Avodart 0.5mg Soft Capsules

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Dutasteride

Tersedia dari:

IMED Healthcare Ltd.

Kode ATC:

G04CB; G04CB02

INN (Nama Internasional):

Dutasteride

Dosis:

0.5 milligram(s)

Bentuk farmasi:

Capsule, soft

Jenis Resep:

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

Area terapi:

Testosterone-5-alpha reductase inhibitors; dutasteride

Status otorisasi:

Authorised

Tanggal Otorisasi:

2010-06-25

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
AVODART 0.5 MG SOFT CAPSULES
Dutasteride
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:
1.
What Avodart is and what it is used for
2.
What you need to know before you take Avodart
3.
How to take Avodart
4.
Possible side effects
5.
How to store Avodart
6.
Contents of the pack and other information
1. 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).
2. WHAT YOU NEED TO KNOW BEFORE YOU

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avodart 0.5mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5mg dutasteride
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
_Product imported from_ the UK and Bulgaria:
Opaque, yellow, oblong soft gelatin capsules imprinted with ‘GX
CE2’ on one side in red ink.
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
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister strips and outer carton of the product on the
market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30
°
C
6.5 NATURE AND CONTENTS OF CONTAINER
Over-labelled cardboard carton containing 3 blister strips.
Pack size: 30 soft capsules.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT
Duta