Abilify 10mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Aripiprazole

Prieinama:

Otsuka Pharmaceuticals (U.K.

ATC kodas:

N05AX12

INN (Tarptautinis Pavadinimas):

Aripiprazole

Dozė:

10mg

Vaisto forma:

Tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 04020100; GTIN: 5012712003335

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABILIFY 5 MG TABLETS
ABILIFY 10 MG TABLETS
ABILIFY 15 MG TABLETS
ABILIFY 30 MG 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 AND PRECAUTIONS
Talk to

Prekės savybės

OBJECT 1
ABILIFY 5 MG TABLETS
Summary of Product Characteristics Updated 25-Jan-2018 | Otsuka
Pharmaceuticals (UK) Ltd
1. Name of the medicinal product
ABILIFY 5 mg tablets
ABILIFY 10 mg tablets
ABILIFY 15 mg tablets
ABILIFY 30 mg tablets
2. Qualitative and quantitative composition
ABILIFY 5 mg tablets
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect
67 mg lactose per tablet
ABILIFY 10 mg tablets
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect
62.18 mg lactose per tablet
ABILIFY 15 mg tablets
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect
57 mg lactose per tablet
ABILIFY 30 mg tablets
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect
186.54 mg lactose per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
ABILIFY 5 mg tablets
Rectangular and blue, engraved with "A-007" and "5" on one side.
ABILIFY 10 mg tablets
Rectangular and pink, engraved with "A-008" and "10" on one side.
ABILIFY 15 mg tablets
Round and yellow, engraved with "A-009" and "15" on one side.
ABILIFY 30 mg tablets
Round and pink, engraved with "A-011" and "30" on one side.
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 _
_Schizophrenia:_ the recommended starting dose for ABILIFY is 10 or 15
mg/day with a maintenance dose
of 15 mg/day administered on a once-a-day schedule without regard to
meals. ABILIFY is ef