APO-RIZATRIPTAN rizatriptan (as benzoate) 5 mg orally disintegrating tablets 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, Quantity: 7.265 mg (Equivalent: rizatriptan, Qty 5 mg)
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
rizatriptan benzoate
Pharmaceutical form:
Tablet, orally disintegrating
Composition:
Excipient Ingredients: sucralose; magnesium stearate; mannitol; crospovidone; microcrystalline cellulose; Flavour
Administration route:
Oral
Units in package:
2
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Rizatriptan is indicated for the acute treatment of migraine attacks with or without aura.
Product summary:
Visual Identification: White to off-white coloured, round-shaped tablets with "APO" engraved on one side and "RZ" over "5" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2016-02-09
Patient Information leaflet
APO-RIZATRIPTAN ORALLY
DISINTEGRATING TABLETS
_Rizatriptan benzoate_
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 rizatriptan. 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
Rizatriptan is used to relieve the
headache pain and other symptoms
of migraine attacks. Rizatriptan does
not work for other types of
headaches.
Migraine is an intense, throbbing,
typically one-sided headache. It often
includes nausea, vomiting, and
sensitivity to light or 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 anywhere from
two hours to two days and they can
return frequently. The severity and
frequency of migraines may vary.
Migraine occurs in about one out
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.
They tend to run in families. Certain
things trigger migraine attacks in
some people, including:
•
certain foods or drinks e.g.
cheese, dairy products, chocolate,
citrus fruit, caffeine, alcohol
(especially red wine)
•
stress, anger, worry
•
changes in routine e.g. under or
over sleeping, missing meals,
change in diet
•
bright light or loud noises
•
hormonal changes in women e.g.
during menstrual periods
If you understand what triggers your
attacks, you may be able to prevent
migraine attacks or reduce their
frequency. Keeping a headache diary
will help you identify and
Read the complete document
Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APO-RIZATRIPTAN (RIZATRIPTAN BENZOATE) ORALLY
DISINTEGRATING TABLETS
1
NAME OF THE MEDICINE
Rizatriptan benzoate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orally disintegrating tablet contains either 5 mg or 10 mg
rizatriptan (corresponding to
7.265 mg or 14.53 mg rizatriptan benzoate, respectively) as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT: sucralose.
For the full list of excipients see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
5 MG ORALLY DISINTEGRATING TABLET:
White to off-white coloured, round-shaped tablets with “APO”
engraved on one side and “RZ”
over “5” on the other side.
10 MG ORALLY DISINTEGRATING TABLET:
White to off-white coloured, round-shaped tablets with “APO”
engraved on one side and “RZ”
over “10” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rizatriptan is indicated for the acute treatment of migraine attacks
with or without aura.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Rizatriptan orally disintegrating tablets are intended for oral
administration.
Administration with liquid is not necessary.
Patients should be instructed not to remove the tablet from the
blister until just prior to
dosing. The tablet should be removed with dry hands and the tablet
placed on the tongue,
where it will dissolve and be swallowed with the saliva.
DOSAGE
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.
2
_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
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