Imigran 20 mg Nasal Spray, Solution

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Sumatriptan

Disponible depuis:

GlaxoSmithKline (Ireland) Limited

Code ATC:

N02CC; N02CC01

DCI (Dénomination commune internationale):

Sumatriptan

Dosage:

20 milligram(s)

forme pharmaceutique:

Nasal spray, solution

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Selective serotonin (5HT1) agonists; sumatriptan

Statut de autorisation:

Marketed

Date de l'autorisation:

1999-07-07

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMIGRAN 10 MG NASAL SPRAY, SOLUTION
IMIGRAN 20 MG NASAL SPRAY, SOLUTION
SUMATRIPTAN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT IMIGRAN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IMIGRAN NASAL SPRAY
3.
HOW TO USE IMIGRAN NASAL SPRAY
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE IMIGRAN NASAL SPRAY
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT IMIGRAN IS AND WHAT IT IS USED FOR
IMIGRAN CONTAINS THE ACTIVE SUBSTANCE SUMATRIPTAN
which belongs to a group of medicines called
triptans
_(also known as 5-HT1 receptor agonists)._
Each pre-filled Imigran 10 mg/ Imigran 20 mg
Nasal Spray device contains 10 mg/ 20 mg sumatriptan respectively in
0.1 ml of aqueous solution.
IMIGRAN NASAL SPRAY IS USED TO TREAT MIGRAINE HEADACHES WITH OR
WITHOUT WARNING SIGNS (AURA)
.
Migraine symptoms may be caused by the temporary widening of blood
vessels in the head. Imigran
Nasal Spray 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
feeling or being sick (nausea or
vomiting) and sensitivity to light and sound.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IMIGRAN NASAL SPRAY
DO NOT USE IMIGRAN:

IF YOU ARE ALLERGIC
to sumatriptan, or any of the other ingredients (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 at

Résumé des caractéristiques du produit

Health Products Regulatory Authority
25 November 2021
CRN00CHWN
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imigran 20 mg Nasal Spray, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each nasal applicator contains 20 mg of sumatriptan in 0.1 ml of
solution.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution.
A clear, pale to dark yellow, buffered solution.
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 Nasal Spray should not be
exceeded.
Imigran 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 Imigran 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 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 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. Imigran
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 next 24 hours,
provided that there is a minimum interval of 2 hours between the two
doses.
No more than two Imigran 20 mg Nasal Sprays to be used in any 24 hour
period.
ADOLESCENTS (12-17 YEARS OF