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Product news (11 December 2010)

By News team

Accessing SPCs

The list of changes to summaries of product characteristics is not exhaustive. SPCs for a number of medicines licensed in the UK are available online


SPC changes


Calcichew-D3 (calcium carbonate/cholecalciferol; Shire) 500mg/400IU (calcium equivalent/cholecalciferol equivalent) should not be given with quinolones or tetracyclines unless certain precautions are followed, according to the product’s updated summary of product characteristics:  quinolones and tetracyclines should be given two hours before, or six hours after Calcichew-D3 due to the risk of impairment of absorption of the antibiotic.

The SPC also states that the administration of Calcichew-D3 and levothyroxine should be separated by at least four hours and that bisphosphonates should be given one hour before Calcichew-D3.


MabThera (rituximab; Roche) is now indicated as maintenance treatment for follicular lymphoma patients responding to induction therapy, the product’s updated SPC states.

The maintenance dose for those who had previously untreated follicular lymphoma before induction therapy is 375mg/m2 once every two months, starting two months after the last dose of induction therapy. This should be continued until disease progression occurs or for a maximum of two years.

For patients who had relapsed or refractory follicular lymphoma before induction therapy, the dose of 375mg/m2 once every three months, should be started three months after the last dose of induction therapy.

Prescription products

Dovobet gel

Dovobet (calcipotriol 50µg and betamethasone 0.5mg) gel is now available from Leo Pharma.

Net price:

1 x 60g, £36.50
2 x 60g, £67.79

Prednisolone EC

Enteric coated prednisolone tablets are now available from Teva.

Net price:

28 x 2.5mg, £8.57
28 x 5mg, £8.65

Supply issues

Gentisone HC

Gentisone HC (gentamicin 0.3%, hydrocortisone 1%) ear drops will be unavailable from Amdipharm until late January 2011. Amdipharm advises that it is best to speak to the patient’s prescriber to determine a suitable alternative product.

Genticin (gentamicin 0.3%) ear drops, which are indicated for bacterial infections in otitis externa, are in limited supply. However, Locorten-Vioform (clioquinol 1%, flumetasone 0.02%) ear drops, which are indicated for eczematous inflammation in otitis externa, are available from Amdipharm.

There is no hydrocortisone-only ear drop available on the UK market, Amdipharm believes.

Goldshield products

Dyazide (triamterene/ hydrochlorothiazide) tablets 50mg/25mg, phenindione tablets 10mg and 25mg and Traxam (felbinac) foam 3.17% are currently unavailable from Goldshield. Dyazide and Traxam are not expected to be available until the end of January 2011.

Phenindione tablets are expected to be available again during December 2010.

Medical information on 08700 703033.

Stock related information on 020 8588 9273.

Citation: The Pharmaceutical Journal URI: 11050777

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