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ORAQIX 25/25 MG PER G PERIODONTAL GEL

Active substance(s): LIDOCAINE / PRILOCAINE

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6-phosphate deficiency (an inherited condition
that happens when your body lacks the important
enzyme glucose-6-phosphate).

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

25/25 mg per g Periodontal Gel
Lidocaine and Prilocaine

Read all of this leaflet carefully before starting
treatment with this medicine.











Keep this leaflet. You may need to read it again.
If you have further questions, please ask your dentist
or dental hygienist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your dentist, dental hygienist or doctor.

In this leaflet:

FPO

Take special care with Oraqix

1. What Oraqix is and what it is used for
2. Before Oraqix is given
3. How Oraqix is given
4. Possible side effects
5. How to store Oraqix
6. Further Information





Using other medicines
You should tell your dentist if you are taking:


1. What Oraqix is and what it is used for
Oraqix is a gel that is used to prevent pain in your gums.
Oraqix is used in adults for pain control in certain types
of dental procedures such as scaling and/or root planing
(cleaning parts of your teeth that your toothbrush cannot
reach) and probing (exploring your teeth and gums).

The use of Oraqix in children and adolescents has
not been assessed and therefore its use is not
recommended in persons less than 18 years old.
Avoid getting Oraqix into your eyes. If you
accidentally get the gel in your eye, the eye must be
washed with water or saline solution immediately
and protected until you recover feeling in it.
Oraqix may occasionally block all feeling in the areas
being treated. Try to avoid accidentally biting your mouth.
Also, avoid drinking very hot drinks and food until the
feeling fully returns.
Oraqix may interfere with tests for substances that
sportswomen and sportsmen are banned from taking. It
may give a false positive reading for these substances.



any other amide type local anaesthetic or products
used to treat irregular heart activity (antiarrhythmics
– e.g. mexilitine) since these medicines in
combination with Oraqix may increase the risk for
the side effects described in section “If you are given
more Oraqix than you should have been”
other medicines that can cause methemoglobinemia,
e.g., certain kinds of antibiotics known as sulphamides.

Do not use Oraqix

Tell your dentist/dental hygienist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.



Pregnancy and breast-feeding

2. Before Oraqix is given






if you are allergic (hypersensitive) to lidocaine,
prilocaine or other similar local anesthetics;
if you are allergic (hypersensitive) to any of other
ingredients of the gel (see Section 6, Further information);
if your doctor has told you that you have congenital
or idiopathic methemoglobinemia (a condition
where too much hemoglobin has changed
into methemoglobin in your blood. If too much
methemoglobin is formed, it becomes more difficult
for the blood to provide the tissue with oxygen);
if your doctor has told you that you have repeated
episodes of porphyria or if you may have inherited
porphyria (porphyrias are a group of conditions that
affect the way your blood is made).

Talk to your dentist/dental hygienist if any of the
following apply to you:





if you have kidney or liver disease;
if you have irregular heart activity or conduction disorders;
if you have mouth ulcers or an infection in your mouth;
If your doctor has told you that you have glucose-

If you are pregnant, thinking of becoming pregnant or
breast-feeding, talk to your dentist or dental hygienist
before being given Oraqix.
• Oraqix should not be used in pregnancy unless
recommended by your dentist.
• Breast-feeding can be continued after treatment with
Oraqix.
Driving and using machines
Oraqix has no known effects that should affect your
ability to drive or use machines.
3. How Oraqix is given
Oraqix will be given by a dentist or dental hygienist. Your
dose is decided by the dentist or dental hygienist and will
depend on how many teeth need to be treated.




Oraqix periodontal gel is intended for use in adults.
Oraqix must not be injected.
Oraqix gel is applied inside the gum with a dental
syringe or by the Oraqix Dispenser and a blunt-tipped
applicator.
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The following information is intended for medical or healthcare professionals only:
For full information about the use of Oraqix, please refer to the Summary of Product Characteristics (SmPC).
Method of administration

Oraqix must not be injected


On average, one cartridge (1.7 g) or less Oraqix will be sufficient for one quadrant of the dentition. The maximum recommended dose of Oraqix
at one treatment session is five cartridges, i.e., 8.5 g gel containing 212.5 mg lidocaine base and 212.5 mg prilocaine base.



When administered, Oraqix must be a liquid. If it has formed a gel, it must be placed in a refrigerator until it becomes a liquid again. The air
bubble visible in the cartridge will move if the cartridge is tilted.



The gel may become opaque at temperatures below 5°C. The gel will return to the original appearance after warming up to room temperature.
Oraqix is a gel after administration.

FPO

Oraqix





The maximum dose in a single treatment is 5 cartridges.
The full effect is achieved after about half a minute
and the dentist or dental hygienist can then start
further treatment. The effect should normally last for
about 20 minutes.
If you feel that the effect of Oraqix is too strong or
too weak, tell your dentist or dental hygienist.
You may receive other local anesthetics at the same
treatment session.
Frequent use of large amounts of Oraqix is not
recommended.

FPO

If you are given more Oraqix than you should have
been
If you are given too much local anesthetic (i.e., Oraqix
in combination with another anesthetic), the following
side effects may occur: numbness of the lips and around
the mouth, nervousness, light-headedness, dizziness,
shakiness, or sometimes blurred vision, drowsiness,
and loss of consciousness. Other rare effects are fits,
breathlessness, and lowered blood pressure.
Too much prilocaine (Oraqix in combination with another
anesthetic containing prilocaine) may also cause
methemoglobinemia (see Section 2). This is characterised
by slate-grey cyanosis (a bluish-grey discoloration of the
lips and the skin).
If you have any of the above symptoms, contact your dentist,
dental hygienist or doctor, go to the emergency department
of your nearest hospital for assessment of the risk and
advice. You may need to be watched for several hours.

If any side effect gets serious, for example you have
breathing difficulties or swelling of the throat or there is
suspicion of an anaphylactic reaction to the anaesthetic,
tell your dentist or doctor immediately or go straight
to the hospital. If you notice any side effects not listed
in this leaflet, please contact your dentist or dental
hygienist while still in the surgery or your doctor if you
have returned home when these occur.
5. How to store Oraqix




Keep out of the sight and reach of children
Do not freeze.
Do not use Oraqix after the expiry date printed on the
carton. The expiry date refers to the last day of that
month.

Medicines should not be disposed of via wastewater or
household waste. Ask the pharmacist how to dispose of
medicines no longer required. These measures will help
protect the environment.
6. Further information
What Oraqix contains
The active substances are prilocaine (base) and
lidocaine (base).
The other ingredients are poloxamer 188 purified,
poloxamer 407 purified, purified water, and dilute
hydrochloric acid, used to adjust pH.
What Oraqix looks like and the contents of the pack

Uncommon side effects (affecting less than 1 in 100
people)

Oraqix is a Periodontal gel. It is a clear, colorless gel in a
glass cartridge for and is single use.
Each gram of Oraqix periodontal gel contains 25 mg of
lidocaine and 25 mg of prilocaine.
Each cartridge contains 1.7 g of gel (42.5 mg lidocaine
and 42.5 mg prilocaine).
Each pack contains 20 cartridges.



Marketing Authorisation Holder

4. Possible side effects
Like all medicines, Oraqix can cause side effects,
although not everybody gets them.








allergic reactions which could include: skin rash,
swelling of the throat, breathing difficulties and fever
dizziness
feeling sick
breathing difficulties and cyanosis (a bluish-grey
discoloration of the lips and the skin).
burning sensation
swelling at site of application
Overdose of Oraqix could result in central nervous
system excitation or depression and depression of
cardiac conduction and function of the heart. In the
event of any concern relating to these possible side
effects you should be taken straight to the hospital.

Common side effects (affecting up to 1 in 10 people)




headache
changes in taste
reactions in mouth (pain, soreness, numbness of other
parts of the mouth or lips, ulcer, irritation and redness)

DENTSPLY Limited, Building 1, Aviator Park, Station
Road, Addlestone, Surrey KT15 2PG, United Kingdom
Medical Information Department Telephone: ++44 (0)
1932 837279
Alternate Telephone: ++44 (0) 1932 853422
Fax: ++44 (0) 1932 857135
Email: enquiry@dentsply-gb.com
Manufacturer
Recipharm Karlskoga AB, Björkbornsvägen 5, SE-691
33 Karlskoga Sweden
This package leaflet was last approved on
June 23, 2010.

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The cartridge and applicator are intended for single use. They fit into the Oraqix Dispenser.



Fill the periodontal pockets with Oraqix gel by means of a dental syringe or the Oraqix Dispenser and the blunt-tipped applicator included
with the pack, until the gel becomes visible at the gingival margin. Wait half a minute before starting treatment (a longer waiting time does not
enhance the anesthesia). The duration of anesthesia, as assessed by probing of pocket depths, is about 20 minutes. If the anesthesia starts to
wear off, re-apply Oraqix as needed.



If additional local anesthesia is needed in combination with Oraqix, please refer to the specific SmPC of each adjunctive anesthetic. Because
the systemic toxic effects are additive (see section 4.5 and 4.9 of the Oraqix SmPC), it is not recommended to give any further local anesthetics
at the same treatment session if the amount of Oraqix administered corresponds to the maximum recommended dose of five cartridges.



Avoid contact with Oraqix to prevent the development of possible allergy.

FPO




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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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