NARAMIG TABLETS 2.5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Naratriptan Hydrochloride 2.78 mg eqv Naratriptan

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

N02CC02

Dosage:

2.5 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Naratriptan Hydrochloride 2.78 mg eqv Naratriptan 2.5 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

GlaxoSmithKline Pharmaceuticals S.A.

Authorization status:

ACTIVE

Authorization date:

1998-07-28

Patient Information leaflet

PHARMA CODE REF. NO. 662

1

10000000033419

GSK-AUS-BORONIA-AUBOR 

SINGAPORE-SGP 

NARAMIG 
 1

PROCESS 

K

LFT017

NO

BOR
ONIA - ADDITIONAL ARTWORK INFORMATION PANEL
COMPONENT NAME
NARAMIG T
ABS 2.5MG LEAFLET SINGAPORE 
COMPONENT NO.
10000000033419
SITE CHANGE NO.
200291098 
SPECIFICATION NO.
TLFT010
NOTE TO SUPPLIER: 
N/A
FRONT OF LEAFLET
PAGE 1 OF 2
NARAMIG
™
NARATRIPTAN
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 2.5 mg of naratriptan as
naratriptan_ _hydrochloride.
PHARMACEUTICAL FORM
Film coated tablets.
CLINICAL PARTICULARS
INDICATIONS
_NARAMIG_ tablets are indicated for the acute treatment of 
migraine attacks with or without aura.
DOSAGE AND ADMINISTRATION
_NARAMIG_ tablets should be taken as early as possible after the
onset 
of a migraine headache but they are effective if taken at a later
stage.
_NARAMIG_ tablets should not be used prophylactically.
_NARAMIG_ tablets should be swallowed whole with water.
•  ADULTS (18 TO 65 YEARS OF AGE)
The recommended dose of _NARAMIG_ tablets is a single 2.5 mg tablet.
The total dose should not exceed two 2.5 mg tablets in any 24 h
period.
If symptoms of migraine should recur, following an initial response, a
second dose may be taken provided 
that there is a minimum interval of 4 h between the two doses.
If a patient does not respond to the first dose of _NARAMIG_ tablets
it is unlikely that a second dose will be 
of benefit in the same attack. _NARAMIG_ tablets may be used for
subsequent migraine attacks.
•  ADOLESCENTS (12 TO 17 YEARS OF AGE)
In a clinical trial in adolescents, a very high placebo response was
observed. The efficacy of _NARAMIG_ in 
this population has therefore not been demonstrated and its use cannot
be recommended.
•  CHILDREN (UNDER 12 YEARS OF AGE)
There are no data available on the use of _NARAMIG_ in children
under 12 years of age therefore its use in 
this age group is not recommended.
•  ELDERLY (OVER 65 YEARS OF AGE)
Th

Summary of Product characteristics

NARAMIG™
NARATRIPTAN_ _
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 2.5 mg of naratriptan as naratriptan
_ _
hydrochloride.
PHARMACEUTICAL FORM
Film coated tablets.
CLINICAL PARTICULARS
INDICATIONS
_NARAMIG_
tablets are indicated for the acute treatment of migraine attacks with
or
without aura.
DOSAGE AND ADMINISTRATION
_NARAMIG_
tablets should be taken as early as possible after the onset of a
migraine
headache but they are effective if taken at a later stage.
_NARAMIG_
tablets should not be used prophylactically.
_NARAMIG_
tablets should be swallowed whole with water.
•
ADULTS (18 TO 65 YEARS OF AGE)
The recommended dose of
_NARAMIG_
tablets is a single 2.5 mg tablet.
The total dose should not exceed two 2.5 mg tablets in any 24 hour
period.
If symptoms of migraine should recur, following an initial response, a
second dose may
be taken provided that there is a minimum interval of four hours
between the two doses.
If a patient does not respond to the first dose of
_NARAMIG_
tablets it is unlikely that a
second dose will be of benefit in the same attack.
_NARAMIG_
tablets may be used for
subsequent migraine attacks.
•
ADOLESCENTS (12 TO 17 YEARS OF AGE)
In a clinical trial in adolescents, a very high placebo response was
observed. The efficacy
of
_NARAMIG_
in this population has therefore not been demonstrated and its use
cannot
be recommended.
•
CHILDREN (UNDER 12 YEARS OF AGE)
There are no data available on the use of
_NARAMIG_
in children under 12 years of age
therefore its use in this age group is not recommended.
•
ELDERLY (OVER 65 YEARS OF AGE)
The safety and effectiveness of
_NARAMIG_
in individuals over age 65 have not been
evaluated. There is a moderate decrease in clearance with age (
_see Pharmacokinetics_
).
•
RENAL IMPAIRMENT
The maximum total daily dose in patients with renal impairment is a
single 2.5 mg tablet.
The use of
_NARAMIG_
is contraindicated in patients with severe renal impairment
(creatinine clearance less than 15 ml/min) (
_see Contraindications and Pharmaco