IPTAM sumatriptan (as succinate) 100mg tablet blister pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

sumatriptan succinate, Quantity: 140 mg (Equivalent: sumatriptan, Qty 100 mg)

Доступна з:

Alphapharm Pty Ltd

ІПН (Міжнародна Ім'я):

sumatriptan succinate

Фармацевтична форма:

Tablet, film coated

Склад:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; triacetin; polydextrose

Адміністрація маршрут:

Oral

Одиниць в упаковці:

5 Tablets, 4 Tablets, 10 Tablets, 2 Tablets, 24 Tablets, 20 Tablets, 18 Tablets, 3 Tablets, 12 Tablets, 6 Tablets

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

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

Огляд продуктів:

Visual Identification: White to off white, round, film-coated tablets debossed 'G' on one side and 'SU100' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Статус Авторизація:

Registered

Дата Авторизація:

2006-08-15

інформаційний буклет

IPTAM
_sumatriptan (as succinate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Iptam.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Iptam against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT IPTAM IS USED FOR
Iptam contains the active ingredient
sumatriptan succinate which belongs
to a group of medicines called
serotonin agonists.
Iptam tablets are used to relieve a
migraine attack. They should not be
used to prevent migraine attacks
from occurring. Iptam 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. These medicines
work by making the blood vessels
normal again and ease the symptoms
of migraine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your Iptam tablets do not work in
other types of headache which are
not migraine.
Iptam is not recommended for use in
children and adolescents under the
age of 18 as its safety and
effectiveness have not been
established in this age group.
Iptam is available only with a
doctor's prescription.
There is no evidence that Iptam is
addictive.
BEFORE YOU TAKE IPTAM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE IPTAM IF YOU ARE
ALLERGIC TO SUMATRIPTAN SUCCINATE
OR ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
DO NOT TAKE IPTAM IF YOU 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 experienc

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION
IPTAM
_Sumatriptan (as succinate) _
1
NAME OF THE MEDICINE
Sumatriptan succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each IPTAM 50 mg and 100 mg tablet contains the active ingredient
sumatriptan (as succinate),
equivalent to 50 mg and 100 mg of sumatriptan, respectively.
Excipients with known effect: sugars (as lactose).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
IPTAM 50 mg
:
Pink, round, film-coated tablet with ‘G’ on one side and
‘SU50’on the other side
IPTAM
100
mg
:
White to off-white, round, film-coated tablet with ‘G’ on one side
and ‘SU100’
on the other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IPTAM tablets are indicated for the acute relief of migraine attacks
with or without aura.
There is no information available on the use of IPTAM in the treatment
of basilar or hemiplegic
migraine.
4.2
DOSE AND METHOD OF ADMINISTRATION
IPTAM is indicated for the acute intermittent relief of migraine. It
should not be used prophylactically.
Ergotamine or ergotamine derivatives and IPTAM 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 sumatriptan
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 IPTAM, a second
dose should not be taken for the same
attack. IPTAM may be used for subsequent attacks.
The initial recommended adult dose of oral IPTAM is 50 mg. Some
patients may require 100 mg. The
dose should be adjusted according to the individual's response. If
symptoms recur further doses may be
given in the next 24 hours provided not more than 300 mg are taken in
any 24 hour period. The tablet
should be swallowed whole wit