SUMATRIPTAN SANDOZ Tablets 50 mg Sumatriptan (as succinate) 50 mg Tablets Blister

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

sumatriptan succinate, Quantity: 69.99 mg

Dostupné z:

Accord Healthcare Pty Ltd

INN (Medzinárodný Name):

sumatriptan succinate

Forma lieku:

Tablet, film coated

Zloženie:

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

Spôsob podávania:

Oral

Počet v balení:

4 tablets, 2 tablets

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

SUMATRIP Tablets are indicated for the acute relief of migraine attacks with or without aura.

Prehľad produktov:

Visual Identification: Pink coloured, 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

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2012-05-11

Príbalový leták

SUMATRIPTAN SANDOZ
®
1
Sumatriptan Sandoz
®
Sumatriptan Succinate Film-Coated Tablets
Consumer Medicine Information
What Is In This Leaflet
Please read this leaflet carefully
before you start taking Sumatriptan
Sandoz tablets.
This leaflet answers some common
questions about Sumatriptan Sandoz
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
Sumatriptan Sandoz 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 Sumatriptan
Sandoz tablets used
for?
Sumatriptan Sandoz tablets contain
the active ingredient sumatriptan
succinate.
This medicine belongs to a group of
drugs called serotonin agonists.
Sumatriptan Sandoz tablets are used
to relieve a migraine attack. They
should not be used to prevent
migraine attacks from occurring.
Sumatriptan Sandoz 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.
Sumatriptan Sandoz tablets work by
making those vessels normal again
and ease the symptoms of migraine.
Your Sumatriptan Sandoz tablets do
not work in other types of headache
which are not a migraine.
Sumatriptan Sandoz tablets are not
addictive.
Before you take
Sumatriptan Sandoz
tablets
Do not take if:
You must not take Sumatriptan
Sandoz 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 n

Súhrn charakteristických

1
AUSTRALIAN PRODUCT INFORMATION – SUMATRIPTAN SANDOZ
50 & 100 MG (SUMATRIPTAN SUCCINATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Sumatriptan succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sumatriptan Sandoz is available in two strengths, 50mg and 100mg"
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
Sumatriptan Sandoz _50 MG (AUST R 187214) _
Each film-coated tablet contains Sumatriptan succinate equivalent to
50 mg Sumatriptan.
Pink coloured, capsule shaped biconvex film coated tablets, plain on
both sides.
Sumatriptan Sandoz _100 MG (AUST R 187215) _
Each film-coated tablet contains Sumatriptan succinate equivalent to
100 mg Sumatriptan.
White to off-white coloured, capsule shaped biconvex film coated
tablets, plain on both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Sumatriptan Sandoz is indicated for the acute relief of migraine
attacks with or without aura.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Sumatriptan is indicated for the acute intermittent relief of both
migraine and cluster headache.
It should not be used prophylactically.
MIGRAINE
It is recommended that treatment be started 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 Sumatriptan, a
second dose should not be taken
for the same attack. Sumatriptan may be used for subsequent attacks.
The initial recommended adult dose of Sumatriptan 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 w