Label: information for the user

Oraqix Gel Periodontal

Lidocaine and prilocaine

Read the entire label carefully before starting to use the medication.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your dentist or dental hygienist.
• This medication 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 adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this label, inform your dentist, dental hygienist, or doctor.

1. What Oraqix is and for what it is used

2. Before using Oraqix

3. How to use Oraqix

4. Possible adverse effects

5. Storage of Oraqix

6. Additional information

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

Do not use Oraqix

• if you are allergic (hypersensitive) to lidocaine, prilocaine, or other similar local anesthetics;
• if you are allergic (hypersensitive) to any of the other components of the gel (see section 6, Additional information);
• if your doctor has explained that you have congenital or idiopathic methemoglobinemia (a disorder in which an excessive amount of hemoglobin in your blood is transformed into methemoglobin. If too much methemoglobin is formed, it becomes more difficult for the blood to provide oxygen to the tissues);
• if your doctor has told you that you suffer from repeated episodes of porphyria or if you may have inherited porphyria (porphyrias are a group of disorders that affect the way your blood is produced).

Consult your dentist or dental hygienist if you are in any of the following situations:

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

Be especially careful 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 having Oraqix enter your eyes. If you accidentally get the gel in your eyes, rinse them with water or saline solutionimmediatelyand protect them until they recover sensitivity.
• Oraqix may occasionally block all sensitivity in the treated areas. Be careful not to bite your mouth accidentally. Also avoid taking hot drinks and foods until you have fully recovered sensitivity.
• Oraqix may interfere with drug tests for athletes. It could give a false positive result for these substances.

Use of other medications

Inform your dentist if you are using:

• any other local anesthetic type amide or products used for the treatment of irregular heart activity (antiarrhythmics such as mexilitine) as these medications in combination with Oraqix may increase the risk of adverse effects described in the section "Using too much Oraqix"
• other medications that may cause methemoglobinemia, for example, certain types of antibiotics known as sulfonamides.

Inform your dentist or dental hygienist if you are using or have recently used other medications, even those purchased without a prescription.

Pregnancy and breastfeeding

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

• Oraqixshould notbe used during pregnancy unless recommended by your dentist.
• Breastfeeding can continue after treatment with Oraqix.

Driving and operating machinery

Oraqix has no known effects that could affect your ability to drive or operate machinery.

Oraqix will be administered by a dentist or dental hygienist. The dose will be 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 should not be injected.
• Oraqix gel is applied inside the gum with a dental syringe or using the Oraqix dispenser and a blunt-tip applicator.
• The maximum dose in a single treatment is 5 cartridges.
• The full effect is achieved after around half a minute, and then the dentist or dental hygienist can start the treatment. The effect should last for around 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 in the same treatment session.
• It is not recommended to use large quantities of Oraqix frequently.

If you use more Oraqix than you should

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, dizziness, vertigo, agitation, or sometimes blurred vision, numbness, and loss of consciousness. Other rare effects are seizures, difficulty breathing, and low blood pressure.

Excessive prilocaine (Oraqix in combination with another anesthetic that contains prilocaine) may also cause methemoglobinemia (see section 2). This is characterized by grayish-blue discoloration of the lips and skin (cyanosis).

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 observed for several hours.

Like all medications, Oraqix may produce adverse effects, although not everyone will experience them.

Common Adverse Effects (affecting up to 1 in 10 people):

• Headache
• Changes in taste
• Mouth reactions (pain, burning, numbness of other parts of the mouth or lips, ulcers, irritation, and redness)

Rare Adverse Effects (affecting less than 1 in 100 people)

• Allergic reactions that may include: skin rash, throat swelling, difficulty breathing, and fever
• Dizziness
• Nausea
• Difficulty breathing and cyanosis (a bluish-gray discoloration of the lips and skin)
• Burning sensation
• Swelling at the application site
• A Oraqix overdose may lead to central nervous system excitement or depression and cardiac circulation and heart function depression. In case of any concern regarding these possible adverse effects, seek immediate hospital attention.

If any adverse effect worsens, for example, difficulty breathing or throat swelling or suspected anaphylactic reaction to the anesthetic, inform your dentist or doctor immediately or go directly to the hospital. If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your dentist or hygienist if you are still in the consultation or your doctor if you are already at home when they occur.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Oraqix

The active principles 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 package

Oraqix is a periodontal gel. It is a transparent and colorless gel in a glass cartridge and is for 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 of lidocaine and 42.5 mg of prilocaine).

Each package contains 20 cartridges.

Marketing Authorization Holder

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

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

Responsible for manufacturing

Recipharm Karlskoga AB, Björkbornsvägen 5, SE-691 33 Karlskoga Sweden

This medicinal product is authorized in the member states of the European Economic Area with the following names:

This leaflet was approved on 23 June 2010.

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This information is intended solely for medical professionals or healthcare professionals:

For more information on the use of Oraqix, see the Product Characteristics Summary (Technical Dossier).

Method of administration

• Oraqix should not be injected.

• On average, one cartridge (1.7 g) or less of Oraqix will be sufficient for one quadrant of the teeth. 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 must be a liquid. If a gel has formed, it should be placed in the refrigerator until it regains a liquid consistency. The visible air bubble in the cartridge will move when tilted.

• The gel may become opaque at temperatures below 5°C. The gel will regain its original appearance at room temperature. Oraqix becomes a gel after administration.

• The cartridge and applicator are for single use. They fit into the Oraqix dispenser.

• Fill the periodontal pouch with Oraqix gel using a dental syringe or the Oraqix dispenser and the blunt-tipped applicator included with the package, until the gel appears at the gingival margin. Wait for one minute before starting treatment (further waiting time does not increase anesthesia). The duration of anesthesia, evaluated by probing the depth of the pockets, is approximately 20 minutes. If anesthesia begins to decrease, reapply Oraqix as needed.

• If you need additional local anesthesia in combination with Oraqix, see the specific technical dossier for each additional anesthetic. Since systemic toxic effects are additive (see sections 4.5 and 4.9 of the Oraqix technical dossier), it is not recommended to administer additional local anesthetics in 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 a possible allergy.