Reckitt Benckiser Ireland Limited

Strepsils Warm Lozenges

Amylmetacresol 0.6mg

2, 4-Dichlorobenzyl Alcohol 1.2mg

Each lozenge contains:

Also contains glucose 1.1g, sucrose 1.4g propylene glycol

For a full list of excipients, see section 6.1

Lozenge

A circular, biplanar red to purple lozenge with a characteristic warm taste of plum and ginger, embossed on both sides with strepsils brand icon.

For mouth and throat infections

Adults and children: One lozenge to be dissolved slowly in the mouth every 2-3 hours or as directed by a physician.

Elderly: There is no need for dosage reduction in the elderly.

For oral administration.

Hypersensitivity to any of the ingredients.

Keep all medicines out of reach of children.

Consult your doctor if symptoms persist or if anything unusual happens

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine

No clinically significant interactions are known

The safety of Strepsils during pregnancy and lactation has not been established, but it is not considered to constitute a hazard during these periods.

No adverse effects are known.

Occasionally hypersensitivity reactions.

Overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.

2, 4-Dichlorobenzyl alcohol and amymetacresol have antiseptic properties.

None stated.

Not applicable.

Fruity Plum Flavour

Soothing Cream Flavour

Warm Sensation Flavour

Tartaric acid

Warm ginger spice flavour

Anthocyanins (E163)

Sucrose

Glucose

Medicum Chain Triglycerides

Propylene glycol (component of flavours)

Not applicable.

2 years for lozenges packed in blister strips within a carton.

3 years for lozenges packed in polypropylene tubes, with an 'in use' shelf life of 3 months.

Blister: Do not store above 25°C.

Tube: Do not store above 25°C. keep the tube tightly closed in order to protect from moisture.

A blister push-through tray of PVC/PVDC laminate heat-sealed to aluminium foil.

24 lozenges (each blister tray contains 12 lozenges packed in a carton).

8 lozenges (one tray contains 8 lozenges in a wrap around cardboard carton with tamper-evident seal).

2 lozenges pack.

An injected moulded white pigmented polypropylene tube with a plastic spring and an injected moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc. The tube contains 10 lozenges.

Not all pack sizes may be marketed.

Not special requirements.

Reckitt Benckiser Ireland Ltd.,

7 Riverwalk,

Citywest Business Campus,

Dublin 24

PA 979/58/1

Date of first authorisation: 24^th July 2009

August 2011