FANAPT TABLETS 6 MG

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

ILOPERIDONE

から入手可能:

MEGAPHARM LTD

ATCコード:

N05AX14

医薬品形態:

TABLETS

構図:

ILOPERIDONE 6 MG

投与経路:

PER OS

処方タイプ:

Required

製:

PATHEON INC, CANADA

治療群:

ILOPERIDONE

治療領域:

ILOPERIDONE

適応症:

FANAPT is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults.

承認日:

2017-06-30

情報リーフレット

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS - 1986
This medicine is dispensed with a physician’s prescription only
FANAPT TABLETS 1 MG
FANAPT TABLETS 2 MG
FANAPT TABLETS 4 MG
FANAPT TABLETS 6 MG
FANAPT TABLETS 8 MG
FANAPT TABLETS 10 MG
FANAPT TABLETS 12 MG
COMPOSITION:
ACTIVE INGREDIENT:
Iloperidone 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg
Each 1 mg tablet contains 53.82 mg lactose
Each 2 mg tablet contains 85.07 mg lactose
Each 4 mg tablet contains 83.07 mg lactose
Each 6 mg tablet contains 110.10 mg lactose
Each 8 mg tablet contains 166.14 mg lactose
Each 10 mg tablet contains 183.50 mg lactose
Each 12 mg tablet contains 220.20 mg lactose
For a list of inactive and allergenic ingredients, see section 6 -
“Additional information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions,
consult your physician or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others.
It may harm them even if it seems to you that their illness is
similar.
WARNING: INCREASED RISK OF DEATH IN ELDERLY PERSONS
SUFFERING FROM DEMENTIA
ELDERLY PATIENTS SUFFERING FROM DEMENTIA-RELATED PSYCHOSIS AND TREATED
WITH ANTIPSYCHOTIC MEDICINES ARE AT INCREASED RISK OF DEATH.
THIS MEDICINE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS.
1. WHAT IS THIS MEDICINE INTENDED FOR?
FANAPT is an atypical antipsychotic agent indicated for the treatment
of schizophrenia
in adults.
Schizophrenia is a disorder with symptoms of hearing, seeing and
sensing
things that are not real, mistaken beliefs, unusual suspiciousness,
becoming
withdrawn, incoherent speech and behavioral and emotional flatness.
Patients
with schizophrenia may also feel depressed, anxious, guilty and tense.
Treatment with FANAPT TABLETS has been shown to reduce the severity
and
occurrence of these symptoms.
THERAPEUTIC GROUP: Antipsychotic medicines.
2. BEFORE USING THE MEDICIN

製品の特徴

Page
1
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1.
NAME OF THE MEDICINAL PRODUCT
FANAPT TABLETS 1 mg, 2 MG, 4 MG, 6 MG, 8 MG, 10 MG, 12 MG.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
FANAPT TABLETS 1 MG,
each 1 mg tablet contains 1 mg iloperidone, oral tablets.
FANAPT TABLETS 2 MG,
each 2 mg tablet contains 2 mg iloperidone, oral tablets.
FANAPT TABLETS 4 MG,
each 4 mg tablet contains 4 mg iloperidone, oral tablets.
FANAPT TABLETS 6 MG,
each 6 mg tablet contains 6 mg iloperidone, oral tablets.
FANAPT TABLETS 8 MG,
each 8 mg tablet contains 8 mg iloperidone, oral tablets.
FANAPT TABLETS 10 MG,
each 10 mg tablet contains 10 mg iloperidone, oral tablets
.
FANAPT TABLETS 12 MG,
each 12 mg tablet contains 12 mg iloperidone, oral tablets.
For the full list of excipients and allergens, see section 6.1
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH.
FANAPT TABLETS IS NOT APPROVED FOR USE IN PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS.
3. PHARMACEUTICAL FORM
FANAPT tablets are available in the following strengths: 1 mg, 2 mg, 4
mg, 6 mg, 8 mg, 10 mg, and 12 mg. The tablets
are white, round, flat, beveled-edged without a score line and
identified with a logo “ ” debossed on one side and tablet
strength “1”, “2”, “4”, “6”, “8”, “10”, or
“12” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FANAPT tablets is an atypical antipsychotic agent indicated for the
treatment of schizophrenia in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION USUAL DOSE:
FANAPT tablets must be titrated slowly from a low starting dose to
avoid orthostatic hypotension due to its
alpha-adrenergic blocking properties. The recommended starting dose
for FANAPT tablets is 1 mg orally
twice daily. Dose increases to reach the target range of 6-12 mg twice
daily (12_24 mg/day) may be made
with daily dosage adjustments not to exceed 2 mg twice daily (4
mg/day). The maximum recommended dose
is 12