Relpax 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eletriptan hydrobromide

Available from:

CST Pharma Ltd

ATC code:

N02CC06

INN (International Name):

Eletriptan hydrobromide

Dosage:

40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401; GTIN: 5055946804583

Patient Information leaflet

PAA144272
PAA144272
Package leaflet:
Information for the user
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 few minutes or
hours).
•
If you have taken ergotam

Summary of Product characteristics

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