Benylin Sore Throat Rapid Relief Berry 8mg Compressed Lozenges

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland

ATC code:

R02AD01

INN (International Name):

BENZOCAINE 8 mg

Pharmaceutical form:

COMPRESSED LOZENGE

Composition:

BENZOCAINE 8 mg

Prescription type:

OTC

Therapeutic area:

THROAT PREPARATIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2022-03-01

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Benylin Sore Throat Rapid Relief Berry 8mg Compressed Lozenges
benzocaine
READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your doctor or 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 taking this
medicine after 3 days.
WHAT IS IN THIS LEAFLET:
1.
What this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
This medicine contains benzocaine, a local anaesthetic. It acts by
numbing the affected area and
thereby relieving the discomfort and irritation of a sore throat.
This medicine is for use in adults and children aged 16 years and
over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE THIS MEDICINE
-
if you are allergic to benzocaine or any of the other ingredients of
this medicine (listed in section
6).
-
if you are under 16 years of age
-
if you have a history of methaemoglobinaemia (a blood disorder)
WARNINGS AND PRECAUTIONS
Stop use and seek immediate medical attention if you or a child in
your care develops pale, grey or
blue colored skin, lips and nail beds, headache, light headedness,
shortness of breath, fatigue, and fast
heartbeat. These could be symptoms of Methaemoglobinaemia and require
urgent care.
Avoid eating or drinking directly after taking a lozenge.
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If you have any known breathing or swallowing problems, ask your
health

Summary of Product characteristics

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6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Benylin Sore Throat Rapid Relief Berry 8mg Compressed Lozenges
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each compressed lozenge contains 8 mg of benzocaine.
Excipient(s) with known effect: propylene glycol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Compressed Lozenge (Lozenge)
Oval, white to slightly yellow/beige lozenge with a size of about 14mm
x 9mm x 6 mm, with debossed
arrows on one side and the text “8” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
This medicine is indicated for the short-term symptomatic relief of
pain and discomfort in acute sore
throat. It is indicated in adults and adolescents 16 years and over.
4.2
POSOLOGY
AND METHOD OF
ADMINISTRATION
ADULTS
AND
CHILDREN
16 YEARS AND OVER
:
1 lozenge to be dissolved slowly in the mouth no more frequently than
every two hours.
Do not exceed 6 lozenges in 24 hours.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms.
Do not use for more than 3 days without seeking prior medical advice.
CHILDREN UNDER 16 YEARS
For use in adults and adolescents 16 years and over. Do not use in
children under 16 years
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4.3
CONTRAINDICATIONS
This medicine must not be used in children aged less than 16 years.
Hypersensitivity to benzocaine or to any of the excipients listed in
section 6.1
In patients who have a history of or are suspected to have
methaemoglobinaemia
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR
USE
Due to the local anaesthetic action of benzocaine patients should
avoid eating or drinking directly after
taking a lozenge.
Benzocaine may cause methemoglobinemia, a rare but serious condition
that must be treated promptly
because it reduces the amount of oxygen carried in the blood. Patients
should stop use and seek immediate
medical attention if they develop pale, grey or blue colored skin,
lips, and nail beds, headache, light
headedness, shortness of breath, fatigue, or t