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PREVORA 100 MG/ML DENTAL SOLUTION

Active substance(s): CHLORHEXIDINE DIACETATE

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Package Leaflet: Information for the User

Prevora 100 mg/ml Dental Solution
Chlorhexidine diacetate
Read all of this leaflet carefully before you start
using this medicine.






Keep this leaflet. You may need to read it again.
If you have further questions, please ask your
dental professional.
This coating has been recommended for your
teeth by your dental professional and will be
applied to your teeth by your dental professional
on several occasions.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your dental professional.

In this leaflet
1. What Prevora is and what it is used for.
2. Before you are treated with Prevora.
3. How you are treated with Prevora.
4. Possible side effects.
5. How to store Prevora.
6. Further information.
1.

WHAT PREVORA IS AND WHAT IT IS USED
FOR

Prevora has not been shown to affect the use of machines.
Important information about some of the ingredients of Prevora
This dental coating can cause a temporary irritation or
stinging of the gums, lips or tongue and can also have a
bitter taste. Chlorhexidine, the active substance in
Prevora, can also cause staining of the teeth; however,
when chlorhexidine is applied as a topical, temporary
dental coating, staining is rare.
3. HOW YOU ARE TREATED WITH PREVORA
This topical, temporary coating on your teeth is applied
by your dental professional in a short appointment in
the dental office. The dental professional will first clean
your teeth, and then apply Stage 1 to all tooth surfaces
(Figure 1), followed immediately by a second coating of
Stage 2. This second coating temporarily protects
Stage 1 from your saliva and from food abrasion.

This dental coating is a topical treatment for the prevention of cavities on the crown and the root of the
tooth of adult patients at high-risk of tooth decay (e.g.
dry mouth sufferers or those with a number of cavities
when you visit the dentist). This coating temporarily
covers your teeth to reduce the bacteria on your teeth
which cause tooth decay.
Oral hygiene and sugar intake: If you have poor oral
hygiene and/or you frequently consume sugars you
need to make sure you brush your teeth with fluoridated tooth paste and control your sugar intake, as they
are important contributors to the overall success of
Prevora.
2. BEFORE YOU ARE TREATED WITH
PREVORA
Special warnings and precautions
Prevora may in rare cases cause severe allergic reactions, leading to a drop in blood pressure and even
to unconsciousness. Early symptoms of a severe
allergic reaction may be skin rash or asthma. If you
notice these symptoms, stop using Prevora and
contact your doctor as soon as possible (see under
section 4: “Possible side effects”)
Do not take/use Prevora

If you are allergic (hypersensitive) to chlorhexidine gluconate, Sumatra benzoin or ethanol (see
section 6).

If you are allergic to the ingredients of the Stage
2 sealant, which is a secondary coating applied
immediately over Stage 1. The ingredients of this
second coating are methacrylate, triethyl citrate
and purified water.

If you have been treated with a fluoride dental
varnish in the past 3 days.
Take special care with Prevora

before undergoing treatment with Prevora, to
report your medical condition including asthma,
eczema and other allergies, to your dentist.
Taking other medicines
Please inform your dental professional if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your dentist for advice before taking or receiving
any medicine.
Driving and using machines
Prevora has not been shown to affect driving.

Figure 1 – Stage 1 followed by a second coating will be
applied to your teeth so as to reduce your risk of tooth
decay.
At the start of your treatment with Prevora, you will
require 4 weekly treatments followed by another single
treatment in 6 months. Thereafter, your need for more
treatments with Prevora will be evaluated by your
dental professional.
You will be told by your Dental Professional that:

The dried Prevora coating will begin coming off the
teeth during the next meal

You should avoid eating hard foods (e.g. meat,
apples) for at least 4 hours after treatment.

You should not chew gum for at least 24 hours.

You should not brush your teeth for 24 hours after
treatment. Then you resume brushing with a new
brush 2 to 3 times daily with fluoride tooth paste.

You should not floss for 3 days after treatment.
Then you resume flossing daily.

If dentures are worn, clean and disinfect these
dentures regularly prior to use. Disinfect using
soap and warm water.
Effects when the Prevora treatment is finished
Temporarily, you may have a bitter taste, a sensation
of a coating on your teeth and/or a stinging or burning
along your gum line or tongue. The stinging will last for
a few minutes, the coating for a few hours. The coating
will be invisible on your teeth. Chlorhexidine, the
active substance in Prevora , can stain the teeth when
used in a mouth rinse or gel; however, in controlled
clinical studies and dental office use, the occurrence of
tooth staining by the Prevora dental coating is rare.
If staining occurs it is not permanent and can largely be
eliminated by brushing with a conventional fluoridated
toothpaste, once tooth brushing re-commences 24
hours after treatment with Prevora. A professional
cleaning will remove any staining but if conducted
within 7 days of treatment will also minimize the effect
of Prevora. If you receive a professional cleaning, it
should be done 7 days after the Prevora treatment.

What to do after you are treated with Prevora

6. FURTHER INFORMATION

To preserve this coating on your teeth for as long as
possible, eat soft foods at your next meal (e.g. soup).
Do not eat hard foods (e.g. meat, apples) for at least 4
hours after treatment. Do not chew gum for at least 24
hours.

What Prevora contains:

Do not brush your teeth for 24 hours after this treatment. Then resume brushing with a new tooth brush
and brush 2 to 3 times daily with fluoride toothpaste.

Stage 1 chlorhexidine coating:
100 mg/ml Dental Solution
The active substance is Chlorhexidine diacetate.
The other ingredients are Sumatra benzoin and Ethanol
Stage 2 sealant coating:
The ingredients are Ammonio methacrylate copolymer
dispersion, Type B and Triethyl citrate

Do not floss your teeth for 3 days following this treatment. Then resume flossing daily.
If dentures are worn, clean and disinfect at home prior
to use. Disinfect using soap and warm water.

What Prevora looks like and contents of the pack:
Dental Solution

Make sure you receive all the treatments of Prevora,
recommended by your dentist.
It is an important contribution to the overall success of
this treatment, that you regularly brush your teeth with
a fluoridated tooth paste, and that you control your
consumption of foods and drinks which have a high
amount of sugar and acid.
If you have any further questions on the use of this
product, ask your dental professional.
4. POSSIBLE SIDE EFFECTS
If you experience any of the following reactions stop
using Prevora and get immediate help:
swelling of the face, lips, tongue or throat; a red
itchy skin rash; wheezing or difficulty breathing; feeling
faint and dizzy; a strange metallic taste in the mouth;
collapse. You may be having an allergic reaction.
If you develop a rash or your skin becomes itchy, red,
dry or inflamed where you have used the product as a
skin wash, stop using it and talk to your doctor or pharmacist.

The chlorhexidine coating is a clear, slightly brownish
solution with a noticeable scent, free of any floating
particles in the solution.
The sealant coating is a milky-white liquid with a faint
scent
Each treatment set of Prevora 100 mg/ml Dental Solution consists of:
6 vials of Stage 1 chlorhexidine coating in a 2 ml Type 1
glass vial
6 vials of Stage 2 sealant coating in a 2 ml Type 1 glass
vial
Marketing Authorization Holder and
Manufacturer
Marketing Authorization Holder:
CHX Technologies Europe Limited
Guinness Enterprise Centre
Taylor’s Lane
Dublin 8, Ireland
Tel: (01) 4100600

Like all medicines, Prevora can cause side
effects, although not everybody gets them.

Manufacturer:

If you have prolonged stinging or burning of the gums,
lips or tongue, you should see your dental professional
as soon as possible. If your teeth appear stained after
treatment with Prevora, please inform your dental
professional.

Jenson Pharmaceutical Services Ltd.
Carradine House
237 Regents Park Road
London N3 3LF
United Kingdom

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

This leaflet was last approved in June 2014.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. 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 PREVORA
Keep out of the reach and sight of children.
Do not use Prevora after the expiry date which is stated
on the carton and single vial labels after EXP. The
expiry date refers to the last day of that month.
Discard any remaining solution immediately after use.
Prevora should be stored in a refrigerator (2ºC - 8ºC) at
your dental professional’s office.
Medicines should not be disposed of via wastewater or
household waste. These measures will help to protect
the environment.

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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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