SPC changes
Diovan capsules
The summary of product characteristics for Diovan (valsartan)
capsules has been updated (Novartis Pharmaceuticals). The following statement
has been added to the special precautions for use section: "As a consequence
of inhibiting the renin-aldosterone-angiotensin system, increases of blood
urea and serum creatinine and changes in renal function, including renal
failure (very rarely), have been reported, particularly in patients with
pre-existing renal dysfunction or those with severe cardiac insufficiency."
The following very rarely reported adverse events have been added to the
undesirable effects section: syncope, diarrhoea, liver function abnormalities,
arthralgia, dizziness, headache, renal dysfunction, isolated cases of
renal impairment and cough.
Urispas 200 tablets
The summary of product characteristics for Urispas 200 (flavoxate hydrochloride) tablets has been updated (Shire Pharmaceuticals). The coating of the tablets has been changed from a sugar-coating to a film-coating. The shelf-life has been increased from two years to three years. The following statement has been added to the special precautions for storage section: "Do not store above 30C. Protect from light."
Lamisil tablets
The summary of characteristics for Lamisil (terbinafine) tablets has been updated. Lamisil is not recommended in patients with chronic or active liver disease and should be used with caution in patients with psoriasis. The interaction section draws attention to the possibility of interactions between terbinafine and compounds metabolised by cytochrome P450 2D6, such as tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors and monoamine-oxidase inhibitors type B. The undesirable effects section now states that extremely rare cases of vertigo have been reported and that psychiatric disturbances, such as depression and anxiety, as well as exacerbations of psoriasis have been reported rarely. The overdose section now includes additional information on the experience of overdose and its management. A section on preclinical safety data is now included.
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