IGLU GEL - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Iglu Gel

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Lidocaine hydrochloride monohydrate 0.66% w/w

Aminoacridine hydrochloride 0.05% w/w

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oromucosal Gel

Soft, pale yellow, slightly opalescent oromucosal gel.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For fast, effective relief from the pain of common mouth ulcers.

4.2 Posology and method of administration

For use in the mouth.

For adults, the elderly and children over 7 years old.

Apply sparingly, directly to the affected area(s) with a clean finger tip or a cotton wool bud. Re-apply as necessary – the aim being to keep the affected area(s) protected with a thin layer of gel. As a guide, each application should normally last for an hour or more, although eating and/or drinking may necessitate more frequent re-application. In some cases, applications may remain in place for several hours.

4.3 Contraindi­cations

Do not use in cases of known sensitivity to lidocaine hydrochloride monohydrate (or other local anaesthetics of the amide-type), aminoacridine hydrochloride or any of the other ingredients.

4.4 Special warnings and precautions for use

Not suitable for treatment of teething in children.

Keep the product away from the eyes. In case of accidental contact, wash eye immediately with water: keep rinsing for 10 to 15 minutes, holding the eyelids well apart and avoid getting the rinse liquid into the other eye. Consult a doctor if irritation persists.

It is very important that a doctor or dentist is consulted where an unexplained mouth ulcer lasts for more than 3 weeks or keeps coming back. This is to exclude the rare possibility of oral cancer, which can benefit from early diagnosis and treatment.

4.5 Interactions with other medicinal products and other forms of interaction None stated.

4.6 Fertility, pregnancy and lactation

Animal studies are insufficient with respect to effects on pregnancy and lactation (see section 5.3). The potential risk for humans is unknown.

Caution should therefore be exercised before recommending this treatment for use during pregnancy and lactation.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Rare instances of hypersensitivity reactions to lidocaine and aminoacridine have been reported.

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.

4.9 Overdose

Overdosage is unlikely to be a problem because of the low formulated concentrations. Severe overdosage (e.g. if a large quantity is swallowed) may impair swallowing and this enhances the risk of aspiration. Likewise, generalised numbness of the tongue or buccal membranes may lead to biting trauma when eating. Systemic adverse reactions to excessive overdosage include excitory and depressant effects on the CNS and depressant cardiovascular reactions. Emergency treatment of such systemic side effects should be directed to assuring adequate ventilation and averting convulsions. In the meantime, use of this product should be discontinued.

5.1 Pharmacodynamic properties

Iglu Gel is strongly mucoadhesive, thereby localising the active ingredients in a depot over the site(s) of application and forming a physical barrier to protect the sensitive and delicate underlying lesion as it heals.

Applied topically to mucous membranes, lidocaine hydrochloride monohydrate produces rapid, local and superficial anaesthesia which lasts for up to 30 minutes. Its mode of action is to prevent initiation of nerve impulses.

Aminoacridine hydrochloride acts as a broad spectrum antiseptic by disrupting microbial metabolic pathways.

5.2 Pharmacokinetic properties

The active ingredients are readily absorbed through mucous membranes. Both are rapidly metabolised, even when swallowed. This, and the low doses involved, means that systemic effects are very unlikely.

5.3 Preclinical safety data

No relevant information additional to that contained elsewhere in this SPC.

6.

6.1

Carbomer

Hydroxypropyl­cellulose

White Soft Paraffin

Liquid Paraffin Peppermint Oil

6.2 Incompatibilities

None encountered.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

1) 8 g high density polyethylene (HDPE) tube with HDPE/linear low density polyethylene (LLDPE) nozzle and polypropylene cap

2) 8 g co-extruded HDPE laminate tube with inclined HDPE nozzle and polypropylene cap.

3) 8 g enamelled, internally lacquered, aluminium tube with membrane seal and spiked polyethylene screw cap.

6.6 Instruction for use and handling

Not applicable.