SANDOMIGRAN pizotifen 0.5mg (as malate) tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pizotifen malate, Quantity: 0.725 mg

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; povidone; Acacia; purified talc; sucrose; lactose monohydrate; cetyl palmitate; magnesium stearate; maize starch; titanium dioxide

Administration route:

Oral

Units in package:

100, 30, 2

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 14 JUNE 2004: Prophylactic (interval) treatment of vascular headaches: Typical and atypical migraine, vasomotor headache, cluster headache (Horton's syndrome). Sandomigran is without effect in the migraine attack. For this purpose preparations containing ergotamine are recommended.

Product summary:

Visual Identification: Off-white, circular biconvex tablet approx 6mm in diameter.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-06-24

Patient Information leaflet

SANDOMIGRAN
®
_Pizotifen malate_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sandomigran.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. Some more recent
information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE
.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Sandomigran
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE
.
You may need to read it again.
WHAT SANDOMIGRAN IS
USED FOR
Sandomigran is used to prevent
"vascular" headaches, including
migraine, cluster headaches and
vasomotor headaches.
Vascular headaches are thought to be
caused by temporary changes in the
size of small blood vessels in the
brain. These changes cause the pain
and problems with vision that often
happen during a severe headache.
Sandomigran prevents an attack by
stopping the blood vessels from
changing in size.
Sandomigran is only used to prevent
severe headaches from happening. It
will not stop an attack once it has
started.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Sandomigran is only available with a
doctor's prescription. It is not
addictive.
There is not enough information to
recommend this medicine for
children.
BEFORE YOU TAKE
SANDOMIGRAN
_WHEN YOU MUST NOT TAKE IT_
_ _
DO NOT TAKE SANDOMIGRAN IF YOU
HAVE AN ALLERGY TO PIZOTIFEN (THE
ACTIVE INGREDIENT) OR TO ANY OF THE
OTHER INGREDIENTS OF SANDOMIGRAN
LISTED AT THE END OF THIS LEAFLET.
Som

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SANDOMIGRAN (PIZOTIFEN
MALATE) TABLET
1
NAME OF THE MEDICINE
Pizotifen malate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 500 micrograms of pizotifen present as 725
micrograms of pizotifen malate.
Excipients with known effects: lactose, sucrose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Off-white, circular biconvex sugar coated tablet, approx 6mm in
diameter
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prophylactic (interval) treatment of vascular headaches.

Typical and atypical migraine

Vasomotor headache

Cluster headache (Horton's syndrome)
Sandomigran is without effect in the migraine attack. For this purpose
preparations containing
ergotamine are recommended.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The
dosage
should
be
progressively
increased,
starting
with
0.5
mg
daily.
The
average
maintenance dosage is 1.5 mg daily in single or divided doses. Recent
studies have shown a single
daily dose of 3 tablets (1.5 mg) taken at night to be effective. In
refractory cases the dosage may
be gradually raised to 3 - 4.5 mg daily in two or three divided doses.
4.3
C
ONTRAINDICATIONS
Hypersensitivity to pizotifen or any of the excipients in the
formulation.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
_USE IN RENAL IMPAIRMENT _
Caution is required in patients with renal impairment. Dosage
adjustment may be necessary.
2
_HEPATIC IMPAIRMENT _
Hepatic injury has been reported, ranging from transaminase elevations
to severe hepatitis.
Pizotifen treatment should be discontinued if there is any clinical
evidence of hepatic dysfunction
during treatment and until the cause of the liver abnormality is
determined.
Caution is required in patients with hepatic impairment. Dosage
adjustment may be necessary.
_ANTICHOLINERGIC EFFECTS _
In view of the very slight anticholinergic effect of pizotifen,
caution is required in patients with
narrow angle glaucoma (except those successfully treated by surgery)
or urinary rete