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Activase Clove Oil

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PACKAGE LEAFLET: INFORMATION FOR THE USER ACTIVASE CLOVE OIL (CLOVE OIL)

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 Clove Oil 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, dentist or qualified healthcare practitioner if your symptoms worsen or do not improve after one week.

If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you use Clove Oil

3.    How to use Clove Oil

4.    Possible side effects

5.    How to store Clove Oil

6.    Further information

1.    WHAT CLOVE OIL IS AND WHAT IT IS USED FOR

The name of your medicine is Activase Clove Oil. It contains the active ingredient called Clove Oil.

It is a traditional herbal medicinal product used for the temporary relief of toothache, based on traditional use only.

2.    BEFORE YOU USE CLOVE OIL

Do not use Clove Oil if you are allergic (hypersensitive) to Clove Oil or Peru balsam. See section 6.

Do not use Clove Oil if you are under 18 years of age.

Take special care with Clove Oil

If toothache persists for more than one week consult your dentist.

Taking other medicines

Please consult your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and Breast-feeding

Do not use this product if you are pregnant or breast feeding

Follow the directions on this package leaflet or pack carefully, and ask your pharmacist to explain any part you do not understand.

Adults and the Elderly:

Soak a small piece of cotton wool and apply to the tooth. Repeat administration after 20 minutes, then every two hours if necessary. Avoid contact with the gums.

Do not use more than the recommended dose.

Duration of use:

If symptoms worsen or persist for more than one week, a doctor, dentist or qualified healthcare practitioner should be consulted.

If you accidentally swallow large quantities of Clove oil, please consult your doctor or pharmacist as soon as possible.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, clove oil may cause side-effects, although not everybody gets them.

• Mucosal irritations and allergic reactions have been reported with Clove oil.

If any of the side-effects gets serious or if you notice any side-effect not listed here, please tell your doctor or pharmacist.

Making medicines safer

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

Alternatively you can get a paper Yellow Card form from your doctor's surgery or a pharmacy, or call Freephone 0808 100 3352 (available 10am-2pm Monday to Friday).

5.    HOW TO STORE CLOVE OIL

Keep out of the sight and reach of children.

Keep the container tightly closed.

Do not use Clove Oil after the expiry date which is stated on the label. The expiry date refers to the last date of the month.

Clove Oil should not be disposed of via wastewater or household waste, Ask your pharmacist how to dispose of this product no longer required. These measures will help to protect environment.

The active substance is Clove oil.

Each ml consists of Clove oil 100% v/v (Syzygium aromaticum (L.) Merill et L. M. Perry).

There are no excipients.

What Clove oil looks like and contents of the pack

Clove oil is clear colourless or pale yellow solution. It comes in a glass bottle with plastic cap in pack sizes of 10 ml and 15 ml.

Not all pack sizes may be marketed.

Traditional Herbal registration Holder:

Bell Sons and Company (Druggists) Limited

Gifford House

Slaidburn Crescent

Southport

PR9 9AL

THR 03105/0002

THR Certification Mark