Halls Max Strength Sore Throat Relief Original lozenges

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hexylresorcinol; Benzalkonium chloride

Available from:

Ernest Jackson & Co. Ltd

ATC code:

R02AA20

INN (International Name):

Hexylresorcinol; Benzalkonium chloride

Dosage:

2.5mg ; 1.2mg

Pharmaceutical form:

Lozenge

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12030300; GTIN: 5011842195408

Patient Information leaflet

CLIENT:
Subiaco Associates Limited
JOB:
Throaties Lozenges PIL - Page 1
SIZE:
200 x 140mm
CUTTER GUIDE:
Not applicable
DATE:
14 February 2012
SAVED AS:
14069 PIL Page 1.ai
PROOF NO:
02
FOLDER:
Subiaco 14069
FILE LOCATION:
Mac 1 Pocket Drive
APPROVAL DATE
PRINTS:
1
colour
PACKAGE LEAFLET: INFORMATION FOR THE USER
THROATIES MAX STRENGTH SORE THROAT RELIEF
ORIGINAL LOZENGES
READ ALL OF 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 .
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 doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.
You must contact a doctor if your symptoms
worsen or do not improve.
WHAT IS IN THIS LEAFLET
1. What this medicine is and what it is used for
2. 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
Hexylresorcinol and Benzalkonium Chloride Solution
WHAT THIS MEDICINE IS AND WHAT IT
IS USED FOR
1
These lozenges provide relief from painful,
inflamed sore throats. The active ingredients
hexylresorcinol and benzalkonium chloride solution
have antiseptic properties which combat the
bacteria that cause sore throats.
They also act as an anaesthetic to bring soothing
relief from pain and discomfort.
BEFORE YOU TAKE THIS MEDICINE
2
DO NOT
take these lozenges if you are hypersensitive
(allergic) to the active ingredients or any of
the other ingredients in this medicine (listed in
section 6).
give to children under 7 years.
PREGNANCY AND BREAST-FEEDING
Ask your doctor or pharmacist for advice before
taking any medication.
If you are pregnant, or think you may be pregnant
please ask your doctor or pharmacist before using
these lozenges. They may not be suitable for you.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS OF THIS MEDI

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Halls Max Strength Sore Throat Relief Original Lozenges
Throaties Max Strength Sore Throat Relief Original Lozenges
Superdrug Extra Strength Throat Lozenges
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hexylresorcinol 2.5mg and Benzalkonium Chloride Solution 1.2mg
3
PHARMACEUTICAL FORM
Lozenge
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic relief of sore throat, the associated pain and
pharyngitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including the elderly) and children over the age of 12:_ One
lozenge dissolved
slowly in the mouth every three hours or as required. Do not take more
than 8
lozenges in 24 hours.
_Children aged 7 to 12 years:_ One lozenge dissolved slowly in the
mouth every three
hours or as required. Do not take more than 4 lozenges in 24 hours.
Not to be given to
children under 7 years.
4.3
CONTRAINDICATIONS
Patients with hypersensitivity to any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep out of reach & sight of children. If symptoms persist, consult
your doctor.
Contains a total of 2.4g of sucrose and liquid glucose solid per
lozenge. Patients with
rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or
sucrase-isomaltase insufficiency should not take this medicine.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None
4.6
PREGNANCY AND LACTATION
There is a lack of evidence of safety of the product in human
pregnancy and in
animals, but both hexylresorcinol and benzalkonium chloride have been
used widely
in lozenges for many years without apparent ill consequence. However,
as with all
medicines, caution should be exercised during pregnancy and lactation.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None
4.8
UNDESIRABLE EFFECTS
Isolated cases of hypersensitivity reaction, including rash, urticaria
and angioedema,
have been reported. There have been isolated reports of tongue
soreness.
4.9
OVERDOSE
The oral toxic dose o