Aripiprazole 1mgml oral solution

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Aripiprazole

제공처:

Wockhardt UK Ltd

ATC 코드:

N05AX12

INN (International Name):

Aripiprazole

복용량:

1mg/1ml

약제 형태:

Oral solution

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04020100; GTIN: 5012727912585

환자 정보 전단

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 Oral Solution is and
what it is used for
2. What you need to know before you
take Aripiprazole Oral Solution
3. How to take Aripiprazole Oral Solution
4. Possible side effects
5. How to store Aripiprazole Oral Solution
6. Contents of the pack and other
information
1. WHAT ARIPIPRAZOLE ORAL
SOLUTION IS AND WHAT IT IS
USED FOR
Aripiprazole Oral Solution 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 Oral Solution 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 Oral Solution.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ARIPIPRAZOLE
ORAL SOLUTION
DO NOT TAKE ARIPIPRAZOLE ORAL SOLUTION
•
if you are allergic to aripiprazole or any
of the other ingredients of this
medicine (l

제품 특성 요약

OBJECT 1
ARIPIPRAZOLE WOCKHARDT 1MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 31-Aug-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Aripiprazole Wockhardt 1mg/ml Oral Solution
2. Qualitative and quantitative composition
Each ml contains 1 mg of aripiprazole.
Excipients:
200 mg fructose per ml
400 mg sucrose per ml
1.8 mg methyl parahydroxybenzoate (E218) per ml
0.2 mg propyl parahydroxybenzoate (E216) per ml
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
Clear, colourless to light yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Aripiprazole is indicated for the treatment of schizophrenia in adults
and in adolescents aged 15 years and
older.
Aripiprazole 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 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 is 10
or 15 mg/day (i.e. 10 or 15 ml
solution/day) with a maintenance dose of 15 mg/day administered on a
once-a-day schedule without
regard to meals. A calibrated measuring cup and a 2 ml calibrated
dropper are included in the carton.
Aripiprazole is effective in a dose range of 10 to 30 mg/day (i.e. 10
to 30 ml solution/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.
_Manic episodes in Bipolar I Disorder: _the recommended starting dose
for aripiprazole is 15 mg (i.e. 15
ml solution/day) administered on a once-a-day schedule without regard
to meals as monotherapy or