Avodart capsules soft

País: Armênia

Língua: inglês

Origem: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes ativos:

dutasteride

Disponível em:

GlaxoSmithKline Pharmaceuticals S.A.

Código ATC:

G04CB02

DCI (Denominação Comum Internacional):

dutasteride

Dosagem:

0,5mg

Forma farmacêutica:

capsules soft

Unidades em pacote:

(30/3x10/) in blister

Tipo de prescrição:

Prescription

Status de autorização:

Registered

Data de autorização:

2023-03-10

Folheto informativo - Bula

1
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 BEFORE YOU TAKE

Características técnicas

1
SUMMARY OF PRODUCT CHARACTERISTICS
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).
_ _
_ _
_ _
_ _
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).
4.3
CONTRAINDICATIO