Aripiprazole 1mgml oral solution

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Aripiprazole

متاح من:

Mylan

ATC رمز:

N05AX12

INN (الاسم الدولي):

Aripiprazole

جرعة:

1mg/1ml

الشكل الصيدلاني:

Oral solution

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 04020100; GTIN: 5016695006925

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARIPIPRAZOLE 1 MG/ML ORAL SOLUTION
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 contains the active substance aripiprazole, which 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 d

خصائص المنتج

OBJECT 1
ARIPIPRAZOLE 1 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 21-May-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Aripiprazole 1 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml contains 1 mg of aripiprazole.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
A 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. 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 (i.e. 30 ml solution/day).
_Recurrence prevention of manic episodes in Bipolar I Disorder:_ for
preventing recurrence of manic
epis