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                    Aceclofenac
                  
                
                
                  
                    
                    
                  
                  
                    
                    Aceclofenac
                    
                      
                        
                        Aceclofenac
                      
                    
                  
                
                
                  
                    
                    Lactose Monohydrate
                  
                
                
                  
                    
                    Cellulose, Microcrystalline
                  
                
                
                  
                    
                    Sodium Carbonate
                  
                
                
                  
                    
                    Colloidal Silicon Dioxide
                  
                
                
                  
                    
                    Crospovidone
                  
                
                
                  
                    
                    Poloxamer 407
                  
                
                
                  
                    
                    Magnesium Stearate
                  
                
                
                  
                    
                    Alcohol
                  
                
                
                  
                    
                    Hypromellose 2208 (15000 MPA.S)
                  
                
                
                  
                    
                    Carbomer 941
                  
                
                
                  
                    
                    Hypromellose 2910 (6 MPA.S)
                  
                
                
                  
                    
                    Alcohol
                  
                
                
                  
                    
                    Methylene Chloride
                  
                
                
                  
                    
                    Hypromellose 2910 (5 MPA.S)
                  
                
                
                  
                    
                    Titanium Dioxide
                  
                
                
                  
                    
                    Ethylcelluloses
                  
                
                
                  
                    
                    Diethyl Phthalate
                  
                
                
                  
                    
                      
                    
                    
                  
                  
                    
                    
                  
                
                
                  
                    
                      
                    
                    
                  
                  
                    
                    
                    
                      
                        
                          
                        
                        
                      
                      
                        
                        
                      
                    
                  
                
              
              
                
                  
                  
                  
                    
                  
                
              
              
                
                  
                  
                    
                      
                        
                      
                    
                  
                
              
              
                
                  
                  
                    
                  
                
              
              
                
                  
                  
                
              
              
                
                  
                  
                    Film-coated white oblong tablet
                  
                
              
              
                
                  
                  UT;CR;CT


      
        
          
          
          
            
              DESCRIPTION
            
            White, oblong, film-coated tablet, engraved with "UT" on one side and "CL CR" on the other side.

            
          
          
        

      
      
        
          
          
          
            
              INDICATIONS
            
            CLANZA CR is indicated for Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism.

            
          
          
        

      
      
        
          
          
          
            Dosage and Administration
            Adults: The recommended dose is 200 mg daily, taken as one dose (every 24 hours).  However, the dose and dose frequency of CLANZA CR can be modified under the supervison of physician or pharmacist.

            
          
          
        

      
      
        
          
          
          
            
              CONTRAINDICATIONS
            
            Patients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer.

            
          
          
        

      
      
        
          
          
          
            
              CAUTIONS
            
            Patients with symptoms indicative of gastro-intestinal disorders, with a history of gastroulceration.  Patients with severe hepatic impairment or cardiac or renal impairment.  Patients under the medication of diuretics.  Patients in recovery after surgical treatment.

            
          
          
        

      
      
        
          
          
          
            
              ADVERSE REACTIONS
            
            The majority of side effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness.  To report suspected adverse reactions, call 1-800-FDA-1088.

            
          
          
        

      
      
        
          
          
          
            
              GENERAL PRECAUTIONS
            
            Patients suffering from dizziness, vertigo, or other central nervous system disorders while taking NSAIDS should refrain from driving or handling dangerous machinery.

            
          
          
        

      
      
        
          
          
          
            
              DRUG INTERACTIONS
            
            There has been no drug interactions reported, but close monitoring of patients on combination with lithium and digoxin, oral antidiabetic agents, anticoagulants, diuretics, and other analgesics. 

            
          
          
        

      
      
        
          
          
          
            
              USE IN PREGNANCY AND NURSING MOTHERS
            
            Since there is no information on the safe use of CLANZA CR during pregnancy and lactation, the use of CLANZA CR should therefore be avoided in pregnancy and lactation.

            
          
          
        

      
      
        
          
          
          
            
              USE IN CHILDREN
            
            The dosage and indication is not established yet for children with less than 6 years old.

            
          
          
        

      
      
        
          
          
          
            
              OVERDOSAGE
            
            There are no human data available on the consequences of CLANZA CR overdosage.  If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastro-intestinal irritation, respiratory depression, and convulsions.

            
          
          
        

      
      
        
          
          
          
            
              STORAGE
            
            Preserve in tight containers.  Store at room temperature not exceeding 30^oC.
            
              SHELF LIFE
            
            Three (3) years from manufacturing date.  
                Do not exceed the expiry date for use printed on the box
                .
              
            
          
          
        

      
      
        
          
          
          
            
              PACKAGE
            
            10 Blister Packs with 10 Tablets in each Blister Pack

            
          
          
        

      
      
        
          
          
          
            Enter section text here
          
          
        

      
      
        
          
          
          
            label test 
            
          
          
          
            
              Clanza Package Label