Aripiprazole 1mgml oral solution

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Aripiprazole

から入手可能:

Dr Reddy's Laboratories (UK

ATCコード:

N05AX12

INN（国際名）:

Aripiprazole

投薬量:

1mg/1ml

医薬品形態:

Oral solution

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04020100

情報リーフレット

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 is and what it is used for
2.
What you need to know before you take Aripiprazole
3.
How to take Aripiprazole
4.
Possible side effects
5
How to store Aripiprazole
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE 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 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ARIPIPRAZOLE
DO NOT TAKE ARIPIPRAZOLE
•
if you are allergic to aripiprazole or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Aripiprazole if you suffer
from
•
high blood sugar

製品の特徴

OBJECT 1
ARIPIPRAZOLE DR. REDDY'S 1MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 14-Dec-2017 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Aripiprazole Dr. Reddy's 1 mg/ml Oral Solution
2. Qualitative and quantitative composition
Each ml oral solution contains 1 mg of aripiprazole.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
Clear, colourless liquid.
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 5 ml calibrated
syringe 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
combination therapy (see section 5.1). Some patients may benefit from
a higher dose. The maximum
daily dose should not exceed 30 mg.