IMIGRAN FDT sumatriptan 50mg (as succinate) tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

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

Disponível em:

Aspen Pharmacare Australia Pty Ltd

DCI (Denominação Comum Internacional):

Sumatriptan

Forma farmacêutica:

Tablet, film coated

Composição:

Excipient Ingredients: sodium bicarbonate; calcium hydrogen phosphate; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; triacetin; iron oxide red

Via de administração:

Oral

Unidades em pacote:

18 tablets, 2 tablets, 6 tablets, 12 tablets, 4 tablets

Tipo de prescrição:

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

Indicações terapêuticas:

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

Resumo do produto:

Visual Identification: Pink, film-coated, triangular-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

Status de autorização:

Registered

Data de autorização:

2004-08-09

Folheto informativo - Bula

1
IMIGRAN

FDT TABLETS
_(Sumatriptan succinate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet
carefully before you start
taking _Imigran FDT _tablets.
This leaflet answers some
common questions about
_Imigran FDT_. 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 FDT_
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 FDT_
USED FOR?
_Imigran_ _FDT_ contains the
active ingredient sumatriptan
succinate. This medicine
belongs to a group of drugs
called serotonin agonists.
_Imigran_ _FDT_ is used to relieve
a migraine attack. It should not
be used to prevent migraine
attacks from occurring.
_Imigran_ _FDT_ 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_ _FDT_ works by
making those vessels normal
again and eases the symptoms
of migraine.
Your _Imigran_ _FDT_ does not
work in other types of
headache which are not a
migraine.
_Imigran_ _FDT_ is not addictive.
BEFORE YOU TAKE
_IMIGRAN _FDT
_ _
_DO NOT TAKE IF: _
You must not take _Imigran_ _FDT_
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
-
high blood pressur

Características técnicas

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