The Pharmaceutical Journal
Vol 279 No 7474 p435
20 October 2007

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Products

Accessing SPCs
The summaries of product characteristics and patient information leaflets for medicines licensed in the UK are available online

SPC changes
• Aclasta
• Broflex
• Gabitril
Discontinued products
• Minulet and Tri-Minulet
• Novo Nordisk insulins

Recall
• Warfarin tablets
• Boots brand blood glucose monitoring system

SPC changes

Aclasta
Once-a-year administration for the treatment of post-menopausal osteoporosis has been added to the summary of product characteristics for Aclasta (zoledronic acid; Novartis). The recommended dose for the treatment of post-menopausal osteoporosis is a single intravenous infusion of 5mg of Aclasta administered once a year.

Broflex
Additional warnings have been added to the summary of product characteristics for Broflex Syrup (trihexyphenidyl hydrochloride; Alliance).

Broflex Syrup should be used with extreme caution in elderly patients. It is not recommended for use in patients with tardive dyskinesia.

It should be avoided (or be used with great caution) for patients with myasthenia gravis.

It should not be taken by patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-maltase insufficiency.

There is also additional information in the SPC about its use during pregnancy and breast feeding, and the overdose section of the SPC has been updated.

Gabitril
Risk of convulsions in non-epileptic patients has been added to the special warnings and precautions for use section of the summary of product characteristics for Gabitril (tiagabine; Cephalon).

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Discontinued products

Minulet and Tri-Minulet
Wyeth has discontinued Minulet (ethinylestradiol-gestodene) tablets 3 x 21 and Tri-Minulet (ethinylestradiol-gestodene) tablets 3 x 21.

Customer services on 0845 8505544.

Novo Nordisk insulins
Novo Nordisk is discontinuing the following insulin presentations at the end of December: Mixtard 10, 20, 40 and 50 (biphasic isophane insulin) Penfill cartridges 5 x 3ml; Pork Actrapid (soluble porcine insulin) 100iu/ml vials; Pork Mixtard 30 (biphasic isophane porcine insulin) 100iu/ml vials; and Pork Insulatard (isophane porcine insulin) 100iu/ml vials.

Questions can be directed to the Novo Nordisk Customer Care team on 0845 6005055.

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