Tapcom-S Adverse Reactions

In clinical studies, over 484 patients have been treated with Tapcom-S. The most frequently reported treatment-related adverse event was conjunctival/ocular hyperaemia. It occurred in approximately 7% of the patients participating in the clinical studies in Europe, was mild in most cases, and was associated with discontinuation of treatment in 1.2% of patients.
The adverse reactions reported in the clinical studies using Tapcom-S were limited to those earlier reported for either of the single active substances tafluprost or timolol. No new adverse reactions specific for Tapcom-S were observed in the clinical studies. The majority of adverse reactions reported were ocular, mild or moderate in severity and none were serious.
Like other topically applied ophthalmic agents, tafluprost and timolol are absorbed systemically. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic adverse reactions after topical ophthalmic administration is lower than for systemic administration. Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.
The following adverse reactions have been reported with Tapcom-S during clinical trials (within each frequency grouping, adverse reactions are presented in order of decreasing frequency).
The frequency of possible adverse reactions listed as follows is defined using the following convention: (See Tables 1 and 2.)

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Additional adverse reactions that have been seen with either of the active substances (tafluprost or timolol), and may potentially occur also with Tapcom-S are listed as follows: (See Tables 3 and 4.)

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Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.