SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Strepsils Orange with Vitamin C 100mg Strepsils Dry & Sore Throat

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Amylmetacresol BP 0.6mg 2,4-Dichlorobenzyl Alcohol HSE 1.2mg

Vitamin C, (Ascorbic Acid, Sodium Ascorbate Equivalent to EP) 100.0mg

3 PHARMACEUTICAL FORM

Orange flavoured and coloured circular lozenge.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of mouth and throat infections.

4.2 Posology and method of administration

For oral administration.

Adults and children (over 6 years old):

One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.

Not suitable for children under 6 years.

Elderly:

There is no need for dosage reduction in the elderly.

Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Keep all medicines out of the reach of children.

If symptoms persist consult your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions are known.

4.6 Pregnancy and lactation

The safety has not been established, but it is not considered to constitute a hazard.

4.7 Effects on ability to drive and use machines

No adverse effects are known.

4.8 Undesirable effects

Occasionally hypersensitivity reactions.

4.9 Overdose

Overdosage should not present a problem other than gastrointestinal discomfort.

Treatment should be symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Ascorbic acid provides a source of vitamin C, which may be beneficial during infection when vitamin C levels are believed to fall.

5.2 Pharmacokinetic properties

None stated.

5.3 Preclinical safety data

None available.

6.1 List of Excipients

Menthol natural or menthol synthetic Tartaric acid

Blood Orange PHL 105288 Propylene glycol Sunset yellow FCF (E110)

Ponceau 4R (E124)

Solids from liquid sugar demin (or from) liquid sugar T & L T1001 Liquid glucose BPC 1963.

6.2 Incompatibilities

Not applicable.

36 months for lozenges packed in blister strips within a carton.

18 months for blister packs attached to a stencilled card.

24 months for lozenges packed in polypropylene tube, with an in-use shelf life of ‘use within 3 months of opening’.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 16, 20, 24, 32 and 36 lozenges in a cardboard carton.

A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. Two, four or six blisters are attached to a stencilled card.

A blister push-through pack consisting of hard temper aluminium foil heat-sealed to a PVC/PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 8 lozenges in a wrap-round cardboard carton with tamper-evident seal.

An injection moulded white pigmented polypropylene tube with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).

The tube contains 10 lozenges.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Ltd

Slough SL13UH

8    MARKETING AUTHORISATION NUMBER(S)

PL 00063/0391

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/03/2010

10 DATE OF REVISION OF THE TEXT

27/10/2014