Oraqix periodontal gel

Patient Information Leaflet

Introduction

Patient Information Leaflet

Oraqix Periodontal Gel

lidocaine and prilocaine

Please read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your dentist or dental hygienist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your dentist, dental hygienist or doctor.

Leaflet Contents:

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

1. What Oraqix is and what it is used for

Oraqix is a gel used to prevent gum pain. Oraqix is used in adults to control pain during certain dental procedures, such as scaling and root planing (cleaning parts of your teeth that a toothbrush cannot reach) and probing (examination of the teeth and gums).

2. Before using Oraqix

Do not use Oraqix

• if you are allergic (hypersensitive) to lidocaine, prilocaine, or other similar local anaesthetics;
• if you are allergic (hypersensitive) to any of the other ingredients of the gel (see section 6, Additional information);
• if your doctor has told you that you have congenital or idiopathic methemoglobinemia (a disorder in which excessive amounts of hemoglobin in your blood are converted into methemoglobin. If too much methemoglobin is formed, it becomes more difficult for the blood to deliver oxygen to tissues);
• if your doctor has told you that you suffer from recurrent episodes of porphyria or if you may have inherited porphyria (porphyrias are a group of conditions affecting how your blood is produced).

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

• if you have kidney or liver disease;
• if you have irregular heart rhythm or circulation problems;
• if you have ulcers or an infection in your mouth;
• if your doctor has told you that you have glucose-6-phosphate dehydrogenase deficiency (an inherited condition occurring when the body lacks the important enzyme glucose-6-phosphate dehydrogenase).

Take special care with Oraqix

• The use of Oraqix in children and adolescents has not been evaluated and therefore its use is not recommended in individuals under 18 years of age.
• Avoid getting Oraqix into your eyes. If the gel accidentally gets into your eyes, rinse them immediately with water or saline solution and protect them until sensitivity returns.
• Oraqix may occasionally block all sensation in the treated areas. Take care not to accidentally bite your mouth. Also avoid consuming hot drinks and food until sensation has fully returned.
• Oraqix may interfere with tests for banned substances in athletes. It could lead to a false positive result for these substances.

Use of other medicines

Inform your dentist if you are taking:

• any other amide-type local anaesthetics or medicines used to treat irregular heart rhythms (antiarrhythmics such as mexiletine), as these medicines in combination with Oraqix may increase the risk of adverse effects described in the section "If you use more Oraqix than you should";
• other medicines that may cause methemoglobinemia, for example, certain types of antibiotics known as sulfonamides.

Inform your dentist or dental hygienist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant, planning to become pregnant, or breastfeeding, consult your dentist or dental hygienist before using Oraqix. Consult your doctor or pharmacist before using any medicine.

• Oraqix should not be used during pregnancy unless recommended by your dentist.
• Breastfeeding may be continued after treatment with Oraqix.

Driving and using machines

Oraqix has no known effects that would impair your ability to drive or operate machinery.

3. How to use Oraqix

Oraqix will be administered by a dentist or dental hygienist. The dose is determined 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 into the gum using a dental syringe or the Oraqix dispenser with a blunt-tipped applicator.
• The maximum dose in a single treatment is 5 cartridges.
• Full effect is reached after approximately half a minute, after which the dentist or dental hygienist can begin the procedure. The effect should last about 20 minutes.
• If you feel that the effect of Oraqix is too strong or too weak, inform your dentist or dental hygienist.
• You may receive other local anaesthetics during the same treatment session.
• Frequent use of large amounts of Oraqix is not recommended.

If you use more Oraqix than you should

If too much local anaesthetic is administered (i.e., Oraqix in combination with another anaesthetic), the following side effects may occur: numbness of the lips and around the mouth, nervousness, dizziness, vertigo, agitation, or sometimes blurred vision, numbness, and loss of consciousness. Other rare effects include seizures, difficulty breathing, and low blood pressure.

An excess of prilocaine (Oraqix in combination with another anaesthetic containing prilocaine) may also cause methaemoglobinaemia (see section 2). This is characterised by greyish cyanosis (a bluish-grey discoloration of the lips and skin).

If you experience any of these symptoms, consult your dentist, dental hygienist, or doctor and go to the nearest hospital emergency department for risk assessment and advice. You may need to be kept under observation for several hours.

4. Possible adverse effects

Like all medicines, Oraqix may cause adverse effects, although not everyone gets them.

Common adverse effects (may affect up to 1 in 10 people):

• headache
• taste disturbances
• mouth reactions (pain, stinging, numbness in other parts of the mouth or lips, ulceration, irritation, and redness)

Uncommon adverse effects (may affect less than 1 in 100 people):

• allergic reactions which could include: skin rash, swelling of the throat, breathing difficulties, and fever
• dizziness
• nausea
• breathing difficulties and cyanosis (a bluish-grey discolouration of the lips and skin)
• burning sensation
• swelling at the application site
• An overdose of Oraqix could lead to central nervous system excitation or depression, and depression of cardiac circulation and heart function. If you have any concerns regarding these possible adverse effects, go immediately to hospital.

If any adverse effect worsens, for example, if you experience breathing difficulties or swelling of the throat, or if an anaphylactic reaction to the anaesthetic is suspected, inform your dentist or a doctor immediately or go directly to hospital. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your dentist or dental hygienist if you are still at the clinic, or your doctor if you are already at home when they occur.

5. Oraqix Storage

• Keep out of the reach and sight of children.
• Do not freeze.
• Do not use Oraqix after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of Oraqix

The active substances are prilocaine (base) and lidocaine (base).

The other components are purified poloxamer 188, purified poloxamer 407, purified water, and diluted hydrochloric acid used to adjust the pH.

Appearance of Oraqix and contents of the pack

Oraqix is a periodontal gel. It is a clear, colourless gel in a single-use glass cartridge.

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 of lidocaine and 42.5 mg of prilocaine).

Each pack contains 20 cartridges.

Marketing Authorisation Holder

DENTSPLY DETREY GmbH, De-Trey-Str. 1, 78467 Konstanz, Germany

Telephone: +49-(0)7531-583-0

Manufacturer

Meribel Pharma Karlskoga AB, Björkbornsvägen 5, SE-691 33 Karlskoga, Sweden

This medicinal product is authorised in the European Economic Area member states under the following names:

This patient leaflet was approved on 23 June 2010.

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The following information is intended for medical or healthcare professionals only:

For further information on 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 of Oraqix will be sufficient for one dental quadrant. The maximum recommended dose of Oraqix in a single treatment session is five cartridges, i.e., 8.5 g of gel containing 212.5 mg of lidocaine base and 212.5 mg of prilocaine base.

• At the time of administration, Oraqix should be in liquid form. If a gel has formed, place the cartridge in a refrigerator until it returns to a liquid consistency. The visible air bubble in the cartridge will move when tilted.

• The gel may become cloudy at temperatures below 5°C. The gel will return to its original appearance once it reaches room temperature. Oraqix turns into a gel after administration.

• The cartridge and applicator are intended for single use only. They are compatible with the Oraqix dispenser.

• Fill periodontal pockets with Oraqix gel using a dental syringe or the Oraqix dispenser with the blunt-tip applicator provided in the package, until the gel appears at the gingival margin. Wait 30 seconds before starting treatment (longer waiting times do not increase anaesthesia). The duration of anaesthesia, assessed by probing pocket depth, is approximately 20 minutes. If anaesthesia begins to wear off, reapply Oraqix as needed.

• If additional local anaesthesia is required in combination with Oraqix, consult the SmPC of each specific adjuvant anaesthetic. Since systemic toxic effects are additive (see sections 4.5 and 4.9 of the Oraqix SmPC), administration of further local anaesthetics during the same treatment session is not recommended if the amount of Oraqix administered corresponds to the maximum recommended dose of five cartridges.

• Avoid contact with Oraqix to prevent possible sensitization or allergic reactions.