Aripiprazole 1mgml oral solution

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Aripiprazole

Tilgængelig fra:

Actavis UK Ltd

ATC-kode:

N05AX12

INN (International Name):

Aripiprazole

Dosering:

1mg/1ml

Lægemiddelform:

Oral solution

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04020100; GTIN: 5012617025074

Indlægsseddel

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,
pharmacist or nurse.
•
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, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
•
The full name of this medicine is Aripiprazole 1mg/ml
Oral Solution but within the leaflet it will be referred to as
Aripiprazole Oral Solution.
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 TA

Produktets egenskaber

OBJECT 1
ARIPIPRAZOLE 1MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 05-Feb-2018 | Accord-UK Ltd
1. Name of the medicinal product
Aripiprazole 1mg/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
Clear, colourless liquid.
4. Clinical particulars
4.1 Therapeutic indications
Aripiprazole Oral Solution is indicated for the treatment of
schizophrenia in adults and in adolescents
aged 15 years and older.
Aripiprazole Oral Solution 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 Oral Solution 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 Oral
Solution 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 10 ml
calibrated syringe are included in the
carton.
Aripiprazole Oral Solution 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 Oral Solution 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