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ORALDENE Mouthwash (2021)

Αναφορές

Βιβλιογραφική αναφορά

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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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