DuoTrav Adverse Reactions

travoprost + timolol




Firma Chun Cheong
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: In clinical studies involving 2,170 patients treated with DuoTrav eye drops the most frequently reported treatment-related adverse reaction was ocular hyperaemia (12.0%).
Tabulated summary of adverse reactions: The adverse reactions listed in the following table were observed in clinical studies or with post-marketing experience. They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness. (See Table 1.)

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Additional adverse reactions that have been seen with one of the active substances and may potentially occur with DuoTrav eye drops: Travoprost: See Table 2.

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Timolol: Like other topically applied ophthalmic medicinal products, timolol is absorbed into the systemic circulation. This may cause undesirable effects similar to those seen with systemic beta-blocking agents. Additional listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers. The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. For information on how to reduce systemic absorption, see Dosage & Administration. (See Table 3.)

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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.
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