Finasteride 5 mg Film-coated Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Finasteride

可用日期:

Accord Healthcare Ireland Ltd.

ATC代码:

G04CB; G04CB01

INN（国际名称）:

Finasteride

剂量:

5 milligram(s)

药物剂型:

Film-coated tablet

治疗领域:

Testosterone-5-alpha reductase inhibitors; finasteride

授权状态:

Marketed

授权日期:

2008-11-13

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE 5 MG FILM-COATED TABLETS
Finasteride
−
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor, pharmacist or
nurse.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
−
If you get any of the side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Finasteride 5 mg Tablets is and what it is used for
2.
What you need to know before you take Finasteride 5 mg Tablets
3.
How to take Finasteride 5 mg Tablets
4.
Possible side effects
5.
How to store Finasteride 5 mg Tablets
6.
Contents of the pack and other information
1.
WHAT FINASTERIDE 5 MG TABLETS IS AND WHAT IT IS USED FOR
Finasteride belongs to the group of medicines called 5-alpha reductase
inhibitors.
They act by reducing the size of the prostate gland in men.
Finasteride shrinks the prostate gland in men when it is swollen.
Finasteride is used in the treatment and
control of benign (i.e., non-cancerous) enlargement of the prostate
(benign prostatic hyperplasia - BPH).
The prostate gland is found underneath the bladder (but only in man).
It produces the fluid found in
semen. A swollen prostate gland can lead to a condition called
‘benign prostatic hyperplaia’ (BPH).
Finasteride causes shrinkage of the enlarged prostate, improves
urinary flow and symptoms caused by
BPH, and reduces the risk of you developing a sudden inability to pass
urine (known as acute urinary
retention) and the need for surgery.
WHAT IS BPH?
If you have BPH it means that your prostate gland is swollen. It can
press on the tube that urine passes
through, on its way out of your body.
This can lead to problems such as
- Feeling like you need to pa

产品特点

Health Products Regulatory Authority
24 November 2022
CRN00C0RK
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Finasteride 5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5 mg finasteride
Excipient(s) with known effect: lactose monohydrate (90.95 mg)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue, round biconvex, film-coated tablet with "F5" marking on one side
and plain on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Finasteride 5 mg Tablets are indicated for the treatment and control
of benign prostatic hyperplasia (BPH) 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 reduce need for
surgery including transurethral resection of the prostate
(TURP) and prostatectomy.
Finasteride 5 mg tablets should 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 though 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 the elderly_
Dosage adjustments are not necessary although pharmacokinetic studies
have shown that the elimination rate of finasteride is
slightly decreased in patients over the age of 70.
_Dosage in hepatic insufficiency_
The effect of hepatic insufficiency on the pharmacokinetics of
finasteride has not been studied. (See section 4.4).
_Dosage in renal insufficiency_
Dosage adjustments are not necessary in patients with varying degrees
of renal insufficiency (starting from creatinine clearance
as low as 9 ml/min) as in pharmacokineti