AVODART 0.5 Milligram Capsules, Soft

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

DUTASTERIDE

Saatavilla:

LTT Pharma Limited

INN (Kansainvälinen yleisnimi):

DUTASTERIDE

Annos:

0.5 Milligram

Lääkemuoto:

Capsules, Soft

Prescription tyyppi:

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

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2013-12-11

Pakkausseloste

AVODART  0.5MG SOFT CAPSULES
(dutasteride)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
*
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. Do not pass it on to
others. It 
may harm them, even if their symptoms are the same as yours.
*
IF ANY OF THE SIDE EFFECTS GETS SERIOUS, OR IF YOU NOTICE ANY SIDE
EFFECTS  
NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST.
IN THIS LEAFLET:
What Avodart is and what it is used for 
Before you take Avodart
How to take Avodart
Possible side effects
How to store Avodart
Further 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).
BEFORE YOU TAKE AVODART
DO NOT TAKE AVODART
*
if YOU'RE ALLERGIC 
_(HYPERSENSITIVE) _TO DUTASTERIDE, OTHER 5-ALPHA 
REDUCTASE INHIBITORS, SOYA, PEANUT or to any of the other ingredients

Valmisteyhteenveto

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.
Excipients of known effect: Also contains soya lecithin.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules, soft.
_Product imported from the Czech Republic_
The capsules are opaque, yellow, oblong soft gelatin capsules marked with GX CE2.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of
BPH.
For information on effects of treatment and patient populations studied in clinical trials please _see section 5.1._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Avodart can be administered alone or in combination with the alpha-blocker tamsulosin (0.4mg) (see sections 4.4, 4.8
and 5.1).
_Adults (including elderly):_
The recommended dose of Avodart is one capsule (0.5 mg) taken orally once a day. The capsules should be swallowed
whole and not chewed or opened as contact with the capsule contents may result in irritation of the oropharyngeal
mucosa. The capsules may be taken with or without food. Although an improvement may be observed at an early stage,
it can take up to 6 months before a response to the treatment can be achieved. No dose adjustment is necessary in the
elderly.
_Renal impairment_
The effect of renal impairment on dutasteride pharmacokinetics has not been studied. No adjustment in dosage is
anticipated for patients with renal impairment (see section 5.2).
_Hepatic impairment_
The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied so caution shou