Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
Eprosartan is indicated for the treatment of essential hypertension.
Eprosartan is indicated in adults.
The recommended dose is 600 mg eprosartan once daily.
Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment.
Eprosartan may be used alone or in combination with other anti-hypertensives (see sections 4.3, 4.4, 4.5 and 5.1). In particular, addition of a thiazide-type diuretic such as hydrochlorothiazide or a calcium channel blocker such as sustained release nifedipine has been shown to have an additive effect with eprosartan.
Duration of treatment is not limited.
No dose adjustment is required in the elderly.
There is limited experience in patients with hepatic impairment (see section 4.3).
In patients with moderate or severe renal impairment (creatinine clearance <60 ml/min), the daily dose should not exceed 600 mg.
Eprosartan is not recommended for use in children or adolescents due to lack of data on safety and efficacy.
For oral use.
Eprosartan may be taken with or without food.
Limited data are available with regard to overdose in humans. There have been individual reports from postmarketing experience where doses up to 12,000 mg had been ingested. Most patients reported no symptoms. In one subject circulatory collapse occurred after ingestion of 12,000 mg eprosartan. The subject recovered completely. The most likely manifestation of overdose would be hypotension. If symptomatic hypotension should occur, supportive treatment should be instituted.
3 years.
This medicinal product does not require any special storage conditions.
White HDPE bottle with a white opaque polypropylene screw cap with induction sealing liner. Pack size of 500 film-coated tablets
Aluminium foil blisters laminated with PVC on one side and coated with a heat seal lacquer (Aclar/PVC/Al). Pack sizes of 14, 28, 30, 56, 98, 100 or 168 film-coated tablets. Calendar pack sizes of 14, 28, 56, 98 and 168 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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