Reckitt Benckiser Ireland Limited

Strepsils +Plus Anaesthetic Lozenges

Amylmetacresol 0.6mg

2,4-Dichlorobenzyl alcohol 1.2mg

Lidocaine 10mg

Each lozenge contains 0.6 mg Amylmetacresol, 1.2 mg 2, 4-Dichlorobenzyl Alcohol and 10 mg Lidocaine Hydrochloride.

Excipients: also contains glucose 0.98 g and sucrose 1.52 g per lozenge.

For a full list of excipients, see section 6.1.

Lozenge

Pale, blue-green circular lozenges, embossed on both sides with Strepsils brand icon. .

Strepsils +Plus anaesthetic Lozenges are indicated for the symptomatic relief of mouth and throat infections including severe sore throat.

Adults and children over 12 years:

One lozenge to be sucked slowly every two hours as required. No more than 8 to be sucked in any 24 hours.

Children under 12 years:

Not recommended for children under 12 years.

Elderly:

There is no need for dosage reduction in the elderly.

Strepsils +Plus anaesthetic Lozenges are contraindicated in persons who have previously shown hypersensitivity to any of the ingredients.

Not recommended for children under 12 years.

Warning: Do not exceed the stated dose.

Keep all medicines out of the reach of children.

Consult your doctor if symptoms persist or are accompanied by high fever or headache, or if anything unusual happens.

Consult your doctor before taking this product if you are pregnant or breast feeding.

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 this medicinal product for use in human pregnancy has not been established. The product is therefore not recommended during pregnancy and lactation except under medical supervision.

No adverse effects are known.

Occasional hypersensitivity reactions.

In view of the nature and presentation of Strepsils +Plus Anaesthetic Lozenges, accidental or deliberate overdosage is unlikely.

Overdosage will initially produce excessive anaesthesia of the upper alimentary tract. Treatment of potentially toxicological overdose should be symptomatic and supportive and conducted under medical supervision.

2,4-Dichlorobenzyl Alcohol and Amylmetacresol have antiseptic properties. Lignocaine is a local anaesthetic of the amide type.

Lignocaine is readily absorbed from mucous membranes. The plasma elimination half life is about 2 hours.

Lignocaine undergoes significant first pass metabolism in the liver and is rapidly de-ethylated to the active metabolite and then hydrolysed to various metabolites including glycinexylidide. Less than 10% is excreted unchanged by the kidneys. The metabolites are also excreted in the urine.

No data available on amylmetacresol and 2, 4-dichlorobenzyl alcohol.

Not applicable.

Tartaric acid

Sodium saccharin

Levomenthol

Peppermint oil

Star Anise oil

Quinoline yellow (E104)

Indigo carmine (E132)

Liquid sucrose

Liquid glucose

Not applicable.

3 years.

Do not store above 25°C.

The lozenges are contained in an AL/PVC/PVDC blister strip pack.

Pack size: 24 lozenges in two blister strips (2 x 12) in a cardboard carton.

No special requirements.

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

PA 979/40/1

Date of first authorisation: 03 October 1995

Date of last renewal: 03 October 2010

October 2011