Iglu oromucosal gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aminoacridine hydrochloride; Lidocaine hydrochloride

Available from:

Dendron Ltd

INN (International Name):

Aminoacridine hydrochloride; Lidocaine hydrochloride

Dosage:

500microgram/1gram ; 6.6mg/1gram

Pharmaceutical form:

Oromucosal gel

Administration route:

Oromucosal; Gingival

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5016379296604

Patient Information leaflet

mouth ulcer treatment
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS PRODUCT.
Keep this leaflet. You may need to read it again. Ask your doctor,
dentist or pharmacist
if you need more information or advice. You must contact a doctor or
dentist if your symptoms
worsen or do not improve. If any of the side effects gets serious, or
if you notice any side effect
not listed in this leaflet, please tell your doctor, dentist or
pharmacist.
lidocaine hydrochloride 0.66% w/w,
aminoacridine hydrochloride 0.05% w/w
IN THIS LEAFLET:
1. What Iglü Gel is and what it is used for
2. Before you use Iglü Gel
3. How to use Iglü Gel
4. Possible side effects
5. How to store Iglü Gel
6. Further information
1. WHAT IGLÜ GEL IS AND WHAT
IT IS USED FOR
• Iglü Gel is a treatment for fast, effective
relief of pain from common mouth ulcers,
sore gums and denture rubbing.
• The product, which at first looks like a
pale yellow paste, forms a smooth, flexible
and adhesive protective gel coating when
it becomes wet on contact with saliva
inside the mouth.
• Iglü Gel is suitable for use by ADULTS,
THE ELDERLY AND CHILDREN OVER 7 YEARS
OF AGE.
• The product works in three ways:
• by forming a gel coating to protect the
sensitive and delicate area of the mouth
lining as it heals, and
• by the actions of its two ACTIVE
INGREDIENTS, lidocaine hydrochloride
and aminoacridine hydrochloride,
which work by:
•
stopping pain (lidocaine
hydrochloride is a local anaesthetic),
and
•
preventing infection (aminoacridine
hydrochloride is an antiseptic).
2. BEFORE YOU USE IGLÜ GEL
DO NOT USE Iglü Gel if you are ALLERGIC
(HYPERSENSITIVE) to lidocaine hydrochloride,
aminoacridine hydrochloride or any of the
other ingredients of Iglü Gel listed in Section 6.
TAKE SPECIAL CARE when using this product:
• Apply it sparingly.
• Keep the product away from your eyes.
USING OTHER MEDICINES
Iglü Gel is not known to affect, or to be
affected by, any other medicines.
PREGNANCY AND BREAST-FEEDING
It is unclear whether this product i

Summary of Product characteristics

OBJECT 1
IGLU GEL
Summary of Product Characteristics Updated 10-Jun-2015 | Diomed
Developments Limited
1. Name of the medicinal product
IGLÜ
®
GEL
2. Qualitative and quantitative composition
Lidocaine Hydrochloride 0.66% w/w; Aminoacridine Hydrochloride 0.05%
w/w.
For excipients, see section List of Excipients.
3. Pharmaceutical form
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 Iglü 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 Interaction 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 Preclinical
Safety Data). 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