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SPC changes: April 2014

05 April 2014

Ciclosporin

Neoral (ciclosporin; Novartis) is now indicated for the treatment of sight-threatening intermediate or posterior uveitis of noninfectious aetiology in patients in whom conventional therapy has failed or caused unacceptable side effects, and for the treatment of Behçet uveitis with repeated inflammatory attacks involving the retina in patients without neurological manifestations.

The shelf life for Sandimmun (ciclosporin; Novartis) capsules has been reduced from 42 to 36 months. Hirsutism has been added as a very common side effect of both product ranges, and leucopenia, convulsions, flushing, peptic ulcer, acne, pyrexia and hyperglycaemia have been added as common side effects. Both products have had extensive changes to their summaries of product characteristics.

Nalorex

Nalorex (naltrexone hydrochloride; Bristol-Myers Squibb) is now contraindicated in combination with methadone, according to the updated summary of product characteristics. Concomitant administration of naltrexone with other opioid-containing medicines should also be avoided.

PecFent

The summary of product characteristics for PecFent (fentanyl citrate; Archimedes) now advises caution when PecFent is co-administered with drugs that affect the serotonergic neurotransmitter systems because of the risk of developing serotonin syndrome. If serotonin syndrome is suspected, treatment with PecFent should be discontinued.

Questran Light

Constipation has been added as a very common side effect of Questran Light (anhydrous colestyramine; Bristol-Myers Squibb). Doses of more than 24g per day of colestyramine resin may interfere with normal fat absorption, according to the updated summary of product characteristics. Therefore the diet may require supplementation with vitamins A, D and K during prolonged high-dose administration. To minimise potential gastrointestinal side effects, it is desirable to start all therapy in children with one dose of Questran daily and then build up gradually for effective control. Additionally, chronic use of Questran may be associated with increased bleeding due to hypoprothrombinaemia associated with vitamin K deficiency. There is also a possibility that  prolonged use of colestyramine resin in high doses may produce hyperchloraemic acidosis.

Citation: The Pharmaceutical Journal URI: 20065387

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