SUMATRAN sumatriptan (as succinate) 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sumatriptan succinate, Quantity: 139.98 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

sumatriptan succinate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose; magnesium stearate; microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; titanium dioxide

Administration route:

Oral

Units in package:

2 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SUMATRAN Tablets are indicated for the acute relief of migraine attacks with or without aura.

Product summary:

Visual Identification: White to off-white, capsule shaped, biconvex, film coated tablet plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-05-11

Patient Information leaflet

SUMATRAN 50 MG AND 100 MG TABLETS
Page 1 of 4
2021
_SUMATRIPTAN SUCCINATE _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please
read
this
leaflet
carefully
before
you
start
taking Sumatran Tablets.
This
leaflet
answers
some
common
questions
about
Sumatran
Tablets.
It
does
not
contain
all
of
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
expected
benefits
of
you
taking
Sumatran
Tablets
against
the risks this medicine could
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
ARE
SUMATRAN
TABLETS USED FOR?
Sumatran
Tablets
contain
the
active
ingredient
sumatriptan succinate.
This medicine belongs to a
group
of
drugs
called
serotonin agonists.
Sumatran Tablets are used
to relieve a migraine attack.
They should not be used to
prevent
migraine
attacks
from occurring.
Sumatran
Tablets
may
be
used
for
migraine
headaches with or without
what is known as ‘aura’.
It is thought that migraine
headache is due to widening
of certain blood vessels in
the head. Sumatran Tablets
work
by
making
those
vessels
normal
again
and
ease
the
symptoms
of
migraine.
Your
Sumatran
Tablets
do
not work in other types of
headache which are not a
migraine.
Sumatran Tablets are not
addictive.
BEFORE
YOU
TAKE
SUMATRAN TABLETS
_DO NOT TAKE IF: _
You must not take Sumatran
Tablets if:
•
YOU
HAVE
EVER
HAD
AN
ALLERGIC
REACTION
TO
SUMATRIPTAN
SUCCINATE
(SEE “WHAT ARE THE SIDE
EFFECTS?”)
OR
ANY
OF
THE
INGREDIENTS LISTED TOWARD
THE END OF THIS LEAFLET. (SEE
“INGREDIENTS”).
•
YOU HAVE OR HAVE HAD:
–
Heart
disease
or
heart
attack.
–
Shortness of breath, pain
or tightness in the chest,
jaw or upper arm.
–
Peripheral
vascular
disease (pain in the back
of the legs) or are prone
to cold, tingling or numb
hands and feet.
–
Prinzmetal’s
angina
(an
uncommon
form
of
angina
where
pain
is
experienced
at

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
SUMATRAN
(SUMATRIPTAN SUCCINATE) TABLETS
1
NAME OF THE MEDICINE
Sumatriptan succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE: Sumatriptan (as the succinate salt).
Sumatriptan takes the form of a white to pale yellow
powder. Sumatriptan succinate takes the form
of a white to off white powder.
Sumatran tablets are available in two strengths, 50 mg and 100 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SUMATRAN 50 MG (AUST R 187216)_ _
Each film-coated tablet contains Sumatriptan succinate equivalent to
50 mg Sumatriptan.
Pink coloured, capsule shaped biconvex film coated tablets, plain on
both sides.
Excipients with known effect: contains sugars (as lactose).
SUMATRAN 100 MG (AUST R 187217)_ _
Each film-coated tablet contains Sumatriptan succinate equivalent to
100 mg Sumatriptan.
White to off-white coloured, capsule shaped biconvex film coated
tablets, plain on both sides.
Excipients with known effect: contains sugars (as lactose).
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Sumatran is indicated for the acute relief of migraine attacks with or
without aura.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Sumatran is indicated for the acute intermittent relief of both
migraine and cluster headache. It
should
not be used prophylactically
.
MIGRAINE
It is recommended that treatment be started at the first sign of a
migraine headache or associated
symptoms such as nausea, vomiting or photophobia. The efficacy of
Sumatran is independent of the
duration of the attack when starting treatment.
Administration during a migraine aura prior to other symptoms
occurring may not prevent
the
development of a headache.
If a patient does not respond to the first dose of Sumatran, a second
dose should not be taken for
the
same attack. Sumatran may be used for subsequent attacks.
2
TABLETS: The initial recommended adult dose of Sumatran is 50 mg. Some
patients may require 100
mg. The dose should be adjusted according to the individual's
re