OCTOCAINE 20 mg/ml + 0.02 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Octocaine 20 mg/ml + 0.02 mg/mlinjectable solution

lidocaine / 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, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Octocaine 20 mg/ml + 0.02 mg/ml injectable solution is and what it is used for.
2. What you need to know before you use Octocaine 20 mg/ml + 0.02 mg/ml injectable solution.
3. How to use Octocaine 20 mg/ml + 0.02 mg/ml injectable solution.
4. Possible side effects.

5. Storage of Octocaine 20 mg/ml + 0.02 mg/ml injectable solution.

1. Contents of the pack and further information.

1. What Octocaine 20 mg/ml + 0.02 mg/ml injectable solution is and what it is used for

Octocaine is indicated for local anesthesia in dentistry, by infiltration or trunk block in adults, adolescents, and children over 4 years.

Octocaine 20 mg/ml + 0.02 mg/ml injectable solution: It is especially indicated in cases where little bleeding is required.

2. What you need to know before you use Octocaine 20 mg/ml + 0.02 mg/ml injectable solution.

Do not useOctocaine 20 mg/ml + 0.02 mg/mlinjectable solutionif:

• you are under 4 years old.
• you are allergic (hypersensitive) to lidocaine hydrochloride, amide-type anesthetics, epinephrine, or any of the other components of this medicine (listed in section 6).
• you are taking tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
• you have untreated or uncontrolled severe 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.
• you have severe coagulation disorders (severe bleeding).
• you have any degenerative nerve disease.
• you have a deficit in plasma cholinesterase activity.
• you have untreated or uncontrolled congestive heart failure.
• you have recently undergone coronary artery bypass surgery.
• you are allergic or hypersensitive to sulfite.
• you have severe bronchial asthma.

Warnings and precautions

Consult your doctor or dentist before starting to use Octocaine 20 mg/ml + 0.02 mg/ml injectable solution:

• if you have untreated 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 lung disease, especially allergic asthma.
• if you have any uncontrolled thyroid gland disease.
• if you have narrow-angle glaucoma (vision loss due to retinal degeneration).
• if you have advanced diabetes.
• if you have epilepsy.
• if you have acute porphyria.
• if you have pheochromocytoma.
• if you have arteriosclerosis.

Children

Octocaine 20 mg/ml + 0.02 mg/ml injectable solution should not be used in children under 4 years old.

Accompanying adults of small children should be informed that, due to prolonged numbness of the soft tissues, there is a risk that the child may accidentally bite themselves.

Use of Octocaine 20 mg/ml + 0.02 mg/ml injectable solution with other medicines

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

You should inform your dentist if you are taking any of the following medicines, as they may alter the effect of Octocaine 20 mg/ml + 0.02 mg/ml injectable solution.

• 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).
• Oxytocics of the ergotamine type (medicines used to induce labor).

Use of Octocaine 20 mg/ml + 0.02 mg/ml injectable solution 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 consumption of alcohol 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.

There are no safety studies on fetal development. Administration should be carefully considered in these cases, mainly in the early stages.

Driving and using machines

Although no effects on the ability to drive vehicles are expected, the dentist will decide when you are able to drive and operate machinery.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Octocaine 20 mg/ml + 0.02 mg/ml injectable solution contains potassium metabisulfite and sodium.

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains potassium metabisulfite.

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

3. How to use Octocaine 20 mg/ml + 0.02 mg/ml injectable solution

Your dentist will determine the dose and method of administration of Octocaine 20 mg/ml + 0.02 mg/ml injectable solution, guided by the following recommendations.

The smallest possible volume of solution necessary to achieve effective anesthesia should be used.

Octocaine 20 mg/ml + 0.02 mg/ml injectable solution

• Recommended dose (number of 1.8 ml cartridges: 0.5-1.0). Maximum dose: 5.5 cartridges of 1.8 ml.

The dosage depends on the patient's idiosyncrasy, the area to be anesthetized, the vascularization of the tissues involved, and the anesthetic technique.

The maximum dose in 24 hours is 500 mg of lidocaine, and it should not exceed 7 mg/kg of body weight in adults.

Use in children:

Do not administer to children under 4 years old.

In children under 10 years old, it is rare to need to use more than 0.5 cartridges per procedure.

The average dose to be used is in the range of 20 mg to 30 mg of lidocaine hydrochloride per session.

Do not exceed the equivalent of 5 mg of lidocaine hydrochloride per kilogram of body weight.

Dosage in elderly patients and patients with underlying diseases:

In elderly patients, there may be an increase in plasma levels of Octocaine 20 mg/ml + 0.02 mg/ml injectable solution due to decreased metabolic processes and lower volume of distribution. The same applies to weak patients or those with liver or kidney problems. Therefore, in all these cases, the lowest possible dose that achieves a deep anesthetic effect should be used.

Method of administration

Infiltration and perineural route. For dental anesthesia only.

Aspiration is highly recommended as it avoids the risk of intravascular injection and minimizes the possibility of undesirable effects. The preparation should always be administered slowly.

For single use.Opened cartridges should not be used in other patients. Any unused portion of the solution should be discarded.

If you use more Octocaine 20 mg/ml + 0.02 mg/ml injectable solution 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, tinnitus. More severe symptoms include difficulty speaking, muscle stiffness, or spasms that can trigger generalized convulsions.

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

If you experience any of these symptoms, immediately or shortly after being administered Octocaine 20 mg/ml + 0.02 mg/ml injectable solution, inform your dentist immediately.

If you have been administered more than recommended, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount used.

4. Possible side effects

Like all medicines, Octocaine 20 mg/ml + 0.02 mg/ml can cause side effects, although not everybody gets them.

Cardiovascular disorders:

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

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

Nervous system disorders:

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

Metallic taste, tinnitus, feeling 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:

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

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. Especially 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 Pharmacovigilance System for Human Use www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Octocaine 20 mg/ml + 0.02 mg/ml injectable solution

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use Octocaine 20 mg/ml + 0.02 mg/ml after the expiration date stated on the packaging, after the abbreviation CAD. The expiration 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 dispose of cartridges and medicines no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Octocaine 20 mg/ml + 0.02 mg/ml injectable solution.

The active ingredients are Lidocaine (hydrochloride) and Epinephrine (bitartrate).

The other ingredients (excipients) are: sodium chloride, potassium metabisulfite, sodium edetate, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injectable preparations.

Appearance of the product and contents of the pack

Octocaine 20 mg/ml + 0.02 mg/ml injectable solution, colorless and translucent.

Pack containing 50 cartridges of 1.8 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Clarben S.A. – Av. Valdelaparra 27 – 28108 Alcobendas Spain

Manufacturer:

Laboratorios Clarben S.A. C/ Eduardo Marconi, 2. Polígono Industrial Codein. Fuenlabrada 28946 Madrid- Spain

This leaflet was last revised inJanuary 2019

Detailed and updated 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 / Dental use

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

Instructions for use:

1. Open the package.
2. Remove a cartridge and place it in the syringe body.
3. Adjust the syringe piston over the cartridge plunger.
4. Carefully insert the short end of the double-pointed needle into the syringe end and proceed to screw it in 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 base axis of the syringe, creates negative pressure inside the cartridge, ensuring 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.