ORALDENE

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 out after use. Children under 12 years Not recommended.

Method of administration For oromucosal use.

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.

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 Not known Dysgeusia 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 Not known Transient anaesthesia 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.

ORALDENE mouthwash is for external use only; the solution must therefore not be swallowed. 8 mg of alcohol (ethanol) in each 15 ml. The amount in 15 ml of this medicine is equivalent to less than 15 ml beer or 6 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

Azorubine (E122) may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per 15 ml, that is to say essentially ‘sodium-free’. Not suitable for persistent symptoms.

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