VEXAZONE pioglitazone (as hydrochloride) 15mg tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

pioglitazone hydrochloride, Quantity: 16.53 mg (Equivalent: pioglitazone, Qty 15 mg)

Prieinama:

Alphapharm Pty Ltd

INN (Tarptautinis Pavadinimas):

Pioglitazone hydrochloride

Vaisto forma:

Tablet, uncoated

Sudėtis:

Excipient Ingredients: polysorbate 80; hypromellose; colloidal anhydrous silica; lactose monohydrate; croscarmellose sodium; magnesium stearate

Vartojimo būdas:

Oral

Vienetai pakuotėje:

98, 7, 50, 28

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Vexazone is indicated for the treatment of type 2 diabetes mellitus inadequately controlled by diet and exercise: as monotherapy; as dual therapy to improve glycaemic control: in combination with metformin or sulfonylurea, in combination with insulin; as triple therapy to improve glycaemic control: in combination with metformin and sulfonylurea.

Produkto santrauka:

Visual Identification: 6mm normal convex, white tablet debossed with "PG" over 15 one side and "G" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Autorizacija statusas:

Registered

Leidimo data:

2011-02-02

Pakuotės lapelis

VEXAZONE
_contains the active ingredient pioglitazone hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vexazone.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Vexazone against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT VEXAZONE IS
USED FOR
Vexazone is a tablet that is used to
improve the action of the body's
naturally produced insulin. Vexazone
is used to treat type 2 diabetes
mellitus not adequately controlled by
diet and exercise.
Type 2 diabetes is also known as
non-insulin dependent diabetes
mellitus or adult-onset diabetes, and
is controlled by diet, exercise, certain
oral medications and occasionally
insulin.
This medicine is also called
pioglitazone and is a member of a
class of drugs called glitazones. They
are insulin-sensitising agents, which
decrease insulin resistance. These
medicines help control the level of
sugar in your blood when you have
type 2 diabetes by helping your body
make better use of the insulin it
produces.
Vexazone may be used on its own
(when diet and exercise is not enough
to treat your diabetes) or in
combination with metformin and/or a
sulphonylurea which are also oral
anti-diabetic medicines.
It may also be used in combination
with insulin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
The use of Vexazone has not been
studies in children.
BEFORE YOU TAKE
VEXAZONE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE VEXAZONE IF:
•
you have heart failure requiring
treatment. Talk to your doctor if
you have heart failure
•
type 1 diabetes or diabetic
ketoac

Prekės savybės

AUSTRALIAN PRODUCT INFORMATION
VEXAZONE
_Pioglitazone hydrochloride tablets, uncoated _
1
NAME OF THE MEDICINE
Pioglitazone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vexazone tablet contains 15 mg, 30 mg or 45 mg pioglitazone (as
hydrochloride) as the active ingredient.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Vexazone 15 mg white to off-white, round, bi-convex, uncoated tablet
debossed with “PG” over 15 on one
side and “G” on the other side
Vexazone 30 mg white to off-white, round, bi-convex, uncoated tablet
debossed with “PG” over 30 on one
side and “G” on the other side.
Vexazone 45 mg white to off-white, round, bi-convex, uncoated tablet
debossed with “PG” over 45 on one
side and “G” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vexazone is indicated for the treatment of type 2 diabetes mellitus
inadequately controlled by diet and
exercise:
AS MONOTHERAPY
;
AS DUAL THERAPY
to improve glycaemic control:
•
in combination with metformin or sulfonylurea
•
in combination with insulin
AS TRIPLE THERAPY
to improve glycaemic control:
•
in combination with metformin and sulfonylurea
4.2
DOSE AND METHOD OF ADMINISTRATION
Vexazone should be taken once daily with or without food.
After initiation of Vexazone or with dose increase, patients should be
carefully monitored for adverse events
related to fluid retention (see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
FEMALE PATIENTS
Oedema has been reported more often in women. Dosage should start at
15 mg and be increased cautiously,
paying attention to the development of oedema.
MONOTHERAPY
The recommended dose of Vexazone is 15 mg or 30 mg once daily,
increasing after 4 weeks, if greater
therapeutic effect is needed, to 45 mg once daily.
DUAL THERAPY
The recommended dose of Vexazone is 30 mg once daily in combination
with sulfonylureas, insulin or
metformin. It may be possible to achieve metaboli