RELPAX TABLET 40 mg

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

ELETRIPTAN HYDROBROMIDE EQV ELETRIPTAN

Commercializzato da:

VIATRIS PRIVATE LIMITED

Codice ATC:

N02CC06

Dosaggio:

40 mg

Forma farmaceutica:

TABLET, FILM COATED

Composizione:

ELETRIPTAN HYDROBROMIDE EQV ELETRIPTAN 40 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Pfizer Italia S.r.l.

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2002-01-14

Foglio illustrativo

RELPAX 
Eletriptan Hydrobromide 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

RELPAX 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Tablets containing 20 mg, 40 mg or 80 mg eletriptan as eletriptan hydrobromide. 

3. 
PHARMACEUTICAL FORM 

Film-coated tablets. 

The 20 mg tablet is a 6.25 mm orange film coated standard round convex tablets with 
a clear overcoat, engraved with ‘REP 20’ on one side and ‘Pfizer’ on the reverse. 

The 40 mg tablet is an 8.0 mm orange film coated standard round convex tablets with 
a clear overcoat, engraved with ‘REP 40’ on one side and ‘Pfizer’ on the reverse. 

The 80 mg tablet is a 10.0 mm orange film coated standard round convex tablets with 
a clear overcoat, engraved with ‘REP 80’ on one side and ‘Pfizer’ on the reverse. 

4. 

4.1 

CLINICAL PARTICULARS 

THERAPEUTIC INDICATION 

Acute treatment of migraine with or without aura. 

4.2 

POSOLOGY AND METHOD OF ADMINISTRATION 

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. 

Eletriptan tablets should not be used prophylactically_._
_ _

The tablets should be swallowed whole with water. 

Adults (18-65 years of age) 

The recommended initial dose is 40 mg. 

If headache returns within 24 hours:_ _If after an initial response migraine headache 
recurs within 24 hours, an additional 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 dose. 

If no response is obtained_:_ If a patient does not achieve a headache response to the 
first�

Scheda tecnica

Page 1 of 12
RELPAX

Eletriptan Hydrobromide
1.
TRADE NAME OF THE MEDICINAL PRODUCT
RELPAX

2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 20 mg, 40 mg or 80 mg eletriptan as eletriptan
hydrobromide
3.
PHARMACEUTICAL FORM
Film-coated tablets
The 20 mg tablet is a 6.25 mm orange film-coated standard round convex
tablets with
a clear overcoat, engraved with ‘REP 20’ on one side and ‘VLE’
on the reverse.
The 40 mg tablet is an 8.0 mm orange film-coated standard round convex
tablets with
a clear overcoat, engraved with ‘REP 40’ on one side and ‘VLE’
on the reverse.
The 80 mg tablet is a 10.0 mm orange film-coated standard round convex
tablets with
a clear overcoat, engraved with ‘REP 80’ on one side and ‘VLE’
on the reverse.
Not all presentations may be available locally.
4.
4.1
CLINICAL PARTICULARS
THERAPEUTIC INDICATION
Acute treatment of migraine with or without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
Eletriptan tablets should not be used prophylactically.
The tablets should be swallowed whole with water.
Page 2 of 12
Adults (18-65 years of age)
The recommended initial dose is 40 mg.
If headache returns within 24 hours:_ _If after an initial response
migraine headache
recurs within 24 hours, an additional 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 dose.
If no response is obtained_:_ If a patient does not achieve a headache
response to the
first dose of eletriptan 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 have shown that the majority of patients who do not
respond to the
treatment of an attack will respond to the treatment of a subsequent
attack.
Patients