Aripiprazole 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aripiprazole

Available from:

Aspire Pharma Ltd

ATC code:

N05AX12

INN (International Name):

Aripiprazole

Dosage:

5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5060209731322

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE 5MG TABLETS
ARIPIPRAZOLE 10MG TABLETS
ARIPIPRAZOLE 15MG TABLETS
ARIPIPRAZOLE 30MG 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 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
THIS MEDICINE 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

Summary of Product characteristics

OBJECT 1
ARIPIPRAZOLE ASPIRE 5MG TABLETS
Summary of Product Characteristics Updated 27-Jun-2018 | Aspire Pharma
Ltd
1. Name of the medicinal product
Aripiprazole Aspire 5 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg of aripiprazole.
Excipients with known effect: 28mg of maltose per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Blue round and biconvex tablets of 6.1 in diameter, engraved with
“5” on one side
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 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. 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
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.
_Recurrence prevention of manic episodes in Bipolar I Disorder: _for
preventing recurrence of manic
episodes in patien