Tyrozets lozenges

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tyrothricin; Benzocaine

Available from:

McNeil Products Ltd

ATC code:

n/a

INN (International Name):

Tyrothricin; Benzocaine

Dosage:

1mg ; 5mg

Pharmaceutical form:

Lozenge

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12030300; GTIN: 5027097050003

Patient Information leaflet

TOP
■
This medicine is used to relieve minor mouth and throat irritations.
TYROZETS™ LOZENGES may also be taken to relieve irritation after
mouth and throat surgery.
■
This medicine is for use by adults and children aged 3 and over.
■
DO NOT TAKE THIS MEDICINE:
■
If you have ever had a BAD REACTION to any of the ingredients.
_For the list of ingredients see section 6_ ▶
■
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are shown in
the dosage table. _See Section 3 _▶
■
The lozenges are for oral use only and should not be used for
longer than 5 consecutive days.
NOW READ THIS WHOLE LEAFL ET CAREFULLY BEFORE YOU USE THIS
MEDICINE. Keep the leafl et: you might need it again.
1 WHAT TYROZETS
™ LOZENGES ARE
AND WHAT THEY ARE USED FOR
TYROZETS
™
LOZENGE is a medicine which is used to relieve minor
mouth and throat irritations. TYROZETS
™
LOZENGES may also be
taken to relieve irritation after mouth and throat surgery, for
example
having your tonsils taken out. The lozenges contain tyrothricin, which
is an antibiotic that helps fi ght throat infection, and benzocaine,
a
local anaesthetic that numbs sore throat pain. The lozenges dissolve
in
the mouth, gradually releasing the active ingredients which reach the
painful throat area at the back of the mouth.
TYROZETS
™
LOZENGES are not intended to replace other antibiotic
medicines prescribed by your doctor but are an aid to prevention and
control of local infections in the mouth and throat.
This medicine is for use in adults and children aged 3 years and over.
2 WHAT YOU NEED TO KNOW BEFORE YOU
USE TYROZETS
™ LOZENGES
This medicine is suitable for most adults and children aged 3 years
and
over, but a few people should not use it. If you are in any doubt,
talk to
your doctor or pharmacist. DO NOT TAKE THIS MEDICINE…
■
If you have ever had a BAD REACTION to any of the ingredients.
If you think you have become allergic during use, stop treatment
immediately and see your doctor.
If this applies to you, GET ADVICE FROM A DOCTOR OR
PHARMACIST WIT

Summary of Product characteristics

OBJECT 1
TYROZETS
Summary of Product Characteristics Updated 27-Jun-2017 | McNeil
Products Ltd
1. Name of the medicinal product
Tyrozets Lozenges
2. Qualitative and quantitative composition
Each lozenge contains:
Tyrothricin EP 1mg
Benzocaine BP/EP 5mg
Excipients with known effect:
Sucrose 989.19 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Lozenge
Pink, aniseed flavoured, flat bevelled edge lozenge imprinted on both
sides.
4. Clinical particulars
4.1 Therapeutic indications
As an antibiotic and local analgesic-anaesthetic. For minor mouth and
throat irritations; secondary
irritation following tonsillectomy and other mouth and throat surgery.
4.2 Posology and method of administration
Adults and children 12 years and older: 1 lozenge to be dissolved
slowly in the mouth every three hours.
Do not exceed 8 lozenges in 24 hours.
Children aged 3 to 11 years: dosage should be reduced in children.
Maximum 6 lozenges in 24 hours. Do
not use this medicine in children less than 3 years of age.
If an adequate response is not evident within two days, consider
stopping Tyrozets lozenges. Do not use
for longer than five consecutive days.
To allow maximum contact with inflamed tissues, Tyrozets lozenges
should not be chewed or swallowed
whole, but allowed to dissolve slowly in the mouth.
4.3 Contraindications
Hypersensitivity to tyrothricin, benzocaine or to any of the
excipients listed in section 6.1. If evidence of
sensitivity occurs during therapy, Tyrozets lozenges should be
discontinued.
4.4 Special warnings and precautions for use
The use of antibiotics may cause over-growth of non-susceptible
organisms. If new infections due to
bacteria or fungi appear during therapy, Tyrozets lozenges should be
stopped and appropriate measures
taken.
Topical use of Tyrozets lozenges as an aid to prevention of local
infection in no way alters the need for
adequate systemic therapy if an infection should develop.
Benzocaine may cause methaemoglobinaemia, a rare but serious condition
that must be treated promp