RIXALT 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)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
rizatriptan benzoate
Available from:
Arrow Pharma Pty Ltd
INN (International Name):
rizatriptan benzoate
Authorization status:
Registered
Patient Information leaflet
1
RIXALT CMI v1.0
RIXALT
ORALLY DISINTEGRATING TABLETS
_Rizatriptan benzoate_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before
you start using RIXALT. This leaflet
answers some common questions
about RIXALT. 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 RIXALT 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 RIXALT IS USED
FOR
RIXALT is used to relieve the
headache pain and other symptoms of
migraine attacks. RIXALT does 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
If you understand what triggers your
attacks, you may be able to pr
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Summary of Product characteristics
1
AUSTRALIAN PI – RIXALT(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).
Also contains aspartame.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each orally disintegrating tablet contains 5 mg of rizatriptan -
White, round, flat, bevel-edged tablet
embossed with “IZ 5” on one side and plain on the other side.
Each orally disintegrating tablet contains 10 mg of rizatriptan -
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
RIXALT 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.
2
_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
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