Bristol-Myers Squibb Pharmaceuticals Ltd has revised the summaries of product characteristics for Dutonin (nefazodone hydrochloride) 50mg, 100mg and 200mg tablets, Lipostat (pravastatin sodium) 10mg, 20mg and 40mg tablets and Zerit (stavudine) 15mg, 20mg, 30mg and 40mg capsules. The undesirable effects section of the SPC for Dutonin tablets has been ammended to include the addition of a paragraph referring to withdrawal reactions associated with serotonin re-uptake inhibitors and a paragraph about rare cases of liver necrosis and failure. An addition has been made to the therapeutic indications section of the SPC for Lipostat under coronary artery disease. Lipostat is now also indicated to reduce the number of days of hospitalisation. The wording referring to the occurrence of cataract formation under the undesirable effects section has also been altered.
Throughout the revised SPC for Zerit, the term "children" has been expanded to include "adolescents, children and infants". The therapeutic indications section now states: "Antiviral combination treatment of HIV-1 infected patients. Zerit is not recommended for use as monotherapy." Other changes to the text have been made under the "effects on ability to drive and use machines" and the "pharmacodynamics" sections. The SPC wording has been extended in the following sections: Pharmaceutical form, special warnings and precautions for use, interactions, pregnancy and lactation and undesirable effects. Zerit should not be stored above 30C and should be stored in the original package.