Paliperidone Krka 3 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paliperidone

Available from:

Krka d.d., Novo mesto

ATC code:

N05AX; N05AX13

INN (International Name):

Paliperidone

Dosage:

3 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

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

Therapeutic area:

Other antipsychotics; paliperidone

Authorization status:

Not marketed

Authorization date:

2018-06-22

Patient Information leaflet

Navodila prepognjena na sredini z vidno prvo stranjo (naslovom);
pharma kodi, ki izhajata iz sredine navodila, morata biti vidni!
smer vlaken
smer branja kode
70 mm ± 0,5 mm
70 mm ± 0,5 mm
smer branja kode
Šifra: XXXXXX
Emb. mat.: NA.Paliperidone Krka tbl
IE
Dimenzije: 148 ± 0,5 mm x 594 ± 0,8 mm
Material: papir tip B
PhC št.: 1234
Merilo: 1:1
Datum: 29.05.2018
Izdelal: A. Mohorič
Pregledal: N. Regina
_Oddelek za oblikovanje_
_ - PMS-433U-KRKA_
_NA.Paliperidone Krka tbl IE _
prva stran
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Paliperidone Krka 3 mg
prolonged-release tablets
Paliperidone Krka 6 mg
prolonged-release tablets
Paliperidone Krka 9 mg
prolonged-release tablets
Paliperidone
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 Paliperidone Krka is and what it is used for
2. What you need to know before you take Paliperidone
Krka
3. How to take Paliperidone Krka
4. Possible side effects
5. How to store Paliperidone Krka
6. Contents of the pack and other information
1. What Paliperidone Krka is and what it is
used for
Paliperidone Krka contains the active substance paliperidone
which belongs to the class of antipsychotic medicines.
Paliperidone Krka is used to treat schizophrenia in adults
and in adolescents aged 15 years and older.
Schizophrenia is a disorder with symptoms such as
hearing things, seeing or sensing things that are not there,
mistaken beliefs, unusual suspiciousness, becoming
withdrawn, incoherent speech, and behaviour and
emotional flatness. People with this

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paliperidone Krka 3 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 3 mg paliperidone.
Excipient with known effect
Each tablet contains 15.7 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White to greyish white round biconvex film-coated tablets with
possible uneven surface and imprinted with mark P3 on
one side of the tablet. Diameter: approximately 9 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paliperidone Krka is indicated for the treatment of schizophrenia in
adults and in adolescents 15 years and older.
Paliperidone Krka is indicated for the treatment of schizoaffective
disorder in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Schizophrenia (adults)_
The recommended dose of Paliperidone Krka for the treatment of
schizophrenia in adults is 6 mg once daily,
administered in the morning. Initial dose titration is not required.
Some patients may benefit from lower or higher doses
within the recommended range of 3 mg to 12 mg once daily. Dosage
adjustment, if indicated, should occur only after
clinical reassessment. When dose increases are indicated, increments
of 3 mg/day are recommended and generally
should occur at intervals of more than 5 days.
_Schizoaffective disorder (adults)_
The recommended dose of Paliperidone Krka for the treatment of
schizoaffective disorder in adults is 6 mg once daily,
administered in the morning. Initial dose titration is not required.
Some patients may benefit from higher doses within
the recommended range of 6 mg to 12 mg once daily. Dosage adjustment,
if indicated, should occur only after clinical
reassessment. When dose increases are indicated, increments of 3
mg/day are recommended and generally should occur
at intervals of more than 4 days.
_Switching to other antipsychotic medicinal products_
There are no systematically collected data to specifically address
switc