PROFAL 5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FINASTERIDE

Available from:

Accord Healthcare Limited

ATC code:

G04CB01

INN (International Name):

FINASTERIDE

Dosage:

5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Testosterone-5-alpha reductase inhibitors

Authorization status:

Authorised

Authorization date:

2018-03-16

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Profal 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg finasteride.
Excipient with known effect: Each film-coated tablet contains 90.96 mg
lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Blue, round biconvex tablet marked “F5”. The diameter is 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Profal is indicated for the treatment and control of benign prostatic
hyperplasia (BPH) in patients with an enlarged
prostate to:
cause regression of the enlarged prostate, improve urinary flow and
improve the symptoms associated with BPH
reduce the incidence of acute urinary retention and the need for
surgery including transurethral resection of the
prostate (TURP) and prostatectomy.
Profal 5 mg tablets should only be administered in patients with an
enlarged prostate (prostate volume above ca. 40
ml).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only.
The recommended dosage is one 5 mg tablet daily with or without food.
The tablet should be swallowed whole and must not be divided or
crushed (see section 6.6).
Even if improvement can be seen within a short time, treatment for at
least 6 months may be necessary in order to
determine objectively whether a satisfactory response to treatment has
been achieved.
Dosage in hepatic insufficiency
There are no data available in patients with hepatic insufficiency
(see section 4.4).
Dosage in renal insufficiency
Dosage adjustments are not necessary in patients with varying degrees
of renal insufficiency (with creatinine clearance
down to as low as 9 ml/min) as in pharmacokinetic studies renal
insufficiency was not found to affect the elimination of
finasteride. Finasteride has not been studied in patients on
haemodialysis.
Dosage in the elderly
Dosage adjustments are not
necessary although pharmacokinetic studies have shown that
the elimination rate of
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