Aripiprazole Krka 10mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aripiprazole

Available from:

KRKA, d.d., Novo mesto

ATC code:

N05AX; N05AX12

INN (International Name):

Aripiprazole

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antipsychotics; aripiprazole

Authorization status:

Marketed

Authorization date:

2015-02-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARIPIPRAZOLE KRKA 5 MG TABLETS
ARIPIPRAZOLE KRKA 10 MG TABLETS
ARIPIPRAZOLE KRKA 15 MG TABLETS
ARIPIPRAZOLE KRKA 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 Aripiprazole Krka is and what it is used for
2.
What you need to know before you take Aripiprazole Krka
3.
How to take Aripiprazole Krka
4.
Possible side effects
5.
How to store Aripiprazole Krka
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE KRKA IS AND WHAT IT IS USED FOR
Aripiprazole Krka 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 Krka 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 Krka.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE KRKA
DO NOT TAKE ARIPIPRAZOLE KRKA
-
if you a

Summary of Product characteristics

Health Products Regulatory Authority
03 May 2023
CRN00DGDK
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aripiprazole Krka 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg aripiprazole.
Excipient with known effect: lactose monohydrate.
Each tablet contains 60 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Light pink, rectangular tablets with possible darker and lighter spots
and engraved with A10 on one side (length: 8 mm, width:
4.5 mm, thickness: 2.1–3.1 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aripiprazole Krka is indicated for the treatment of schizophrenia in
adults and in adolescents aged 15 years and older.
Aripiprazole Krka 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 Krka 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 Krka
is 10 mg/day or 15 mg/day with a maintenance dose of
15 mg/day administered on a once-a-day schedule without regard to
meals.
Aripiprazole Krka is effective in a dose range of 10 mg/day 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 Krka 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 shoul