IGLU GEL - patient leaflet, side effects, dosage

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 Iglu Gel is and what it is used for

• 2. Before you use Iglu Gel

• 3. How to use Iglu Gel

• 4. Possible side effects

• 5. How to store Iglu Gel

• 6. Further information

1. WHAT IGLU GEL IS AND WHAT IT IS USED FOR

• Iglu Gel is a treatment for fast, effective relief of pain from common mouth ulcers.
• 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.
• Iglu 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 monohydrate and aminoacridine hydrochloride, which work by:
• stopping pain (lidocaine hydrochloride monohydrate is a local anaesthetic), and
• preventing infection (aminoacridine hydrochloride is an antiseptic).

2. before you use iglu gel

Do not use Iglu Gel if you are allergic (hypersensitive) to lidocaine hydrochloride monohydrate, aminoacridine hydrochloride or any of the other ingredients of Iglu 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: Apply it sparingly.
• Keep the product away from your eyes.

Using other medicines

Iglu 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 iglu gel

Only use Iglu Gel for mouth ulcers.

For adults, the elderly and children over 7 years of age:

• Wash your hands before and after use.
• If you are treating several ulcers, repeat steps 1 to 3 below for each one:

• 1. Use a clean tissue to gently remove excess moisture/saliva from the ulcer area.

• 2. Squeeze a small quantity of Iglu onto a clean, dry finger tip or cotton bud, and then apply it directly to the ulcer using a single, gentle wiping action (avoid dabbing).

• 3. At first, the product may seem quite pasty and sticky, but after contact with saliva, the product will form a flexible and adhesive gel coating over and around the ulcer area.

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• Re-apply the gel, following steps 1 to 3 above, as necessary for each ulcer. The aim is to keep the ulcer area(s) protected with a coating of gel. As a guide, each application should normally last for an hour or more, although, on occasions, eating or drinking may make it necessary to re-apply the gel. In some cases, Iglu may remain in place for several hours, as it has strong adhesive properties.
• Do not apply excessive amounts of the gel, and avoid applying gel to the back of the tongue and throat area.
• If you are treating mouth ulcers caused by rubbing from false teeth/dentures etc, avoid using Iglu at the same time (e.g. use the gel at night or when not wearing dentures).

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 Iglu 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 Iglu 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, Iglu 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 Iglu 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:.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store iglu gel

• Keep out of the sight and reach of children.
• Do not use Iglu Gel after the expiry date shown on the fold of the tube and on the carton. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Always replace the cap tightly after use.
• Moisture coming into contact with the nozzle of the tube may cause the gel to thicken and block the opening. If this happens, carefully clear it using a clean pin.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Iglu 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 Iglu Gel looks like and contents of the pack

• Although classified as a gel, when squeezed from the tube the product looks like a thick, pale yellow paste. It forms a flexible and adhesive gel coating when it becomes wet on contact with saliva inside the mouth.
• The product has a peppermint odour and is available in plastic tubes containing 8g.