IMITREX NASAL SPRAY 20 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

SUMATRIPTAN

Tilgjengelig fra:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC-kode:

N02CC01

Legemiddelform:

SOLUTION

Sammensetning:

SUMATRIPTAN 20 MG / 0.1 ML

Administreringsrute:

NASAL

Resept typen:

Required

Produsert av:

GLAXO SMITH KLINE MANUFACTURING SPA,ITALY

Terapeutisk gruppe:

SUMATRIPTAN

Terapeutisk område:

SUMATRIPTAN

Indikasjoner:

Imitrex nasal spray is indicated for the acute treatment of migraine attacks with or without aura.

Autorisasjon dato:

2014-04-30

Informasjon til brukeren

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed according to a physician’s prescription
only
IMITREX NASAL SPRAY 20 MG
Each nasal spray unit (0.1 ml of solution) contains a single dose of
sumatriptan
20 mg.
For
the
list
of
inactive
and
allergenic
ingredients,
see
section
6
“ Additional
information”.
READ THE ENTIRE LEAFLET CAREFULLY 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.
1. WHAT IS THE MEDICINE INTENDED FOR?
Imitrex Nasal Spray 20 mg is indicated for the acute treatment of
migraine attacks
with or without aura.
THERAPEUTIC GROUP
Selective 5-HT
1
receptor agonists.
Migraine symptoms may be caused by the temporary widening of blood
vessels in
the head. Imitrex Nasal Spray 20 mg is believed to reduce 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.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
•
IF YOU ARE SENSITIVE (ALLERGIC) to sumatriptan or to any of the
additional
ingredients contained in the medicine (listed in section 6).
•
IF YOU HAVE A HEART PROBLEM such as narrowing of the arteries
(ischaemic heart
disease)
or chest pains
(angina)
, or have already 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 YOU HAVE HIGH BLOOD PRESSURE. You may be able to use Imitrex Nasal
Spray
20 mg if your high blood pressure is mild and is being treated.
•
IF YOU HAVE SERIOUS LIVER DISEASE.
•
WITH OTHER MIGRAINE MEDICINES, includ

Preparatomtale

Page
1
of
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IMITREX NASAL SPRAY 20 MG
1
NAME OF THE MEDICINAL PRODUCT
Imitrex Nasal Spray 20 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imitrex Nasal Spray 20 mg: Unit dose spray device for intranasal
administration. The device
delivers 20 mg of sumatriptan in 0.1 mL of an aqueous buffered
solution.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Nasal Spray, solution.
Clear pale yellow to dark yellow liquid, in glass vials in a single
dose nasal spray device.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imitrex Nasal Spray is indicated for the acute treatment of migraine
attacks with or without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Imitrex Nasal Spray should not be used prophylactically.
The recommended dose of Imitrex Nasal Spary should not be exceeded.
Imitrex Nasal Spray is recommended as monotherapy for the acute
treatment of a migraine
attack and should not be given concomitantly with ergotamine or
derivatives of ergotamine
(including methysergide) (see section 4.3).
It is advisable that Imitrex Nasal Spray be given as early as possible
after the onset of a migraine
headache. It is equally effective at whatever stage of the attack it
is administered.
Adults (18 years of age and over)
The optimal dose of Imitrex Nasal Spray is 20 mg for administration
into one nostril.
If a patient does not respond to the first dose of Imitrex Nasal
Spray, a second dose should not
be taken for the same attack. In these cases the attack can be treated
with paracetamol,
acetylsalicylic acid or non-steroidal anti-inflammatory drugs. Imitrex
Nasal Spray may be taken
for subsequent attacks.
If the patient has responded to the first dose but the symptoms recur,
a second dose may be
given in the following 24 hours, provided that there is a minimum
interval of 2 hours between
the two doses.
No more than two doses of 20 mg Nasal Spray should be taken in any
24-hour period.
Children (under 18 years of age)
The use of Imitrex Nasal Spray 20 mg is not recommended in patients
under the age of 1