Xilonibsa 20 mg/ml + 0.0125 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

XILONIBSA 20 mg/ml + 0.0125 mg/ml, Injection solution

Hydrochloride lidocaine + Epinephrine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What XILONIBSA 20 mg/ml + 0.0125 mg/ml is and what it is used for
2. What you need to know before using XILONIBSA 20 mg/ml + 0.0125 mg/ml
3. How to use XILONIBSA 20 mg/ml + 0.0125 mg/ml
4. Possible adverse effects
5. How to store XILONIBSA 20 mg/ml + 0.0125 mg/ml
6. Contents of the pack and other information

1. What XILONIBSA 20 mg/ml + 0.0125 mg/ml is and what it is used for

XILONIBSA 20 mg/ml + 0.0125 mg/ml is a local anesthetic (an agent that reduces or eliminates sensations, affecting a particular region), belonging to the amide subgroup. This medicine is used in local dental anesthesia for both routine and long-duration dental procedures.

2. What you need to know before using XILONIBSA 20 mg/ml + 0.0125 mg/ml

Do not use XILONIBSA 20 mg/ml + 0.0125 mg/ml:

• in children under 4 years of age.
• if you are allergic to lidocaine hydrochloride, amide-type local anesthetics, epinephrine, or any of the other components of this medicine (listed in section 6).
• if you are taking tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
• if you have untreated or uncontrolled severe hypertension, heart rhythm disorders, unstable angina, or have recently had a heart attack. Please consult your doctor, as this medicine may not be suitable for you.
• if you have coagulation disorders (severe bleeding).
• if you have a degenerative neurological disease.
• if you have deficient plasma cholinesterase activity.
• if you have untreated or uncontrolled congestive heart failure.
• if you have recently undergone coronary artery bypass surgery.
• if you are allergic or hypersensitive to sulfites.
• if you have severe bronchial asthma.

Warnings and precautions

Consult your doctor before using XILONIBSA 20 mg/ml + 0.0125 mg/ml if:

• you have severe untreated hypertension (high blood pressure).
• you have a serious heart condition or have recently undergone heart surgery.
• you have severe anemia.
• you have a serious liver disease.
• you have poor blood circulation.
• you have blood coagulation disorders or are undergoing anticoagulant therapy (medications to prevent blood clots).
• you have a lung disease, especially allergic asthma.
• you have uncontrolled thyroid disease.
• you have narrow-angle glaucoma (vision loss due to retinal degeneration).
• you have advanced diabetes.
• you have epilepsy.
• you have acute porphyria.
• you have pheochromocytoma.
• you have atherosclerosis.

Use of XILONIBSA 20 mg/ml + 0.0125 mg/ml with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Inform your dentist if you are taking any of the following medicines, as they may alter the effects of XILONIBSA 20 mg/ml + 0.0125 mg/ml:

• Phenothiazines and butyrophenones used to treat psychotic disorders.
• Tricyclic antidepressants or MAO inhibitors used to treat depression.
• Non-selective beta-blockers such as propranolol used to treat high blood pressure.
• Anticoagulants such as heparin or acetylsalicylic acid used to prevent blood clot formation.
• Antiarrhythmics used to regulate heart rhythm.
• NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen used to treat inflammation, pain, or fever.
• Plasma substitutes (dextran).
• Ergot-type oxytocics (medications used to induce labor).

Use of XILONIBSA 20 mg/ml + 0.0125 mg/ml with food, drinks, and alcohol

It is recommended not to eat until sensation has returned, to prevent the risk of biting the inside of the mouth. Excessive alcohol consumption may reduce sensitivity to anesthetics.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Depending on the dose and site of administration, local anesthetics may affect mental function and temporarily impair mobility and coordination. After administration of this medicine, the physician or dentist should assess in each individual case whether reaction capacity is impaired and whether the patient is allowed to drive or operate machinery. The patient should remain under observation in the clinic for at least 30 minutes after the procedure.

XILONIBSA 20 mg/ml + 0.0125 mg/ml contains metabisulfite, which may very rarely cause allergic reactions and bronchospasm (feeling of suffocation).

This medicine contains less than 1 mmol of sodium (23 mg) per cartridge and is therefore considered essentially sodium-free.

3. How to use XILONIBSA 20 mg/ml + 0.0125 mg/ml

XILONIBSA 20 mg/ml + 0.0125 mg/ml will be administered by your doctor or dentist as an injection.

The recommended dose is 1 to 2 ml in adults, depending on the anesthetic procedure being performed, the area to be anesthetized, body weight, clinical condition, and response to anesthesia.

The maximum dose within 24 hours is 490 mg of lidocaine (calculated for a 70 kg individual), and under no circumstances should the dose exceed 7 mg/kg of body weight.

Use in children

XILONIBSA 20 mg/ml + 0.0125 mg/ml, Injectable solution, is indicated in children over 4 years of age. The average dose to be used ranges from 20 mg to 30 mg of lidocaine hydrochloride per session. The dose in mg of lidocaine hydrochloride that may be administered to children can alternatively be calculated using the following formula: child's weight (in kilograms) × 1.33. Do not exceed the equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight.

The use of XILONIBSA 20 mg/ml + 0.0125 mg/ml is contraindicated in children under 4 years of age.

If you use more XILONIBSA 20 mg/ml + 0.0125 mg/ml than you should

In case of overdose, adverse reactions affecting the nervous system and heart may occur.

Initial symptoms include agitation, numbness sensation in the lips, tongue, and around the mouth, dizziness, visual and auditory disturbances, and tinnitus. Difficulty speaking, muscle stiffness, or spasms are more severe symptoms that may lead to generalized seizures.

Cardiovascular symptoms include feeling of warmth, sweating, changes in blood pressure and heart rhythm, which may lead to cardiovascular arrest.

If these signs of toxicity appear, the anesthetic injection must be immediately discontinued.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, XILONIBSA 20 mg/ml + 0.0125 mg/ml may cause adverse effects, although not everyone experiences them.

Rare adverse effects (may affect up to 1 in 1,000 patients).

Cardiovascular disorders:

Sensation of warmth, sweating, migraine-type headaches, angina pectoris disorders, disturbances in blood pressure and cardiac impulse conduction, decreased heart rate, cardiac arrest.

Nervous system disorders:

Metallic taste, tinnitus (ringing in the ears), dizziness, nausea, vomiting, anxiety, tremors, restlessness, nystagmus (involuntary eye movements), headache, increased respiratory rate, paresthesia (loss of sensation accompanied by burning) of the lip and/or tongue, loss of consciousness, and convulsions.

Respiratory disorders:

Increased respiratory rate, followed by decreased respiratory rate, potentially leading to respiratory arrest.

Very rare adverse effects (may affect up to 1 in 10,000 patients).

Skin rash, erythema (redness), edema (swelling) of the tongue, mouth, lips, or throat. Particularly in bronchial asthmatics, allergic reactions may occur manifesting as vomiting, diarrhea, wheezing, acute asthma attack, clouding of consciousness, or anaphylactic shock.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines at www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of XILONIBSA 20 mg/ml + 0.0125 mg/ml

Keep this medicine out of sight and reach of children.

Store below 30°C and protect from light.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of XILONIBSA 20 mg/ml + 0,0125 mg/ml

• The active substances are lidocaine hydrochloride and epinephrine.

• The other components are sodium chloride, sodium metabisulfite, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), citric acid monohydrate and water for injections.

Appearance of the product and contents of the pack

XILONIBSA 20 mg/ml + 0,0125 mg/ml is packaged in glass cartridges.

Pack containing 100 cartridges with flat plunger of 1.8 ml for self-aspiration.

Pack containing 100 cartridges with plunger with cavity of 1.8 ml for manual aspiration.

Marketing Authorization Holder and Manufacturer

Laboratorios Inibsa, S.A.
Ctra. Sabadell a Granollers, km. 14.5
08185 Lliçà de Vall (Barcelona)
Spain
Telephone: +34 938 609 500
Fax: +34 938 439 695
e-mail: [email protected]

Date of the most recent revision of this leaflet: May 2014

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only

Local injection / Oromucosal use.
For exclusive use in dental anaesthesia.

Injections must always be administered slowly and with prior aspiration in at least two planes (by rotating the needle 180º) to avoid accidental intravascular injection.

The injection rate must not exceed 0.5 ml in 15 seconds, equivalent to one cartridge per minute.

Dosage and administration guidelines and recommendations to ensure correct use of the product are included in the Summary of Product Characteristics (see Dosage and method of administration; Warnings and special precautions for use).

Instructions for use:

1. Open the package (tray with 10 cartridges).
2. Remove one cartridge and place it into the syringe barrel.
3. Adjust the syringe rod (or piston) onto the cartridge plunger.
4. Carefully insert the short end of the double-ended needle into the syringe end and screw it in securely.
5. Remove and discard the protective cap from the long end of the needle and proceed with the injection.

SELF-ASPIRATION

To perform self-aspiration, an automatic aspiration syringe is required. Self-aspiration is achieved by applying gentle pressure on the piston and immediately releasing it. The elastic spring of the cartridge membrane, which is initially pressed against the base shaft of the syringe, creates a negative pressure within the cartridge, ensuring aspiration.

MANUAL ASPIRATION

To perform manual aspiration, a syringe with a hook or harpoon is required. Manual aspiration is achieved by attaching the harpoon to the anaesthetic cartridge and pulling back the plunger.