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Ledermix ^ ^{For Dental Use}

Demeclocycline hydrochloride and Triamcinolone acetonide PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

COMBINATION KIT

Please read all of this leaflet carefully before you receive the medicine.

Keep the leaflet as you may want to read it again.

If you have any further questions please ask your dentist.

If you experience any troublesome side effects or any effects not listed in this leaflet tell your dentist or doctor.

In this leaflet:

1

2.

3.

4.

5.

6.

1.    What LEDERMIX is and what it is used for

LEDERMIX is a combination kit which contains a dental paste, a dental cement powder and two dental liquids (slow and fast setting hardeners).

LEDERMIX dental paste contains the active ingredients demeclocycline calcium and triamcinolone acetonide.

LEDERMIX dental cement powder contains the active ingredients demeclocycline hydrochloride and triamcinolone acetonide.

Demeclocycline hydrochloride is one of a group of antibiotics called tetracyclines which is used to treat or prevent infections. Triamcinolone acetonide is a corticosteroid used to reduce swelling or inflammation.

LEDERMIX is used by dentists to treat deep and possibly painful cavities (holes in the teeth) which are close to the nerve or involve the nerve in the tooth, and as a dressing during the treatment of the root canal.

2.    Before you receive LEDERMIX You should not receive this medicine if:

•    you are allergic to any tetracycline antibiotic (e.g. oxytetracycline, tetracycline, chlortetracycline, demeclocycline, doxycycline or minocycline) or any of the ingredients in this medicine (see section 6 for more details)

•    you have badly infected dental pulp

This medicine must not be used in children under 12 years and should be avoided where possible in children over 12 years of age. The use of tetracyclines in this age group can cause permanent discolouration and incomplete development of hard tooth surface.

Important information about some of the ingredients of LEDERMIX This medicine contains sodium sulphite anhydrous (E221) which may rarely cause allergic reactions and bronchospasm (difficulty breathing).

Taking other medicines

Before you receive this medicine please tell your dentist if you are taking any other medicines.

Pregnancy and breast-feeding

This medicine should not be used in pregnancy or breast-feeding unless considered essential. The use of this medicine during tooth development in the last half of pregnancy and breast-feeding may cause permanent discolouration and incomplete development of the hard tooth surface.

Driving and operating machinery

There are no known effects of this medicine on your ability to drive or use machinery.

3.    How LEDERMIX is used

This medicine will be used by your dentist. The amount of paste or cement used will depend on the individual person's condition. They can be used on teeth with small holes which may be painful or teeth which have no holes, but are painful. Sometimes this pain is caused by an abscess.

They can also be used as a dressing during the treatment of the nerve or root canal.

LEDERMIX dental paste is only a temporary treatment. It is very important that you keep your next appointment with your dentist so that the paste can be properly removed. Sometimes the paste will be used a second time.

LEDERMIX dental cement is a permanent treatment which can be used at the next visit after using the paste.

This medicine must not be used in children under 12 years and should be avoided where possible in children over 12 years of age.

4.    Possible Side-effects

As with all medicines LEDERMIX can cause side-effects in some people, although because the medicine is not swallowed or injected unwanted effects are very rare.

Tell your dentist immediately or go to hospital if you experience any of the following symptoms of an allergic reaction:

•    swelling of the eyes, mouth and possibly hands, feet and throat

•    breathing difficulties

•    rash