Lemilvo 15mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ARIPIPRAZOLE

Available from:

Actavis Group PTC ehf

ATC code:

N05AX12

INN (International Name):

ARIPIPRAZOLE

Pharmaceutical form:

TABLET

Composition:

ARIPIPRAZOLE 15 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2015-06-11

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lemilvo 5 mg tablets
Lemilvo 10 mg tablets
Lemilvo 15 mg tablets
Lemilvo 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect: 27.9 mg lactose monohydrate per tablet
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect: 55.8 mg lactose monohydrate per tablet
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect: 83.7 mg lactose monohydrate per tablet
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect: 167.4 mg lactose monohydrate per tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet 5 mg
Round, biconvex and white, 5 mm, debossed "5" on one side and "ZL" on
one side.
Tablet 10 mg
Capsule shaped, biconvex and white, 8 mm x 5 mm, debossed "10" on one
side and "ZL" on
one side.
Tablet 15 mg
Round, biconvex and white 7 mm, debossed "15" on one side and "ZL" on
one side.
Tablet 30 mg
Round, biconvex and white 9 mm, debossed "30" on one side and "ZL" on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lemilvo is indicated for the treatment of schizophrenia in adults and
in adolescents aged
15 years and older.
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21
Lemilvo 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).
Lemilvo 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 Lemilvo 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.
Lemilvo is effective in a dose range of 10 to 30 mg/day. Enhanced
efficacy a