User Information Leaflet

Octocaine 20 mg/ml + 0.01 mg/mlInjectable Solution

Lidocaine / Epinephrine

Read this leaflet carefully before you start using the 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, pharmacist, or nurse.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

1.What isOctocaine 20 mg/ml + 0.01 mg/mlInjectable Solutionand what it is used for.

2.What you need to know before starting to use Octocaine 20 mg/ml + 0.01 mg/ml Injectable Solution.

3.How to use Octocaine 20 mg/ml + 0.01 mg/ml Injectable Solution.

4.Possible side effects

5Storage of Octocaine 20 mg/ml + 0.01 mg/ml Injectable Solution.

6.Contents of the pack and additional information.

Octocaineisindicated for local anesthesia in odontostomatology, by infiltration or truncal block in adults, adolescents, and children over 4 years old.

Octocaine 20 mg/ml + 0.01 mg/ml injectable solution: It is especially indicated in most dental interventions and in children.

No useOctocaine 20 mg/ml + 0.01 mg/mlinjectable solution:

• in children under 4 years old.
• if you are allergic (hypersensitivity) 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 high blood pressure, 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 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 or dentist before starting to useOctocaine 20 mg/ml + 0.01 mg/ml injectable solution:

• if you have severe, untreated high blood pressure.
• if you have a serious heart disease or have recently undergone heart surgery.
• if you have severe anemia.
• if you have a serious liver disease.
• if you have poor blood circulation.
• if you have blood clotting disorders or are taking anticoagulants (blood thinners).
• if you have a serious 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.

Children

Octocaine 20 mg/ml + 0.01 mg/ml injectable solutionshould not be used in children under 4 years old.

Inform the caregivers of small children that, due to prolonged numbness of soft tissues, there is a risk of accidental biting.

Use of Octocaine 20 mg/ml + 0.01 mg/ml injectable solutionwith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

You must inform your dentist if you are taking any of the following medications, as they may alter the effect of Octocaine 20 mg/ml + 0.01 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 blood clots.
• 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 Octocaine 20 mg/ml + 0.01 mg/ml injectable solutionwith food, drinks, and alcohol

It is recommended not to eat until numbness is recovered 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, or think you may be pregnant, consult your doctor before using this medication.

There are no studies on the safety of this medication for fetal development. The administration of this medication should be carefully considered, especially in the early stages.

Driving and operating machinery

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

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical test for doping control.

Octocaine 20 mg/ml + 0.01 mg/ml injectable solution contains potassium metabisulfite and sodium.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) due to the presence of potassium metabisulfite.

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

Your dentist will determine the dose and method of administration ofOctocaine20 mg/ml + 0.01 mg/ml injectable solution.To do this, they will generally follow the following recommendations.

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

Octocaine 20 mg/ml + 0.01 mg/ml injectable solution

Recommended dose (number of 1.8 ml cartridges: 0.5 –2.5). Maximum dose: 8.5 cartridges of 1.8 ml.

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

The maximum dose in 24 hours is 500 mg of lidocaine, not to be exceeded in any case by 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 more than 0.5 cartridge 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 in patients with underlying diseases:

In elderly patients, an increase in plasma levels of Octocaine 20 mg/ml + 0.01 mg/ml injectable solution may occur due to decreased metabolic processes and reduced volume of distribution. The same applies to weak patients, or those with liver or kidney function problems. Therefore, in all these cases, the lowest possible dose that achieves deep anesthesia should be used.

Administration form

Infiltration and perineural route. Only for use in dental anesthesia.

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

For single use only.The 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 +0.01 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, numbness of the lips, tongue, and around the mouth, dizziness, visual and auditory disturbances, and ringing in the ears. More severe symptoms such as difficulty speaking, muscle rigidity, or spasms may occur, leading to generalized convulsions.

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

If you experience any of these symptoms, immediately inform your dentist.

If more than the recommended amount has been administered, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20 indicating the medication and the amount used.

Like all medications, Octocaine 20 mg/ml + 0.01 mg/ml may cause adverse effects, although not everyone will experience them.

CARDIOVASCULAR DISORDERS:

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

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

NEUROLOGICAL DISORDERS:

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

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:

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

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, altered 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 Medicines for Human Usewww.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No requires special conditions for conservation.

Keepout of the sight and reach of children.

Do not useOctocaine 20 mg/ml + 0.01 mg/mlafter the expiration date appearing on the packaging, after the abbreviation CAD. 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 that you no longer need. In this way, you will help protect the environment.

Composition ofOctocaine 20 mg/ml + 0.01 mg/mlinjectable solution.

The active principles are Lidocaine (hydrochloride) and epinephrine (bitartrate).

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

Appearance of the product and contents of the packaging

Octocaine 20 mg/ml + 0.01 mg/ml injectable solution, colorless and transparent.

Package containing 50 cartridges of 1.8 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Clarben S.A. - C/ Asura 111 - 28043 Madrid-Spain

Responsible for Manufacturing:

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

Last review of this leaflet was inJanuary 2019

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es