Aripiprazole Mylan 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ARIPIPRAZOLE

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

N05AX12

INN (International Name):

ARIPIPRAZOLE 5 mg

Pharmaceutical form:

TABLET

Composition:

ARIPIPRAZOLE 5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2018-03-09

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARIPIPRAZOLE MYLAN 5 MG TABLETS
ARIPIPRAZOLE MYLAN 10 MG TABLETS
ARIPIPRAZOLE MYLAN 15 MG TABLETS
ARIPIPRAZOLE MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Aripiprazole Mylan
3.
How to take Aripiprazole Mylan
4.
Possible side effects
5.
How to store Aripiprazole Mylan
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE MYLAN IS AND WHAT IT IS USED FOR
Aripiprazole Mylan contains the active substance aripiprazole and
belong 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 Mylan 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 Aripiprazole
Mylan.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPI

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazole Mylan 5 mg tablets
Aripiprazole Mylan 10 mg tablets
Aripiprazole Mylan 15 mg tablets
Aripiprazole Mylan 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Aripiprazole Mylan 5 mg tablets _
Each tablet contains 5 mg of aripiprazole.
_ _
_Aripiprazole Mylan 10 mg tablets _
Each tablet contains 10 mg of aripiprazole
_. _
_Aripiprazole Mylan 15 mg tablets _
Each tablet contains 15 mg of aripiprazole.
_ _
_Aripiprazole Mylan 30 mg tablets _
Each tablet contains 30 mg of aripiprazole.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
_Aripiprazole Mylan 5 mg tablets _
A white to off-white, round, flat-faced, beveled edge tablet of
approximately 5 mm of diameter debossed
with "M" on one side of the tablet and "AT5" on the other side.
_ _
_Aripiprazole Mylan 10 mg tablets _
A white to off-white, round, flat-faced, beveled edge tablet of
approximately 6mm of diameter debossed
with "M" on one side of the tablet and "AT6" on the other side.
_ _
_Aripiprazole Mylan 15 mg tablets _
A white to off-white, round, flat-faced, beveled edge tablet of
approximately 7.1 mm of diameter
debossed with "M" on one side of the tablet and "AT7" on the other
side.
_Aripiprazole Mylan 30 mg tablets _
A white to off-white, round, flat-faced, beveled edge tablet of
approximately 9 mm of diameter debossed
with "M" on one side of the tablet and "AT9" on the other side.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazole Mylan is indicated for the treatment of schizophrenia in
adults and in adolescents aged 15
years and older.
Aripiprazole Mylan 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 predominantly manic
episodes and whose manic episodes responded to aripiprazole treatment
(see section 5.1).
Aripiprazole Mylan is indicated for the treatment up to 12 weeks of