Finasteride 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Finasteride

Available from:

DE Pharmaceuticals

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

PACKAGE LEAFLET:
INFORMATION FOR THE
USER
FINASTERIDE 5 MG
FILM-COATED TABLETS
Finasteride
P1521660
Black
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.
WHAT IS IN THIS LEAFLET
1.
What Finasteride is and what it is used for
2.
What you need to know before you take
Finasteride
3.
How to take Finasteride
4.
Possible side effects
5.
How to store Finasteride
6.
Contents of the pack and other information
1.
WHAT FINASTERIDE 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 is used in the treatment and
control of benign enlargement of the prostate
(benign prostatic hyperplasia - BPH). It causes
regression of the enlarged prostate, improves
urinary flow and symptoms caused by BPH,
and reduces the risk of acute urinary retention
and the need for surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FINASTERIDE
DO NOT TAKE FINASTERIDE
-
if you are allergic to finasteride or any of the
other ingredients of this medicine (listed in
section 6)
-
if you are a woman (because this medicine
is for men)
-
if you are a child.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Finasteride.
−
if you have a large amount of residual urine
and/or severely reduced urinary flow. If this
is the case, you should be closely monitored
for narrowing of the urinary tract.
−
if you have a PSA test (test used to detect
prostate cancer). Tell your doctor that you
are taking finasteride. Finasteride can affec

Summary of Product characteristics

OBJECT 1
FINASTERIDE 5MG TABLETS
Summary of Product Characteristics Updated 17-Dec-2018 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Finasteride 5mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 5mg finasteride
Excipient with known effect: lactose monohydrate (97.5mg)
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet
Blue coloured, circular, biconvex, beveled edged film-coated tablets
debossed with 'E' on one side and
'61' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Finasteride 5mg is 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 prosta