Oraldene Icemint
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ORALDENE ICEMINT
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ORALDENE ICEMINT contains 0.1% w/v hexetidine.
For the full list of excipients, see section 6.1.
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 postdental surgery.
4.2 Posology and method of administration
Posology
Usual dosage in adults and children 6 years and over:
Method of administration
Shake well before use. Rinse the mouth, or gargle with at least 15 ml of undiluted solution, two or three times a day. Do not swallow the solution but spit out after use.
4.3
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
ORALDENE ICEMINT mouthwash is for external use only; the solution must therefore not be swallowed.
Not suitable for persistent symptoms.
4.5 Interaction with other medicinal products and other forms of interaction
No interactions are known.
4.6 Fertility, 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 has no or negligible influence on the ability to drive and use machines.
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.
Adverse drug reactions (ADRs) identified during post-marketing experience with hexetidine are included in the tables below. The frequencies are provided according to the following convention:
Very common 1/10 Common 1/100 and <1/10 Uncommon 1/1,000 and <1/100 Rare 1/10,000 and <1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
ADRs identified during post-marketing experience are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, when available or 2) when incidence is unavailable, frequency category is listed as Not known.
Table 1 Adverse Drug Reactions Identified During Post-Marketing Experience with Hexetidine by Frequency Category Estimated from Clinical Trials or Epidemiology Studies:
Immune System Disorders
Not known Hypersensitivity reactions*;
Angioedema
Nervous System Disorders
Very rare Dysgeusia
Not known Ageusia
Respiratory, Thoracic and Mediastinal Disorders
Not known Cough; Dyspnoea**
Gastrointestinal Disorders
Not known Dry mouth; Dysphagia; Nausea;
Salivary gland enlargement;
Vomiting
General Disorders and Administration Site Conditions
Very rare Transient anaesthesia
Not known Application site reactions***
*Inclusion of the PT of hypersensitivity reactions was based on cases reporting the following additional MedDRA PTs: Hypersensitivity and Urticaria.
** Observed in the context of Hypersensitivity.
*** Inclusion of the PT of Application site reactions was based on cases reporting multiple MedDRA PTs. These included Mouth and Throat mucosa irritation, Paraesthesia oral, Tongue discolouration, Tooth discolouration, Inflammation, Blistering and Ulceration.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms
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.
No adverse effects have been reported in overdose other than those seen in normal use.
Hexetidine, at the strength present in ORALDENE ICEMINT, is unlikely to be toxic when used as directed.
Ingestion of sufficient quantities of hexetidine in alcoholic solution may lead to signs/symptoms of alcohol intoxication.
Management
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
Pharmacotherapeutic group: Antiinfectives and antiseptics for local oral treatment. ATC code: A01AB12.
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 prescriber.
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 Levomenthol Sodium Calcium Edetate Sodium Hydroxide E524 Purified water
6.2. Incompatibilities
None.
6.3 Shelf life
2 years. 6 months after first opening.
6.4 Special precautions for storage
Store below 30°C. Keep the bottle in the outer carton in order to protect from light.
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.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
UK
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
24/05/2016