Pharmaceutical Composition Comprising (1r,4r)-6'-fluoro-N, N-dimethyl-4-phenyl-4',9' -dihydro-3'H-spiro[cyclohexane-1,1' -pyrano[3,4,b]indol]-4-amine and Paracetamol or Propacetamol

Abstract

The invention relates to a pharmaceutical composition comprising a first pharmacologically active ingredient selected from (1r,4r)-6′-fluoro-N,N-dimethyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine and the physiologically acceptable salts thereof, and a second pharmacologically active ingredient selected from paracetamol and propacetamol.

1 .- 15 . (canceled) 
     
     
         16 . A pharmaceutical composition comprising:
 (a) a first pharmacologically active ingredient selected from   
       
         
           
           
               
               
           
         
          and physiologically acceptable salts thereof, and 
         (b) paracetamol as a second pharmacologically active ingredient, 
       
       wherein the first and second pharmacologically active ingredient are adapted for simultaneous administration, by either the same or a different pathway of administration. 
     
     
         17 . The pharmaceutical composition according to claim  1 , wherein the first pharmacologically active ingredient is 
       
         
           
           
               
               
           
         
       
       in form of a hydrochloride, hemicitrate or maleate salt. 
     
     
         18 . A pharmaceutical dosage form comprising the pharmaceutical composition according to  claim 16 . 
     
     
         19 . The pharmaceutical dosage form according to  claim 18 , which is for oral, intravenous, intraperitoneal, transdermal, intrathecal, intramuscular, intranasal, transmucosal, subcutaneous, or rectal administration. 
     
     
         20 . The pharmaceutical dosage form according to  claim 18 , which provides under in vitro conditions immediate release or controlled release of the first pharmacologically active ingredient, the second pharmacologically active ingredient, or both the first and second pharmacologically active ingredient. 
     
     
         21 . A kit comprising a first pharmaceutical dosage form, which comprises the first pharmacologically active ingredient according to  claim 16 , and a second pharmaceutical dosage form, which comprises the second pharmacologically active ingredient according to  claim 16 . 
     
     
         22 . The kit according to  claim 21 , wherein the first and the second pharmaceutical dosage form are adapted for administration by the same pathway. 
     
     
         23 . The kit according to  claim 21 , wherein the first and the second pharmaceutical dosage form are adapted for administration by different pathways. 
     
     
         24 . A method of preventing or treating pain comprising simultaneous administration of:
 (a) a first pharmacologically active ingredient selected from   
       
         
           
           
               
               
           
         
          and physiologically acceptable salts thereof, and 
         (b) paracetamol as a second pharmacologically active ingredient. 
       
     
     
         25 . The method according to  claim 24 , wherein the first pharmacologically active ingredient is in form of a hydrochloride, hemicitrate or maleate salt. 
     
     
         26 . The method according to  claim 24 , wherein the pain is chronic pain. 
     
     
         27 . The method according to  claim 24 , wherein the pain is moderate to severe pain. 
     
     
         28 . The method according to  claim 24 , wherein the pain is low back pain, visceral pain, or headache. 
     
     
         29 . The method according to  claim 24 , wherein the pain is post-operative, cancer, or inflammatory pain. 
     
     
         30 . The method according to  claim 24 , wherein the first and second pharmacologically active ingredient are administered by the same pathway. 
     
     
         31 . The method according to  claim 30 , wherein the administration pathway is selected from the group consisting of oral, intravenous, intraperitoneal, transdermal, intrathecal, intramuscular, intranasal, transmucosal, subcutaneous, or rectal. 
     
     
         32 . The method according to  claim 24 , wherein the first and second pharmacologically active ingredient are administered by two different pathways. 
     
     
         33 . The method according to  claim 32 , wherein each of the two different administration pathways is selected from the group consisting of oral, intravenous, intraperitoneal, transdermal, intrathecal, intramuscular, intranasal, transmucosal, subcutaneous, or rectal.