SPC changes
Voltarol Ophtha eye-drops
The licensed indications
for Voltarol Ophtha (diclofenac sodium) 0.1 per cent eye-drops have been
extended (Novartis Pharmaceuticals). Voltarol Ophtha is now additionally
licensed for the treatment of inflammation and discomfort after strabismus
(squint) surgery. One drop should be instilled four times daily in the
first week, three times daily in the second week, twice daily in the third
week and as required in the fourth week. The warning that no specific
studies of use have been performed in children has been removed.
Voltarol Ophtha is additionally licensed for the
treatment of ocular pain and discomfort after radial keratotomy. One drop
should be instilled before surgery and one drop should be instilled immediately
after surgery and then one drop four times daily for up to two days.
Bezalip tablets
The summaries of product characteristics for Bezalip
(bezafibrate) tablets and Bezalip Mono tablets have been updated (Roche
Products). Changes have been made with reference to usage in patients
with renal dysfunction. The undesirable effects sections for both products
has has been reformatted. See SPC.
Madopar preparations
The summaries of product characteristics for Madopar
(levodopa, benserazide) capsules, Madopar dispersible tablets and Madopar
CR capsules have been revised (Roche Products). Additions have been made
with regard to anaesthesia and drug interactions with ferrous sulphate,
metoclopramide, diazepam, tricyclic antidepressants, antihypertensive
agents, monoamine-oxidase inhibitors and treatment with a catechol-O-methyltransferase
inhibitor. The undesirable effects section has been reformatted. See SPC.
Convulex capsules
Information on use in pregnancy and breast feeding
has been updated in the summaries of product characteristics for Convulex
(valproic acid) 150mg, 300mg and 500mg capsules (Pharmacia). The storage
requirements have been amended from "store at room temperature" to "do
not store above 25C".
Maxtrex tablets
The shape of Maxtrex (methotrexate) 10mg tablets
has been changed from round to capsule-shaped (Pharmacia). The summary
of product characteristics has been amended accordingly.
Nicorette Microtab
The summary of product characteristics for Nicorette
Microtab 2mg sublingual tablet has been updated to include palpitations
and atrial fibrillation under the undesirable effects section (Pharmacia).
The shelf-life of the product has been changed from three to two years.
The storage requirements have been changed from "store at room temperature"
to "do not store above 25C".
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