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STREPSILS EXTRA CITRUS MENTHOL LOZENGES

Active substance(s): HEXYLRESORCINOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Strepsils Extra Citrus Menthol Lozenges Strepsils Extra Strength Lemon Menthol Lozenges

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Hexylresorcinol Ph Eur 2.4mg For excipients, see 6.1

3

PHARMACEUTICAL FORM
Lozenge

4
4.1

CLINICAL PARTICULARS
Therapeutic indications As an antiseptic and local anaesthetic for the relief of sore throat and its associated pain.

4.2

Posology and method of administration For oral administration Adults, the elderly and children 6 years and over: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 12 lozenges in 24 hours. Not to be given to children under 6 years.

4.3

Contraindications Hypersensitivity to any of the ingredients.

4.4

Special warnings and precautions for use The label will convey: Do not exceed the stated dose. Keep out of the reach of children. Not to be given to children under 6 years. This product is unsuitable hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrose-isomaltase deficiency.

4.5

Interaction with other medicinal products and other forms of interaction None known.

4.6

Pregnancy and lactation There is a lack of evidence of safety of the product in human pregnancy, but hexylresorcinol has been used widely in lozenges for many years without apparent ill consequence. However as with all medicines, caution should be exercised during pregnancy and lactation.

4.7

Effects on ability to drive and use machines No adverse effects known.

4.8

Undesirable effects None known.

4.9

Overdose Hexylresorcinol overdosage may cause minor gastrointestinal irritation. Treatment would be withdrawal of the product and symptomatic measures as appropriate.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Hexylresorcinol is a local anaesthetic for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated. The product base has a demulcent action.

5.2

Pharmacokinetic properties Pharmacokinetic considerations do not arise since the pharmacological action is local to the oropharyngeal cavity.

5.3

Preclinical safety data There are no pre-clinical data available specific to the product.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients Liquid Sucrose, Liquid Glucose, Propylene Glycol, Levomenthol, Lemon Flavour, Quinoline Yellow (E104), Indigo Carmine (E132).

6.2

Incompatibilities Not applicable

6.3

Shelf life 24 months

6.4

Special precautions for storage Do not store above 25C. Store in the original packaging. Keep in the outer carton.

6.5

Nature and contents of container Blister packs of 250 micron PVC coated 40 gsm PVDC with 20 micron hard temper aluminium foil, heat sealed to the PVC/PVDC blister containing 6, 8, 10, 12, 16, 20, 24, 32 or 36 lozenges in a carton. Not all pack sizes may be marketed.

6.6

Special precautions for disposal None specific to the product/ pack

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd Slough SL1 3UH

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0394

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/04/2010

10

DATE OF REVISION OF THE TEXT
06/04/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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