Aripiprazole Teva 5mg Tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: myHealthbox

सक्रिय संघटक:

Aripiprazole

थमां उपलब्ध:

TEVA UK Limited

ए.टी.सी कोड:

N05AX12

INN (इंटरनेशनल नाम):

Aripiprazole

डोज़:

5mg

फार्मास्यूटिकल फॉर्म:

Tablets

प्रशासन का मार्ग:

Oral use

पैकेज में यूनिट:

Pack sizes of 7, 7 x 1, 14, 14 x 1, 15, 28, 28 x 1, 30, 49, 56, 56 x 1, 60, 98, 98 x 1 and 100 tablets.

प्रिस्क्रिप्शन प्रकार:

POM - Prescription Only Medicine

चिकित्सीय समूह:

Nervous system; psycholeptics; antipsychotics; other antipsychotics

चिकित्सीय संकेत:

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

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2015-05-06

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Aripiprazole Teva 5 mg Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 5 mg of aripiprazole. 

Excipient with known effect: 29.5 mg lactose per tablet. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Tablet 

Light yellow coloured, round, flat-faced bevelled edge tablets with
debossed 
“5” on one side and plain on the other side. The diameter is 5
mm. 

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 than a daily dose of 10 mg has not been
demonstrated 
although individual patients ma