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The Pharmaceutical Journal
Vol 268 No 7200 p760
1 June 2002

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Products

    Prescription Products SPC changes Discontinued products Supply problems Counter medicines Products miscellany

Recall Extraneal peritoneal dialysis solution


Prescription Products

Efcortesol ampoules

A 5-ampoule pack size of Efcortesol (hydrocortisone) 100mg/ml 5ml ampoules has been introduced (Sovereign Medical); net price, £16.99.

Disipal tablets

The markings on Disipal (orphena-drine hydrochloride) 50mg tablets have been changed from "DISIPAL" to "I" (Yamanouchi Pharma). The first batch of Disipal 50mg tablets to have the new markings is batch number 01K2727/36, expiry date November 2004. Further enquiries should be directed to the company's medical information department (tel 01932 345535).

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SPC changes

Durogesic patches

The licensed indications for Durogesic (fentanyl) transdermal patches have been updated (Janssen-Cilag). Durogesic transdermal patches are now additionally licensed for use in the management of chronic intractable pain. See SPC.

Aprovel tablets and CoAprovel tablets

The summaries of product characteristics for Aprovel (irbesartan) tablets and CoAproval (irbesartan, hydrochlorothiazide) tablets have been revised (Bristol-Myers Squibb Pharmaceuticals, Sanofi-Synthelabo). The SPC now states that a combination of lithium and irbesartan is not recommended. If the combination proves necessary, careful monitoring of serum lithium levels is recommended. Tinnitus and arthralgia have been added to the undesirable effects reported during post-marketing, as has the statement "cases of cough have been reported very rarely with irbesartan". See SPC.

Broflex syrup

Additions have been made to the summary of product characteristics for Broflex (trihexyphenidyl hydrochloride) 5mg/5ml syrup (Alliance Pharmaceuticals). The effects on ability to drive and use machines section now states that patients should be warned of a reduction in alertness. The undesirable effects section now states: "Psychiatric symptoms such as agitation, confusion, hallucinations, euphoria, insomnia, restlessness and very occasionally paranoid delusions have been reported. These are more likely to occur in patients receiving higher than recommended doses. There have been reports of abuse of [trihexyphenidyl hydrochloride] due to its euphoric and hallucinogenic properties. Impairment of immediate and short-term memory functions has also been reported." See SPC.

Efexor tablets and Efexor XL capsules new indication

The licensed indications for Efexor (venlafaxine) tablets and Efexor XL capsules have been extended (Wyeth Pharmaceuticals). Both products are additionally licensed for the prevention of relapses of initial episodes of depression or for the prevention of the recurrence of new episodes, following an initial response. Usually the dosage is similar to that used during the first episode. Patients should be reassessed regularly in order to evaluate the benefit of long-term ther-apy. See SPC.

Meningitec vaccine

The summary of product characteristics for Meningitec meningococcal group C conjugate vaccine has been updated and now includes additional information with regard to the incidence of adverse reactions. See SPC.

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Discontinued products

Genus products

Genus Pharmaceuticals has discontinued the following products:

• Aciclovir dispersible tablets 200mg, pack size 25; 400mg, pack size 56; 800mg, pack size 35

• Betahistine tablets 8mg, pack size 120; 16mg, pack size 84

• Bisoprolol 5mg and 10mg tablets, pack size 28

• Clotrimazole 20g cream

• Domperidone 10mg tablet, pack sizes 30 and 100

• Ethimil MR (verapamil) 240mg tablets, pack size 28

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Supply problems

Maalox TC tablets

Aventis is unable to supply Maalox TC (magnesium hydroxide, dried aluminium hydroxide) tablets owing to manufacturing problems. The company expects this to be a long-term problem and is cancelling existing orders and not holding any back orders. Further information can be obtained from the company's customer services department (tel 0870 513347).

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Counter medicines

Idrolax sachets

Idrolax (macrogol 4,000) 10g sachets, for the symptomatic treatment of constipation in adults, have been launched (Schwarz Pharma); retail price, 20 £8.64. Legal category: pharmacy medicine.

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Products miscellany

Abbott nutritional products

Paediasure Plus Fibre liquid tube feed, in a 500ml ready-to-hang container, has been launched (Abbott Laboratories); net price, 15 £93.75. The product is Advisory Committee on Borderline Substances (ACBS) approved. Ensure Plus Yogurt Style nutritional supplement drink is now available in an "orange burst" flavour, which is also ACBS approved; net price, 27 £42.12. Ensure Plus 200ml tetrapaks have been replaced by 220ml tetrapaks which are now ACBS approved.

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