Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Clove oil may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
this medicine
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1. What the medicine is for
Clove Oil
MHRA Header Box
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Fonts Used
23706806
210 x 123mm flat (27 x 123mm folded)
Turn over
Dimensions
Pregnant or breastfeeding….
Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding. Clove Oil should not be used in pregnancy unless the doctor has told you to do so.
23706806
IG Code
Talk to your doctor or pharmacist if you or your child are taking….
If you swallow some
Swallowing small amounts of Clove Oil once applied to your tooth is unlikely to cause a problem. If you accidentally swallow liquid straight from the bottle see a doctor straight away. Take the pack with you to show which medicine you have swallowed.
Keyline (Does not print)
10ml
Talk to your doctor or pharmacist if you or your child have….
Adults, the elderly and children over 2 years old
Pack Size
Now read the rest of the leaflet before you use this medicine. It includes other information which might be especially important for you.
Apply it only to the affected tooth.
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Do not use the medicine….
Leaflet
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2. Before you use this medicine
Important things you need to know first….
Component
Clove Oil has a local anaesthetic and mild antiseptic effect and can be used to relieve toothache temporarily.
Datamatrix: 23706806 VERIFIED
Important information about Clove Oil
The active substance in Clove Oil BP is clove oil.
This leaflet reproduces the patient information leaflet approved for Clove Oil BP, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the temporary relief of toothache.
Dental use.Adults, the elderly and children over 2 years old:Apply a small amount on a cotton bud directly on the tooth cavity as required.
Hypersensitivity to clove oil, eugenol or Peru balsam.Teething.
Use with caution in the mouth.Avoid contact with the skin and gums.Repeated use may cause gum damage.Seek dental attention as soon as possible.Not recommended for use in children under 2 years of age due to lack of adequate data.
May enhance inhibition of platelet activity in patients receiving anti-coagulant therapy e.g. warfarin.
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.Studies on the effects on fertility have not been performed.
None known.
Contact with skin or soft tissue may cause transient irritation, contact dermatitis, inflammation of the lips, and inflammation or ulceration of the mouth. The eugenol present in clove oil may act as an irritant to skin and mucous membranes; it may also cause hypersensitivity and is reported to inhibit prostaglandin synthesis. Patients may 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.mgra.gov.uk/yellowcard.
No case of overdose from oromucosal or dental use has been reported.After oral administration of 5-10 ml of clove oil in children below 2 years of age, life threatening conditions were observed. Adverse effects included coma, acidosis, a generalised seizure, disordered blood clotting, and acute liver damage.Overdose may lead to CNS depression, urinary abnormalities, anion-gap acidosis, deterioration of liver function, coma, seizure and low blood glucose levels. Treatment should be supportive and symptomatic; there have been reports in the literature that N-acetylcysteine has been successfully used as an antidote.
Ask anything about Clove Oil BP. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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