AAA Sore Throat Spray

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

BENZOCAINE

Tillgänglig från:

Manx Pharma Ltd Taylor Group House, Wedgnock Lane Warwick, CV34 5YA, United Kingdom

ATC-kod:

R02AD01

INN (International namn):

BENZOCAINE 1.5 µg/dose

Läkemedelsform:

OROMUCOSAL SPRAY

Sammansättning:

BENZOCAINE 1.5 µg/dose

Receptbelagda typ:

OTC

Terapiområde:

THROAT PREPARATIONS

Bemyndigande status:

Withdrawn

Tillstånd datum:

2007-03-02

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
AAA SORE THROAT SPRAY
1.5MG OROMUCOSAL SPRAY
Benzocaine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
This medicine is available without prescription.
Keep this leaflet. You may need to read it again
Ask your pharmacist if you need more information
or advice
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
You must talk to a doctor if you do not feel better or
if you feel worse after 3 days.
WHAT IS IN THIS LEAFLET
1. WHAT AAA SORE THROAT SPRAY IS AND WHAT IT IS
USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AAA
SORE THROAT SPRAY
3. HOW TO USE AAA SORE THROAT SPRAY
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE AAA SORE THROAT SPRAY
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT AAA SORE THROAT SPRAY IS AND WHAT IT
IS USED FOR
AAA Sore Throat Spray 1.5mg Oromucosal Spray
(hereinafter referred to as AAA Sore Throat Spray)
contains benzocaine, which is a local anaesthetic.
This means that it relieves pain by acting on the
surface area treated.
The spray is used to relieve the pain of sore throats
and minor mouth infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
AAA SORE THROAT SPRAY
DO NOT USE AAA SORE THROAT SPRAY:
if you have difficulty in breathing, noisy breathing
or severe difficulty in swallowing. Talk to your
pharmacist or doctor if this applies to you
if you are allergic to benzocaine or any of the other
ingredients (listed in section 6)
if you have a rare blood condition called
methaemoglobinaemia
if you are pregnant or breast-feeding.
Do not use this medicine for children under 6 years
of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using AAA
Sore Throat Spray:
if your sore throat is severe or prolonged, or
accompanied by fever, headache, or feeling sick.
D

Produktens egenskaper

1.
NAME OF THE MEDICINAL PRODUCT
AAA Sore Throat Spray 1.5mg Oromucosal Spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzocaine 1.5mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oromucosal spray
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic temporary relief of pain associated with sore throat pain
and minor infections
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and children from 13 years:
Spray two metered doses every two to three hours if required (not more
than sixteen doses
in every 24 hours) or as directed by the physician.
Children:
Children 6 – 12 years: One metered dose every two to three hours if
required (not more
than eight doses in every 24 hours) or as directed by the physician.
Not suitable for children under 6 years.
ROUTE OF ADMINISTRATION
Topical application to the mucosa of the mouth and throat by means of
a metered dose
aerosol.
Can be shaken before use.
4.3
CONTRAINDICATIONS
Known hypersensitivity to benzocaine or any of the other ingredients
Methaemoglobinaemia
Children under 6 years
Page
1
of
5
Epiglottitis
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not administer to children under 6 years
Do not use for more than 3 consecutive days
Do not spray into eyes
If sore throat is severe or persistent, or accompanied by fever,
headache or nausea, consult
your doctor.
You should experience temporary numbness in your throat after using
the spray. This
indicates that the product is working. Avoid eating or drinking as
long as the numbness
lasts.
Labelling will include the following information:
Do not use if you have any difficulty in breathing, noisy breathing or
severe difficulty in
swallowing.
Do
not
use
if
you
have
been
told
that
you
have
a
rare
blood
condition
called
methaemoglobaemia.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
FERTILITY, PREGNANCY AND LACTATION
Animal studies are insufficient with respect to effects on pregnancy
and lactation. The
potential
risk
for