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ACTIVASE CLOVE OIL

Active substance(s): CLOVE OIL / CLOVE OIL / 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, eugenol or Peru balsam. See
section 6.
Do not use Clove Oil if you are under 18 years of age.
Do not use Clove Oil in babies/children who are teething.
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. Tell your doctor if you are taking medicines used to prevent
blood clotting such as warfarin, as the anti-clotting effects could be increased by using Clove Oil.

Pregnancy and Breast‐feeding
Do not use this product if you are pregnant or breast feeding
3. HOW TO USE CLOVE OIL
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 directly to the affected tooth as required. Repeat
administration after 20 minutes, then every two hours if necessary. Avoid contact with skin and the
gums.
Do not use more than the recommended dose. Repeated use may cause gum damage.
Duration of use:
If symptoms worsen or persist for more than one week, a doctor, dentist or qualified healthcare
practitioner should be consulted.
Swallowing small amounts of Clove Oil once applied to your tooth is unlikely to cause a problem. If
you accidentally swallow the liquid straight from the bottle, see a doctor straightaway. Take the
pack with you to show which medicine you have taken.
4. POSSIBLE SIDE EFFECTS
Like all medicines, clove oil may cause side‐effects, although not everybody gets them.
Side effects that may be experienced include:
 Mucosal irritation such as temporary skin irritation.
 Dermatitis (skin rash, itching, flaking).
 Allergic reactions such as swelling of the lips, blistering and swelling in the mouth.
 You may also become sensitive to Clove Oil.

Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

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.
6. FURTHER INFORMATION
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
Leaflet revised
28 April 2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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