Avodart 0.5 mg soft capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dutasteride

Available from:

LTT Pharma Limited

ATC code:

G04CB; G04CB02

INN (International Name):

Dutasteride

Dosage:

0.5 milligram(s)

Pharmaceutical form:

Capsule, soft

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Testosterone-5-alpha reductase inhibitors; dutasteride

Authorization status:

Authorised

Authorization date:

2014-10-17

Patient Information leaflet

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 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
What Avodart is and what it is used for
What you need to know before you take Avodart
How to take Avodart
Possible side effects
How to store Avodart
Contents of the pack and other information
WHAT AVODART IS AND WHAT IT IS USED FOR
AVODART IS USED TO TREAT MEN WITH AN ENLARGED PROSTATE _(benign
prostatic_
_hyperplasia)_ - a non-cancerous growth of the prostate gland, caused
by
producing too much of a hormone called dihydrotestosterone.
The active ingredient is dutasteride.It belongs to a group of
medicines called
5-alpha reductase inhibitors.
As the prostate grows, it can lead to urinary problems, such as
difficulty in
passing urine and a need to go to the toilet frequently. It can also
cause the
flow of the urine to be slower and less forceful. If left untreated,
there is a
risk that your urine flow will be completely blocked _(acute urinary
retention)_.
This requires immediate medical treatment. In some situations surgery
is
necessary to remove or reduce the size of the prostate gland. Avodart
lowers the production of dihydrotestosterone, which helps to shrink
the
prostate and relieve the symptoms. This will reduce the risk of acute
urinary
retention and the need for surgery.
Avodart may also be used with another medicine called tamsulosin (used
to
treat the symptoms of an enlarged prostate).
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AVODART
DO NOT TAKE AVODART
*
if you are ALLERGIC _TO DUTASTERIDE,_ OTHER 5-ALPHA REDUCTASE
INHIBITORS,
SOYA, PE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avodart 0.5 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg dutasteride.
Excipient with known effect:
Each capsule contains lecithin (which may contain soya oil)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
_Product imported from Greece._
The capsules are opaque, yellow, oblong soft gelatin capsules marked
with GX CE2.
4 CLINICAL PARTICULARS
As per PA1077/104/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/104/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Capsule contents:_
mono- and diglycerides of caprylic/capric acid
butylhydroxytoluene (E321).
_Capsule shell:_
gelatin
glycerol
titanium dioxide (E171)
iron oxide yellow (E172)
triglycerides, medium chain
lecithin (may contain soya oil)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30
°
C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters of opaque PVC/PVDC film containing 10 soft gelatin capsules
packed into containers of 30 capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND O