Abilify 15mg orodispersible tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Aripiprazole

제공처:

Otsuka Pharmaceuticals (U.K.

ATC 코드:

N05AX12

INN (국제 이름):

Aripiprazole

복용량:

15mg

약제 형태:

Orodispersible tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 04020100; GTIN: 5012712003618

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABILIFY 10 MG ORODISPERSIBLE TABLETS
ABILIFY 15 MG ORODISPERSIBLE TABLETS
ABILIFY 30 MG ORODISPERSIBLE 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 ABILIFY is and what it is used for
2.
What you need to know before you take ABILIFY
3.
How to take ABILIFY
4.
Possible side effects
5
How to store ABILIFY
6.
Contents of the pack and other information
1.
WHAT ABILIFY IS AND WHAT IT IS USED FOR
ABILIFY contains the active substance aripiprazole and belong 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.
ABILIFY 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
ABILIFY.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABILIFY
DO NOT TAKE ABILIFY
•
if you are allergic to aripiprazole or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS

제품 특성 요약

OBJECT 1
ABILIFY 10 MG ORODISPERSIBLE TABLETS
Summary of Product Characteristics Updated 25-Jan-2018 | Otsuka
Pharmaceuticals (UK) Ltd
1. Name of the medicinal product
ABILIFY 10 mg orodispersible tablets
ABILIFY 15 mg orodispersible tablets
ABILIFY 30 mg orodispersible tablets
2. Qualitative and quantitative composition
ABILIFY 10 mg orodispersible tablets
Each orodispersible tablet contains 10 mg of aripiprazole.
Excipient with known effect
2 mg aspartame (E 951) and 0.075 mg lactose per orodispersible tablet
ABILIFY 15 mg orodispersible tablets
Each orodispersible tablet contains 15 mg of aripiprazole.
Excipient with known effect
3 mg aspartame (E 951) and 0.1125 mg lactose per orodispersible tablet
ABILIFY 30 mg orodispersible tablets
Each orodispersible tablet contains 30 mg of aripiprazole.
Excipient with known effect
6 mg aspartame (E 951) and 0.225 mg lactose per orodispersible tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Orodispersible tablet
ABILIFY 10 mg orodispersible tablets
10 mg: Round and pink, marked with "A" over "640" on one side and "10"
on the other.
ABILIFY 15 mg orodispersible tablets
15 mg: Round and yellow, marked with "A" over "641" on one side and
"15" on the other.
ABILIFY 30 mg orodispersible tablets
30 mg: Round and pink, marked with "A" over "643" on one side and "30"
on the other.
4. Clinical particulars
4.1 Therapeutic indications
ABILIFY is indicated for the treatment of schizophrenia in adults and
in adolescents aged 15 years and
older.
ABILIFY 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).
ABILIFY 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 _
_Schiz