VELMETIA 50/1000 sitagliptin (as phosphate monohydrate) 50 mg and metformin hydrochloride1000 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

09-07-2022

Summary of Product characteristics (SPC)

09-07-2022

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

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

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Metformin hydrochloride,sitagliptin phosphate monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

56 tablets, 14 tablets (starter pack)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VELMETIA (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: Red, film coated tablet with "577" 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

Authorization status:

Licence status A

Authorization date:

2014-11-19

Patient Information leaflet

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

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Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
VELMETIA
® (SITAGLIPTIN PHOSPHATE MONOHYDRATE/METFORMIN
HYDROCHLORIDE) 50 MG/500 MG, 50 MG/850 MG & 50 MG/1000 MG
VELMETIA
® 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
VELMETIA and VELMETIA XR both contain sitagliptin phosphate and
metformin
hydrochloride. VELMETIA tablets consist of sitagliptin and an
immediate-release formulation
of metformin, and VELMETIA XR tablets consist of sitagliptin and a
modified release
formulation of metformin.
VELMETIA 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 (VELMETIA 50 mg/500 mg), 850
mg metformin
hydrochloride (VELMETIA 50 mg/850 mg) or 1000 mg metformin
hydrochloride (VELMETIA
50 mg/1000 mg).
VELMETIA 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 (VELMETIA XR 50 mg/500 mg*),
or 1000 mg
metformin hydrochloride modified release (VELMETIA XR 50 mg/1000 mg).
Additionally,
VELMETIA 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 (VELMETIA XR 100 mg/1000 mg).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
VELMETIA 50 mg/500 mg - a light pink, film coated tablet with "575" on
one side and plain
on the other.
VELMETIA 50 mg/850 mg - a pink, film coated tablet with "515" on one
side and plain on the
other.
VELMETIA 50 mg/1000 mg - a red, film coated tablet with "577" on one
side and plain on the
other.
VELMETIA XR consists of a

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