Paliperidone Teva 100 mg prolonged-release suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paliperidone

Available from:

Norton Waterford

ATC code:

N05AX13

INN (International Name):

Paliperidone

Dosage:

100 milligram(s)

Pharmaceutical form:

Prolonged-release suspension for injection

Therapeutic area:

paliperidone

Authorization status:

Marketed

Authorization date:

2021-12-03

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
PALIPERIDONE TEVA 25 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION
PALIPERIDONE TEVA 50 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION
PALIPERIDONE TEVA 75 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION
PALIPERIDONE TEVA 100 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION
PALIPERIDONE TEVA 150 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION
_TREATMENT INITIATION PACK _
PALIPERIDONE TEVA 150 MG AND PALIPERIDONE TEVA 100 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 Paliperidone Teva is and what it is used for
2.
What you need to know before you use Paliperidone Teva
3.
How to use Paliperidone Teva
4.
Possible side effects
5.
How to store Paliperidone Teva
6.
Contents of the pack and other information
1.
WHAT PALIPERIDONE TEVA IS AND WHAT IT IS USED FOR
Paliperidone Teva 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 Paliperidone Teva
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),
o

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2024
CRN00F113
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paliperidone Teva 100 mg prolonged-release suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paliperidone Teva 100 mg Prolonged-release Suspension for Injection
Each pre-filled syringe contains 156 mg paliperidone palmitate in 1 mL
equivalent to 100 mg paliperidone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release suspension for injection (prolonged-release
injection).
The suspension is white to off-white. The suspension is pH neutral
(approximately 7.0).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paliperidone Teva 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, paliperidone may
be used without prior stabilisation with oral treatment if psychotic
symptoms are mild to moderate and a long-acting injectable
treatment is needed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended initiation of Paliperidone Teva is with a dose of 150 mg
on treatment day 1 and 100 mg one week later (day 8),
both administered in the deltoid muscle in order to attain therapeutic
concentrations rapidly (see section 5.2). The third dose
should be administered one month after the second initiation dose. The
recommended monthly maintenance dose is 75 mg;
some patients may benefit from lower or higher doses within the
recommended range of 25 to 150 mg based on individual
patient tolerability and/or efficacy. Patients who are overweight or
obese may require doses in the upper range (see
section 5.2). Following the second initiation dose, monthly
maintenance doses can be administered in either the deltoid or
gluteal muscle.
Adjustment of the maintenance dose may be made monthly. When making
dose adjustments, the prolonged release
characteristics of