RIZATRIPTAN ODT GH rizatriptan (as benzoate) 5 mg orally disintegrating tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
13-10-2020
Summary of Product characteristics
(SPC)
13-10-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
rizatriptan benzoate, Quantity: 7.265 mg (Equivalent: rizatriptan, Qty 5 mg)
Available from:
Generic Health Pty Ltd
INN (International Name):
rizatriptan benzoate
Pharmaceutical form:
Tablet, orally disintegrating
Composition:
Excipient Ingredients: mannitol; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; crospovidone; aspartame; calcium silicate; Flavour
Administration route:
Oral
Units in package:
6, 3, 2
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
RIZATRIPTAN ODT GH is indicated for the acute treatment of migraine attacks with or without aura.
Product summary:
Visual Identification: White, round, flat, bevel-edged tablet embossed with "IZ 5" on one side and plain on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2015-02-19
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
RIZATRIPTAN ODT GH
(RIZATRIPTAN BENZOATE) ORALLY DISINTEGRATING TABLET
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using
Rizatriptan ODT GH. This leaflet
answers some common
questions about Rizatriptan ODT
GH. 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 taking
Rizatriptan ODT GH 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 need to read it again.
WHAT RIZATRIPTAN ODT GH
IS USED FOR
Rizatriptan ODT GH are used to
relieve headache pain and other
symptoms of migraine attacks.
Rizatriptan ODT GH do not work
for other types of headaches.
Migraine is an intense,
throbbing, typically one-sided
headache. It often includes
nausea, vomiting, sensitivity to
light, and sensitivity to sound.
Some people may have visual
symptoms before the headache,
called an aura. An aura can
include flashing lights or wavy
lines.
Migraine attacks last anything
from two hours to two days and
they can return frequently. The
severity and frequency of
migraine attacks may vary.
Migraine occurs in about one out
of every 10 people. It is three
times more common in women
than men.
Six out of ten migraine sufferers
have their first attack before the
age of 20.
There is no single cause of
migraine. It tends to run in
families. Certain things, singly or
in combination, can trigger
migraine attacks in some
people. Some of these triggers
are:
•
certain foods or drinks, eg.
cheese and other dairy
products, chocolate, citrus
fruit, caffeine, alcohol
(especially red wine);
•
stress, anger, worry;
•
changes in routine, eg. under
or over sleeping, missing a
meal, change in diet;
•
bright light or loud noises;
•
hormonal changes in women,
eg. during menstrual periods.
If you understand what triggers
y
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – RIZATRIPTAN ODT GH
(RIZATRIPTAN BENZOATE) ORALLY DISINTEGRATING TABLETS
1
NAME OF THE MEDICINE
Rizatriptan benzoate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
orally
disintegrating
tablet
contains
either
7.265 mg
or
14.53 mg
of
rizatriptan
benzoate
(corresponding to 5 mg or 10 mg of rizatriptan, respectively).
List of excipients with known effects: aspartame, mannitol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Rizatriptan ODT GH 5 mg orally disintegrating tablet - White, round,
flat, bevel-edged tablet embossed
with “IZ 5” on one side and plain on the other side.
Rizatriptan ODT GH 10 mg orally disintegrating tablet - White, round,
flat, bevel-edged tablet embossed
with “IZ 10” on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rizatriptan ODT GH is indicated for the acute treatment of migraine
attacks with or without aura.
4.2 DOSE AND METHOD OF ADMINISTRATION
Rizatriptan ODT GH orally disintegrating tablets are rapidly
dissolving tablets. Administration with liquid
is not necessary.
Patients should be instructed not to remove the orally disintegrating
tablet from the blister until just
prior to dosing. The orally disintegrating tablet should then be
pushed through the foil with dry hands
and placed on the tongue.
The recommended dose is 10 mg. Clinical experience has shown that this
dose provides the optimal
clinical benefit.
Onset of relief (ie. reduction of headache pain to mild or none) can
occur within 30 minutes after dosing.
Rizatriptan ODT GH v4
Page 2 of 17
(rizatriptan benzoate) orally disintegrating tablet
RE-DOSING
Doses should be separated by at least 2 hours. No more than 30 mg
should be taken in any 24-hour
period.
•
_For headache recurrence within 24 hours: _If headache returns after
relief of the initial attack, further
doses may be taken. The above dosing limits should be observed.
•
_After non-response: _The effectiveness of a second dose for treatment
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