Finasteride 5mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FINASTERIDE

Available from:

Accord Healthcare Limited

ATC code:

G04CB01

INN (International Name):

FINASTERIDE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

FINASTERIDE 5 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Authorised

Authorization date:

2011-04-01

Patient Information leaflet

Page 1 of 6
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 yo

Summary of Product characteristics

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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 
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that the elimination rate of