SPC changes
Angeliq
The summary of product characteristics for Angeliq (drospirenone, estradiol
hemihydrate; Schering) now includes additional warnings. Women with elevated
blood pressure may experience a decrease in blood pressure under treatment
with Angeliq due to the aldosterone antagonist activity of drospirenone.
Angeliq should not be used to treat hypertension. Concomitant use of
Angeliq, non-steroidal anti-inflammatory drugs and angiotensin-converting
enzyme inhibitors/angiotensin-II receptor antagonists may cause a small
increase in serum potassium, which may be more pronounced in diabetic
women. Depression has been added to list of common side effects. Erythema
nodosum, erythema multiforme, chloasma and haemorrhagic dermatitis are
now listed as undesirable effects reported in association with hormone
replacement therapy. See SPC.
Campto
The summary of product characteristics for Campto (irinotecan hydrochloride;
Pfizer) has been updated to include information on the use of Campto
in combination with Avastin. See SPC.
Durogesic DTrans
The summary of product characteristics for Durogesic DTrans (fentanyl;
Janssen-Cilag) transdermal patch now includes information about different
brands of transdermal fentanyl patch and about use during pregnancy.
Patients should not be changed from one make of fentanyl transdermal
patches to another without specific counselling on the change from
health care professionals. Patients should check with their doctor
or pharmacist before using a patch that looks different from those
used previously. The SPC also now states that Durogesic DTrans should
not be used during pregnancy unless clearly indicated and that use
of Durogesic DTrans during childbirth is not recommended because fentanyl
passess through the placenta and may cause respiratory depression in
the newborn child. See SPC.
Perfalgan
The summary of product characteristics for Perfalgan (paracetamol; Bristol-Myers
Squibb) solution for infusion now states that increased international
normalised ratio monitoring should be conducted during (and for one
week after) concomitant use of paracetamol (4g per day for at least
four days) and oral anticoagulants. It also warns that close monitoring
is needed at the end of infusions, particularly for central route infusions,
to avoid air embolism. See SPC.
Xyrem
The summary of product characteristics for Xyrem (sodium oxybate; UCB
Pharma) now lists its indication as treatment of narcolepsy with cataplexy
in adult patients. The dosing increments have been raised to 1.5g/dose.
The following have been added as undesirable adverse effects: anxiety,
arthralgia, balance disorder, cataplexy, disturbance in attention,
dyspnoea, fall, hypertension, hypoaesthesia, insomnia, nervousness,
paraesthesia, peripheral oedema, sedation, snoring, urinary incontinence.
See SPC.
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