□ ALLIANCE

Occlusal⁸ 26% w/w cutaneous solution

salicylic acid Information for Patients

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Occlusal carefully to get the best results from it,

*    Keep this leaflet, You may need to read it again.

*    Ask your pharmacist if you need more information or advice.

*    You must contact a doctor, pharmacist or nurse 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, pharmacist or nurse.

The information in this leaflet has been divided into the following sections:

1.    What Occlusal is and what it is used for

2.    Check before you use Occlusal

3.    How to use Occlusal

4.    Possible side effects

5.    How to store Occlusal

6.    Further information

11. What Occlusal is and what it is used for    ~|

Occlusal is used to treat and remove raised warts (usually found on the hands, elbows or knees] and verrucas (warts on the feet]. Occlusal is a special solution which can be easily applied to the wart, dries guickly, needs no piasters and if used properly should cause minimal irritation.

Warts, or verrucas as they are often called, are found most commonly on the hands, feet and knees. They are commonest amongst children of school age,

Warts are caused by a virus which gets into the upper layers of the skin. The body then reacts to the virus, which leads to the formation of the wart or verruca, Warts are most freguently transmitted by contact, e.g, swimming pools and communal changing rooms are often associated with infection. Warts can occur singly or in groups and can be transferred from one part of the body to another, e.g, from one foot to the other,

Occlusal contains a high concentration of salicylic acid which when used regularly removes the dead cells from the outer layer of the skin and steadily reduces the size of the wart.

| 2. Check before you use Occlusal    ~|

Do not use Occlusal:

*    if you are allergic (hypersensitive] to salicylic acid (aspirin] or any of the other ingredients of Occlusal (see section 6 Further information]

*    if you have diabetes

*    if you have poor blood circulation

*    if the wart or skin surrounding it is inflamed or broken

*    on moles, birthmarks, unusual warts with hairgrowth

*    on your face

*    on warts in the anal or genital region.

Take special care with Occlusal

Occlusal is flammable - keep it away from flames and fire.

Occlusal is for external use only and should only be applied to warts,

Do not use on broken or damaged skin such as cuts or grazes.

Try not to get Occlusal on the normal skin around the wart, You should apply Occlusal to the centre of the wart therefore avoiding the surrounding healthy skin.

Do not allow Occlusal to come into contact with mucous membranes (e.g. your mouth, nose and other body openings] or your eyes.

If Occlusal gets into any of these areas, flush immediately with water for 15 minutes.

Using other medicines

When used according to the instructions, Occlusal is not known to interfere with any other medicines. However you should not use any other treatments on your warts or verrucas at the same time as using Occlusal,

Pregnancy and breast-feeding

The safe use of Occlusal during pregnancy and breast-feeding has not been established, Therefore Occlusal should be used with caution or following the advice of your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

| 3. How to use Occlusal    ~|

Apply Occlusal once daily as follows:

Dry the affected area thoroughly using a towel.

The towel should not be used by anyone else otherwise the wart could be passed to them.

Use the applicator brush supplied in the cap to apply Occlusal to the wart. Do not get any on the surrounding healthy skin. Allow Occlusal to dry completely and then apply a second coat. You do not need to cover the wart with a piaster or bandage.

You should notice an improvement within 1-2 weeks but for maximum effect, continue treatment for 4-6 weeks. Do not allow the solution to drip onto the neck of the bottle or you may find it difficult to open the bottle next time. What to do if you use more Occlusal than you should

If you accidentally swallow Occlusal, use too much of it or use it for long periods of time, the body could absorb too much salicylic acid, This could cause ringing in the ears, feeling or being sick, If this occurs, or you notice any other symptoms, stop using Occlusal and consult your doctor.

If you forget to use Occlusal

If you forget to use Occlusal on any occasion, do not worry, just continue to use daily as before,

If you have any further guestions on the use of this product, ask your doctor, nurse or pharmacist.

14. Possible side effects

Do not worry. Like all medicines, Occlusal can cause side effects, although not everyone gets them.

If any of the following symptoms occur you should stop using Occlusal and contact your doctor or pharmacist:

*    ringing in the ears

*    feeling or being sick,

Other side effects include:

*    redness, rash or itching affecting the normal skin around the wart. If this occurs, stop using Occlusal for a few days until the irritation goes away, When you re-start treatment, be careful to apply the solution only to the wart itself.

If Occlusal causes a lot of skin irritation, stop using it and contact your doctor or pharmacist,

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:

UK:The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie, E-mail: medsafety@hpra.ie.

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

| 5. How to store Occlusal

Occlusal is flammable - keep away from fire or flame.

Keep out of the reach and sight of children.

Do not use Occlusal after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of that month after EXP,

Do not store Occlusal above 25°C. Keep bottle tightly closed when not in use and avoid dripping the solution on to the thread of the bottle-neck which can make opening difficult,

Do not use Occlusal if you notice a change in the colour of the solution,

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required, These measures will help protect the environment,

| 6. Further information What is in Occlusal?

The active ingredient in this medicine is salicylic acid 26% w/w.

The other ingredients are polyvinyl butyral, dibutyl phthalate, isopropyl alcohol, butyl acetate and acrylates copolymer,

What Occlusal looks like and contents of the pack

Occlusal is a colourless to pale yellow solution with a characteristic smell of nail varnish.

Occlusal is available in glass bottles of 10 millilitres with an applicator brush in the cap.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire, SN15 2BB, UK.

Manufacturer: Pharmasol Ltd, North Way, Andover, Hants, SP10 5AZ, UK.

The information in this leaflet applies only to Occlusal. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist,

This leaflet was last approved: 20th March 201 5.

Occlusal is a registered trademark in the UK and a trademark in Ireland of Alliance Pharmaceuticals Limited, Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited,

© Alliance Pharmaceuticals Ltd 201 5,

xxxxxxx