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DE/H/3682/001/IA/020_approved_common_SPC

                             Timolol                                   dyspnoea*     bronchospasm
                             maleate   eye                                           (predominantl
                             drops, solution                                         y in patients
                                                                                     with     pre-
                                                                                     existing
                                                                                     bronchospasti
                                                                                     c disease)*,
                                                                                     respiratory
                                                                                     failure,
                                                                                     cough*
               Gastrointest  Combined        dysgeusia
               inal          dorzolamide/ti
               disorders     molol
                             preservative
                             free
                             formulation
                             Dorzolamide                nausea*                      throat
                             hydrochloride                                           irritation,
                             eye     drops,                                          dry mouth*
                             solution
                             Timolol                                   nausea*,      diarrhoea,     dysgeusia,
                             maleate   eye                             dyspepsia*    dry mouth*,    abdominal pain,
                             drops, solution
                                                                                                    vomiting
               Skin    and Combined                                                  contact
               subcutaneo    dorzolamide/ti                                          dermatitis,
               us    tissue molol                                                    Stevens-
               disorders     preservative                                            Johnson
                             free                                                    syndrome,
                             formulation                                             toxic

                                                                                     epidermal
                                                                                     necrolysis
                             Dorzolamide                                             rash*
                             hydrochloride
                             eye     drops,
                             solution
                             Timolol                                                 alopecia*,     skin rash
                             maleate   eye                                           psoriasiform
                             drops, solution                                         rash       or
                                                                                     exacerbation
                                                                                     of psoriasis*
               Musculoskel   Timolol                                                 systemic lupus  myalgia
               etal    and maleate eye                                               erythematosus
               connective    drops, solution
               tissue
               disorders
               Renal   and Combined                                    urolithiasis
               urinary       dorzolamide/ti
               disorders     molol
                             preservative
                             free
                             formulation
               Reproductiv   Timolol                                                 Peyronie’s     sexual
               e    system maleate     eye
                                                                                                       11
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