APO-ZOLMITRIPTAN zolmitriptan 2.5mg tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

zolmitriptan, Quantity: 2.5 mg

Tersedia dari:

Arrotex Pharmaceuticals Pty Ltd

INN (Nama Internasional):

Zolmitriptan

Bentuk farmasi:

Tablet, film coated

Komposisi:

Excipient Ingredients: lactose; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type A; titanium dioxide; hypromellose; macrogol 6000; iron oxide red; macrogol 400

Rute administrasi :

Oral

Unit dalam paket:

2 tablets, 6 tablets

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

For the acute treatment of migraine with or without aura.

Ringkasan produk:

Visual Identification: Light pink, round, film-coated tablet with '2.5' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2013-06-19

Selebaran informasi

APO-Zolmitriptan Tablets
1
APO-ZOLMITRIPTAN
_Zolmitriptan _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about zolmitriptan. It does
not contain all 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 risks of you using this medicine
against the benefits they expect it
will 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Zolmitriptan is used to relieve
migraine headaches. It belongs to a
group of medicines called serotonin
agonists.
_HOW IT WORKS _
Migraine is thought to be caused by
the widening of certain blood vessels
in the brain. Zolmitriptan narrows
the blood vessels to help ease the
migraine.
Some people have a warning stage
called 'aura' before the migraine
headache starts. Aura can include
numbness in the face or down one
arm, mood changes, or problems
with eyesight such as seeing blank
spots or flashing lights.
Zolmitriptan can be used in migraine
with or without aura. It should not be
used to treat types of migraine called
'hemiplegic' or 'basilar' migraine.
Zolmitriptan does not work in
headaches that are not migraine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is no experience of
zolmitriptan use in children under 12
years of age. One study in children
aged 12 to 17 years indicated no
benefit with zolmitriptan treatment.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
zolmitriptan
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION
APO-ZOLMITRIPTAN (ZOLMITRIPTAN) 2.5 MG TABLETS
1
NAME OF THE MEDICINE
Zolmitriptan.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg zolmitriptan, as the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
2.5 MG FILM COATED TABLET
Light pink, round, film coated tablets, debossed with ‘2.5’ on one
side and plain on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zolmitriptan is indicated for the acute treatment of migraine with or
without aura.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Zolmitriptan tablets are intended for oral administration.
The tablet should be swallowed whole with water.
DOSAGE
The recommended initial dose of zolmitriptan to treat a migraine
attack is 2.5 mg.
If symptoms of migraine persist or recur within 24 hours of an initial
response, a second dose
may be taken. If a second dose is required, it should not be taken
within 2 hours of the initial
dose.
If a patient does not achieve satisfactory relief with 2.5 mg doses,
subsequent attacks can be
treated with 5 mg doses of zolmitriptan.
The onset of action in responders is apparent within 1 hour of dosing.
Zolmitriptan is equally effective whenever the tablets are taken
during a migraine attack,
although it is advisable that tablets are taken as early as possible
after the onset of migraine
headache.
In the event of recurrent attacks, it is recommended that the total
intake of zolmitriptan, in a 24
our period, should not exceed 10 mg.
Zolmitriptan is not indicated for prophylaxis of migraine.
2
PATIENT SUB-GROUPS
Zolmitriptan is consistently effective in migraine, with or without
aura, and in menstrually-
associated migraine. The efficacy of zolmitriptan is also unaffected
by gender, duration of the
attack, pre-treatment nausea and concomitant use of common
prophylactic migraine drugs.
PAEDIATRIC USE
The efficacy of zolmitriptan tablets was not established in a
placebo-controlle