PIOLET 45MG TABLETS

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

Pioglitazone Hydrochloride..

Beschikbaar vanaf:

JETPHARMA SDN. BHD.

INN (Algemene Internationale Benaming):

Pioglitazone Hydrochloride..

Eenheden in pakket:

30Tablet Tablets; 10Tablet Tablets

Geproduceerd door:

INTAS PHARM LTD

Productkenmerken

_WEIGHT GAIN:_
There was evidence of dose related weight gain, which may be due to
fat
accumulation and in some cases associated with fluid retention. In
some cases
weight increase may be a symptom of cardiac failure, therefore weight
should be
closely monitored. Part of the treatment of diabetes is dietary
control. Patients
should be advised to adhere strictly to a calorie-controlled diet.
_HAEMATOLOGY:_
There was a small reduction in mean haemoglobin and haematocrit. These
changes
primarily occurred within the first 4 to 12 weeks of therapy and
remained relatively
constant thereafter. These changes may be related to increased plasma
volume and
have rarely associated with any significant haematologic clinical
effects.
_HYPOGLYCAEMIA_
As a consequence of increased insulin sensitivity, patients receiving
pioglitazone
in dual or triple oral therapy with a sulphonylurea or in dual therapy
with insulin
may be at risk for dose-related hypoglycaemia, and a reduction in the
dose of the
sulphonylurea or insulin may be necessary.
_EYE DISORDERS:_
Post-marketing reports of new-onset or worsening diabetic macular
oedema with
decreased visual acuity have been reported with thiazolidinediones,
including
pioglitazone. Many of these patients reported concurrent peripheral
oedema. It is
unclear whether or not there is a direct association between
pioglitazone and
macular oedema but prescribers should be alert to the possibility of
macular
oedema
if
patients
report
disturbances
in
visual
acuity;
an
appropriate
ophthalmological referral should be considered.
_OTHERS:_
The risk of fractures should be considered in the long term care of
women
treated with pioglitazone.
As a consequence of enhancing insulin action, pioglitazone treatment
in patients
with polycystic ovarian syndrome may result in resumption of
ovulation. These
patients may be at risk of pregnancy. Patients should be aware of the
risk of
pregnancy and if a patient wishes to become pregnant or if pregnancy
occurs, the
treatment should be discontinued (see section, Pregn