SPC changes
Actos
The summary of product characteristics for Actos (pioglitazone; Takeda)
now includes an additional indication for combination with insulin for
patients with type 2 diabetes mellitus who have insufficient glycaemic
control on insulin and for whom metformin is inappropriate because of
contraindications or intolerance. The SPC states that, for this indication,
the current insulin dose can be continued upon initiation of Actos therapy
and that if patients report hypoglycaemia, the dose of insulin should
be decreased. The SPC also now states that Actos can cause fluid retention,
which may exacerbate or precipitate heart failure. Patients with at least
one risk factor for the development of congestive heart failure should
start on the lowest available dose of Actos and the dose should be increased
gradually. Concomitant administration of insulin and Actos may increase
the risk of oedema. Patients should be observed for signs and symptoms
of heart failure, weight gain or oedema when Actos is used in combination
with insulin, and Actos should be discontinued if any deterioration in
cardiac status occurs. Information has been added to the undesirable
effects and pharmacological properties sections to reflect the new indication.
See SPC.
Yasmin
The summary of product characteristics for Yasmin (drospirenone, ethinylestradiol;
Schering) has been updated. The section describing changing from a
progestogen-only method of contraception has been expanded to include
progestogen-only pill, injection, implant or intrauterine system. The
advice for action in response to gastrointestinal disturbances has
been amended. The SPC now states that in women on chronic treatment
with hepatic enzyme-inducing active substances, another reliable, non-hormonal,
method of contraception is recommended. See SPC.
Primolut N
The summary of product characteristics for Primolut N (norethisterone;
Schering) now states that patients with hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
should not take Primolut N. See SPC.
Back to Top
|
The
Pharmaceutical Journal