Avodart capsules soft

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

dutasteride

Disponible desde:

GlaxoSmithKline Pharmaceuticals S.A.

Código ATC:

G04CB02

Designación común internacional (DCI):

dutasteride

Dosis:

0,5mg

formulario farmacéutico:

capsules soft

Unidades en paquete:

(30/3x10/) In blister

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2018-01-10

Información para el usuario

DUTASTERIDE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule for oral use contains 0.5 mg dutasteride (_see _
_List of Excipients_).
PHARMACEUTICAL FORM
Capsules: dull yellow in colour, opaque, oblong soft
gelatin capsules marked with GX CE2.
CLINICAL PARTICULARS
INDICATIONS
_AVODART_ treats and prevents progression of benign
prostatic hyperplasia (BPH) through alleviating symptoms,
reducing prostate size (volume), improving urinary flow
rate and reducing the risk of acute urinary retention (AUR)
and the need for BPH-related surgery.
_AVODART_ in combination with the alpha-blocker
tamsulosin, treats and prevents progression of benign
prostatic hyperplasia (BPH) by reducing prostate size,
alleviating symptoms, improving urinary flow and
reducing the risk of acute urinary retention (AUR) and the
need for BPH-related surgery (_see Clinical Studies_).
DOSAGE AND ADMINISTRATION
ADULT MALES (INCLUDING ELDERLY)
Capsules should be swallowed whole and not chewed or
opened, as contact with the capsule contents may result
in irritation of the oropharyngeal mucosa.
_AVODART_ may be taken with or without food.
The recommended dose of _AVODART _is one capsule
(0.5 mg) taken orally once a day.
Although an improvement may be observed at an early
stage, treatment for at least 6 months may be necessary
in order to assess objectively whether a satisfactory
response to the treatment can be achieved.
For treatment of BPH, _AVODART _can be administered
alone or in combination with the alpha-blocker
tamsulosin (0.4 mg).
RENAL IMPAIRMENT
The effect of renal impairment on dutasteride
pharmacokinetics has not been studied. However, no
adjustment in dosage is anticipated for patients with renal
impairment (_see Pharmacokinetics_).
HEPATIC IMPAIRMENT
The effect of hepatic impairment on dutasteride
pharmacokinetics has not been studied (_see Warnings and _
_Precautions and Pharmacokinetics_).
CONTRAINDICATIONS
_AVODART_ is contraindicated in patients with known
hypersensitivity to dutasteride, other 5 alpha-reductase
inhibitors, or any

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
AVODART

, DUTASTERIDE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule for oral use contains 0.5 mg dutasteride (_see List of
Excipients_). _ _
3. PHARMACEUTICAL FORM
Capsules: dull yellow in colour, opaque, oblong soft gelatin capsules
marked with GX
CE2._ _
4. CLINICAL PARTICULARS
4.1 INDICATIONS
_AVODART_ treats and prevents progression of benign prostatic
hyperplasia (BPH) through
alleviating symptoms, reducing prostate size (volume), improving
urinary flow rate and
reducing the risk of acute urinary retention (AUR) and the need for
BPH-related surgery.
_AVODART_ in combination with the alpha-blocker tamsulosin, treats and
prevents
progression of benign prostatic hyperplasia (BPH) by reducing prostate
size, alleviating
symptoms, improving urinary flow and reducing the risk of acute
urinary retention
(AUR) and the need for BPH-related surgery (_see Clinical Studies_).
4.2 DOSAGE AND ADMINISTRATION
ADULT MALES (INCLUDING ELDERLY)
Capsules should be swallowed whole and not chewed or opened, as
contact with the
capsule contents may result in irritation of the oropharyngeal mucosa.
_AVODART_ may be taken with or without food.
The recommended dose of _AVODART _is one capsule (0.5 mg) taken orally
once a day.
Although an improvement may be observed at an early stage, treatment
for at least
6 months may be necessary in order to assess objectively whether a
satisfactory response
to the treatment can be achieved.
For treatment of BPH, _AVODART _can be administered alone or in
combination with the
alpha-blocker tamsulosin (0.4 mg).
RENAL IMPAIRMENT
The effect of renal impairment on dutasteride pharmacokinetics has not
been studied.
However, no adjustment in dosage is anticipated for patients with
renal impairment (_see _
_Pharmacokinetics_).
HEPATIC IMPAIRMENT
The effect of hepatic impairment on dutasteride pharmacokinetics has
not been studied
(_see Warnings and Precautions and Pharmacokinetics_).
4.3 CONTRAINDICATIONS
_AVODART_ is contrain