SAPHRIS asenapine (as maleate) 5mg sublingual wafer blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

asenapine maleate, Quantity: 7.03 mg (Equivalent: asenapine, Qty 5 mg)

Boleh didapati daripada:

ORGANON PHARMA PTY LTD

INN (Nama Antarabangsa):

asenapine maleate

Borang farmaseutikal:

Wafer

Komposisi:

Excipient Ingredients: Gelatin; mannitol

Laluan pentadbiran:

Sublingual

Unit dalam pakej:

100 tablets, 60 tablets, 20 tablets

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

SAPHRIS is indicated in the: = treatment of schizophrenia in adults = treatment of acute manic or mixed episodes associated with Bipolar 1 Disorder in adults as monotherapy or in combination with lithium or sodium valproate = prevention of relapse of manic or mixed episodes in Bipolar 1 Disorder in adults as monotherapy or in combination with lithium or sodium valproate.

Ringkasan produk:

Visual Identification: White to off-white, circular wafers, debossed with "5" on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2011-03-11

Risalah maklumat

SAPHRIS
®
_5MG AND 10MG SUBLINGUAL WAFERS_
_Asenapine (as maleate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SAPHRIS.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SAPHRIS
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SAPHRIS IS
USED FOR
SAPHRIS is used to treat the mental
illnesses:
•
Schizophrenia - an illness with
disturbances in thinking, feelings
and behaviour.
•
Bipolar 1 disorder - an illness in
which there are sustained mood
swings either up (mania) or down
(low moods). During mania,
patients experience episodes of
overactivity, elation or irritability.
During low moods, patients may
feel depressed or guilty, lack
energy, lose their appetite and
have trouble sleeping.
SAPHRIS belongs to a group of
medicines called antipsychotics. It
helps to correct chemical imbalances
in the brain, which may cause these
mental illnesses.
Your doctor may have prescribed
SAPHRIS for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SAPHRIS HAS
BEEN PRESCRIBED FOR YOU.
SAPHRIS is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
SAPHRIS
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SAPHRIS IF YOU HAVE
AN ALLERGY TO:
•
ASENAPINE THE ACTIVE INGREDIENT
IN SAPHRIS
•
ANY OF THE OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET
Some of the symptoms of an allergic
reaction to SAPHRIS may include
shortness of breath, wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of the
body; rash, itching or hives on the
skin or you may feel faint.
If you have diabetes or risk factors
for diabetes, such as being
overweight or a family history of
diabetes, your blood

Ciri produk

S-CCDS-MK8274- SB-T-102017
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
SAPHRIS
®
ASENAPINE (AS MALEATE)
1
NAME OF THE MEDICINE
Asenapine (as maleate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SAPHRIS is available as 5 mg and 10 mg wafers containing 5 mg
asenapine (7.03 mg
asenapine maleate) and 10 mg asenapine (14.06 mg asenapine maleate),
respectively.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SAPHRIS 5 MG contains 5 mg of asenapine as maleate. It is a round
wafer, white to off-white
in colour with “5” debossed on one side.
SAPHRIS 10 MG contains 10 mg of asenapine as maleate. It is a round
wafer, white to off-
white in colour with “10” debossed on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SAPHRIS is indicated in the:
•
treatment of schizophrenia in adults
•
treatment of acute manic or mixed episodes associated with Bipolar 1
Disorder in adults
as monotherapy or in combination with lithium or sodium valproate
•
prevention of relapse of manic or mixed episodes in Bipolar 1 Disorder
in adults as
monotherapy or in combination with lithium or sodium valproate
4.2
DOSE AND METHOD OF ADMINISTRATION
Schizophrenia
The recommended dose range of SAPHRIS is 5 mg to 10 mg twice daily.
SAPHRIS should
be administered at an initial daily dose of 5 mg twice daily. An
increase in dose to 10 mg twice
daily is recommended only after clinical assessment. In controlled
trials, there was no
suggestion of added benefit with a higher dose of 10 mg twice daily
but there was a clear
increase in certain adverse reactions. The safety of doses above 10 mg
twice daily has not
been evaluated in clinical trials (see SECTION 5.1 PHARMACODYNAMIC
PROPERTIES, CLINICAL
TRIALS).
Acute and maintenance treatment of manic or mixed episodes in Bipolar
1 Disorder
The recommended starting dose of SAPHRIS as monotherapy is 10 mg twice
daily. The dose
can be reduced to 5 mg twice daily, according to clinical assessment.
For combination therapy a starting dose of 5 mg twice d