RIZATRIPTAN-AU rizatriptan (as benzoate) 10 mg orodispersible tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
21-04-2021
Summary of Product characteristics
(SPC)
27-04-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
rizatriptan benzoate, Quantity: 14.53 mg (Equivalent: rizatriptan, Qty 10 mg)
Available from:
Medsurge Pharma Pty Ltd
INN (International Name):
rizatriptan benzoate
Pharmaceutical form:
Tablet, orally disintegrating
Composition:
Excipient Ingredients: crospovidone; aspartame; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; calcium silicate; mannitol; Flavour
Administration route:
Oral
Units in package:
6, 2, 3
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
RIZATRIPTAN-Au 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 10" 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
1
Rizatriptan‐Au CMI 200610 v1.1
RIZATRIPTAN-AU
ORODISPERSIBLE
TABLETS
_Rizatriptan benzoate_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before
you start using RIZATRIPTAN-AU.
This leaflet answers some common
questions about RIZATRIPTAN-AU.
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-AU
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-
AU
ARE USED FOR
RIZATRIPTAN-AU are used to
relieve the headache pain and other
symptoms of migraine attacks.
RIZATRIPTAN-AU 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, for
example, cheese and other dairy
products, chocolate, citrus fruit,
caffeine, alcohol (especially red
wine)
stress, anger, worry
changes in routine, for example,
under or over sleeping, missing a
meal, change in diet
bright light or loud noises
hormonal changes in women, for
example, during menstrual
periods
Read the complete document
Summary of Product characteristics
RIZATRIPTAN-AU
_ _
PRODUCT INFORMATION
1
AUSTRALIAN PRODUCT INFORMATION – RIZATRIPTAN-AU
(RIZATRIPTAN BENZOATE) ORODISPERSIBLE TABLETS
1
NAME OF THE MEDICINE
Rizatriptan benzoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains either 7.265 mg or 14.53 mg of
rizatriptan benzoate
(corresponding to 5 mg or 10 mg of rizatriptan, respectively).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
5 mg orodispersible tablet - White, round, flat, bevel-edged tablet
embossed with “IZ 5” on one
side and plain on the other side.
10 mg orodispersible 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
T
HERAPEUTIC INDICATIONS
RIZATRIPTAN-AU is indicated for the acute treatment of migraine
attacks with or without aura.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended dose is 10 mg. Clinical experience has shown that this
dose provides the
optimal clinical benefit.
Onset of relief (i.e., reduction of headache pain to mild or none) can
occur within 30 minutes
after dosing.
_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
of the same attack,
when an initial dose is ineffective, has not been examined in
controlled trials.
o
Clinical studies have shown that patients who do not respond to
treatment of an
attack are still likely to respond to treatment for subsequent
attacks.
_Patients _
_receiving _
_propranolol: _
Plasma
concentrations
of
rizatriptan
may
be
increased
by
concomitant
administration
of
propranolol
(see
Section
4.5
INTERACTIONS
WITH
OTHER
MEDICINES AND OTHER FORMS OF INTERACTIONS)_. _The 10 mg dose is not
appropriate for these
RIZATRIPT
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