IMIGRAN S sumatriptan 10mg/0.1mL nasal spray vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sumatriptan, Quantity: 100 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Sumatriptan

Pharmaceutical form:

Spray, solution

Composition:

Excipient Ingredients: sulfuric acid; monobasic potassium phosphate; purified water; dibasic sodium phosphate; sodium hydroxide

Administration route:

Nasal

Units in package:

2 sprays, 1 spray

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Clear pale yellow to dark yellow liquid; Container Type: Vial; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-02-26

Patient Information leaflet

1
IMIGRAN

NASAL SPRAY
IMIGRAN

S
NASAL SPRAY
_(Sumatriptan) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Unless explained differently,
the information for "_Imigran_
nasal spray" in this leaflet
applies to both _Imigran_ S nasal
spray 10 mg and _Imigran_ nasal
spray 20 mg (refer to the
"Product description" section
near the end of the leaflet for a
description of these two
products).
Please read this leaflet
carefully before you start using
_Imigran _nasal spray.
This leaflet answers some
common questions about
_Imigran _nasal spray. 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 _nasal
spray 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 IS_ IMIGRAN _NASAL
SPRAY USED FOR?
_Imigran_ nasal spray contains
the active ingredient
sumatriptan. This medicine
belongs to a group of drugs
called serotonin agonists.
_Imigran_ nasal spray is used to
relieve a migraine attack. It
should not be used to prevent
migraine attacks from
occurring. _Imigran_ nasal spray
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_ nasal spray
works by making those vessels
normal again and eases the
symptoms of migraine.
Your _Imigran_ nasal spray does
not work in other types of
headache which are not a
migraine.
_Imigran_ nasal spray is not
addictive.
BEFORE YOU USE
_IMIGRAN _NASAL SPRAY
_ _
_DO NOT USE IF: _
You must not use _Imigran_
nasal spray if:

YOU HAVE EVER HAD AN
ALLERGIC REACTION TO
SUMATRIPTAN (SEE “SIDE-
EFFECTS”) OR ANY OF THE
INGREDIENTS LISTED TOWARD
THE END OF THIS LEAFLET.
(SEE “INGREDIENTS”).

YOU HAVE OR HAVE HAD:
-
heart dise

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