Ultra Chloraseptic 0.71% anaesthetic throat spray original

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Benzocaine

Available from:

Prestige Brands (UK

ATC code:

R02AD01

INN (International Name):

Benzocaine

Dosage:

1mg/1actuation

Pharmaceutical form:

Spray

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12030300; GTIN: 5060018880020

Patient Information leaflet

Patient Information Leaflet
ULTRA CHLORASEPTIC
® ANAESTHETIC THROAT SPRAY
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU
START USING YOUR MEDICINE, as it contains important
information for you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more
information or advice.
•
If a side effect occurs and it seems serious to
you, or if you notice a side effect not listed in
this leaflet, tell your doctor or pharmacist.
In this leaflet:
1.
What Ultra Chloraseptic
®
Anaesthetic Throat
Spray is and what it is used for
2.
Before you use Ultra Chloraseptic
®
Anaesthetic
Throat Spray
3.
How to use Ultra Chloraseptic
®
Anaesthetic
Throat Spray
4. Possible side effects
5. How to store your medicine
6. Further information
1. WHAT ULTRA CHLORASEPTIC
® ANAESTHETIC
THROAT SPRAY IS AND WHAT IT IS USED FOR
Ultra Chloraseptic
®
Anaesthetic Throat Spray is
used to relieve sore throat pain.
The product contains the active ingredient
benzocaine which belongs to the group of medicines
called local anaesthetics. It has a fast action and
works by numbing the pain of a sore throat. The
product comes in the form of a spray. It has a swivel
head applicator to help deliver the local anaesthetic
direct to the throat.
2. BEFORE YOU USE ULTRA CHLORASEPTIC
®
ANAESTHETIC THROAT SPRAY
DO NOT use this 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
•
you know you are allergic to benzocaine or any of
the other ingredients (see Section 6, Further
Information)
•
you have been told that you have a rare blood
condition called methaemoglobinaemia
•
you are pregnant or breast-feeding
DO NOT use this medicine for children under 6
years of age.
This medicine contains a small quantity of alcohol
(less than 0.006 units per spray) to dissolve the other
ingredients. Contains propylene glycol - this may
cause skin irritation.
If your sore throat is severe or prolonged, or
accompanied by fever, headache,

Summary of Product characteristics

OBJECT 1
ULTRA CHLORASEPTIC ANAESTHETIC THROAT SPRAY
0.71%
Summary of Product Characteristics Updated 16-Jun-2017 | Prestige
Brands (UK) Ltd
1. Name of the medicinal product
Ultra Chloraseptic Anaesthetic Throat Spray
2. Qualitative and quantitative composition
Benzocaine 0.71 % w/v
For full list of excipients, see 6.1
3. Pharmaceutical form
Oromucosal Spray
Direct application to the throat by spraying
Clear, colourless to straw coloured liquid
4. Clinical particulars
4.1 Therapeutic indications
Symptomatic relief of sore throat pain.
4.2 Posology and method of administration
Posology
Adults and children 13 years and over: Administer 3 sprays (3mg) to
the back of the throat. Repeat every
2-3 hours up to a maximum of 8 doses per day.
Children 6-12 years: Use only under adult supervision. Administer 1
spray (1mg) to the back of the
throat. Repeat every 2-3 hours up to a maximum of 8 doses per day
This product is contraindicated in children under 6 years.
Method of administration: oromucosal
Hold breath and spray to the back of the throat.
Do not use in a child who is unable to hold their breath whilst
spraying.
Before first use, or after prolonged storage, activate the pump by
spraying 3 times away from the face into
the sink.
4.3 Contraindications
Children under 6 years.
Epiglottitis
Known hypersensitivity to benzocaine or any of the other ingredients.
Methaemoglobinaemia
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 blo