IMIGRAN sumatriptan 50mg (as succinate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sumatriptan succinate, Quantity: 70 mg (Equivalent: sumatriptan, Qty 50 mg)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; lactose; croscarmellose sodium; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide red

Administration route:

Oral

Units in package:

2 tablets, 4s and 12s, 2 tablets (sample pack)

Prescription type:

(S3) Pharmacist Only Medicine, (S4) Prescription Only Medicine

Therapeutic indications:

Imigran tablets are indicated for the acute relief of migraine attacks with or without aura. There is no information available on the use of Imigran tablets in the treatment of basilar or hemiplegic migraines.

Product summary:

Visual Identification: Pink, film-coated, capsule-shaped biconvex tablet, engraved '50' on one face and plain on the other; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1995-05-17

Patient Information leaflet

IMIGRAN
®
TABLETS
1
IMIGRAN
® TABLETS
_(Sumatriptan succinate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start taking Imigran
tablets.
This leaflet answers some common
questions about Imigran 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
Imigran 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 IMIGRAN
TABLETS USED FOR?
Imigran tablets contain the active
ingredient sumatriptan succinate.
This medicine belongs to a group of
drugs called serotonin agonists.
Imigran tablets are used to relieve a
migraine attack. They should not be
used to prevent migraine attacks
from occurring. Imigran 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. Imigran tablets
work by making those vessels normal
again and ease the symptoms of
migraine.
Your Imigran tablets do not work in
other types of headache which are
not a migraine.
Imigran tablets are not addictive.
BEFORE YOU TAKE
IMIGRAN TABLETS
_DO NOT TAKE IF: _
You must not take Imigran tablets if:
•
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO SUMATRIPTAN
SUCCINATE (SEE "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 rest rather
than during activity).
−
angina.
�

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
IMIGRAN (SUMATRIPTAN) TABLETS, INJECTION AND NASAL SPRAY
1
NAME OF THE MEDICINE
Sumatriptan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sumatriptan is the therapeutically active ingredient in Imigran nasal
spray and sumatriptan
succinate is the therapeutically active ingredient in Imigran tablets
and injection.
Excipients with known effect: Imigran 50mg and 100mg tablets contain
sugars (as lactose)
IMIGRAN TABLETS 50 MG
Each tablet contains 50 mg sumatriptan base as the succinate salt.
The
tablets
also
contain:
lactose,
lactose
monohydrate,
microcrystalline
cellulose,
croscarmellose sodium, magnesium stearate, Opadry YS-1-1441-G.
IMIGRAN TABLETS 100 MG
Each tablet contains 100 mg sumatriptan base as the succinate salt.
The tablets also contain: lactose monohydrate, microcrystalline
cellulose, croscarmellose
sodium, magnesium stearate, Opadry white OY-S-7393.
IMIGRAN FDT 50 MG
Each tablet contains 50 mg sumatriptan base as the succinate salt.
Imigran
FDT
also
contains:
calcium
hydrogen
phosphate
anhydrous,
microcrystalline
cellulose, sodium bicarbonate, croscarmellose sodium, magnesium
stearate and Opadry YS-
1-1441-G.
IMIGRAN FDT 100 MG
Each tablet contains 100 mg sumatriptan base as the succinate salt.
Imigran
FDT
also
contains:
calcium
hydrogen
phosphate
anhydrous,
microcrystalline
cellulose, sodium bicarbonate, croscarmellose sodium, magnesium
stearate and Opadry
white OY-S-7322.
INJECTION
Imigran MK II injection is available in pre-filled syringes containing
6 mg of sumatriptan base
as the succinate salt, in an isotonic solution containing sodium
chloride and water for
injections (total volume 0.5 mL).
2
IMIGRAN NASAL SPRAY
Each nasal spray is a single dose unit of sumatriptan base in 0.1 mL
aqueous solution
containing sulfuric acid, monobasic potassium phosphate, dibasic
anhydrous sodium
phosphate, sodium hydroxide and purified water. The pH of the nasal
spray solution is 5.5.
3
PHARMACEUTICAL FORM
TABLETS
Sumatriptan tablets are presented in two formulations: Imigran tablets