Source: Health Products Regulatory Authority (ZA) Publisher: RANBAXY (SA) (PTY) LTD, a Sun Pharma company, Ground Floor, Tugela House, Riverside Office Park, 1303 Heuwel Avenue, Centurion
Treatment of mild to moderate hypertension, either alone or in combination with hydrochlorothiazide.
Reduction of cardiovascular morbidity and mortality in patients 55 years or older at high risk of cardiovascular disease; the benefit of treatment is evident after at least 6 months of continued treatment.
The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, the TELGEN dose can be increased to a maximum of 80 mg once daily. Alternatively, TELGEN may be used in combination with a low dose thiazide diuretic such as hydrochlorothiazide 12,5 mg, which has been shown to have an additive blood pressure lowering effect with TELGEN. When considering raising the dose, it must be borne in mind that the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment.
The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of TELGEN are effective in reducing cardiovascular morbidity and mortality.
When initiating TELGEN therapy for the reduction of cardiovascular morbidity and mortality, monitoring of blood pressure is recommended and, if appropriate, adjustment of medications that lower blood pressure may be necessary.
The benefit of treatment is evident only after 6 months of continued treatment.
No dosage adjustment is required for patients with mild to moderate renal impairment. TELGEN is not removed from blood by haemofiltration.
In patients with mild to moderate hepatic impairment the dosage should not exceed 40 mg once daily.
No dosing adjustment is necessary.
There are no data on the safety and efficacy of TELGEN in children and adolescents up to 18 years.
See Section 4.8 Undesirable effects.
No data are available with regard to overdose in humans. The most prominent manifestations of TELGEN overdose were hypotension and tachycardia; bradycardia also occurred. If symptomatic hypotension should occur, supportive treatment should be instituted. TELGEN is not removed by haemodialysis.
36 Months.
Store at or below 25°C in the original package, protected from light and moisture.
Do not remove the blister strips from the carton until required for use.
KEEP OUT OF REACH OF CHILDREN.
This medicine does not require any special storage conditions.
Carton contains 30 tablets packed in desiccant embedded silver cold form blisters or silver cold form blisters of 10 tablets each.
No special requirements.
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