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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benph 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of terazosin (in the form of terazosin hydrochloride dihydrate).
Excipient(s): 110mg lactose monohydrate
0.01mg sunset yellow (E110)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Light orange, round, flat, bevel edged, tablet imprinted “E” and “453” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Benph® tablets are indicated for:
- symptomatic treatment of benign prostatic hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose of terazosin should be managed according to each patient’s response.
An initial dose of 1.0mg daily should be given in the evening. This dose may be increased by approximately doubling
the dose at weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg
once daily. At present there are insufficient data to suggest symptomatic relief with doses above 10mg.
USE WITH THIAZIDE DIURETICS AND OTHER ANTIHYPERTENSIVE AGENTS
The dose of terazosin should be re-titrated if a thiazide diuretic or antihypertensive agent is added to a patients
medication. On initiation of the new medication hypotension may be observed.
_ELDERLY:_
In the elderly, dosage should be kept as low as possible and increments made under close supervision.
_RENAL DYSFUNCTION:_
Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the recommended
dosage. There is no evidence that terazosin aggravates renal dysfunction.
IRISH MEDICINES BOARD
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_Date Printed 27/03/2012_
_CRN 2107136_
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