SPC changes
Accessing SPCs
The summaries of product characteristics and patient
information leaflets for medicines licensed in the UK are available online |
Abilify
Hypersensitivity reactions characterised by allergic symptoms may be
caused by Abilify (aripiprazole; Bristol-Myers Squibb), the product’s
summary of product characteristics now warns. In addition, the following
have been added to the list of Abilify’s undesirable effects: anxiety,
thromboembolic events, abdominal and stomach discomfort, increased alanine
aminotransferase, aspartate aminotransferase and glutamyl transferase,
hyperhidrosis, peripheral oedema and increased creatine phosphokinase.
Lopresor
Information on use during anaesthesia has been added to the summaries
of product characteristics of Lopresor (metoprolol) and Lopresor SR
(metoprolol). In addition, the SPC now includes hepatitis, retroperitoneal
fibrosis and Peyronie’s disease as undesirable effects. Information
about interactions with potent CYP 2D6 inhibitors has also been added.
Voltarol
Additional safety information has been added to the summaries of product
characteristics for Voltarol (diclofenac) tablets, dispersible, ampoules
and suppositories, and Voltarol SR, Voltarol Rapid and Voltarol Retard.
Use during the last trimester of pregnancy is now contraindicated.
New information has been included about: gastrointestinal bleeding
(including possible fatality, especially in the elderly); gastrointestinal
ulceration and perforation; hypersensitivity to ibuprofen; severe renal,
hepatic or heart failure; use in elderly patients; cardiovascular and
cerebrovascular effects; systemic lupus erythematosus and mixed connective
tissue disorder; dermatology; female fertility; use during pregnancy
and breastfeeding; hypotension; confusion; hallucinations; malaise;
optic nerve neuritis; aseptic meningitis; autoimmune disorders; and
hypersensitivity.
Xalacom
Prostaglandin analogues are now listed in the summary of product characteristics
of Xalacom (latanoprost; Pfizer) as products to which an insufficient
response must have been seen (in patients with open angle glaucoma
and ocular hypertension) for Xalacom to be used to reduce intraocular
pressure.
Xigris
Warnings about serious bleeding events associated with Xigris (drotrecogin
alfa [activated]; Eli Lilly) have been added to the product’s
summary of product characteristics. The SPC now states that the incidence
of serious bleeding events with Xigris was higher in patients with
recent surgery (within 30 days) than in medical patients who had not
had surgery. Bleeding risk should be taken into account when considering
the risks and benefits of treatment with Xigris for individual patients.
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