RELPAX MIGRAINE eletriptan hydrobromide 40 mg tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

eletriptan hydrobromide, Quantity: 48.485 mg (Equivalent: eletriptan, Qty 40 mg)

可用日期:

Viatris Pty Ltd

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; sunset yellow FCF; triacetin

给药途径:

Oral

每包单位数:

2 tablets

处方类型:

(S3) Pharmacist Only Medicine

疗效迹象:

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

產品總結:

Visual Identification: Orange, round, convex, film-coated tablet, engraved with "VLE" on one side and "REP40" on the other.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

授权状态:

Registered

授权日期:

2020-12-16

资料单张

RELPAX
® MIGRAINE
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your pharmacist or doctor.
1.
WHY AM I USING RELPAX
® MIGRAINE?
Relpax
®
Migraine contains the active ingredient eletriptan hydrobromide.
Relpax
®
Migraine is used to treat migraine attacks.
For more information, see Section 1. Why am I using Relpax® Migraine?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RELPAX
® MIGRAINE?
Do not use if you have ever had an allergic reaction to eletriptan
hydrobromide or any of the ingredients listed at the end of the CMI.
TALK TO YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR
PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Relpax® Migraine? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Relpax
®
Migraine and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE RELPAX
® MIGRAINE?
•
Always take as directed by your pharmacist or doctor
•
One tablet of Relpax
®
Migraine should be taken as soon as possible after the start of a
migraine attack. It will also provide relief
later during the migraine; if required, a second dose may be taken.
More instructions can be found in Section 4. How do I use Relpax®
Migraine? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RELPAX
® MIGRAINE?
THINGS YOU SHOULD DO
•
Remind any pharmacist, doctor or dentist you visit that you are using
Relpax
®
Migraine.
•
Call your doctor straight away if
o
you become pregnant
o
your migraine headache lasts for longer than 24 hours.
o
your pattern of symptoms has changed.
o
you feel this headache is different or worse than your usual migraine
e.g. more frequent,
more persistent, more severe, or you don’t recover between attacks.
THINGS YO

产品特点

Version: ujprelmi10722
Supersedes: ujprelmi10221
Page 1 of 19
AUSTRALIAN PRODUCT
INFORMATION -
RELPAX
® MIGRAINE (ELETRIPTAN
HYDROBROMIDE)
1.
NAME OF THE MEDICINE
Eletriptan hydrobromide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RELPAX MIGRAINE 40 mg tablets contain eletriptan hydrobromide
equivalent to 40 mg
eletriptan.
_ _
EXCIPIENT(S) WITH KNOWN EFFECT
Each RELPAX MIGRAINE tablet contains sugars as lactose (monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
RELPAX MIGRAINE 40 mg tablets are orange, round, convex, film-coated
tablets, with
“Pfizer” on one side and “REP40” on the other side.
_ _
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
DOSAGE
_ADULTS (18-65 YEARS OF AGE) _
In controlled clinical trials, single doses of 20 mg, 40 mg and 80 mg
were effective for the
acute treatment of migraine in adults. A greater proportion of
patients had a response following
a 40 mg or 80 mg dose than following a 20 mg dose. The recommended
initial dose is 40 mg.
The maximum single dose is 40 mg.
If the initial dose of RELPAX MIGRAINE 40 mg is ineffective,
controlled clinical trials have
not shown a benefit of a second dose to treat the same attack.
However, if the headache returns
following initial improvement, there is evidence to suggest that a
repeat dose of 40 mg may be
beneficial. If a second dose is required, it should not be taken
within 2 hours of the initial dose.
Version: ujprelmi10722
Supersedes: ujprelmi10221
Page 2 of 19
The maximum daily dose should not exceed 80 mg.
METHOD OF ADMINISTRATION
Oral administration.
RELPAX MIGRAINE 40 mg tablet should be taken as early as possible
after the onset of
migraine headache, but they are also effective if taken at a later
stage.
RELPAX MIGRAINE tablets should not be used prophylactically.
The tablets should be swallowed whole with water.
DOSAGE ADJUSTMENT
_HEPA