Iglu Gel
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Iglu Gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine Hydrochloride 0.66%w/w Aminoacridine Hydrochloride 0.05%w/w.
For excipients, see 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, soreness of gums and denture rubbing.
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 (or other local anaesthetics of the amide-type), aminoacridine hydrochloride or any of the other ingredients.
4.4 Special warnings and precautions for use
Keep Iglu Gel 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.
If symptoms persist consult your doctor or dentist.
4.5 Interactions with other medicinal products and other forms of interaction
None stated.
4.6 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.
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 PHARMACOLOGICAL PROPERTIES
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 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. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
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.
7. MARKETING AUTHORISATION HOLDER
Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place
Gosmore
Hitchin
Herts SG4 7QR
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00173/0186
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7 March 2001
10 DATE OF REVISION OF THE TEXT
10/08/2010