Relpax 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eletriptan hydrobromide

Available from:

Sigma Pharmaceuticals Plc

ATC code:

N02CC06

INN (International Name):

Eletriptan hydrobromide

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401

Patient Information leaflet

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 ergotamine or medicines lik

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
RELPAX 20 mg film coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RELPAX 20 mg film-coated tablets
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
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
RELPAX 20 mg film-coated tablets
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 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 a