ORALDENE Mouthwash Ref.[6394] Active ingredients: Hexetidine

ORALDENE mouthwash is for external use only; the solution must therefore not be swallowed.

Excipients with known effect:

This medicine contains 623.5 mg of alcohol (ethanol) in each 15 ml. The amount in 15 ml of this medicine is equivalent to less than 16 ml beer or 7 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.

No interactions are known.

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.

ORALDENE has no or negligible influence on the ability to drive and use machines.

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: 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

None.