TYROZETS 1mg/5mg Milligram Lozenges

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Kjøp det nå

Preparatomtale Preparatomtale (SPC)
28-04-2017

Aktiv ingrediens:

TYROTHRICIN, BENZOCAINE

Tilgjengelig fra:

McNeil Healthcare (Ireland) Ltd

ATC-kode:

R02AB02

INN (International Name):

TYROTHRICIN, BENZOCAINE

Dosering :

1mg/5mg Milligram

Legemiddelform:

Lozenges

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

Antibiotics

Autorisasjon status:

Authorised

Autorisasjon dato:

2009-02-06

Informasjon til brukeren

                                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
                                
                                Les hele dokumentet
                                
                            

Preparatomtale

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tyrozets Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Lozenge contains:
Tyrothricin 1 mg
Benzocaine 5 mg
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 lozenges 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: One 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 aged
3-11. 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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__
                                
                                Les hele dokumentet