Cataflam Tác dụng không mong muốn


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Novartis Pharma
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Adverse Reactions
Tabulated summary of adverse drug reactions: Adverse drug reactions from clinical trials and/or spontaneous or literature reports (table) are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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).
The following undesirable effects include those reported with Cataflam sugar-coated tablets and/or other pharmaceutical forms of diclofenac, with either short-term or long-term use. (See table.)

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Description of selected adverse drug reactions: Risk of Cardiovascular thrombosis: Clinical trials and epidemiology show that the use of diclofenac is associated with increase of risk of cardiovascular thrombosis (such as heart attack and stroke), particularly while using high dose of diclofenac (150 mg/day) and during long term (see more in PRECAUTIONS).
Visual effects: Visual disturbances such as visual impairment, blurred vision or diplopia appear to be NSAID class effects and are usually reversible on discontinuation. A likely mechanism for the visual disturbances is the inhibition of prostaglandin synthesis and other related compounds that alter the regulation of retinal blood flow resulting in potential changes in vision. If such symptoms occur during diclofenac treatment, an ophthalmological examination may be considered to exclude other causes.
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