Avodart 0.5mg soft capsules

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

DUTASTERIDE

Prieinama:

Glaxo SmithKline UK Limited

ATC kodas:

G04CB02

INN (Tarptautinis Pavadinimas):

DUTASTERIDE

Vaisto forma:

SOFT CAPSULE

Sudėtis:

DUTASTERIDE 0.5 mg

Recepto tipas:

POM

Gydymo sritis:

UROLOGICALS

Autorizacija statusas:

Authorised

Leidimo data:

2005-08-13

Pakuotės lapelis

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PACKAGE LEAFLET
Page 2 of 6
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).

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 15
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
Capsules, soft.
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
should be used in patients with mild to moderate hepatic impairment
(see section 4.4 and section
Page 3 of 15
5.2). In patients with severe hepatic impairment, the use of
dutasteride is contraindicated (see
section 4.3).