Eletriptan 40mg film-coated Tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

ELETRIPTAN HYDROBROMIDE

Commercializzato da:

Pfizer Hellas S.A.

Codice ATC:

N02CC06

INN (Nome Internazionale):

ELETRIPTAN HYDROBROMIDE

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

ELETRIPTAN HYDROBROMIDE 40 milligram(s)

Tipo di ricetta:

POM

Area terapeutica:

ANALGESICS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2013-10-28

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ELETRIPTAN 20 AND 40MG 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 Eletriptan is and what it is used for
2. What you need to know before you take Eletriptan
3. How to take Eletriptan
4. Possible side effects
5. How to store Eletriptan
6. Contents of the pack and other information
1. WHAT ELETRIPTAN IS AND WHAT IT IS USED FOR
Eletriptan contains the active substance eletriptan. Eletriptan 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.
Eletriptancan 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 ELETRIPTAN
DO NOT TAKE ELETRIPTAN:
•
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

Scheda tecnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Eletriptan 20 mg film-coated tablets
Eletriptan 40 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Eletriptan 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
Eletriptan 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.
Eletriptan 20 mg film-coated tablets
Round, convex, orange, of dimension 6.25 mm, debossed with ‘REP
20’ on one side and ‘Pfizer’ on
the other.
Eletriptan 40 mg film-coated tablets
Round, convex, orange, of dimension 8 mm, debossed with ‘REP 40’
on one side and ‘Pfizer’ on
the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eletriptan is indicated in adults for acute treatment of the headache
phase of migraine attacks, with
or without aura.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Eletriptan 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.
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Eletriptan, if taken during the aura phase, has not been demonstrated
to prevent migraine headache
and therefore Eletriptan should only be taken during the headache
phase of migraine.
_ _
Eletriptan 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 Eletriptan 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 d