Oraldene Icemint

1. Name Of The Medicinal Product

ORALDENE ICEMINT

2. Qualitative And Quantitative Composition

ORALDENE ICEMINT contains 0.1% w/v hexetidine.

3. Pharmaceutical Form

Mouthwash.

A clear blue green mouthwash.

4. Clinical Particulars

4.1 Therapeutic Indications

ORALDENE ICEMINT is indicated for use in minor mouth infections including thrush, as an aid in the prevention and treatment of gingivitis, and in the management of sore throat and recurrent aphthous ulcers. ORALDENE ICEMINT is also of value in the alleviation of halitosis and pre- and post- dental surgery.

4.2 Posology And Method Of Administration

Adults and children 12 years and over

Topical administration to the buccal cavity.

Rinse the mouth, or gargle with at least 15 ml of undiluted solution, two or three times a day.

ORALDENE ICEMINT should not be swallowed in large quantities.

Children aged 6 to 11 years

As recommended for adults.

Children under 6 years

Not recommended.

The Elderly

As recommended for adults.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions are known.

4.6 Pregnancy And Lactation

No formal studies have been conducted in man. However, on the basis of animal studies and, in theory, the negligible systemic absorption it is considered highly unlikely that the use of ORALDENE ICEMINT during pregnancy will present a risk to the foetus.

It is not known whether hexetidine is excreted in human breast milk, however, in view of the negligible amount of hexetidine which could be predicted to be systemically absorbed, it is unlikely that concentrations of hexetidine in the milk will present any risk to the neonate/infant.

4.7 Effects On Ability To Drive And Use Machines

ORALDENE ICEMINT is unlikely to affect ability to drive or operate machinery.

4.8 Undesirable Effects

ORALDENE ICEMINT is generally very well-tolerated with a low potential for causing irritation, or sensitisation reactions. Prolonged use of ORALDENE ICEMINT is also well-tolerated.

Patch testing with of hexetidine containing ointment was negative for irritation or sensitisation potential.

In a few individuals mild irritation (described as sore mouth, burning or itching), of the tongue and/or buccal tissues has been reported. Other side effects which are reported very rarely include transient anaesthesia and taste impairment.

4.9 Overdose

Signs and Symptoms of Overdose

There are no reports of alcohol intoxication from overdose with ORALDENE ICEMINT.

Hexetidine, at the strength present in ORALDENE ICEMINT, is non-toxic.

Acute alcoholic intoxication is extremely unlikely, however, it is theoretically possible that, if a massive dose were swallowed by a small child, alcoholic intoxication may occur due to the ethanol content.

There is no evidence to suggest that repeated, excessive administration of hexetidine would lead to hypersensitivity-type reactions.

Treatment of Overdose

Treatment of overdose is symptomatic, but rarely required. In the event of accidental ingestion of the contents of a bottle by a child, a doctor should be consulted immediately. Gastric lavage should be considered within two hours of ingestion and management should relate to treatment of alcoholic intoxication.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Hexetidine is a broad spectrum antimicrobial. It is active both in vivo and in vitro, against gram positive and negative bacterium, as well as yeasts (Candida albicans) and fungi.

5.2 Pharmacokinetic Properties

Specific pharmacodynamic studies have not been carried out on ORALDENE ICEMINT in man.

The oral retention of hexetidine to mucous membranes and dental plaque has been observed. In studies using radiolabelled hexetidine it has been shown that retention on buccal tissues can extend to between 8 and 10 hours after a single oral rinse and in some cases hexetidine has been detected on oral tissues up to 65 hours post-treatment.

No absorption studies following the topical application of ORALDENE ICEMINT have been performed in man.

Pharmacokinetics in renal/hepatic impairment

There have been no specific studies of ORALDENE ICEMINT or hexetidine in renal/hepatic impairment.

Pharmacokinetics in elderly

There have been no specific studies of ORALDENE ICEMINT or hexetidine in the elderly.

5.3 Preclinical Safety Data

Pre-clinical safety data does not add anything of further significance to the presciber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polysorbate 60

Citric acid

Saccharin sodium

Ethanol 96%

Quinoline Yellow (70%) E104

Patent Blue V (85%) E131

Mint flavour

Purified water

6.2 Incompatibilities

None.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25°C. Keep the container in the outer carton.

6.5 Nature And Contents Of Container

ORALDENE ICEMINT is presented in a clear (Type 3) 200 ml glass bottles, with white aluminium ROPP cap fitted with PET wad or an HDPE plastic cap fitted with a polyterephthalate ethylene faced aluminium/expanded polyethylene laminated wad

Or

a 400ml PET bottle with aluminium ROPP cap fitted with PET wad or an HDPE plastic cap fitted with a polyterephthalate ethylene faced aluminium/expanded polyethylene laminated wad.

6.6 Special Precautions For Disposal And Other Handling

Shake well before use.

Administrative Data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0107

9. Date Of First Authorisation/Renewal Of The Authorisation

26/09/2006

10. Date Of Revision Of The Text

14 January 2010