MAXALT MIGRAINE RELIEF rizatriptan 5 mg (as benzoate) wafer blister pack

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

rizatriptan benzoate, Quantity: 7.265 mg

थमां उपलब्ध:

ORGANON PHARMA PTY LTD

फार्मास्यूटिकल फॉर्म:

Wafer

रचना:

Excipient Ingredients: Gelatin; aspartame; glycine; mannitol; Flavour

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

2

प्रिस्क्रिप्शन प्रकार:

(S3) Pharmacist Only Medicine

चिकित्सीय संकेत:

For the acute relief of migraine in patients who have a stable, well-established pattern of migraine symptoms.

उत्पाद समीक्षा:

Visual Identification: White to off-white, round wafer with flat or slightly irregular surface, debossed on one side with a modified triangle, on the other side plain; Container Type: Sachet; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2023-04-18

सूचना पत्रक

MAXALT
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ACTIVE INGREDIENT: rizatriptan benzoate
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
MAXALT MIGRAINE RELIEF. YOU SHOULD ALSO SPEAK
TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER
INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS
ABOUT USING MAXALT MIGRAINE RELIEF.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using MAXALT MIGRAINE RELIEF?
2. What should I know before I use MAXALT MIGRAINE
RELIEF?
3. What if I am taking other medicines?
4. How do I use MAXALT MIGRAINE RELIEF?
5. What should I know while using MAXALT MIGRAINE
RELIEF?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING MAXALT MIGRAINE
RELIEF?
MAXALT MIGRAINE RELIEF CONTAINS THE ACTIVE
INGREDIENT RIZATRIPTAN BENZOATE. MAXALT MIGRAINE
RELIEF belongs to a class of drugs called serotonin agonists.
MAXALT MIGRAINE RELIEF IS USED FOR THE ACUTE RELIEF OF
MIGRAINE IN PATIENTS WHO HAVE A STABLE, WELL-ESTABLISHED
PATTERN OF SYMPTOMS. THEY SHOULD NOT BE USED TO
PREVENT MIGRAINE ATTACKS FROM OCCURRING. DO NOT USE
MAXALT MIGRAINE RELIEF UNLESS YOUR CONDITION HAS
BEEN DIAGNOSED BY A DOCTOR.
MAXALT MIGRAINE RELIEF DOES NOT WORK IN OTHER TYPES
OF HEADACHES WHICH ARE NOT MIGRAINE.
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 p

उत्पाद विशेषताएं

Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION
MAXALT
® MIGRAINE RELIEF (RIZATRIPTAN BENZOATE)
1
NAME OF THE MEDICINE
Rizatriptan benzoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rizatriptan benzoate is a white to off-white, crystalline solid.
Rizatriptan benzoate is soluble in
water at about 42 mg per mL (expressed as free base) at 25°C.
Each lyophilised wafer contains 7.265 mg of rizatriptan benzoate
(corresponding to 5 mgof
rizatriptan).
List of excipients with known effect: mannitol, aspartame
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
5 mg wafer - White to off-white round wafer with a flat or slightly
irregular surface.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the acute relief of migraine in patients who have a stable,
well-established pattern of
symptoms.
4.2
DOSE AND METHOD OF ADMINISTRATION
MAXALT MIGRAINE RELIEFs are rapidly dissolving wafers. Administration
with liquid is not
necessary.
The wafer is packaged in a blister within an outer aluminium sachet
(pouch). Patients should
be instructed not to remove the blister from the outer sachet until
just prior to dosing. The
blister pack should then be peeled open with dry hands and the wafer
placed on the tongue,
where it will dissolve and be swallowed with the saliva.
The recommended adult dose (18 years and over) is 10 mg, or two 5 mg
wafers. 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.
If the headache returns after relief of the initial attack, further
doses may be taken. Doses
should be separated by at least 2 hours and no more than 30 mg of
rizatriptan should be taken
in any 24 hour period
_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