Merocaine Lozenges

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Cetylpyridinium chloride; Benzocaine

Fáanlegur frá:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC númer:

R02AA; R02AA06

INN (Alþjóðlegt nafn):

Cetylpyridinium chloride; Benzocaine

Skammtar:

1.4mg/ 10 milligram(s)

Lyfjaform:

Lozenge

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

Antiseptics; cetylpyridinium

Leyfisstaða:

Not marketed

Leyfisdagur:

1982-03-10

Upplýsingar fylgiseðill

MEROCAINE LOZENGES
Benzocaine 10mg and Cetylpyridinium chloride 1.4mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU STARTING TAKING
MEROCAINE LOZENGES BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take Merocaine lozenges exactly as described in this leaflet or
as your pharmacist has
told you.
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 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 three days.
1.
WHAT MEROCAINE LOZENGES ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEROCAINE LOZENGES
3.
HOW TO TAKE MEROCAINE LOZENGES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE MEROCAINE LOZENGES
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT MEROCAINE LOZENGES ARE AND WHAT THEY ARE USED FOR
These lozenges contain benzocaine and cetylpyridinium chloride and are
for the temporary
relief of pain and discomfort in sore throats and superficial mouth
infections. It is also used
for symptomatic relief of pain and discomfort in more serious throat
infections such as
tonsillitis and pharyngitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEROCAINE LOZENGES
DO NOT TAKE MEROCAINE LOZENGES
•
If you are allergic to any of the ingredients in this product listed
in section 6. See
‘Contents of the pack and other information’ for the full list of
ingredients
•
If you have been told by your doctor that you have an intolerance to
some sugars.
The product contains 1.37g sucrose per dose and 1.0496g glucose per
dose. This should be
taken into account in patients with diabetes mellitus.
WARNINGS AND PRECAUTIONS
Use of this product may cause methaemoglobinemia, a serious condition
that must be treated
promptly because it reduces the amount of oxygen carried in the blood.
This can occur even
if you have used this product before. Stop use and seek immediate
medical attention i

Vara einkenni

Health Products Regulatory Authority
18 October 2019
CRN008WWD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Merocaine Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cetylpyridinium chloride 1.4 mg/lozenge
Benzocaine 10.0 mg/lozenge
Excipients with a known effect: also includes sucrose 1.137g per
lozenge and glucose 1.0496g per lozenge.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
Clear green, slightly domed shaped, disc lozenge with a lemon-lime
flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Merocaine Lozenges provide rapid and profound local anaesthetic action
and topical antibacterial effects for the temporary
relief of pain and discomfort in sore throat and superficial mouth
infections. Indicated for relief of minor throat irritations and
adjunctively, for symptomatic relief of pain and discomfort in more
serious throat infections, such as tonsillitis and pharyngitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS
Allow to dissolve slowly in the mouth. One lozenge every 2 hours as
needed but not more than 8 lozenges in 24 hours.
CHILDREN UNDER 12 YEARS
Merocaine lozenges are not recommended for use in children under 12
years (see section 4.4).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredients or any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Consult your doctor in case of severe irritation of your throat with
high fever or if symptoms persist for more than 3 days.
Merocaine Lozenges contain sucrose and glucose. Patients with rare
hereditary problems of fructose intolerance,
glucose-galactose malabsorption or sucrose-isomaltase insufficiency
should not take this medicine.
This should be taken into account in patients with diabetes mellitus.
Cases of methaemoglobinaemia have been reported with Merocaine
Lozenges (see section 4.8). If patients present with signs
or symptoms of methemoglobinemia such as pale, grey or blue coloured
skin, lips and nail beds; headache;