Aripiprazole Teva 20mg Tablets

Страна: Великобритания

Език: английски

Източник: myHealthbox

Активна съставка:

Aripiprazole

Предлага се от:

TEVA UK Limited

АТС код:

N05AX12

INN (Международно Name):

Aripiprazole

дозиране:

20mg

Лекарствена форма:

Tablets

Начин на приложение:

Oral use

Броя в опаковка:

Pack sizes of 7, 7 x 1, 14, 14 x 1, 28, 28 x 1, 30, 49, 56, 56 x 1, 98, 98 x 1 tablets.

Вид предписание :

POM - Prescription Only Medicine

Терапевтична група:

Nervous system; psycholeptics; antipsychotics; other antipsychotics

Терапевтични показания:

It is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.

Статус Оторизация:

Authorised

Дата Оторизация:

2015-05-06

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Aripiprazole Teva 20 mg Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 20 mg of aripiprazole. 

Excipient with known effect: 188.0 mg lactose per tablet. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Tablet 

White to off white or pale cream coloured, capsule shaped,
biconvex tablets 
with debossed “20” on one side and breakline on the other side.
The 
dimensions are 10.7 mm x 5.3 mm. 
The tablet can be divided into equal doses. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Aripiprazole Teva_ _is indicated for the treatment of schizophrenia
in adults and 
in adolescents aged 15 years and older. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

POSOLOGY 

Adults 

_Schizophrenia _
The recommended starting dose for aripiprazole is 10 or 15
mg/day with a 
maintenance dose of 15 mg/day administered on a
once-a-day schedule 
without regard to meals. 

Aripiprazole is effective in a dose range of 10 to 30 mg/day.
Enhanced 
efficacy at doses higher than a daily dose of 15 mg has not been
demonstrated 
although individual patients may benefit from a higher dose. The
maximum 
daily dose should not exceed 30 mg. 

Paediatric population 

_Schizophrenia in adolescents aged 15 years and older_ 
The recommended dose for aripiprazole is 10 mg/day administered on
a once-
a-day schedule without regard to meals. Treatment should be
initiated at 2 mg 
(e.g. using an oral solution) for 2 days, titrated to 5 mg for
2 additional days to 
reach the recommended daily dose of 10 mg. When appropriate,
subsequent 
dose increases should be administered in 5 mg increments without
exceeding 
the maximum daily dose of 30 mg (see section 5.1). 

Aripiprazole is effective in a dose range of 10 to 30 mg/day.
Enhanced 
efficacy at doses higher