Hexetidine

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 hexetidine 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.

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

Hexetidine is generally very well tolerated with a low potential for causing irritation, or sensitisation reactions. Prolonged use of hexetidine 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 list 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.

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.