Relpax tablets film-coated

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

eletriptan (eletriptan hydrobromide)

Mevcut itibaren:

R-Pharm Germany GmbH

ATC kodu:

N02CC06

INN (International Adı):

eletriptan (eletriptan hydrobromide)

Doz:

40mg

Farmasötik formu:

tablets film-coated

Paketteki üniteler:

(2) in blister

Reçete türü:

Prescription

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2017-05-11

Ürün özellikleri

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Relpax 40 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each film-coated tablet contains:
Active ingredient:
eletriptan hydrobromide 48.485 mg (equivalent to 40 mg of eletriptan);
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
40 mg tablets:
orange round biconvex film-coated tablets debossed with "REP 40" on
one side and "Pfizer" on
the other._ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of migraine attacks with or without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route.
The tablets should be swallowed whole with water.
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.
Adults (18-65 years)
The recommended initial dose is 40 mg.
_If headache returns within 24 hours_: If migraine headache is
relieved but then recurs within
24 hours, an additional dose of the same strength of Relpax
®
may be administered. 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. The
patients who do not respond
to the treatment of an attack will respond to the treatment of a
subsequent attack.
Patients who do not obtain satisfactory efficacy with 40 mg may be
effectively treated with
80 mg in a subsequent migraine attack.
The daily dose should not exceed 160 mg.
Patients with mild or moderate hepatic impairment do not require the
dose adjustment.
4.3
CONTRAINDICATIONS
Hypersensitivity to eletriptan or any other component of the product.
3
Severe hepatic impairment.
Age under 18 years (the data on efficacy and safety of the product use
in this age group are
limited).
Concomitant administrat