PATIENT INFORMATION LEAFLET

DENTOGEN CLOVE OIL GEL

Please read all of this leaflet carefully before you start using this medicine. Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

In this leaflet:

1.    What Dentogen Clove Oil Gel is and what it is used for

2.    Before you use Dentogen Clove Oil Gel

3.    How to use Dentogen Clove Oil Gel

4.    Possible side effects

5.    How to store Dentogen Clove Oil Gel

6.    Further information

1.    What Dentogen Clove Oil Gel is and what it is used for

This medicine contains the active ingredient Clove Oil which is a mild analgesic and surface anaesthetic used for the temporary relief of toothache due to a dental cavity.

2.    Before you use Dentogen Clove Oil Gel

Do not use this gel:

•    If you are allergic to Clove Oil, Eugenol, Peru Balsam or any of the other ingredients (see section 6)

•    If you think you may have an abscess

•    In infants or for teething pain in children.

Taking other medicines:

Check with your doctor or pharmacist before using this gel if you are taking a medicine to prevent blood clotting such as warfarin.

Other special warnings:

•    Not recommended for use in children under 2 years of age

•    Prolonged use of this product should be avoided

•    Dental attention should be sought as soon as possible

•    Care should be taken to ensure that the gel is applied directly onto the troublesome tooth and not to the gums or mouth.

Pregnancy and breastfeeding

Do not use during pregnancy or whilst breastfeeding unless advised by your doctor it is safe to do so.

Important information about an ingredient of this gel:

This gel contains propylene glycol which may cause gum or skin irritation.

3.    How to use Dentogen Clove Oil Gel

For dental use:

Adults, the Elderly and Children over 2 years of age:

Apply a little gel accurately to the decayed part of the tooth using either a clean fingertip, or a cotton wool bud. Repeat after 20 minutes and then every 2 hours if necessary.

Not recommended for use on infants under 2 years of age.

If you have used too much gel or accidentally swallowed the gel:

Contact your doctor for advice.

4.    Possible side effects

Like all medicines Dentogen Clove Oil Gel may cause side effects, although not everybody gets them.

Contact of the gel with the skin, gums or mouth may cause temporary irritation, inflammation or ulceration. You may also become sensitive to Clove Oil.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

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.

5.    How to store Dentogen Clove Oil Gel

Do not store above 25°C.

Do not use the gel if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

6.    Further information

Ingredients:

Dentogen Clove Oil Gel contains the following active ingredient:

Clove Oil 20% w/w. It also contains Carbomers, Triethanolamine, Propylene Glycol and Peppermint Essence (containing Peppermint Oil and Propylene Glycol).

What the medicine looks like: Dentogen Clove Oil Gel is a clear, pale yellow gel. This medicine is available in a pack size of 10g.

Who makes this medicine and holds the Product Licence:

The product licence holder is Crescent Pharma Limited,

Units 3 & 4, Quidhampton Business Units, Polhampton Lane,

Overton, Hants RG25 3ED, UK.

The manufacturer is Thorpe Laboratories Ltd., Golf Road Industrial Estate, Mablethorpe, Lincs LN12 1NB.

Date leaflet revised: April 2015.

If you would like this leaflet in a different format please contact the licence holder at the above address.