There have been significant updates to several sections of the SPC, including the following:
Change to section 4.2 - Posology and method of administration
Eprosartan may be used alone or in combination with other anti-hypertensives. 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.
No dose adjustment is required in the elderly.
There is limited experience in patients with hepatic insufficiency (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.
Teveten is not recommended for use in children and adolescents due to lack of data on safety and efficacy
Change to section 4.3 - Contraindications
Haemodynamically significant bilateral renovascular disease or severe stenosis of a solitary functioning kidney
Change to section 4.4 - Special warnings and precautions for Use
Caution is recommended for use in patients with creatinine clearance < 30 ml/min or in patients undergoing dialysis.
Please refer to SPC link below for full information on all changes.