Aripiprazole Teva 30mg Tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Aripiprazole

Available from:

TEVA UK Limited

ATC code:

N05AX12

INN (International Name):

Aripiprazole

Dosage:

30mg

Pharmaceutical form:

Tablets

Administration route:

Oral use

Units in package:

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

Prescription type:

POM - Prescription Only Medicine

Therapeutic group:

Nervous system; psycholeptics; antipsychotics; other antipsychotics

Therapeutic indications:

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

Authorization status:

Authorised

Authorization date:

2015-05-06

Patient Information leaflet

DE/H/5039/001-005/DC
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
 5 MG TABLETS
 10 MG TABLETS
 15 MG TABLETS
 20 MG TABLETS
 30 MG TABLETS
Aripiprazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, 
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side 
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What _ _is and what it is used for
2.
What you need to know before you take __
3.
How to take __
4.
Possible side effects
5.
How to store __
6.
Contents of the pack and other information
1.
WHAT _ _IS AND WHAT IT IS USED FOR
_ _contains the active substance aripiprazole and
belongs to a group of medicines called 
antipsychotics.
It is used to treat adults and adolescents aged 15 years and older who
suffer from a disease 
characterised by symptoms such as hearing, seeing or sensing things
which are not there, 
suspiciousness, mistaken beliefs, incoherent speech and behaviour and
emotional flatness. People with 
this condition may also feel depressed, guilty, anxious or tense.
_ _is used to treat adults and adolescents aged 13
years and older who suffer from a 
condition with symptoms such as feeling “high”, having excessive
amounts of energy, needing much 
less sleep than usual, talking very quickly with racing ideas and
sometimes severe irritability. In adults 
it also prevents this condition from returning in patients who have
responded to the treatment with 
__.
2.
WHAT YOU NEED TO KN

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Aripiprazole Teva 30 mg Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 30 mg of aripiprazole. 

Excipient with known effect: 177.0 mg lactose per tablet. 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Tablet 

Pink to light pink coloured, round, biconvex tablets with debossed
“30” on one 
side and breakline on the other side. The diameter is 9 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 than a daily dose of 10 mg has not been