Imigran 20mg nasal spray

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Sumatriptan

Disponible depuis:

Dowelhurst Ltd

Code ATC:

N02CC01

DCI (Dénomination commune internationale):

Sumatriptan

Dosage:

200mg/1ml

forme pharmaceutique:

Spray

Mode d'administration:

Nasal

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04070401

Notice patient

2
What you need to know before you use Imigran nasal spray
Don’t use Imigran:
•
IF YOU’RE ALLERGIC to sumatriptan, or any of the other
ingredients of this 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 Imigran if your high blood pressure is mild and is
being treated.
•
IF YOU HAVE SERIOUS LIVER DISEASE.
•
WITH OTHER MIGRAINE MEDICINES, including those
which contain ergotamine, or similar medicines
such as methysergide or any triptan/5-HT
1
receptor
agonist (medicines which are also used for treating
migraine).
•
WITH ANTI-DEPRESSANTS CALLED MAOIS _(monoamine _
_oxidase inhibitors),_ or if you have taken these
medicines in the last 2 weeks.
If any of these apply to you:
➔
TELL YOUR DOCTOR, AND DON’T USE IMIGRAN NASAL SPRAY.
Take special care with Imigran
Talk to your doctor or pharmacist before using Imigran.
IF YOU HAVE ANY EXTRA RISK FACTORS
•
IF YOU ARE A HEAVY SMOKER, or are using NICOTINE
REPLACEMENT THERAPY, and especially
•
IF YOU ARE A MAN AGED OVER 40, or
•
IF YOU ARE A WOMAN WHO HAS BEEN THROUGH THE
MENOPAUSE.
In very rare cases, people have developed serious heart
conditions after using Imigran, even though they had
no signs of heart disease before. If any of the points
above applies to you it could mean you have a greater
risk of developing heart disease - so:
➔
TELL YOUR DOCTOR SO THAT YOUR HEART FUNCTION CAN BE
CHECKED before Imigran is prescribed for you.
IF YOU HAVE A HISTORY OF FITS _(seizures)_
Or if you have other conditions which might make it
more likely that you’ll have a fit - for example, a head
injury or alcoholism.
➔ TELL YOUR DOCTOR SO

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Imigran 20 mg Nasal Spray.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imigran 20 mg Nasal Spray: 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
Imigran Nasal Spray is indicated for the acute treatment of migraine
attacks
with or without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Imigran Nasal Spray should not be used prophylactically.
The recommended dose of Imigran should not be exceeded.
Imigran 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 Imigran 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 Imigran Nasal Spray is 20 mg for administration
into one nostril.
However, due to inter/intra patient variability of both the migraine
attacks and the
absorption of sumatriptan, 10 mg may be effective in some patients.
If a patient does not respond to the first dose of Imigran, 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. Imigran
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 Imigran 20 mg Nasal Spray should be taken in
any 24-hour
period.
Adolescents (12–