Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login

SPC changes: April 2014

05 April 2014


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 (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.


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

Recommended from Pharmaceutical Press

  • Dale and Appelbe's Pharmacy and Medicines Law

    Dale and Appelbe's Pharmacy and Medicines Law

    This new edition of Dale and Appelbe's Pharmacy and Medicines Law is the definitive guide to law and ethics for pharmacy practice in the UK. It covers law and professional regulation and is firmly established as the definitive student textbook and reference work on this subject in the UK. Fully updated to include changes to pharmacy laws and regulation.

    £57.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.