XILONIBSA 20 mg/ml + 0.0125 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

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

Lidocaine Hydrochloride + Epinephrine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What XILONIBSA 20 mg/ml + 0.0125 mg/ml is and what it is used for
2. What you need to know before you use XILONIBSA 20 mg/ml + 0.0125 mg/ml
3. How to use XILONIBSA 20 mg/ml + 0.0125 mg/ml
4. Possible side effects
5. Storage of 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), which belongs to the subgroup of amides. This medicine is used in local dental anesthesia for both routine and long-duration dental treatments.

2. What you need to know before you use 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 anesthetics, or epinephrine, or to 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 severe uncontrolled or untreated hypertension, heart rhythm disorders, unstable angina, or have recently had a heart attack. Ask your doctor for advice, as this medicine may not be suitable for you.
• if you have coagulation disorders (severe bleeding).
• if you have any degenerative nerve disease.
• if you have a deficit 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 uncontrolled hypertension (high blood pressure).
• if you have any serious heart disease or have recently undergone heart surgery.
• if you have severe anemia.
• if you have any serious liver disease.
• if you have poor blood circulation.
• if you have blood coagulation disorders or are undergoing treatment with anticoagulants (products to prevent clots).
• if you have any serious lung disease, especially allergic asthma.
• if you have any 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 pheochromocytoma.
• if you have arteriosclerosis.

Using XILONIBSA 20 mg/ml + 0.0125 mg/ml with other medicines

Tell your doctor if you are using, have recently used, or might use any other medicines.

Tell 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, 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 clot formation.
• Antiarrhythmics to regulate heart rhythm.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen to combat inflammation, pain, or fever.
• Plasma substitutes (dextran).
• Ergotamine-type oxytocics (medicines used to induce labor).

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

It is recommended not to ingest food until sensitivity is regained to prevent the risk of biting in 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 plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Depending on the dose and administration site, local anesthetics may affect mental function and temporarily alter locomotion and coordination. When this medicine is administered, the doctor or dentist should assess each particular case to determine if the reaction capacity is compromised and if the patient can drive or use machines, and the patient should remain in the office for at least 30 minutes after the procedure.

XILONIBSA 20 mg/ml + 0.0125 mg/ml containsmetabisulfite, which may rarely cause allergic reactions and bronchospasm (sensation of asphyxiation).

This medicine contains less than 1 mmol of sodium (23 mg) per cartridge, so it is 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 in the form of an injection.

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

The maximum dose in 24 hours is 490 mg of lidocaine (calculated for a 70 kg person), and in no case 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 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 in children can 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 of age.

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, sensation of numbness of the lips, tongue, and around the mouth, dizziness, vision and hearing disturbances, ringing in the ears. More severe symptoms include difficulty speaking, muscle stiffness, or spasms that can trigger generalized convulsions.

Cardiovascular symptoms include a sensation of heat, sweating, alterations in blood pressure and heart rhythm, which can lead to cardiovascular arrest.

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

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

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

4. Possible side effects

Like all medicines, XILONIBSA 20 mg/ml + 0.0125 mg/ml can cause side effects, although not everybody gets them.

Rare side effects (may affect up to 1 in 100 patients).

Cardiovascular disorders:

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

Nervous system disorders:

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

Respiratory disorders:

Increased respiratory rate, followed by decreased respiratory rate, and may cause respiratory arrest.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) www.notificaram.es.

By reporting side 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 the sight and reach of children.

Store below 30°C and protected from light.

Do not use this medicine after the expiry date stated on the pack. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients are lidocaine hydrochloride and epinephrine.

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

Appearance of the product and pack contents

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 auto-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

Phone: +34 938 609 500

Fax: +34 938 439 695

e-mail: [email protected]

Date of last revision of this leaflet: May 2014

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

This information is intended only for healthcare professionals

Local injection / Oromucosal use.

For exclusive use in dental anesthesia.

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

The injection rate 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 correct use of the product (see Dosage and administration; Special warnings and precautions for use).

Instructions for use:

1. Open the pack (tray with 10 cartridges).
2. Remove a cartridge and place it in the syringe body.
3. Adjust the plunger (or piston) of the syringe over the cartridge plunger.
4. Carefully insert the short end of the double-pointed needle into the end of the syringe and proceed to screw it to secure it.
5. Remove and discard the protector from the long end of the needle and proceed with the injection.

AUTO-ASPIRATION

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