TERRY WHITE CHEMISTS 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)
22-06-2016
Summary of Product characteristics
(SPC)
21-06-2016
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
rizatriptan benzoate
Available from:
Apotex Pty Ltd
INN (International Name):
rizatriptan benzoate
Patient Information leaflet
TERRY WHITE CHEMISTS
RIZATRIPTAN
_ORALLY DISINTEGRATING TABLETS_
_Contains the active ingredient Rizatriptan benzoate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about Rizatriptan Orally
Disintegrating Tablets. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is Terry
White Chemists Rizatriptan Orally
Disintegrating Tablets. It contains the
active ingredient rizatriptan benzoate.
It is used to relieve the headache pain
and other symptoms of migraine
attacks.
Rizatriptan Orally Disintegrating
Tablets 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
every 10 people. It is three t
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Summary of Product characteristics
Product Information – Australia
Terry White Chemists Rizatriptan Orally Disintegrating Tablets
Page 1
TERRY WHITE CHEMISTS RIZATRIPTAN ORALLY DISINTEGRATING TABLETS
NAME OF THE MEDICINE
Rizatriptan benzoate
Chemical Name:
N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine
monobenzoate
Structural Formula:
Molecular Formula:
C
15
H
19
N
5
•C
7
H
6
O
2
Molecular Weight:
391.47
CAS Registry Number:
145202-66-0
DESCRIPTION
Rizatriptan benzoate is a white to off-white, crystalline solid. The
molecular weight of the benzoate salt
is 391.47; the molecular weight of the free base is 269.4. Rizatriptan
benzoate is soluble in water at
about 42 mg per mL (expressed as free base) at 25°C.
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) as the
active ingredient. In addition, each
orally disintegrating contains the following inactive ingredients:
microcrystalline cellulose, mannitol,
crospovidone, sucralose,
magnesium stearate
and peppermint flavour (PI no 109068).
PHARMACOLOGY
MECHANISM OF ACTION
Rizatriptan is a potent, orally active serotonergic agonist that has
been shown in radioligand binding
assays and functional pharmacological bioassays to act selectively at
5-HT
1B/1D
receptors. Rizatriptan
has no clinically significant activity at 5-HT
2
or 5-HT
3
receptor subtypes, nor at alpha- and beta-
adrenergic, dopaminergic, histaminergic, muscarinic or benzodiazepine
receptors.
Rizatriptan acts at craniovascular 5-HT
1B
receptors to cause selective constriction of the extracerebral,
intracranial arteries that are thought to be dilated during a migraine
attack. Vasodilatation of these
arteries and stimulation of trigeminal sensory nervous pain pathways
have been postulated to be the
most important underlying mechanisms in migraine pathogenesis. In
anaesthetised dogs, rizatriptan
reduces carotid artery blood flow selectively and has much lesser
effects on blood flow in the coronary
and pulmonary art
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