DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)127. SENNA LEAF (CASSIA) AND RHUBARB/ RADIX et RHIZOMA RHEIThe following statement shall be included on the labels of products containingsenna leaf (cassia) and rhubarb/ radix et rhizoma rhei:Do not use when abdominal pain, nausea or vomiting are presentFrequent or prolong use of this preparation may result independence towards the product and „Imbalanced electrolytes‟128. SODIUM METABISULPHITE (EXCIPIENT)The following statement shall be included in the package inserts of productscontaining Sodium metabisulphite:WARNINGThis preparation contains Sodium metabisulphite that may cause seriousallergic type reactions in certain susceptible patients. Do not use if known tobe hypersensitive to bisulphites.129. SODIUM VALPROATEThe following boxed warning shall be included in the package inserts ofproducts containing Sodium valproate:PANCREATITIS:CASES OF LIFE-THREATENING PANCREATITIS HAVE BEENREPORTED IN BOTH CHILDREN AND ADULTS RECEIVINGVALPROATE. SOME OF THE CASES HAVE BEEN DESCRIBED ASHEMORRHAGIC WITH A RAPID PROGRESSION FROM INITIALSYMPTOMS TO DEATH. CASES HAVE BEEN REPORTED SHORTLYAFTER INITIAL USE AS WELL AS AFTER SEVERAL YEARS OF USE.PATIENTS AND GUARDIANS SHOULD BE WARNED THATABDOMINAL PAIN, NAUSEA, VOMITING, AND/OR ANOREXIA CAN BESYMPTOMS OF PANCREATITIS THAT REQUIRE PROMPT MEDICALEVALUATION. IF PANCREATITIS IS DIAGNOSED, VALPROATESHOULD BE DISCONTINUED.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 416