Beechams Max Strength Sore Throat Relief Lemon and Honey Lozenges

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BENZALKONIUM CHLORIDE, HEXYLRESORCINOL

Available from:

GlaxoSmithKline Consumer Health-care UK Trading Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

ATC code:

R02AA12

INN (International Name):

BENZALKONIUM CHLORIDE 95.6 mg HEXYLRESORCINOL 1.2 mg

Pharmaceutical form:

LOZENGE

Composition:

BENZALKONIUM CHLORIDE 95.6 mg HEXYLRESORCINOL 1.2 mg

Prescription type:

OTC

Therapeutic area:

THROAT PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-04-13

Patient Information leaflet

MAX STRENGTH
_LEMON & HONEY FLAVOUR_
_LOZENGES_
_Hexylresorcinol, Benzalkonium chloride_
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need
to use Beechams Max Strength Sore Throat Lemon & Honey
Flavour Lozenges carefully to get the best results from them.
• Keep this leaflet you may need to read it again.
• If you have any questions, or if there is anything you do not
understand, ask your pharmacist.
IN THIS LEAFLET:
1. What Beechams Max Strength Lozenges do
2. Check before you take Beechams Max Strength Lozenges
3. How to take Beechams Max Strength Lozenges
4. Possible side effects
5. How to store Beechams Max Strength Lozenges
6. Further information
1. What Beechams Max Strength Lozenges do
BEECHAMS MAX STRENGTH LOZENGES ARE USED FOR THE RELIEF OF THE
SYMPTOMS OF SORE THROAT, ITS ASSOCIATED PAIN AND PHARYNGITIS
(INFLAMMATION OF THE THROAT).
This medicine contains two active ingredients. Hexylresorcinol
is an anaesthetic to numb pain in the throat and it is also a mild
antibacterial agent which kills bacteria and germs. Benzalkonium
chloride is also an antibacterial agent which kills bacteria and
germs.
2.
Check before you take Beechams Max
Strength Lozenges
DO NOT TAKE BEECHAMS MAX STRENGTH LOZENGES
• IF YOU HAVE EVER HAD AN ALLERGIC REACTION to hexylresorcinol,
benzalkonium chloride or any of the other ingredients (listed in
Section 6).
• if you have SUGAR ABSORPTION PROBLEMS.
• IF YOU HAVE BEEN TOLD BY YOUR DOCTOR THAT YOU HAVE AN
INTOLERANCE TO SOME SUGARS CONTACT YOUR DOCTOR BEFORE TAKING
THIS MEDICINE.
• if you are UNDER 7 YEARS.
PREGNANCY AND BREAST FEEDING
TALK TO YOUR DOCTOR before taking Beechams Max Strength
Lozenges if you are PREGNANT or BREAST FEEDING.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS
Each lozenge contains a total amount of GLUCOSE AND SUCROSE
OF UP TO 2.5 G. This should be taken into account if you have
diabetes mellitus.
L20220 8.0PT 9.6PT 100% 8.0PT N
L20220
GSK-POL-POZNA

Summary of Product characteristics

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Beechams Max Strength Sore Throat Lemon and Honey Flavour 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
Hypersensitivity to any of the active ingredients or excipients.
Patients with metabolic disorders relating to glucose/sucrose
ingestion or fructose intolerance
Page 2 of 5
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Keep out of the reach and sight of children
If symptoms persist consult your doctor.
Do not exceed the stated dose
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this
medicine.
Contains 2.5 g of total glucose and sucrose per lozenge. This should
be taken into
account in patients with diabetes mellitus.
4.5.
INTERACTIONS 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
Gastrointestinal Disorders: Local irritations or inf