PHARMACOR SUMATRIPTAN 100 sumatriptan succinate 100 mg tablet blister

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

sumatriptan succinate, Quantity: 139.98 mg

Dostopno od:

Pharmacor Pty Ltd

INN (mednarodno ime):

sumatriptan succinate

Farmacevtska oblika:

Tablet, film coated

Sestava:

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

Pot uporabe:

Oral

Enote v paketu:

2 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

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

Povzetek izdelek:

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

Status dovoljenje:

Licence status A

Datum dovoljenje:

2010-03-26

Navodilo za uporabo

PHARMACOR SUMATRIPTAN
_Sumatriptan succinate _
_ _
_ _
_ _
_ _
CONSUMER MEDICINE INFORMATION
Pharmacor Sumatriptan (V 02)
Page 1 of 3
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Pharmacor
Sumatriptan.
This leaflet answers some common
questions about Pharmacor
Sumatriptan. 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
Pharmacor Sumatriptan 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 PHARMACOR
SUMATRIPTAN USED FOR?
Pharmacor Sumatriptan contain the
active ingredient sumatriptan
succinate.
This medicine belongs to a group of
drugs called serotonin agonists.
Pharmacor Sumatriptan are used to
relieve a migraine attack. They
should not be used to prevent
migraine attacks from occurring.
Pharmacor Sumatriptan 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.
Pharmacor Sumatriptan work by
making those vessels normal again
and ease the symptoms of migraine.
Your Pharmacor Sumatriptan do not
work in other types of headache
which are not a migraine.
Pharmacor Sumatriptan is not
addictive.
BEFORE YOU TAKE
PHARMACOR SUMATRIPTAN
_DO NOT TAKE IF: _
You must not take Pharmacor
Sumatriptan 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
un

Lastnosti izdelka

Pharmacor Sumatriptan (V 03)
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLETS
1
NAME OF THE MEDICINE
Sumatriptan succinate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Sumatriptan succinate equivalent to
50 mg Sumatriptan.
Each film-coated tablet contains Sumatriptan succinate equivalent to
100 mg Sumatriptan.
List of excipients with known effects: sugars as lactose.
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pharmacor Sumatriptan is available in two strengths, 50 mg and 100 mg.
PHARMACOR SUMATRIPTAN 50
Pink coloured, capsule shaped biconvex film coated tablets, plain on
both sides.
PHARMACOR SUMATRIPTAN 100
White to off-white coloured, capsule shaped biconvex film coated
tablets, plain on both sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pharmacor Sumatriptan are indicated for the acute relief of migraine
attacks with or without aura.
There is no information available on the use of Sumatriptan tablets in
the treatment of basilar or
hemiplegic migraine.
4.2 DOSE AND METHOD OF ADMINISTRATION
Pharmacor Sumatriptan are indicated for the acute intermittent relief
of both migraine and
cluster headache. It should not be used prophylactically.
Ergotamine or ergotamine derivatives and sumatriptan should not be
administered concurrently
(see SECTION 4.3 CONTRAINDICATIONS).
MIGRAINE
It is recommended to start the treatment at the first sign of a
migraine headache or associated
symptoms such as nausea, vomiting or photophobia. The efficacy of
Pharmacor Sumatriptan is
independent of the duration of the attack when starting treatment.
Pharmacor Sumatriptan (V 03)
Page 2 of 14
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 Pharmacor
Sumatriptan, a second dose should
not be taken for the same attack. Pharmacor Sumatriptan may be used
for subsequent attacks.
TABLETS
Th