Oraldene

1. Name Of The Medicinal Product

ORALDENE

2. Qualitative And Quantitative Composition

ORALDENE contains 0.1% w/v hexetidine.

3. Pharmaceutical Form

A clear red solution.

4. Clinical Particulars

4.1 Therapeutic Indications

ORALDENE 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 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 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 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 is unlikely affect ability to drive or operate machinery.

4.8 Undesirable Effects

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

Hexetidine, at the strength present in ORALDENE, 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 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 have been performed in man.

Pharmacokinetics in renal/hepatic impairment

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

Pharmacokinetics in elderly

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

5.3 Preclinical Safety Data

Pre-clinical safety data do not add anything of further significance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polysorbate 60

Citric acid

Saccharin sodium

Peppermint flavour

Star Anise oil

Methyl salicylate

Levomenthol

Clove oil

Eucalyptus oil

Ethanol 96%

Azorubin (85%) (E122)

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 container in outer carton.

6.5 Nature And Contents Of Container

ORALDENE is presented in a clear 100 ml, 200 ml and 30 ml glass bottles, with white aluminium ROPP cap 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 15513/0067

9. Date Of First Authorisation/Renewal Of The Authorisation

29^th April 1998

10. Date Of Revision Of The Text

14 January 2010