SPC changes
Hepsera
The summary of product characteristics for Hepsera (adefovir; Gilead)
has been updated. Rash and pruritis have been added to the undesirable
effects section. See SPC.
Reminyl
The summaries of product characteristics for Reminyl and Reminyl XL (galantamine;
Shire) have been updated. They now state that a diagnosis of probable
Alzheimer type of dementia should be adequately confirmed according
to current clinical guidelines before start of treatment. It says that
the tolerance and dosing of Remanyl should be reassessed on a regular
basis, preferably with three months of start of treatment. It also
now states that the benefit of Reminyl in other types of dementia or
memory impairment has not been demonstrated. Reminyl should be given
with caution in people with uncorrected electrolyte disturbance and
in those with cardiovascular diseases. Cerebrovascular events have
been observed uncommonly in patients treated with Reminyl and this
should be considered when administering to patients with cerebrovascular
disease. The adverse events section has also been updated. Depression,
very rarely with suicidal insomnia, is now listed as a common adverse
event, as are syncope, tremor asthenia and fever. See SPC.
Transiderm Nitro
The summary of product characteristics for Transiderm Nitro (glyceryl
trinitrate; Novartis) now states that all phosphodiesterase type 5
inhibitors (such as sildenafil) have been shown to potentiate the hypotensive
effects of nitrates and their co-administration with nitrates or nitric
oxide donors is therefore contraindicated. See SPC.
Viread
The summary of product characteristics for Viread (tenofovir disproxil;
Gilead) has been updated. Nephritis and nephrogenic diabetes insipidus
have been added as adverse events. See SPC.
Zyvox
The summary of product characteristics for Zyvox (linezolid; Pfizer)
has been updated. It now states that peripheral neuropathy and optic
neuropathy, sometimes progressing to loss of vision, have been reported
in patients treated with Zyvox; these reports have primarily been in
patients treated for longer than the maximum recommended duration of
28 days. It says that all patients should be advised to report symptoms
of visual impairment, such as changes in visual acuity, changes in
colour vision, blurred vision, or visual field defects. In such cases,
prompt evaluation is recommended with referral to an ophthalmologist
as necessary. If any patients are taking Zyvox for longer than 28 days,
their visual function should be regularly monitored. It adds that if
peripheral or optic neuropathy occurs, the continued use of Zyvox should
be weighed against the potential risks. The undesirable effects section
has also been updated. See SPC.
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