SPC changes
Casodex tablets
The licensed indications
for Casodex (bicalutamide) tablets (AstraZeneca) have been extended. Casodex
is now indicated, at a dose of 150mg daily, for use as immediate therapy
in patients with localised prostate cancer who are not being treated by
radical prostatectomy or radiotherapy and as immediate therapy either
alone or as adjuvant to radical prostatectomy or radiotherapy in patients
with locally advanced prostate cancer.
Cellcept
The summaries of product characteristics for Cellcept
(mycophenolate mofetil) capsules, tablets and powder for infusion (Roche
Pharmaceuticals) have been amended. Cellcept capsules and tablets are
now recommended for use in children aged 2 to 18 receiving renal transplants
at a dose of 600mg/m2 twice daily (up to a maximum of 2g daily).
However, no data are available for use in children receiving cardiac or
hepatic transplants. For Cellcept tablets, the section on storage now
states that the tablets should be kept in the outer carton. The requirement
that the tablets should be protected from light has been removed. The
new SPC for Cellcept powder for infusion states that its safety and efficacy
in paediatric patients has not been established. See SPC for full details.
Manerix tablets
The summary of product characteristics for Manerix
(moclobemide) tablets (Roche Pharmaceuticals) has been revised. The special
warnings section now states that hypersensitivity may occur in susceptible
individuals, symptoms of which include rash and oedema. The section on
overdose now contains the statement: “Overdoses of moclobemide alone induce
generally mild and reversible signs of central nervous system and gastrointestinal
irritation”. See SPC for full details.
Roaccutane capsules
The summary of product characteristics for Roaccutane
(isotretinoin) capsules (Roche Pharmaceuticals) has been amended. Several
changes have been made to the section on special warnings and precautions
for use, including the addition of the following statements: “If oral
contraception is chosen as the most appropriate contraceptive method for
women undergoing retinoid treatment, then a combined oestrogen-progesterone
formulation is recommended”, “Bone changes, including premature epiphyseal
closure, have occurred after several years of administration at high doses
for treating disorders of keratinization” and “Roaccutane has been associated
with inflammatory bowel disease in patients without a prior history of
intestinal disorders. Patients experiencing severe diarrhoea should discontinue
Roaccutane immediately”. The new SPC also states that transitory and reversible
increases in liver transaminases have been reported and that when transaminase
levels exceed the normal levels, reduction of the dose or discontinuation
of treatment may be necessary. The new SPC also states that visual disturbance
may occur during treatment, therefore patients should be advised to be
cautious when driving or operating machinery. The section on undesirable
effects has been divided into subsections. See SPC for full details.
Seroquel tablets
The summary of product characteristics for Seroquel
(quetiapine) tablets (AstraZeneca) has been updated. The following two
statements have been added to the undesirable effects section: “There
have been very rare reports of priapism in patients administered Seroquel”
and “As with other antipsychotic agents, rare cases of peripheral oedema
have been reported in patients treated with Seroquel”.
Back to Top
|
