Source: European Medicines Agency (EU) Publisher: Glenmark Pharmaceuticals s.r.o., Hvězdova 1716/2b, 140 78, Praha 4, Czech Republic
Secondary prophylaxis, after a first coronary or cerebrovascular ischaemic event, of:
The recommended dose is 600 mg/day as single or divided doses.
Safety and efficacy in subjects under 18 years of age have not been established.
Clinical experience in patients with renal or hepatic impairment is limited, and special care is therefore recommended when treatment is started in this type of patients. In patients with end stage renal disease on conventional haemodialysis, pre- and post-dialysis plasma levels of the main triflusal metabolite, HTB (2-hydroxy-4-(trifluoromethyl)benzoic acid), have shown no significant changes, and no dose adjustment is therefore required.
Capsules are swallowed whole with a small amount of water.
Triflusal is recommended to be taken preferably with meals.
No case of overdose has been reported.
In the event of an accidental overdose, which may only occur after the intake of very high doses, symptoms of salicylate poisoning may occur. If these occur, administration of the medicinal product should be discontinued and both symptomatic treatment and any required support measures should be started.
2 years.
Do not store above 25°C.
Aluminium/PVC-PVDC blisters.
Carton box with 3 PVC/PVDC with 10 hard capsules.
Carton box with 5 PVC/PVDC with 10 hard capsules.
Carton box with 6 PVC/PVDC with 10 hard capsules.
Carton box with 9 PVC/PVDC with 10 hard capsules.
No special requirements.
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