GOAB 10 Oral tablet 10 mg

Држава: Танзанија

Језик: Енглески

Извор: Tanzania Medicinces & Medical Devices Authority

Активни састојак:

Solifenacin Succinate Tablets 10mg

Доступно од:

Hetero Laboratories Limited, INDIA

INN (Међународно име):

Solifenacin Succinate Tablets 10mg

Дозирање:

10 mg

Фармацеутски облик:

Oral tablet

Произведен од:

ANNORA PHARMA PRIVATE LIMITED, INDIA

Резиме производа:

Physical description: White to off white colour, round, biconvex tablets debossed "V" on one side and "19" on other side; Local technical representative: SURYA PHARMA LIMITED (29253)

Статус ауторизације:

Registered/Compliant

Датум одобрења:

2022-07-19

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Solifenacin Succinate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film coated tablet contains 10 mg Solifenacin Succinate.
The
qualitative
and
quantitative
composition
excipient
with
known
effects;
Lactose
monohydrate. (55.625mg)
Full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
DOSAGE FORM: Tablet
DESCRIPTION: White to off white color, round, biconvex tablets
debossed “V”on one side and
“19”.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of urge incontinence and/or increased urinary
frequency and urgency
as may occur in patients with overactive bladder syndrome
4.2 POSOLOGY AND METHOD OF ADMINISTRATION.
ADULTS, INCLUDING THE ELDERLY
POSOLOGY
THE RECOMMENDED DOSE IS 5 MG SOLIFENACIN SUCCINATE TABLETS ONCE DAILY.
IF NEEDED,
THE DOSE MAY BE INCREASED TO 10 MG SOLIFENACIN SUCCINATE TABLETS ONCE
DAILY. PEDIATRIC POPULATION
The safety and efficacy of solifenacin succinate tablets in children
have not yet been
established. Therefore, solifenacin succinate tablets should not be
used in children.
Patients with renal impairment
No dose adjustment is necessary for 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 receive no
more than 5 mg once
daily.
PATIENTS WITH HEPATIC IMPAIRMENT
No dose adjustment is necessary for patients with mild hepatic
impairment. Patients with
moderate hepatic impairment (Child-Pugh score of 7 to 9) should be
treated with caution and
receive no more than 5 mg once daily.
Potent inhibitors of cytochrome P450 3A4
The maximum dose of Solifenacin succinate tablets should be limited to
5 mg when treated
simultaneously with ketoconazole or therapeutic doses of other potent
CYP3A4-inhibitors
e.g. ritonavir, nelfinavir, itraconazole.
Method of administration
Solifenacin succinate tablets should be taken orally and should be
swallowed whole w