RELPAX eletriptan hydrobromide 20mg tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

eletriptan hydrobromide

Fáanlegur frá:

Upjohn Australia Pty Ltd

Leyfisstaða:

Registered

Vara einkenni

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Supersedes: pfprelxt10319
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AUSTRALIAN PRODUCT
INFORMATION –
RELPAX
® (ELETRIPTAN HYDROBROMIDE)
1.
NAME OF THE MEDICINE
Eletriptan hydrobromide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RELPAX 40 mg tablets contain eletriptan hydrobromide equivalent to 40
mg eletriptan.
_ _
RELPAX 80 mg tablets contain eletriptan hydrobromide equivalent to 80
mg eletriptan.
EXCIPIENT(S) WITH KNOWN EFFECT:
contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
RELPAX 40 mg tablets are orange, round, convex, film-coated tablets,
with “Pfizer” on one
side and “REP40” on the other side.
_ _
RELPAX 80 mg tablets are orange, round, convex, film-coated tablets,
with “Pfizer” on one
side and “REP80” on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acute treatment of migraine headache with or without aura.
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 80 mg.
If the initial dose 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,
Version: ujprelxt10821
Supersedes: pfprelxt10319
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there is evidence to suggest that a repeat dose may be beneficial. If
a second dose is required,
it should not be taken within 2 hours of the initial dose.
The maximum daily dose should not exceed 160 mg.
METHOD OF ADMINISTRATION
Oral administration.
RELPAX tablets 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 tablets should not be used prophylactically.
The tablets should b