RELPAX 20mg film-coated tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

ELETRIPTAN

থেকে পাওয়া:

Upjohn EESV

এটিসি কোড:

N02CC; N02CC06

INN (আন্তর্জাতিক নাম):

ELETRIPTAN

ডোজ:

20 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Film-coated tablet

থেরাপিউটিক এলাকা:

Selective serotonin (5HT1) agonists; eletriptan

অনুমোদন অবস্থা:

Not marketed

অনুমোদন তারিখ:

2001-11-16

তথ্য লিফলেট

2022-0078206
PACKAGE LEAFLET: INFORMATION FOR THE USER
RELPAX™ 20 MG AND 40 MG FILM-COATED TABLETS
ELETRIPTAN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Relpax is and what it is used for
2
What you need to know before you take Relpax
3
How to take Relpax
4
Possible side effects
5
How to store Relpax
6
Contents of the pack and other information
1. WHAT RELPAX IS AND WHAT IT IS USED FOR
Relpax contains the active substance eletriptan. Relpax is one of a
group of medicines called
serotonin receptor agonists. Serotonin is a natural substance found in
the brain that helps to
narrow the blood vessels.
Relpax can be used to treat migraine headache with or without aura in
adults. Before the start of
a migraine headache, you may experience a phase called an aura, which
can involve vision
disorders, numbness and speech disorders.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RELPAX
DO NOT TAKE RELPAX
:
•
If you are allergic (hypersensitive) to eletriptan, or any of the
other ingredients of this
medicine (listed in section 6).
•
If you have severe liver or kidney disease.
•
If you have moderate to severe high blood pressure or untreated mild
high blood pressure.
•
If you have ever had heart problems, [e.g. heart attack, angina, heart
failure or significant
abnormal heart rhythm (arrhythmia), temporary, sudden narrowing of one
of the coronary
arteries].
•
If you have poor circulation (peripheral vascular disease).
•
If you have ever had a stroke (even a mild one that lasted for only a
f

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
23 April 2021
CRN009WPD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RELPAX 20mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg eletriptan (as hydrobromide).
Excipients with known effect:
Each film-coated tablet contains 23 mg lactose and 0.036 mg Sunset
yellow
Forthe full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, convex orange tablets debossed with ‘REP 20’ on one side
and ‘Pfizer’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RELPAX is indicated in adults for the acute treatment of the headache
phase of migraine attacks, with or without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
RELPAX tablets should be taken as early as possible after the onset of
migraine headache but they are also effective iftaken at a
later stage during a migraine attack.
RELPAX, if taken during the aura phase, has not been demonstrated to
prevent migraine headache and therefore RELPAX
should only be taken during the headache phase of migraine.
RELPAX tablets should not be used prophylactically_._
_Adults (18-65 years of age):_
The recommended initial dose is 40 mg.
_If headache returns within 24 hours_: If the migraine headache recurs
within 24 hours of an initial response, a second dose of the
same strength of RELPAX has been shown to be effective in treating the
recurrence. If a second dose is required, it should not
be taken within 2 hours of the initial dose.
_If no response is obtained:_ If a patient does not achieve a headache
response to the first dose of RELPAX within 2 hours, a
second dose should not be taken for the same attack as clinical trials
have not adequately established efficacy with the second
dose. Clinical trials show that patients who do not respond to the
treatment of an attack are still likely to respond to the
treatment of a subsequent attack_._
Patients who do not obtain satisfactory efficacy after an appr