Blog Nashville: Strepsils Cool

1. Name Of The Medicinal Product

Strepsils Cool

2. Qualitative And Quantitative Composition

Amylmetacresol BP 0.6mg

2,4-Dichlorobenzyl alcohol HSE 1.2mg

For excipients, see 6.1

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. Clinical Particulars

4.1 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.

5. Pharmacological Properties

5.1 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.

6. Pharmaceutical Particulars

6.1 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 25°C.

6.5 Nature And Contents Of Container

A blister push-through pack consisting of 15 or 20µm hard temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister.

The tray contains an appropriate number of lozenges to give pack sizes of 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 20µm hard temper aluminium foil heat-sealed to a 250µm 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 And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 3UH

8. Marketing Authorisation Number(S)

PL 00063/0469

9. Date Of First Authorisation/Renewal Of The Authorisation

11/02/2010

10. Date Of Revision Of The Text