AVODART

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

DUTASTERIDE

Saatavilla:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-koodi:

G04CB02

Lääkemuoto:

CAPSULES SOFT

Koostumus:

DUTASTERIDE 0.5 MG

Antoreitti:

PER OS

Prescription tyyppi:

Required

Valmistaja:

GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND

Terapeuttinen ryhmä:

DUTASTERIDE

Terapeuttinen alue:

DUTASTERIDE

Käyttöaiheet:

Avodart is indicated for : 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.

Valtuutus päivämäärä:

2023-05-31

Pakkausseloste

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician’s prescription
only
AVODART
SOFT CAPSULES
EACH SOFT CAPSULE CONTAINS: 0.5 MG DUTASTERIDE.
For a list of the inactive and allergenic ingredients in the
preparation, see
section 2 “Important information about some ingredients of the
medicine” and
section 6 “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet
contains concise information about the medicine. If you have any other
questions, refer to the physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
This medicine is intended for men only.
1. WHAT IS THE MEDICINE INTENDED FOR?
- 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.
THERAPEUTIC GROUP
testosterone-5-alpha reductase inhibitors.
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.
As the prostate grows, it can lead to urinary system 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
condition 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 call

Valmisteyhteenveto

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_Page 1 of 14 _
AVODART
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
imprinted 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 5.2). In patients with
severe hepatic impairment, the use of dutasteride is contraindicated
(see section 4.3).
_Page 2 of 14 _
4.3
CONTRAINDICAT