Avandia
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
08-06-2016
Charakterystyka produktu
(SPC)
08-06-2016
Sprawozdanie z oceny publicznego
(PAR)
08-06-2016
Składnik aktywny:
rosiglitazone
Dostępny od:
SmithKline Beecham Plc
Kod ATC:
A10BG02
INN (International Nazwa):
rosiglitazone
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus, Type 2
Wskazania:
Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:as monotherapy-in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intoleranceas dual oral therapy in combination with-metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin-a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylureaas triple oral therapy in combination with-metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).
Podsumowanie produktu:
Revision: 23
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-07-11
Ulotka dla pacjenta
52
B. PACKAGE LEAFLET
Medicinal product no longer authorised
53
PACKAGE LEAFLET: INFORMATION FOR THE USER
AVANDIA 2 MG FILM-COATED TABLETS
AVANDIA 4 MG FILM-COATED TABLETS
AVANDIA 8 MG FILM-COATED TABLETS
rosiglitazone
_ _
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 AVANDIA IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE AVANDIA
3.
HOW TO TAKE AVANDIA
4.
POSSIBLE SIDE EFFECTS
5
HOW TO STORE AVANDIA
6.
FURTHER INFORMATION
1.
WHAT AVANDIA IS AND WHAT IT IS USED FOR
AVANDIA IS 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. Avandia helps to reduce your blood sugar towards a normal
level, by helping your body
make better use of the insulin it produces.
Avandia can be used alone or in combination with other medicines to
treat diabetes (such as
metformin or a sulphonylurea).
2.
BEFORE YOU TAKE AVANDIA
To help manage your diabetes, it is important that you follow any diet
and lifestyle advice from your
doctor as well as taking Avandia.
DON’T TAKE AVANDIA:
•
IF YOU ARE ALLERGIC
(
_hypersensitive_
) to rosiglitazone or any of the other ingredients of
Avandia (
_listed in Section 6)_
•
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 HAVE HAD DIABETIC KETOACIDOSIS
(a complication of diabetes causing rapid weight
loss, nausea or vomiting) CHECK WITH YOUR DOCTOR
if you think any of these
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
AVANDIA
2 mg film-coated tablets.
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains rosiglitazone maleate corresponding to 2 mg
rosiglitazone.
Excipient
Contains lactose (approximately 108 mg).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink film-coated tablets debossed with “GSK” on one side and "2"
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rosiglitazone is indicated in the treatment of type 2 diabetes
mellitus:
as MONOTHERAPY
–
in patients (particularly overweight patients) inadequately controlled
by diet and exercise for
whom metformin is inappropriate because of contraindications or
intolerance
as
DUAL ORAL THERAPY
in combination with
–
metformin, in patients (particularly overweight patients) with
insufficient glycaemic control
despite maximal tolerated dose of monotherapy with metformin
–
a sulphonylurea, only in patients who show intolerance to metformin or
for whom metformin is
contraindicated, with insufficient glycaemic control despite
monotherapy with a sulphonylurea
as
TRIPLE ORAL THERAPY
in combination with
–
metformin and a sulphonylurea, in patients (particularly overweight
patients) with insufficient
glycaemic control despite dual oral therapy (see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Rosiglitazone therapy is usually initiated at 4 mg/day. This dose can
_ _
be increased to 8 mg/day after
eight
_ _
weeks if greater glycaemic control is required. In patients
administered rosiglitazone in
combination with a sulphonylurea, an increase in rosiglitazone to 8
mg/day should be undertaken
cautiously following appropriate clinical evaluation to assess the
patient's risk of developing adverse
reactions relating to fluid retention (see 4.4 and 4.8).
Rosiglitazone may be given once or twice a day.
Rosiglitazone may be taken with or without food.
Elderly (see section 4.
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