Avandamet

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

rosiglitazone, metformin hydrochloride

Available from:

SmithKline Beecham Plc

ATC code:

A10BD03

INN (International Name):

rosiglitazone, metformin

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients:who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea (see section 4.4).

Product summary:

Revision: 16

Authorization status:

Withdrawn

Authorization date:

2003-10-20

Patient Information leaflet

Medicinal product no longer authorised
105
B. PACKAGE LEAFLET
Medicinal product no longer authorised
106
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVANDAMET 1 MG/500 MG FILM-COATED TABLETS
AVANDAMET 2 MG/500 MG FILM-COATED TABLETS
AVANDAMET 2 MG/1000 MG FILM-COATED TABLETS
AVANDAMET 4 MG/1000 MG FILM-COATED TABLETS
rosiglitazone/metformin HCl
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
IF ANY OF THE SIDE EFFECTS GETS SERIOUS, OR IF YOU NOTICE ANY SIDE
EFFECTS NOT LISTED IN THIS
LEAFLET, TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET
:
1.
WHAT AVANDAMET IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE AVANDAMET
3.
HOW TO TAKE AVANDAMET
4.
POSSIBLE SIDE EFFECTS
5
HOW TO STORE AVANDAMET
6.
FURTHER INFORMATION
1.
WHAT AVANDAMET IS AND WHAT IT IS USED FOR
AVANDAMET TABLETS ARE A COMBINATION OF TWO DIFFERENT MEDICINES
called
_rosiglitazone_
and
_metformin. _
These two medicines are used to treat
TYPE 2 DIABETES.
People with type 2 diabetes either don’t make enough insulin (a
hormone that controls blood sugar
levels), or don’t respond normally to the insulin their body makes.
Rosiglitazone and metformin work
together so your body makes better use of the insulin it produces, and
this helps reduce your blood
sugar to a normal level. Avandamet can be used alone or with a
sulphonylurea, another medicine for
diabetes.
2.
BEFORE YOU TAKE AVANDAMET
To help manage your diabetes, it is important that you follow any diet
and lifestyle advice from your
doctor as well as taking Avandamet.
DON’T TAKE AVANDAMET:
•
IF YOU ARE ALLERGIC
(
_hypersensitive_
) to rosiglitazone or metformin or any of the other
ingredients of Avandamet (
_listed in Section 6)_
•
IF YOU HAVE HAD A HEART ATTACK OR SEVERE ANGINA,
that’s being treated in hospital
•

Summary of Product characteristics

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
AVANDAMET 1 mg/500 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each tablet contains 1 mg of rosiglitazone (as rosiglitazone maleate)
and 500 mg of metformin
hydrochloride (corresponding to metformin free base 390 mg).
Excipients:
Each tablet contains lactose (approximately 6 mg).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow film-coated tablets marked "gsk" on one side and "1/500" on the
other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AVANDAMET is indicated in the treatment of type 2 diabetes mellitus
patients, particularly
overweight patients:
-
who are unable to achieve sufficient glycaemic control at their
maximally tolerated dose of oral
metformin alone.
-
in triple oral therapy with sulphonylurea in patients with
insufficient glycaemic control despite
dual oral therapy with their maximally tolerated dose of metformin and
a sulphonylurea (see
section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The usual starting dose of AVANDAMET is 4 mg/day rosiglitazone plus
2000 mg/day metformin
hydrochloride.
Rosiglitazone can be increased to 8 mg/day after 8 weeks if greater
glycaemic control is required. The
maximum recommended daily dose of AVANDAMET is 8 mg rosiglitazone plus
2000 mg metformin
hydrochloride.
The total daily dose of AVANDAMET should be given in two divided
doses.
Dose titration with rosiglitazone (added to the optimal dose of
metformin) may be considered before
the patient is switched to AVANDAMET.
When clinically appropriate, direct change from metformin monotherapy
to AVANDAMET may be
considered.
Taking AVANDAMET with or just after food may reduce gastrointestinal
symptoms associated with
metformin.
Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see
section 4.4)
Medicinal product no longer authorised
3
-
Patients on metformin and sulp