Prospecto: information for the user

XILONIBSA 20 mg/ml + 0.0125 mg/ml, Injectable Solution

Lidocaína hidrocloruro + Epinefrina

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to 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 not listed in this prospect. See section 4.

1. What isXILONIBSA 20 mg/ml + 0.0125 mg/mland for what it is used

2. What you need to know before starting to useXILONIBSA 20 mg/ml + 0.0125 mg/ml

3. How to useXILONIBSA 20 mg/ml + 0.0125 mg/ml

4. Possible adverse effects

5. Storage ofXILONIBSA 20 mg/ml + 0.0125 mg/ml

6. Contents of the package and additional information

XILONIBSA 20 mg/ml + 0.0125 mg/ml is a local anesthetic (agent that reduces or eliminates sensations, affecting a particular region), which belongs to the subgroup of amides. This medication is used in local dental anesthesia for both routine dental treatments and long-duration treatments.

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

• in children under 4 years.
• if you are allergic to lidocaine hydrochloride, amide-type anesthetics, epinephrine, or any of the other components of this medication (listed in section 6).
• if you are taking tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
• if you have severe, untreated, or uncontrolled hypertension, heart rhythm disorders, unstable angina, or have recently had a heart attack. Consult your doctor, as this medication may not be recommended for you.
• if you have severe bleeding disorders.
• if you have any degenerative nervous system diseases.
• if you have a deficiency in 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 sulfite.
• if you have severe bronchial asthma.

Warnings and precautions

Consult your doctor before starting to use XILONIBSA 20 mg/ml + 0.0125 mg/ml:

• if you have severe, untreated hypertension (high blood pressure).
• if you have any severe heart disease or have recently undergone heart surgery.
• if you have severe anemia.
• if you have any severe liver disease.
• if you have poor blood circulation.
• if you have blood clotting disorders or are taking anticoagulants (blood clot preventers).
• if you have any lung disease, especially allergic asthma.
• if you have uncontrolled thyroid gland disease.
• if you have narrow-angle glaucoma (vision loss due to retina degeneration).
• if you have advanced diabetes.
• if you have epilepsy.
• if you have acute porphyria.
• if you have phaeochromocytoma.
• if you have arteriosclerosis.

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

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

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

• Phenothiazines, butyrophenones for the treatment of psychotic disorders.
• Tricyclic antidepressants or MAOIs for the treatment of depression.
• Non-selective beta-blockers such as propranolol for the treatment of high blood pressure.
• Anticoagulants such as heparin or acetylsalicylic acid to prevent blood clotting.
• Antiarrhythmics to regulate heart rhythm.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen to combat 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 returns to prevent the risk of biting your tongue or cheek. Excessive alcohol consumption may reduce sensitivity to anesthetics.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Driving and operating machinery

Depending on the dose and administration site, local anesthetics may affect mental function and temporarily alter locomotion and coordination. When administering this medication, the doctor or dentist must assess in each case whether reaction capacity is compromised and whether the patient can drive or operate machinery, and should remain in the consultation for at least 30 minutes after the procedure.

XILONIBSA 20 mg/ml + 0.0125 mg/ml containssulfite, which may cause rare allergic reactions and bronchospasm (sensation of asphyxiation) in some individuals.

This medication contains less than 1 mmol of sodium (23 mg) per cartridge, making it essentially sodium-free.

XILONIBSA 20 mg/ml + 0.0125 mg/ml will be administered by your doctor or dentist in the form of an injection.

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

The maximum dose in 24 hours is 490 mg of lidocaine (calculated for a person weighing 70 kg), and should not exceed in any case a dose of 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 old. The average dose to be used is in the range of 20 mg to 30 mg of lidocaine hydrochloride per session. The dose in mg of lidocaine hydrochloride that can be administered to children may be alternatively calculated from the expression: child's weight (in kilograms) x 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 old.

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

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

The initial symptoms are agitation, numbness of the lips, tongue, and around the mouth, dizziness, alterations in vision and hearing, buzzing in the ears. More severe symptoms such as difficulty speaking, muscle stiffness, or spasms may lead to generalized seizures.

The cardiovascular symptoms are a feeling of heat, sweating, alterations in blood pressure and heart rhythm, which may lead to cardiovascular arrest.

If these signs of toxicity appear, the injection of the anesthetic should be stopped immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

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

Like all medications, XILONIBSA 20 mg/ml + 0.0125 mg/ml may cause adverse effects, although not everyone will experience them.

Rare adverse effects (may affect up to 1 in 1000 patients).

CARDIOVASCULAR DISORDERS:

Heat sensation, sweating, migraine-type headaches, chest angina disorders, blood pressure and heart impulse conduction alterations, decreased heart rate, cardiovascular arrest.

NEUROLOGICAL DISORDERS:

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

RESPIRATORY DISORDERS:

Increased respiratory rate, followed by decreased respiratory rate, and potentially causing 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 asthmatic bronchial patients, allergic reactions may occur, manifesting with vomiting, diarrhea, wheezing, acute asthma attack, impaired consciousness, or anaphylactic shock.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store below 30°C and protected from light.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of XILONIBSA 20 mg/ml + 0.0125 mg/ml

• The active principles 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 injection preparations.

Appearance of the product and contents of the package

XILONIBSA 20 mg/ml + 0.0125 mg/ml is packaged in glass cartridges.

Package containing 100 cartridges with a flat plunger of 1.8 ml for auto-aspiration.

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Inibsa, S.A.

Ctra. Sabadell a Granollers, km. 14.5

08185 Lliçà de Vall (Barcelona)

Spain

Phone: +34 938 609 500

Fax: +34 938 439 695

e-mail:[email protected]

Last review date of this leaflet: May 2014

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals

Local injection / Oromucosal use.

For exclusive use in dental anesthesia.

Injections must always be performed slowly and with prior aspiration in at least two planes (through rotation of the needle 180°) to avoid accidental intravascular injection.

The injection speed should not exceed 0.5 ml in 15 seconds, which is equivalent to one cartridge per minute.

The technical data sheet includes guidelines and recommendations to ensure proper use of the product (seePosology and administration method; Warnings and special precautions for use).

Instructions for use:

1. Open the package (tray with 10 cartridges).

2. Remove a cartridge and place it in the syringe body.

3. Adjust the syringe plunger (or piston) on the cartridge plunger.

4. Carefully introduce the short end of the double-pointed needle into the syringe end and proceed to secure it by screwing.

5. Remove and discard the protective cover of the long end of the needle and proceed with the injection.

AUTOASPIRATION

To perform auto-aspiration, an automatic aspiration syringe is required. Auto-aspiration is performed by applying a gentle pressure on the piston and immediately releasing it. The elastic spring of the cartridge membrane, initially pressed onto the axis of the syringe base, creates a negative pressure inside the cartridge that ensures aspiration.

MANUAL ASPIRATION

To perform manual aspiration, a syringe with a hook or harpoon is required. Manual aspiration is achieved when the harpoon is fixed to the anesthesia cartridge and the plunger is pulled back.