ORALDENE Mouthwash (2021)
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Περιεχόμενα
Name of the medicinal product
ORALDENE.
Qualitative and quantitative composition
ORALDENE contains 0.1% w/v hexetidine. <u>Excipients with known effect:</u> Ethanol (96%) 4.3 g per 100ml (4.33% w/v) Azorubine (E122) For the full list of excipients, see section 6.1.
Pharmaceutical form
Mouthwash. A clear red solution.
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 ...
Posology and method of administration
Posology Adults and children 12 years and over Shake well before use. Rinse the mouth, or gargle with at least 15 ml of undiluted solution, two to three times a day. Do not swallow the solution but spit ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
ORALDENE mouthwash is for external use only; the solution must therefore not be swallowed. <u>Excipients with known effect:</u> This medicine contains 623.5 mg of alcohol (ethanol) in each 15 ml. The amount ...
Interaction with other medicinal products and other forms of interaction
No interactions are known.
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 ...
Effects on ability to drive and use machines
ORALDENE has no or negligible influence on the ability to drive and use machines.
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 ...
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 ...
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 ...
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 ...
Preclinical safety data
Pre-clinical safety data do not add anything of further significance to the prescriber.
List of excipients
Polysorbate 80 Citric acid Saccharin sodium Levomenthol Eucalyptus oil Ethanol 96% Azorubin (85%) (E122) Sodium calcium edetate Sodium hydroxide (E524) Purified water
Incompatibilities
None.
Shelf life
2 years. 6 months after first opening.
Special precautions for storage
Do not store above 30°C. Keep the bottle in the outer carton in order to protect from light.
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 ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Marketing authorization number(s)
PL 15513/0067
Date of first authorization / renewal of the authorization
29<sup>th</sup> April 1998
Date of revision of the text
24 February 2021
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