■    This medicine is used to relieve minor mouth and throat irritations. Tyrozets may also be taken to relieve irritation after mouth and throat surgery.

■    This medicine is for use by adults and children aged 3 and over.

■    Do not take this medicine:

If you have ever had a bad reaction to any of the ingredients.

For the list of ingredients see section 6 ►

■    Follow the dosage instructions carefully. These are shown in the dosage table. See Section 3 ►

The lozenges are for oral use only and should not be used for longer than 5 consecutive days.

Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.

1 What the medicine is for

Tyrozets is a medicine which is used to relieve minor mouth and throat irritations. Tyrozets may also be taken to relieve irritation after mouth and throat surgery, for example having your tonsils taken out. The lozenges contain tyrothricin, which is an antibiotic that helps fight throat infection, and benzocaine, a local anaesthetic that numbs sore throat pain quickly. The lozenges dissolve in the mouth, gradually releasing the active ingredients which reach the painful throat area at the back of the mouth.

Tyrozets are not intended to replace other antibiotic medicines prescribed by your doctor but are an aid to prevention and control of local infections in the mouth and throat.

This medicine is for use in adults and children aged 3 years and over.

2    Before taking this medicine

This medicine is suitable for most adults and children aged 3 years and

over, but a few people should not use it. If you are in any doubt, talk to

your doctor or pharmacist.

□ Do not take this medicine...

■    If you have ever had a bad reaction to any of the ingredients.

If you think you have become allergic during use, stop treatment immediately and see your doctor.

If this applies to you, get advice from a doctor or

pharmacist without taking Tyrozets.

^^If you are pregnant or breast-feeding

■    If you are pregnant, think you might be pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.

ome of the ingredients can cause problems

■    If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Tyrozets contain 1 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus.

3    How to take this medicine

Check the tables that follow to see how much

medicine to take.

■    For oral use only.

■    Do not use more than the stated dose shown in the table.

■    The lozenges are for short term treatment only. If, after 2 days of taking this medicine, your symptoms have not improved, you should consider discontinuing use and speak to your doctor or pharmacist. Do not use for longer than 5 consecutive days.

■    To benefit from taking Tyrozets you should allow the lozenge to dissolve slowly in the mouth and not swallow it whole.

■    As Tyrozets contain a local anaesthetic, you may wish to avoid eating whilst the anaesthesia (numbness) is at its greatest. It is also a good idea to rinse your mouth out with water after eating to avoid any further irritation to the mouth lining by small amounts of food left in the mouth.

Children under 3 years old

This medicine is not recommended for children under 3 years old.

Children aged 3

Age    Dose

Children aged 3 years    Dissolve one lozenge slowly in

and over.    the mouth every 3 hours.

■    Leave at least 3 hours between doses.

■    Do not exceed 6 lozenges in any 24 hour period.

■    Do not use for longer than 5 consecutive days.

■    If your symptoms get worse or the lozenges nave no effect, talk to your doctor.

O Adults

Age    Dose

Adults.    Dissolve one lozenge slowly in the

mouth every 3 hours.

■    Leave at least 3 hours between doses.

■    Do not exceed 8 lozenges in any 24 hour period.

■    Do not use for longer than 5 consecutive days.

■    If your symptoms get worse or the lozenges nave no effect, talk to your doctor.

If anyone takes too much of this medicine

If anyone takes too many Tyrozets, contact your doctor or nearest Accident and Emergency department (Casualty) taking this leaflet with you.

If you forget to take the medicine

You should only take this medicine as required following the dosage instructions above carefully. If you forget to take a dose, you can take another lozenge as long as you do not take more than 8 lozenges in any 24 hour period (or 6 lozenges for children) and a minimum of 3 hours has passed since you took a lozenge. Do not take a double dose.

4 Possible side-effects

Tyrozets can have side-effects, like all medicines, although these don't affect everyone and are usually mild.

If you experience any of the effects listed below tell your doctor:

■    Skin rashes.

■    Use of antibiotics can sometimes allow the development of infections different from those they are intended to treat. If you think you are developing a new or different infection, stop taking Tyrozets and talk to your doctor.

■    Rarely, after taking benzocaine, a blood disorder may occur in infants and children. This can cause symptoms including shortness of breath and blueness of the lips.

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.

UK - You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Ireland - You can also report side-effects directly via 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    Storing this medicine

Keep the product out of the reach and sight of children.

Do not store above 25°C and store in the original package to protect from light.

Do not use your medicine if the pack is damaged, or after the expiry date on the packaging.

6    Further information

What's in this medicine?

The active ingredients in Tyrozets are: 1 mg Tyrothricin and 5 mg Benzocaine.

Other ingredients are: Acacia, magnesium stearate, maize starch, sodium chloride, sucrose, anethole, erythrosine (El 27) and peppermint oil.

Marketing Authorisation Holder:

McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

Product Authorisation Holder:

McNeil Healthcare (Ireland) Ltd, Airton Road, Tallaght, Dublin 24, Ireland.

Manufacturer:

Lusomedicamenta - Sociedade Tecnica Farmaceutica S.A.,

Estrada Consiglieri Pedroso no. 69B, Queluz de Baixo, 2730-055 Barcarena, Portugal.

This leaflet was revised June 2015

Tyrozets is a registered trade mark.

Other effects which may occur include:

■ Blackness or soreness of the tongue, which disappears when the treatment is stopped.

What the medicine looks like

Tyrozets are pink aniseed flavoured lozenges. They are available in packs of 24 lozenges.

CRR: 320679 Ref: AW_104386 Date: 26/06/2015 Dimensions: 140 x295mm