RELERT 20 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ELETRIPTAN HYDROBROMIDE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

N02CC06

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ELETRIPTAN HYDROBROMIDE 24.242 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

R - PHARM GERMANY GMBH

Therapeutic group:

ELETRIPTAN

Therapeutic area:

ELETRIPTAN

Therapeutic indications:

Acute treatment of the headache phase of migraine attacks, with or without aura.

Authorization date:

2011-12-31

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
04.06.2015
םש
רישכת
תילגנאב
רפסמו
םושירה
םש
רישכת
תילגנאב
רפסמו
םושירה
/
01
124.28.30370.00
RELERT 20MG
RELERT 40MG 124.29.30371.00 /01
RELERT 80MG 124.30.30372.00
/01
םש
לעב
םושירה :
רזייפ
יא ףא יפ
מ"עב הקיטבצמרפ
! דבלב תורמחהה טורפ
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
SPECIAL WARNINGS
AND PRECAUTIONS
FOR USE
N/A
Reports of transient and permanent blindness
and significant partial vision loss have been
reported with the use of
5 HT1 agonists. Since visual disorders may
be part of a migraine attack, a causal
relationship between these events and the
use of 5 HT1 agonists have not been clearly
established.
UNDESIRABLE
EFFECTS
In post-marketing experience, the
following
additional
undesirable
effects have been reported:
…
Nervous System Disorders:
Rare
cases of syncope.
In post-marketing experience, the following
additional undesirable effects have been
reported:
…
Nervous System Disorders: Serotonin
syndrome, rare cases of syncope,
cerebrovascular accident.

Summary of Product characteristics

Relert Tablets, 02 June 2015 2014-0005401, 2014-0005377, 2015-0011107,
2015-0010225
RELERT TABLETS
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20mg, 40mg and 80mg eletriptan (as
hydrobromide).
Excipients with known effect:
Each film-coated tablet of Relert 20 mg contains 23 mg lactose
monohydrate and Sunset yellow.
Each film-coated tablet of Relert 40 mg contains 46 mg lactose
monohydrate and Sunset yellow.
Each film-coated tablet of Relert 80 mg contains 92 mg lactose
monohydrate and Sunset yellow.
For the full list of excipients, see section 6.1.
2. PHARMACEUTICAL FORM
Film-coated tablet.
Round, convex orange tablets debossed with ‘REP 20’, ‘REP 40’
and ‘REP 80’on one side and ‘Pfizer’ on the other.
3. CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
Acute treatment of the headache phase of migraine attacks, with or
without aura.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
PosologyRELERT 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.
RELERT, if taken during the aura phase, has not been demonstrated to
prevent migraine headache and therefore
RELERT should only be taken during the headache phase of migraine.
_ _
RELERT 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 the migraine headache recurs within 24 hours of an initial
response, a second
dose of the same strength of RELERT 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
RELERT 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 t