Name of the Medicinal Product

Tesco Antiseptic Lozenges Lemon Flavour

Superdrug Honey & Lemon Sore Throat Lozenges

Morrisons Antiseptic Throat Lozenges Honey & Lemon Flavour

Sainsbury’s Throat Lozenges Honey & Lemon

Boots Sore Throat Relief 0.6 mg Lozenges Honey & Lemon Flavour

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Amylmetacresol BP 0.6 mg per Lozenge

3.    PHARMACEUTICAL FORM

Lozenge

4 CLINICAL PARTICULARS

4.1. Therapeutic indications

For the relief of sore throat and coughs

4.2. Posology and method of administration

Adults, the Elderly, and Children aged 3 years and over:-Suck one lozenge slowly as required.

Do not take more than 12 lozenges in 24 hours.

Not to be given to children under 3 years.

4.3. Contraindications

Hypersensitivity to any of the ingredients.

Special warnings and precautions for use

Keep out of reach and sight of children. If symptoms persist consult your doctor. Not to be given to children under 3 years.

Contains a total of 2.4g of sucrose and glucose per lozenge. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5. Interactions with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no or inadequate evidence of the safety of the active ingredients in this medicine in human pregnancy. The potential risk for humans is unknown.

In the absence of sufficient data, the use during pregnancy is not recommended. Lactation

It is not known whether the active ingredients of this product are excreted in human breast milk.

In the absence of sufficient data, the use during lactation is not recommended.

Fertility

Studies on the effects on fertility have not been investigated.

4.7.    Effects on ability to drive and use machines

None known.

4.8.    Undesirable Effects

The following adverse events have been reported during post-marketing experience with amylmetacresol-containing products:

Immune system disorders Frequency unknown - Hypersensitivity

Gastrointestinal disorders Frequency unknown - Glossodynia

4.9.    Overdose

Theoretically symptoms are possible in children if at least 50 lozenges (more than 4 packs) are consumed in a short space of time. In such extreme overdosage, related to

menthol ingestion, symptoms may include nausea and vomiting, diarrhoea, profuse sweating and intense thirst.

5 PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Amylmetacresol is an antiseptic.

The product base has a demulcent action.

5.2. Pharmacokinetic properties

Pharmacokinetic considerations do not arise since the pharmacological action is local to the oro-pharangeal cavity and the constituents are systemically innocuous in the concentrations used.

5.3 Preclinical safety data

No relevant data on the product are available.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose Liquid Glucose Tartaric Acid Menthol, Laevo Lemon Flavour Honey Flavour 510167E Betacarotene E160a

6.2. Incompatibilities

None.

Shelf life

36 months for the unopened pack.

6.4. Special precautions for storage

None.

6.5 Nature and contents of container

Lozenges are individually wrapped in wax paper, 10 gsm and packed in flexible laminate containers of paper/aluminium foil/polyethylene 12 gsm.

Pack sizes: 8 and 12 lozenges.

Individual blisters of 250micron PVC coated 40gsm PVDC, lidded with HT aluminium foil of 20 micron. Packs sizes: 12 (1x12), 16 (2x8), 24 (2x12), 36 (3x12) lozenges.

Not all pack sizes may be marketed.

6.6. Instructions for use, handling and disposal

None specific to the product/pack.

7. MARKETING AUTHORISATION HOLDER

Ernest Jackson & Co. Ltd.

High Street Crediton Devon EX17 3AP UK

8. MARKETING AUTHORISATION NUMBER

PL 00094/0012

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18^th November 1993. Renewed: 29^th December 1998

DATE OF REVISION OF THE TEXT

25/02/2015