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STREPSILS COOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Strepsils Cool

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amylmetacresol BP 2,4-Dichlorobenzyl alcohol HSE For excipients, see 6.1 0.6mg 1.2mg

3

PHARMACEUTICAL FORM
White to pale yellow coloured lozenge with a characteristic taste of cool mint and the Strepsils brand icon intagliated on both sides

4
4.1

CLINICAL PARTICULARS
Therapeutic indications For the symptomatic relief of mouth and throat infections.

4.2

Posology and method of administration Adults: One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.

Children over 12 years: One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 8 lozenges in 24 hours. Elderly: There is no need for dosage reduction in the elderly. Not suitable for children under 12 years. For oral administration.

4.3

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.
Patients with rare hereditary problems of fructose intolerance, glucose-glalctose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.

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 of Strepsils Cool has not been established, therefore not recommended.

4.7

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

4.8

Undesirable effects Occasional hypersensitivity reactions.

4.9

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

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5.1

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

5.2

Pharmacokinetic properties
Pharmacokinetically the active ingredients, when present in a dosage form such as a lozenge, will exert their desired effect locally on the oropharynx.

5.3

Preclinical safety data There are no preclinical data of relevance to the prescriber, which are additional to that included in other sections of the SPC.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients Xylitol Cool Mint Sensation Flavour (contains propylene glycol). Levomenthol Spearmint Eucalyptus oil Liquid Sucrose Liquid Glucose

6.2

Incompatibilities Not applicable.

6.3

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

6.4

Special precautions for storage
Do not store above 25C.

6.5

Nature and contents of container
A blister push-through pack consisting of 15 or 20m hard temper aluminium foil heat-sealed to a 250m PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give pack sizes of 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36, 40, 44, 48 and 720 lozenges in a cardboard carton or a flow wrap composed of PET/aluminium foil/polyethylene A blister push-through pack consisting of 15 or 20m hard temper aluminium foil heat-sealed to a 250m PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of 8 lozenges in a wrap around 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. 20 lozenges consisting of a bundled pack of 2 tubes of 10 lozenges each. Not all pack sizes may be marketed.

6.6

Special precautions for disposal Not applicable.

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

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MARKETING AUTHORISATION NUMBER(S)
PL 00063/0469

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/02/2010

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DATE OF REVISION OF THE TEXT
18/09/2012

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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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