Xeplion

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

paliperidone palmitate

Available from:

Janssen-Cilag International N.V.

ATC code:

N05AX13

INN (International Name):

paliperidone

Therapeutic group:

Psycholeptics

Therapeutic area:

Schizophrenia

Therapeutic indications:

Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2011-03-04

Patient Information leaflet

67
B. PACKAGE LEAFLET
68
PACKAGE LEAFLET: INFORMATION FOR THE USER
XEPLION 25 MG PROLONGED RELEASE SUSPENSION FOR INJECTION
XEPLION 50 MG PROLONGED RELEASE SUSPENSION FOR INJECTION
XEPLION 75 MG PROLONGED RELEASE SUSPENSION FOR INJECTION
XEPLION 100 MG PROLONGED RELEASE SUSPENSION FOR INJECTION
XEPLION 150 MG PROLONGED RELEASE SUSPENSION FOR INJECTION
Paliperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist, or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Xeplion is and what it is used for
2.
What you need to know before you use Xeplion
3.
How to use Xeplion
4.
Possible side effects
5.
How to store Xeplion
6.
Contents of the pack and other information
1.
WHAT XEPLION IS AND WHAT IT IS USED FOR
Xeplion contains the active substance paliperidone which belongs to
the class of antipsychotic
medicines and is used as a maintenance treatment for the symptoms of
schizophrenia in adult patients
stabilised on paliperidone or risperidone.
If you have shown responsiveness to paliperidone or risperidone in the
past and have mild to moderate
symptoms your doctor may start treatment with Xeplion without prior
stabilisation with paliperidone
or risperidone.
Schizophrenia is a disease with “positive” and “negative”
symptoms. Positive means an excess of
symptoms that are not normally present. For example, a person with
schizophrenia may hear voices or
see things that are not there (called hallucinations), believe things
that are not true (called delusions),
or feel unusually suspicious of others. Negative means a lack of
behaviours or feelings that are
normally present. For example, a person with schizophrenia may appear
withdrawn and may not
respond at all emotionally or may have t

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xeplion 25 mg prolonged release suspension for injection
Xeplion 50 mg prolonged release suspension for injection
Xeplion 75 mg prolonged release suspension for injection
Xeplion 100 mg prolonged release suspension for injection
Xeplion 150 mg prolonged release suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg prolonged release suspension for injection
Each pre-filled syringe contains 39 mg paliperidone palmitate in 0.25
mL equivalent to 25 mg
paliperidone.
50 mg prolonged release suspension for injection
Each pre-filled syringe contains 78 mg paliperidone palmitate in 0.5
mL equivalent to 50 mg
paliperidone.
75 mg prolonged release suspension for injection
Each pre-filled syringe contains 117 mg paliperidone palmitate in 0.75
mL equivalent to 75 mg
paliperidone.
100 mg prolonged release suspension for injection
Each pre-filled syringe contains 156 mg paliperidone palmitate in 1 mL
equivalent to 100 mg
paliperidone.
150 mg prolonged release suspension for injection
Each pre-filled syringe contains 234 mg paliperidone palmitate in 1.5
mL equivalent to 150 mg
paliperidone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged release suspension for injection.
The suspension is white to off-white. The suspension is pH neutral
(approximately 7.0).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xeplion is indicated for maintenance treatment of schizophrenia in
adult patients stabilised with
paliperidone or risperidone.
In selected adult patients with schizophrenia and previous
responsiveness to oral paliperidone or
risperidone, Xeplion may be used without prior stabilisation with oral
treatment if psychotic symptoms
are mild to moderate and a long-acting injectable treatment is needed.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended initiation of Xeplion is with a dose of 150 mg on
treatment day 1 and 100 mg
one week later (day 8), both administered in the deltoid