The Pharmaceutical Journal
Vol 280 No 7496 p395
5 April 2008

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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
• Acezide
• Aredia
• Champix
• Lyrica
• Sebivo
Counter products
• Feminax Ultra
• Piriton

SPC changes

Acezide
Concomitant use of alpha blocking agents may increase the antihypertensive effects of captopril and increase the risk of orthostatic hypotension, the summary of product characteristics for Acezide (captopril/hydrochlorothiazide; Bristol-Myers Squibb) now states.

The SPC also now states that concomitant use of carbamazepine and hydrochlorothiazide has been associated with risk of symptomatic hyponatraemia and that electrolyes should be monitored during concomitant use or, if possible, another class of diuretics should be used.

Aredia
Aredia (disodium pamidronate; Novartis) is now contraindicated in pregnancy and during breastfeeding, the product’s summary of product characteristics states. In addition, the SPC warns that patients must be assessed before administration of Aredia to ensure they are properly hydrated, especially those receiving diuretic therapy.

Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial, or a single, dose of Aredia, it says. Information regarding severe and occasionally incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates has also been added.

Champix
The summary of product characteristics for Champix (varenicline; Pfizer) has been updated with the following statement: “Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation and suicide attempt, has been reported in patients undergoing a smoking cessation attempt. These symptoms have also been reported while attempting to quit smoking with Champix.

Clinicians should be aware of the possible emergence of significant depressive symptomatology in patients undergoing a smoking cessation attempt, and should advise patients accordingly.”

Lyrica
There have been post-marketing reports of congestive heart failure in some patients receiving Lyrica (pregabalin; Pfizer), the product’s summary of product characteristics now states. These reactions, it says, are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication and Lyrica should be used with caution in these patients.

Stevens-Johnson syndrome and urinary retention have been added to the list of adverse events with unknown frequency.

Sebivo
The summary of product characteristics for Sebivo (telbivudine; Novartis) has been updated to include information about uncommon reports of peripheral neuropathy in patients treated with Sebivo. It states: “An increased risk of peripheral neuropathy has been been observed when telbivudine and pegylated interferon alfa-2a are co-administered. Such increased risk cannot be excluded for other interferons alfa (pegylated or standard).

Moreover, the benefit of this combination of telbivudine with interferon alfa (pegylated or standard) is not currently established.”

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Counter products

Feminax Ultra
Feminax Ultra (naproxen) tablets are now available from Bayer Healthcare for treatment of women aged 15 to 50 years with primary dysmenorrhoea.

Recommended retail price: 9 x 250mg, £4.29
Legal category: P

Piriton
Piriton (chlorphenamine maleate) tablets 4mg are now available from GlaxoSmithKline in 60-tablet packs.

Recommended retail price: £5.99
Legal category: P

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