Patient Information Leaflet

Aphtheal™ 5% Oromucosal Paste

(amlexanox)    MEDA

Important information before taking your medicine

Please read this leaflet carefully before using Aphtheal for the first time. It contains a summary of information available on the product. If, after reading this you have any questions about Aphtheal ask your pharmacist, doctor or dentist.

What is Aphtheal?

The active ingredient in Aphtheal is amlexanox. Each gram of beige coloured, granular, oral paste contains 50mg of amlexanox.

The paste also contains: liquid paraffin, gelatin, pectin, carmellose sodium, glyceryl monostearate 40-55, soft white paraffin and benzyl alcohol.

Aphtheal is supplied in plastic tubes containing 3 or 5 grams of the oral paste.

Who makes Aphtheal?

The licence holder Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishop’s Stortford, CM22 6PU.

The paste is manufactured by Contract Pharmaceuticals Ltd, Ontario, Canada, L5N 6L6.

What is Aphtheal used for?

The active ingredient in Aphtheal, amlexanox, is an anti-allergic and anti-inflammatory agent. Aphtheal is used for the treatment of minor mouth ulcers in adults. Clinical studies have shown that Aphtheal speeds up the healing and relieves the pain of minor mouth ulcers (minor aphthous ulcers is the medical term).

Should you use Aphtheal?

•    Do not use Aphtheal if you are allergic to amlexanox or any of the other ingredients listed above.

•    Do not use Aphtheal if you are pregnant or breastfeeding

•    Do not use Aphtheal if you are under 18 years of age or over 65 years of age.

•    Check with your doctor or dentist before using Aphtheal if you are being treated for renal (kidney) or hepatic (liver) conditions.

How do you use Aphtheal?

Aphtheal should ideally be applied at the first sign that you are developing a mouth ulcer and in any case treatment must be started within 48 hours of the first symptoms. The paste should be applied four times daily, after breakfast, lunch, dinner and at bedtime and after cleaning your teeth.

Before using Aphtheal you should wash your hands and then apply as follows:

•    Dry the ulcer(s) by gently patting with a soft clean cloth.

•    Squeeze 0.5cm (V4 inch) of paste onto a wet finger tip.

•    Dab the paste onto each ulcer - do not rub into the ulcer as this will cause irritation.

•    Repeat with a further 0.5cm (V4 inch) for each other ulcer.

•    After applying Aphtheal you should wash your hands.

•    Treat no more than three ulcers at a time unless your doctor or dentist has advised you differently.

Treatment with Aphtheal should only be continued for a maximum of 7 days. If significant healing or pain relief does not occur within 10 days of starting treatment then you should consult your doctor or dentist. In case of contact with your eyes, they should be bathed with water several times.

Does Aphtheal have any side effects?

Like all medicines, Aphtheal can cause side effects, although not everybody gets them.

Most people find using Aphtheal causes no problems however the following side effects have been reported. If you experience any side effect not mentioned below you should tell your doctor or dentist.

Common side effects (likely to affect less than 1 in 10 people and more than 1 in 100):

•    Temporary pain, stinging or burning sensation at the site of application

Uncommon side effects (likely to affect less than 1 in 100 people and more than 1 in 1,000):

•    Reddening and tenderness of the mouth lining (oral mucositis)

•    Dry lips

•    Bumps on the lips

•    Feeling unwell or sick (nausea)

•    Diarrhoea

•    Allergic reaction at the site of application Other side effects which may occur:

•    Serious allergic reaction which causes swelling of the face or throat (angioedema)

Contact your doctor immediately if you experience any rapid swelling of the face or throat after using this medicine.

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.

What happens if you swallow excessive amounts of Aphtheal?

Do not swallow Aftasol. If you or anyone else swallows excessive amounts of Aphtheal you should contact your doctor if you can do so. If not, go to the nearest hospital casualty department immediately, taking the Aphtheal tube and pack with you.

How should you store Aphtheal?

•    Do not use Aphtheal after the expiry date printed on the carton.

•    This medicine does not require any special storage conditions.

•    Store out of the reach and sight of children.

•    Replace cap tightly.

•    Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

Leaflet last revised: January 2014