Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

aripiprazole

Saatavilla:

Mylan Pharmaceuticals Limited

ATC-koodi:

N05AX12

INN (Kansainvälinen yleisnimi):

aripiprazole

Terapeuttinen ryhmä:

Psycholeptics

Terapeuttinen alue:

Schizophrenia; Bipolar Disorder

Käyttöaiheet:

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

Tuoteyhteenveto:

Revision: 16

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2015-06-30

Pakkausseloste

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE MYLAN PHARMA 5 MG TABLETS
ARIPIPRAZOLE MYLAN PHARMA 10 MG TABLETS
ARIPIPRAZOLE MYLAN PHARMA 15 MG TABLETS
ARIPIPRAZOLE MYLAN PHARMA 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 Pharma is and what it is used for
2. What you need to know before you take Aripiprazole Mylan Pharma
3. How to take Aripiprazole Mylan Pharma
4. Possible side effects
5. How to store Aripiprazole Mylan Pharma
6. Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE MYLAN PHARMA IS AND WHAT IT IS USED FOR
ARIPIPRAZOLE MYLAN PHARMA 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 Mylan Pharma 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

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazole Mylan Pharma 5 mg tablets
Aripiprazole Mylan Pharma 10 mg tablets
Aripiprazole Mylan Pharma 15 mg tablets
Aripiprazole Mylan Pharma 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aripiprazole Mylan Pharma 5 mg tablets
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect
28 mg of maltose per tablet
Aripiprazole Mylan Pharma 10 mg tablets
_ _
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect
56 mg of maltose per tablet
Aripiprazole Mylan Pharma 15 mg tablets
_ _
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect
84 mg of maltose per tablet
Aripiprazole Mylan Pharma 30 mg tablets
_ _
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect
168 mg of maltose per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Aripiprazole Mylan Pharma 5 mg tablets
Light blue to blue, mottled round and biconvex tablets of 6.1 mm in
diameter, engraved with “5” on
one side
Aripiprazole Mylan Pharma 10 mg tablets
Pink, round and biconvex tablets of 8.1 mm in diameter, engraved with
“10” on one side
_ _
3
Aripiprazole Mylan Pharma 15 mg tablets
Yellow, round and biconvex tablets of 10.1 mm in diameter, engraved
with “15” on one side
_ _
Aripiprazole Mylan Pharma 30 mg tablets
Pink, oval and biconvex tablets of 17.1 mm in length, 8.1 mm in width,
engraved with “30” on one
side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aripiprazole Mylan Pharma is indicated for the treatment of
schizophrenia in adults and in adolescents
aged 15 years and older.
Aripiprazole Mylan Pharma 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 Pharma is indicated for the treatment up to 12