
sulfonylurea as an adjunct to diet
and exercise in patients with type 2 diabetes mellitus inadequately
controlled with any two of the
three agents: metformin, sitagliptin, or a sulfonylurea.
JANUMET is indicated in patients with type 2 diabetes mellitus as an
adjunct to diet and exercise to
improve glycaemic control in combination with premixed or
long/intermediate acting insulin.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
The dosage of anti-hyperglycaemic therapy with JANUMET should be
individualised on the basis of
the patient’s current regimen, effectiveness, and tolerability while
not exceeding the maximum
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