Vesomni tablets film-coated modified-release

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

tamsulosin (tamsulosin hydrochloride), solifenacin (solifenacin succinate)

Предлага се от:

Astellas Pharma Europe B.V.

АТС код:

G04CA53

INN (Международно Name):

tamsulosin (tamsulosin hydrochloride), solifenacin (solifenacin succinate)

дозиране:

6mg+ 0,4mg

Лекарствена форма:

tablets film-coated modified-release

Броя в опаковка:

(10/1x10/) in blister, (30/3x10/) in blister

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2019-06-13

Данни за продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Vesomni 6 mg/0.4 mg modified release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains a layer of 6 mg solifenacin succinate,
corresponding to 4.5 mg solifenacin free
base and a layer of 0.4 mg tamsulosin hydrochloride, corresponding to
0.37 mg of tamsulosin free
base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet
Each tablet is round, approximately 9 mm in diameter, red film-coated
and debossed with “6/0.4”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe storage symptoms (urgency, increased
micturition frequency) and
voiding symptoms associated with benign prostatic hyperplasia (BPH) in
men who are not adequately
responding to treatment with monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adult_ _males, including older people _
One Vesomni tablet (6 mg/0.4 mg) once daily taken orally with or
without food. The maximum daily
dose is one Vesomni tablet (6 mg/0.4 mg).
The tablet must be swallowed whole, intact without biting or chewing.
Do not crush the tablet._ _
_Patients with renal impairment _
The effect of renal impairment on the pharmacokinetics of Vesomni has
not been studied. However,
the effect on the pharmacokinetics of the individual active substances
is well known (see section 5.2).
Vesomni can be used in patients with mild to moderate renal impairment
(creatinine clearance
> 30 mL/min). Patients with severe renal impairment (creatinine
clearance ≤ 30 mL/min) should be
treated with caution and the maximum daily dose in these patients is
one Vesomni tablet
(6 mg/0.4 mg) (see section 4.4).
_Patients with hepatic impairment _
The effect of hepatic impairment on the pharmacokinetics of Vesomni
has not been studied.
However, the effect on the pharmacokinetics of the individual active
substances is well known (see
section 5.2). Vesomni can be used in patients with mild hepatic
impairment (Child-Pugh score ≤ 7).
2