Vipdomet 12.5mg1000mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Metformin hydrochloride; Alogliptin benzoate

Available from:

Takeda UK Ltd

ATC code:

A10BD13

INN (International Name):

Metformin hydrochloride; Alogliptin benzoate

Dosage:

1gram ; 12.5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010203; GTIN: 5035382011288

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIPDOMET 12.5 MG/850 MG FILM-COATED TABLETS
VIPDOMET 12.5 MG/1000 MG FILM-COATED TABLETS
alogliptin/metformin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vipdomet is and what it is used for
2.
What you need to know before you take Vipdomet
3.
How to take Vipdomet
4.
Possible side effects
5.
How to store Vipdomet
6.
Contents of the pack and other information
1.
WHAT VIPDOMET IS AND WHAT IT IS USED FOR
WHAT VIPDOMET IS
Vipdomet contains two different medicines called alogliptin and
metformin in one tablet:
-
alogliptin belongs to a group of medicines called DPP-4 inhibitors
(dipeptidyl peptidase-4
inhibitors). Alogliptin works to increase the levels of insulin in the
body after a meal and
decrease the amount of sugar in the body.
-
metformin belongs to a group of medicines called biguanides which also
help to lower blood
sugar by lowering the amount of sugar made in the liver and helping
insulin to work more
effectively.
Both of these groups of medicines are “oral anti-diabetics”.
WHAT VIPDOMET IS USED FOR
Vipdomet is used to lower blood sugar levels in adults with type 2
diabetes. Type 2 diabetes is also
called non-insulin-dependent diabetes mellitus or NIDDM.
Vipdomet is taken when your blood sugar cannot be adequately
controlled by diet, exercise and other
anti-diabetic medicines such as metformin alone; insulin alone; or
metformin and pioglitazone taken
together.
If you are already taking both alogliptin and metformin as single

Summary of Product characteristics

OBJECT 1
VIPDOMET 12.5 MG/1000 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 12-Jan-2017 | Takeda UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Vipdomet 12.5 mg/850 mg film-coated tablets
Vipdomet 12.5 mg/1000 mg film-coated tablets
2. Qualitative and quantitative composition
Vipdomet 12.5 mg/850 mg film-coated tablets
Each tablet contains alogliptin benzoate equivalent to 12.5 mg
alogliptin and 850 mg metformin
hydrochloride.
Vipdomet 12.5 mg/1000 mg film coated tablets
Each tablet contains alogliptin benzoate equivalent to 12.5 mg
alogliptin and 1000 mg metformin
hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Vipdomet 12.5 mg/850 mg film-coated tablets
Light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide),
biconvex, film-coated tablets with
“12.5/850” debossed on one side and “322M” debossed on the
other side.
Vipdomet 12.5 mg/1000 mg film coated tablets
Pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide),
biconvex, film-coated tablets with
“12.5/1000” debossed on one side and “322M” debossed on the
other side.
4. Clinical particulars
4.1 Therapeutic indications
Vipdomet is indicated in the treatment of adult patients aged 18 years
and older with type 2 diabetes
mellitus:
• as an adjunct to diet and exercise to improve glycaemic control in
adult patients, inadequately controlled
on their maximal tolerated dose of metformin alone, or those already
being treated with the combination
of alogliptin and metformin.
• in combination with pioglitazone (i.e. triple combination therapy)
as an adjunct to diet and exercise in
adult patients inadequately controlled on their maximal tolerated dose
of metformin and pioglitazone.
• in combination w