Avaglim

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
17-01-2011
Summary of Product characteristics Summary of Product characteristics (SPC)
17-01-2011
Public Assessment Report Public Assessment Report (PAR)
17-01-2011

Active ingredient:

rosiglitazone, glimepiride

Available from:

SmithKline Beecham Ltd

ATC code:

A10BD04

INN (International Name):

rosiglitazone, glimepiride

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus, Type 2

Therapeutic indications:

AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.

Product summary:

Revision: 11

Authorization status:

Withdrawn

Authorization date:

2006-06-27

Patient Information leaflet

                                Medicinal product no longer authorised
46
B. PACKAGE LEAFLET
Medicinal product no longer authorised
47
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVAGLIM 4 MG/4 MG FILM-COATED TABLETS
AVAGLIM 8 MG/4 MG FILM-COATED TABLETS
rosiglitazone/glimepiride
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 AVAGLIM IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE AVAGLIM
3.
HOW TO TAKE AVAGLIM
4.
POSSIBLE SIDE EFFECTS
5
HOW TO STORE AVAGLIM
6.
FURTHER INFORMATION
1.
WHAT AVAGLIM IS AND WHAT IT IS USED FOR
AVAGLIM TABLETS ARE A COMBINATION OF TWO DIFFERENT MEDICINES
called
_rosiglitazone_
and
_glimepiride. _
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 glimepiride work
together so your body makes better use of the insulin it produces, and
this helps reduce your blood
sugar to a normal level.
2.
BEFORE YOU TAKE AVAGLIM
To help manage your diabetes, it is important that you follow any diet
and lifestyle advice from your
doctor as well as taking Avaglim.
DON’T TAKE AVAGLIM:
•
IF YOU ARE ALLERGIC
(
_hypersensitive_
) to rosiglitazone, glimepiride, or any of the other
ingredients of Avaglim (
_listed in Section 6), _
or to
_ _
other medicines called sulphonylureas
(like
_glibenclamide_
) or sulphonamides
•
IF YOU HAVE HAD A HEART ATTACK OR SEVERE ANGINA,
that’s being treated in hospital
•
IF YOU HAVE HEART FAILURE,
or have had heart failure in the past
•
IF YOU HAVE LIVER DISEASE
•
IF YOU 
                                
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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
AVAGLIM 4 mg/4 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each tablet contains rosiglitazone maleate corresponding to 4 mg
rosiglitazone and 4 mg glimepiride.
Excipient
-
contains lactose (approximately 104 mg)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, rounded triangular tablet with “gsk” debossed on one side
and “4/4” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AVAGLIM is indicated in the treatment of type 2 diabetes mellitus
patients who are unable to achieve
sufficient glycaemic control on optimal dosage of
sulphonylurea monotherapy, and for whom
metformin is inappropriate because of contraindication or intolerance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
AVAGLIM therapy should be individualised for each patient. Before
therapy is initiated with
AVAGLIM appropriate clinical evaluation should be made to assess the
patient’s risk of developing
hypoglycaemia (see section 4.4).
AVAGLIM should be taken once daily shortly before or during a meal
(usually the first main meal of
the day). If a dose is forgotten, the following dose must not be
increased.
_For patients inadequately controlled on glimepiride monotherapy
(typically 4 mg)._
Concomitant
administration should be considered before the patient is switched to
AVAGLIM. Where clinically
appropriate, direct change from glimepiride monotherapy to AVAGLIM may
be considered
.
The
starting dose is 4 mg/day rosiglitazone plus 4 mg/day glimepiride
(given as one tablet AVAGLIM
4 mg/4 mg).
_Patients unable to achieve glycaemic control on at least half-maximum
dose of other sulphonylurea _
_monotherapy (except chlorpropamide, see section 4.4)._
Rosiglitazone 4 mg should be administered
concomitantly with the dose of sulphonylurea already being taken. Once
glycaemic control is stable at
these doses
                                
                                Read the complete document

Similar products

Active ingredient rosiglitazone, glimepiride

rosiglitazone, glimepiride

ATC code A10BD04

A10BD04

Marketed by SmithKline Beecham Ltd

SmithKline Beecham Ltd

INN (International Name) rosiglitazone, glimepiride

rosiglitazone, glimepiride

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 17-01-2011
Summary of Product characteristics Summary of Product characteristics Bulgarian 17-01-2011
Public Assessment Report Public Assessment Report Bulgarian 17-01-2011
Patient Information leaflet Patient Information leaflet Spanish 17-01-2011
Summary of Product characteristics Summary of Product characteristics Spanish 17-01-2011
Public Assessment Report Public Assessment Report Spanish 17-01-2011
Patient Information leaflet Patient Information leaflet Czech 17-01-2011
Summary of Product characteristics Summary of Product characteristics Czech 17-01-2011
Public Assessment Report Public Assessment Report Czech 17-01-2011
Patient Information leaflet Patient Information leaflet Danish 17-01-2011
Summary of Product characteristics Summary of Product characteristics Danish 17-01-2011
Public Assessment Report Public Assessment Report Danish 17-01-2011
Patient Information leaflet Patient Information leaflet German 17-01-2011
Summary of Product characteristics Summary of Product characteristics German 17-01-2011
Public Assessment Report Public Assessment Report German 17-01-2011
Patient Information leaflet Patient Information leaflet Estonian 17-01-2011
Summary of Product characteristics Summary of Product characteristics Estonian 17-01-2011
Public Assessment Report Public Assessment Report Estonian 17-01-2011
Patient Information leaflet Patient Information leaflet Greek 17-01-2011
Summary of Product characteristics Summary of Product characteristics Greek 17-01-2011
Public Assessment Report Public Assessment Report Greek 17-01-2011
Patient Information leaflet Patient Information leaflet French 17-01-2011
Summary of Product characteristics Summary of Product characteristics French 17-01-2011
Public Assessment Report Public Assessment Report French 17-01-2011
Patient Information leaflet Patient Information leaflet Italian 17-01-2011
Summary of Product characteristics Summary of Product characteristics Italian 17-01-2011
Public Assessment Report Public Assessment Report Italian 17-01-2011
Patient Information leaflet Patient Information leaflet Latvian 17-01-2011
Summary of Product characteristics Summary of Product characteristics Latvian 17-01-2011
Public Assessment Report Public Assessment Report Latvian 17-01-2011
Patient Information leaflet Patient Information leaflet Lithuanian 17-01-2011
Summary of Product characteristics Summary of Product characteristics Lithuanian 17-01-2011
Public Assessment Report Public Assessment Report Lithuanian 17-01-2011
Patient Information leaflet Patient Information leaflet Hungarian 17-01-2011
Summary of Product characteristics Summary of Product characteristics Hungarian 17-01-2011
Public Assessment Report Public Assessment Report Hungarian 17-01-2011
Patient Information leaflet Patient Information leaflet Maltese 17-01-2011
Summary of Product characteristics Summary of Product characteristics Maltese 17-01-2011
Public Assessment Report Public Assessment Report Maltese 17-01-2011
Patient Information leaflet Patient Information leaflet Dutch 17-01-2011
Summary of Product characteristics Summary of Product characteristics Dutch 17-01-2011
Public Assessment Report Public Assessment Report Dutch 17-01-2011
Patient Information leaflet Patient Information leaflet Polish 17-01-2011
Summary of Product characteristics Summary of Product characteristics Polish 17-01-2011
Public Assessment Report Public Assessment Report Polish 17-01-2011
Patient Information leaflet Patient Information leaflet Portuguese 17-01-2011
Summary of Product characteristics Summary of Product characteristics Portuguese 17-01-2011
Public Assessment Report Public Assessment Report Portuguese 17-01-2011
Patient Information leaflet Patient Information leaflet Romanian 17-01-2011
Summary of Product characteristics Summary of Product characteristics Romanian 17-01-2011
Public Assessment Report Public Assessment Report Romanian 17-01-2011
Patient Information leaflet Patient Information leaflet Slovak 17-01-2011
Summary of Product characteristics Summary of Product characteristics Slovak 17-01-2011
Public Assessment Report Public Assessment Report Slovak 17-01-2011
Patient Information leaflet Patient Information leaflet Slovenian 17-01-2011
Summary of Product characteristics Summary of Product characteristics Slovenian 17-01-2011
Public Assessment Report Public Assessment Report Slovenian 17-01-2011
Patient Information leaflet Patient Information leaflet Finnish 17-01-2011
Summary of Product characteristics Summary of Product characteristics Finnish 17-01-2011
Public Assessment Report Public Assessment Report Finnish 17-01-2011
Patient Information leaflet Patient Information leaflet Swedish 17-01-2011
Summary of Product characteristics Summary of Product characteristics Swedish 17-01-2011
Public Assessment Report Public Assessment Report Swedish 17-01-2011

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Avaglim