Patient Leaflet Updated 21-Oct-2019 | Diomed Developments Limited
PACKAGE LEAFLET Information for the user
mouth ulcer treatment
lidocaine hydrochloride monohydrate 0.66% w/w, aminoacridine hydrochloride 0.05% w/w
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 get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor, dentist or pharmacist.
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
2. BEFORE YOU USE IGLÜ GEL
Do not use Iglü Gel if you are allergic (hypersensitive) to lidocaine hydrochloride monohydrate, aminoacridine hydrochloride or any of the other ingredients of Iglü Gel listed in Section 6.
Not suitable for treatment of teething in children.
It is very important that you tell your doctor or dentist if you have an unexplained mouth ulcer that 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.
Take special care when using this product:
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 is safe for use during pregnancy and breast-feeding. The potential risks are unknown. If in doubt, ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machinery
Using this product is not known to affect your ability to drive or use machinery.
3. HOW TO USE IGLÜ GEL
Only use Iglü Gel for mouth ulcers.
For adults, the elderly and children over 7 years of age:
If the gel accidentally gets into the eyes it may cause irritation. If it gets into the eyes, rinse immediately with plenty of water and continue rinsing for 10 to 15 minutes, holding the eyelids well apart. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, contact a doctor.
If you use too much Iglü Gel overdosage of the active ingredients is unlikely to occur because of the low concentrations used and the small pack size. Overdose may make swallowing difficult due to the loss of feeling. This may increase the risk of food or drink going down the wrong way. Generalised numbness of the mouth may also lead to biting the inside of your mouth when eating.
Excessive overdose may also lead to generalised side effects. If you experience any of the following, seek urgent medical attention; nervousness, drowsiness, breathing problems or low blood pressure.
If you occasionally forget to use Iglü Gel do not worry, just carry on using it when you remember.
If you have any further questions on the use of this product, ask your doctor, dentist or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Iglü Gel can cause side effects, although not everybody gets them. On rare occasions, hypersensitivity reactions to lidocaine hydrochloride monohydrate and aminoacridine hydrochloride can occur, involving wheezing or shortness of breath. Seek urgent medical attention if you experience these symptoms. If you experience any other symptoms not mentioned in this leaflet, stop using the product and tell your doctor, dentist or pharmacist.
Overdose can also lead to other side effects (see section above: If you use too much Iglü Gel).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE IGLÜ GEL
6. FURTHER INFORMATION
What Iglü Gel contains:
The active ingredients are
lidocaine hydrochloride monohydrate (0.66% w/w) and aminoacridine hydrochloride (0.05% w/w).
The other ingredients are carbomer, hydroxypropylcellulose, white soft paraffin, liquid paraffin and peppermint oil.
What Iglü Gel looks like and contents of the pack
The Marketing Authorisation holder is:
The Manufacturer is:
The Distributor is:
This Patient Information Leaflet was last revised in July 2019.
To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information: Iglü Gel, 00173/0186.
This is a service provided by the Royal National Institute of Blind People (RNIB).
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866
+44 (0)1462 420 565