STREPSILS INTENSIVE Lozenge Ref.[50291] Active ingredients: Flurbiprofen

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Strepsils Intensive 8.75 mg Lozenges.

Pharmaceutical Form

Lozenge.

Clear, round lozenge.

Qualitative and quantitative composition

Active Ingredient flurbiprofen 8.75mg

Excipients with known effects:

Glucose 1.069 g/lozenge. Total maximum daily dose (MDD) is 5.345 g.

Sucrose 1.407 g/lozenge. Total MDD is 7.035 g.

Invert Sugar (Honey) 50.3 mg/lozenge. Total MDD is 0.2515 g.

Sulphites-Sulphur Dioxide (E220) 0.137 ppm/lozenge which is present in liquid glucose.

Wheat Starch (containing gluten), one lozenge contains no more than 21.38 micrograms of gluten which is present in liquid glucose.

Butylated hydroxyanisole (E320) present in Lemon flavour (0-1%).

Lemon flavour containing allergens (citral, citronellol, d-Limonene, farnesol, geraniol and linalool).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Flurbiprofen

Flurbiprofen is a propionic acid derivative NSAID which acts through inhibition of prostaglandin synthesis. In humans flurbiprofen has potent analgesic, antipyretic and anti-inflammatory properties.

List of Excipients

Macrogol 300
Potassium Hydroxide
Lemon Flavour (butylated hydroxyanisole (E320), citral, citronellol, d-Limonene, farnesol, geraniol and linalool)
Levomenthol
Liquid Glucose (wheat starch containing gluten, sulphur dioxide (E220)
Liquid sucrose
Honey

Pack sizes and marketing

Lozenges are packed in blisters made up of white opaque 250micron Polyvinyl Chloride (PVC), coated with 40gsm or 90gsm Polyvinylidene Chloride (PVDC); heat sealed to 20 microns Aluminium lidding material coated with 7gsm of heat sealing lacquer containing 16 lozenges.

Marketing authorization holder

Reckitt Benckiser Ireland Ltd, 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0979/041/001

Date of first authorisation: 07 March 2003
Date of last renewal: 07 March 2008

Drugs

Drug Countries
STREPSILS INTENSIVE Ecuador, Estonia, Ireland, Lithuania, Nigeria, Poland, Romania, South Africa

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