NARAMIG TABLETS 2.5 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

NARATRIPTAN AS HYDROCHLORIDE

Tilgjengelig fra:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kode:

N02CC02

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

NARATRIPTAN AS HYDROCHLORIDE 2.5 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND

Terapeutisk gruppe:

NARATRIPTAN

Terapeutisk område:

NARATRIPTAN

Indikasjoner:

Naramig tablets are indicated for the acute treatment of migraine attacks with or without aura.

Autorisasjon dato:

2014-01-31

Informasjon til brukeren

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician's prescription only
NARAMIG TABLETS 2.5 MG
EACH FILM-COATED TABLET CONTAINS: NARATRIPTAN (AS HYDROCHLORIDE) 2.5
MG.
For the list of the inactive and allergenic ingredients in the
medicine, see
section 2 –
Important information about some of the ingredients of the
medicine and section 6 –
Additional information.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
any other
questions, refer to the physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar.
Naramig Tablets 2.5 mg, called in this leaflet Naramig.
NARAMIG IS NOT RECOMMENDED for children under the age of 18 or for
adults
aged over 65.
1. WHAT IS THE MEDICINE INTENDED FOR?
NARAMIG IS USED TO TREAT MIGRAINE.
Migraine symptoms may be caused by the temporary widening of blood
vessels in the head. Naramig reduces the widening of these blood
vessels.
This in turn helps to take away the headache and relieve other
symptoms of a
migraine attack, such as nausea or vomiting and sensitivity to light
and sound.
THERAPEUTIC GROUP:
Naramig contains naratriptan (as hydrochloride), which belongs to a
group of
medicines called triptans (also called selective serotonin agonists
(5-HT
1
)).
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
• IF YOU ARE SENSITIVE (ALLERGIC) to naratriptan or to any of the
additional
ingredients contained in this medicine (as listed in section 6).
•
IF YOU HAVE A HEART PROBLEM, such as heart failure or chest pains (
angina
),
or have had a heart attack.
• IF YOU HAVE CIRCULATION PROBLEMS IN YOUR LEGS that cause cramp-like
pains when you walk (
peripheral vascular disease
).
• IF
YOU
HAVE
HAD
A
STROKE
or
a
mini-stroke
(
also
called
a
transient
ischaemic attack or TIA
).
•
IF

Preparatomtale

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NARAMIG TABLETS 2.5 MG
1.
NAME OF THE MEDICINAL PRODUCT
Naramig Tablets 2.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 2.5 mg of naratriptan as naratriptan hydrochloride.
Excipient with known effect:
94.07 mg anhydrous lactose/film-coated tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naramig Tablets are indicated for the acute treatment of migraine
attacks with or
without aura.
4.2
POSOLOGY AND METHOD OF 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 are recommended as monotherapy for the acute treatment
of a
migraine attack.
Naramig Tablets should not be used prophylactically.
Posology
ADULTS (18-65 YEARS OF AGE)
The recommended dose of Naramig Tablets is a single 2.5mg tablet.
The total dose should not exceed two 2.5mg tablets in any 24 hour
period.
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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 a first dose of Naramig Tablets a
second dose should
not be taken for the same attack, as it is unlikely to be of benefit.
However Naramig
Tablets may be used for subsequent migraine attacks.
ADOLESCENTS (12-17 YEARS OF AGE)
Efficacy
of
Naramig
Tablets
at
single
doses
of
0.25,
1.0
and
2.5mg
was
not
demonstrated to be greater than placebo in a placebo-controlled study
in adolescents
(12 to 17 years). Therefore, the use of Naramig Tablets in patients
under 18 years of
age is not recommended.
CHILDREN (UNDER 12 YEARS OF AGE)
There are no data available on the use of naratriptan 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 naratriptan in individuals over age 65
have not been
evaluat