Lemilvo 5mg tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
03-08-2018
Summary of Product characteristics
(SPC)
03-08-2018
Active ingredient:
Aripiprazole
Available from:
Actavis Group PTC ehf
ATC code:
N05AX; N05AX12
INN (International Name):
Aripiprazole
Dosage:
5 milligram(s)
Pharmaceutical form:
Tablet
Administration route:
Oral use
Units in package:
blister packs: 14, 28, 30, 56, and 98 tablets. Bottles: 100 tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Manufactured by:
Actavis Ltd
Therapeutic group:
psycholeptics, other antipsychotics
Therapeutic area:
Other antipsychotics; aripiprazole
Therapeutic indications:
It is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older; 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; for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older
Authorization status:
Marketed
Authorization date:
2015-07-10
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).
WARNINGS AND PRECAUTIONS
Talk to your doctor
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lemilvo 5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect: 27.9 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.
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.
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
_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 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 Lemilvois 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 patients
who have been receiving aripiprazole as monotherapy or combination
therapy, continue therapy at the same dose.
Adjustments of
Read the complete document
