Finasteride 5mg Film-coated Tablets tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

finasteride

Available from:

Accord Healthcare Limited

ATC code:

G04CB01

INN (International Name):

finasteride

Dosage:

5mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2016-09-19

Patient Information leaflet

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 are and what
they are 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
ARE AND WHAT THEY ARE 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 hyperplasia
(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

Summary of Product characteristics

FINASTERIDE 5 MG FILM-COATED TABLETS
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
pharmacokinetic studies renal
insufficiency was not found to affect the elimination of fin