Avaglim
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
17-01-2011
Charakterystyka produktu
(SPC)
17-01-2011
Sprawozdanie z oceny publicznego
(PAR)
17-01-2011
Składnik aktywny:
rosiglitazone, glimepiride
Dostępny od:
SmithKline Beecham Ltd
Kod ATC:
A10BD04
INN (International Nazwa):
rosiglitazone, glimepiride
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus, Type 2
Wskazania:
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.
Podsumowanie produktu:
Revision: 11
Status autoryzacji:
Withdrawn
Data autoryzacji:
2006-06-27
Ulotka dla pacjenta
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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Charakterystyka produktu
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
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