Avodart 0.5mg soft capsules

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Dutasteride

Dostupné s:

PCO Manufacturing Ltd.

ATC kód:

G04CB; G04CB02

INN (Mezinárodní Name):

Dutasteride

Dávkování:

0.5 milligram(s)

Léková forma:

Capsule, soft

Druh předpisu:

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

Terapeutické oblasti:

Testosterone-5-alpha reductase inhibitors; dutasteride

Stav Autorizace:

Authorised

Datum autorizace:

2008-06-20

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 BEFOR

Charakteristika produktu

Health Products Regulatory Authority
08 June 2022
CRN00CZ1Q
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avodart 0.5mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg dutasteride.
Excipient(s) 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, France, Spain, Italy and Bulgaria:_
The capsules are opaque, yellow, oblong soft gelatin capsules marked
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 (may contain soya oil).
Red printing ink containing iron oxide red (E172) as the colourant,
polyvinyl acetate phthalate, propylene glycol and Macrogol
400.
6.2 INCOMPATIBILITIES
Not applicable.
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.
Health Products Regulatory Authority
08 June 2022
CRN00CZ1Q
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 30 soft capsules
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Dutasteride is absorbed through the skin, therefore contact with
leaking capsules must be avoided. If contact is made with
leaking capsules, the contact area should be washed immediately with
soap and water (see section 4.4).
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath