Relpax 40mg tablets

Country: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Eletriptan hydrobromide

থেকে পাওয়া:

Dowelhurst Ltd

এটিসি কোড:

N02CC06

INN (International Name):

Eletriptan hydrobromide

ডোজ:

40mg

ফার্মাসিউটিকাল ফর্ম:

Oral tablet

প্রশাসন রুট:

Oral

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 04070401

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER.
RELPAX® 40MG FILM-COATED TABLETS
(eletriptan hydrobromide)
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.
The name of your medicine is Relpax 40mg film-coated tablets
but will be referred to as Relpax throughout the remainder of the
leaflet.
Relpax is also available in 20mg strength.
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
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 YOU TAKE
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 he

পণ্য বৈশিষ্ট্য

1. NAME OF THE MEDICINAL PRODUCT
RELPAX 40 mg film coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RELPAX 40 mg film-coated tablets
Each film-coated tablet contains 40 mg eletriptan (as hydrobromide).
Excipients with known effect:
Each film-coated tablet contains 46 mg lactose and 0.072 mg Sunset
yellow
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
RELPAX 40 mg film-coated tablets
Round, convex orange tablets debossed with ‘REP 40’ on one side
and ‘Pfizer’ on the other.
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 if taken 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 appropriate
trial of 40 mg, (e.g. good
tolerability and fa