Finasteride 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Finasteride

Available from:

Fannin (UK) Ltd

ATC code:

G04CB01

INN (International Name):

Finasteride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040200

Patient Information leaflet

_121 LEAFLET Proscar 20171202 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROSCAR
® 5MG TABLETS
(finasteride)
Your medicine is known as PROSCAR
®
5mg TABLETS but will be
referred to as Proscar throughout the following leaflet.
This medicine is for use in men only
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 or
pharmacist.

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 side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
IN THIS LEAFLET:
1.
What Proscar is and what it is used for
2.
What you need to know before you take Proscar
3.
How to take Proscar
4.
Possible side effects
5.
How to store Proscar
6.
Contents of the pack and other information
1.
WHAT PROSCAR IS AND WHAT IT IS USED FOR
Proscar contains a medicine called finasteride. This belongs to a
group of medicines called ‘5-alpha reductase inhibitors’.
Proscar shrinks the prostate gland in men when it is swollen.
The prostate gland is found underneath the bladder (but only in
men). It produces the fluid found in semen.
A swollen prostate gland can lead to a condition called ‘benign
prostatic hyperplasia’ or BPH.
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 pass urine more often, especially at
night

feeling that you must pass urine right away

finding it difficult to start passing urine

when you pass urine the flow of urine is weak

when you pass urine the flow stops and starts

feeling that you cannot empty your bladder completely
In some men, BPH can lead to more serious prob

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Finasteride 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5 mg of finasteride.
Excipients:
Each tablet contains 90.95 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets. Blue, round biconvex 7 mm film-coated tablet with
“F5”
marking on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Finasteride 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.
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
_Dosage in Adults_
_: _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 six months may be necessary in order to
determine
objectively whether a satisfactory response to the treatment has been
achieved.
_Dosage in Children:_ Finasteride is contraindicated in children (see
section 4.3).
_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: _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 (starting from creatinine
clearance as
low as 9 ml/min) as in pharmacokinetic stud