ZOLTRIP zolmitriptan 2.5mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

zolmitriptan, Quantity: 2.5 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Zolmitriptan

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; lactose; sodium starch glycollate type A; titanium dioxide; hypromellose; macrogol 6000; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

6 tablets, 2 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the acute treatment of migraine with or without aura.

Product summary:

Visual Identification: Light pink, round, film-coated tablet with '2.5' on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-06-19

Patient Information leaflet

ZOLTRIP
_Zolmitriptan _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about ZOLTRIP. It does not contain
all the information that is known
about ZOLTRIP. 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 ZOLTRIP
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 ZOLTRIP IS FOR
ZOLTRIP belongs to a group of
medicines called serotonin
agonists. These medicines are used
to relieve migraine.
Migraine is thought to be caused
by the widening of certain blood
vessels in the brain. ZOLTRIP
makes the blood vessels narrower
to ease the migraine.
Some people have a warning stage
called 'aura' before the migraine
headache starts. Aura can include
numbness in the face or down one
arm, changes in mood, or
problems with eyesight such as
seeing blank spots or flashing
lights.
ZOLTRIP can be used in migraine
with or without aura. It should not
be used to treat types of migraine
called 'hemiplegic' or 'basilar'
migraine.
ZOLTRIP does not work in
headaches that are not migraine.
Your doctor will have explained
why you are being treated with
ZOLTRIP and told you what dose to
take.
Follow all directions given to you
by your doctor carefully. They may
differ from the information
contained in this leaflet.
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more
information.
ZOLTRIP is not addictive.
BEFORE YOU TAKE ZOLTRIP
_WHEN YOU MUST NOT TAKE IT _
DO NOT USE ZOLTRIP IF YOU ARE
PREGNANT OR BREASTFEEDING UNLESS
YOUR DOCTOR SAYS SO. The safety of
taking this medicine when you are
pregnant is unknown.
DO NOT GIVE ZOLTRIP TO CHILDREN.
There is no experience of its use in
children under 12 years of age.
One study in children aged 12 to
17 years indicated no benefit with
ZOLTR

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ZOLTRIP
(ZOLMITRIPTAN)TABLETS
1
NAME OF THE MEDICINE
Zolmitriptan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zolmitriptan is a white to almost white powder slightly soluble in
water (1.3 mg/mL at 250°C) but
shows greater solubility in 0.1M hydrochloric acid. Zolmitriptan has a
pKa of 9.6. Zolmitriptan is a
chiral molecule, which is synthesised as the S enantiomer.
ZOLTRIP tablets contain 2.5 mg of zolmitriptan.
Excipients of known effect: The tablets also contain lactose
monohydrate. For full list of excipients,
see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
_ZOLTRIP_
Light pink, round, film-coated tablets, debossed with ‘2.5’ on one
side and plain on
the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ZOLTRIP is indicated for the acute treatment of migraine with or
without aura.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended initial dose of zolmitriptan to treat a migraine
attack is 2.5 mg.
ZOLTRIP tablet should be swallowed whole with water.
If symptoms of migraine persist or recur within 24 hours of an initial
response, a second dose may be
taken. If a second dose is required, it should not be taken within 2
hours of the initial dose.
If a patient does not achieve satisfactory relief with 2.5 mg doses,
subsequent attacks can be treated
with 5 mg doses of zolmitriptan.
The onset of action in responders is apparent within 1 hour of dosing.
2
Zolmitriptan is equally effective whenever the tablets are taken
during a migraine attack; although it
is advisable that tablets are taken as early as possible after the
onset of migraine headache.
In the event of recurrent attacks, it is recommended that the total
intake of zolmitriptan, in a 24 hour
period, should not exceed 10 mg.
Zolmitriptan is not indicated for prophylaxis of migraine.
PATIENT SUBGROUPS
Zolmitriptan is consistently effective in migraine, with or without
aura, and in menstrually associated
migraine. The efficacy of zolmitriptan is also unaffected by gender,
duration of the attack, pr