Aripiprazole Accord Healthcare 10mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ARIPIPRAZOLE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

N05AX12

INN (International Name):

ARIPIPRAZOLE 10 mg

Pharmaceutical form:

TABLET

Composition:

ARIPIPRAZOLE 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2015-06-11

Patient Information leaflet

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PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPIPRAZOLE ACCORD HEALTHCARE 5 MG TABLETS
ARIPIPRAZOLE ACCORD HEALTHCARE 10 MG TABLETS
ARIPIPRAZOLE ACCORD HEALTHCARE 15 MG TABLETS
ARIPIPRAZOLE ACCORD HEALTHCARE 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 Aripiprazole Accord Healthcare is and what it is used for
2.
What you need to know before you take Aripiprazole Accord Healthcare
3.
How to take Aripiprazole Accord Healthcare
4.
Possible side effects
5
How to store Aripiprazole Accord Healthcare
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE ACCORD HEALTHCARE IS AND WHAT IT IS USED FOR
Aripiprazole Accord Healthcare 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.
Aripiprazole Accord Healthcare 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 p

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazole Accord Healthcare 5 mg tablets
Aripiprazole Accord Healthcare 10 mg tablets
Aripiprazole Accord Healthcare 15 mg tablets
Aripiprazole Accord Healthcare 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect: 27.9 mg lactose monohydrate per tablet
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect: 55.8 mg lactose monohydrate per tablet
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect: 83.7 mg lactose monohydrate per tablet
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect: 167.4 mg lactose monohydrate per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet 5 mg
Round, biconvex and white, 5 mm, debossed "5" on one side and "ZL" on
one side.
Tablet 10 mg
Capsule shaped, biconvex and white, 8 mm x 5 mm, debossed "10" on one
side and "ZL" on one
side.
Tablet 15 mg
Round, biconvex and white 7 mm, debossed "15" on one side and "ZL" on
one side.
Tablet 30 mg
Round, biconvex and white 9 mm, debossed "30" on one side and "ZL" on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazole Accord Healthcare is indicated for the treatment of
schizophrenia in adults and in
adolescents aged 15 years and older.
Aripiprazole Accord Healthcare is indicated for the treatment of
moderate to severe manic episodes
in Bipolar I Disorder and for the prevention of a new manic episode in
adults who experienced
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predominantly manic episodes and whose manic episodes responded to
aripiprazole treatment (see
section 5.1).
Aripiprazole Accord Healthcare is indicated for the treatment up to 12
weeks of moderate to severe
manic episodes in Bipolar I Disorder in adolescents aged 13 years and
older (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
_Schizophrenia: _
the recommended starting dose for Aripiprazole Accord Healthcar