Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution

articaine hydrochloride /epinephrine

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you. Keep this leaflet, as you may need to read it again. If you have any questions, consult your dentist, doctor, or pharmacist. If you experience any adverse effects, consult your dentist, doctor, or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

1. What Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution is and what it is used for
2. What you need to know before Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution is administered to you
3. How to use Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution
4. Possible side effects
5. How to store Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution

Contents of the pack and other information

1. What Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution is and what it is used for

Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution is used to numb (anesthetize) the oral cavity during dental procedures.

This medicine contains two active substances:

• Articaine, a local anesthetic that prevents pain.
• Adrenaline, a vasoconstrictor that narrows the blood vessels at the injection site, thereby prolonging the effect of articaine. It also reduces bleeding during surgery.

Your dentist will administer either Ultracain with adrenaline 40 mg/ml + 5 micrograms/ml injectable solution or Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution.

Ultracain is indicated in children over 4 years of age (approximately 20 kg body weight), adolescents, and adults.

Depending on the type of dental procedure performed, the dentist will choose one of the two medicines:

• Ultracain with adrenaline 40 mg/ml + 5 micrograms/ml injectable solution is usually used for simple and short dental procedures.
• Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution is more suitable for longer procedures or those with potential for significant bleeding.

2. What you need to know before Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution is administered to you

Do not use Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution if you have any of the following conditions:

• allergy to articaine or adrenaline, or to any of the other components of this medicine (listed in section 6).
• allergy to other local anaesthetics.
• epilepsy not properly controlled with medication.

Warnings and precautions

Talk to your dentist before starting to use Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution if you have any of the following conditions:

• severe heart rhythm disorders (e.g., second- or third-degree AV block).
• acute heart failure (acute cardiac weakness, e.g., unexpected chest pain at rest or after myocardial infarction [i.e., heart attack]).
• low blood pressure (hypotension).
• abnormally rapid heartbeat.
• myocardial infarction within the last 3–6 months.
• coronary artery bypass graft within the last 3 months.
• you are taking blood pressure medications called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of the pulse (see section "Use of Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution with other medicines").
• very high blood pressure.
• you are simultaneously taking medications for depression and Parkinson’s disease (tricyclic antidepressants). These medicines may intensify the effects of adrenaline.
• epilepsy.
• deficiency of a naturally occurring blood chemical called cholinesterase (plasma cholinesterase deficiency).
• kidney problems.
• severe liver problems.
• a disease called Myasthenia Gravis that causes muscle weakness.
• porphyria causing both neurological complications and skin problems.
• if you are using other local anaesthetics that cause reversible loss of sensation (including volatile anaesthetics such as halothane).
• if you are taking medications called antiplatelet agents or anticoagulants to prevent narrowing or hardening of blood vessels in arms and legs.
• if you are over 70 years old.
• you have or have had any heart problems.
• you have uncontrolled diabetes.
• severe overactivity of the thyroid gland (thyrotoxicosis).
• a tumour called phaeochromocytoma.
• a condition called closed-angle glaucoma affecting the eyes.
• inflammation or infection at the site where the injection will be given.
• reduced oxygen levels in body tissues (hypoxia), high potassium levels in the blood (hyperkalaemia), and metabolic disorders resulting from excess acid in the blood (metabolic acidosis).

Use of Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution with other medicines

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

It is extremely important to inform your dentist if you are taking any of the following medicines:

• Other local anaesthetics causing reversible loss of sensation (including volatile anaesthetics such as halothane).
• Sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before the dental procedure.
• Medicines for heart and blood pressure (such as guanadrel, guanethidine, propranolol, nadolol).
• Tricyclic antidepressants for treating depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline).
• COMT inhibitors for treating Parkinson’s disease (such as entacapone or tolcapone).
• MAO inhibitors for treating depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid).
• Medicines for irregular heartbeats (e.g., digitalis, quinidine).
• Medicines for migraine attacks (such as methysergide or ergotamine).
• Sympathomimetic vasopressors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline), used to raise blood pressure: if taken within 24 hours prior to the planned dental treatment, the procedure should be postponed.
• Neuroleptic drugs (e.g., phenothiazines).

Use of Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution with food

Avoid eating, including chewing gum, until normal sensation has returned. Otherwise, there is a risk of biting your lips, cheeks, or tongue, especially in children.

Pregnancy, breastfeeding, and fertility

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

Your dentist or doctor will decide whether you can use Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution during pregnancy.

Breastfeeding may be resumed 5 hours after anaesthesia.

No adverse effects on fertility are expected with the doses used in dental procedures.

Driving and use of machines

If you experience adverse effects, including dizziness, blurred vision, or fatigue, do not drive or operate machinery until you have fully recovered (usually within 30 minutes after the dental procedure).

Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution contains sodium and sodium metabisulphite.

• This medicine contains less than 23 mg of sodium (1 mmol) per cartridge, i.e., essentially "sodium-free".
• This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulphite.

If there is any risk of an allergic reaction, your dentist will choose another medicine for anaesthesia.

3. How to use Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection

Only doctors and dentists are trained to use Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection.

Your dentist will choose between Ultracain with adrenaline 40 mg/ml + 5 micrograms/ml solution for injection or Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection and will determine the appropriate dose based on your age, weight, general health status, and the dental procedure being performed.

The lowest effective dose providing adequate anesthesia should be used.

This medicine is administered by slow injection into the oral cavity.

If you are given more Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection than you should

It is unlikely that you will be given too much of this injection, but if you begin to feel unwell, inform your dentist immediately. Symptoms of overdose include sudden weakness, pallor, headache, agitation or restlessness, disorientation, loss of balance, involuntary tremors or shivering, pupil dilation, blurred vision, difficulty focusing objects clearly, speech disturbances, dizziness, seizures, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing which may lead to temporary respiratory arrest, inability of the heart to contract (cardiac failure).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

While you are at the dentist, your dentist will closely monitor the effects of Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution.

Inform your dentist, doctor, or pharmacist immediately if you experience any of the following serious adverse effects:

• Swelling of the face, tongue, or pharynx, difficulty swallowing, urticarial rash, or difficulty breathing (angioedema)
• Rash, itching, swelling of the throat, and difficulty breathing: these may be symptoms of an allergic reaction (hypersensitivity)
• A combination of drooping eyelid and pupil constriction (Horner's syndrome)

These adverse effects are rare (may affect up to 1 in 1,000 people).

Other adverse effects not listed above may also occur in some patients.

Common adverse effects: may affect up to 1 in 10 people:

• Gum inflammation
• Neuropathic pain: pain due to nerve injury
• Numbness or reduced sense of touch inside and around the mouth
• Metallic taste, taste disturbances, or loss of taste function
• Increased, unpleasant, or abnormal sense of touch
• Increased sensitivity to heat
• Headache
• Abnormally rapid heartbeat
• Abnormally slow heartbeat
• Low blood pressure
• Swelling of the tongue, lips, and gums

Uncommon adverse effects: may affect up to 1 in 100 people:

• Burning sensation
• High blood pressure
• Swelling of the tongue and mouth
• Nausea, vomiting, diarrhea
• Rash, itching
• Pain in the neck or at the injection site

Rare adverse effects: may affect up to 1 in 1,000 people:

• Nervousness, anxiety
• Facial nerve disorder (facial paralysis)
• Somnolence
• Involuntary eye movements
• Double vision, temporary blindness
• Drooping eyelid and pupil constriction (Horner's syndrome)
• Sunken eyeball within the orbit (enophthalmos)
• Ringing in the ears, increased ear sensitivity
• Palpitations
• Flushing
• Wheezing (bronchospasm, whistling or hissing sounds in the bronchi), asthma
• Difficulty breathing
• Exfoliation and ulceration of the gums
• Exfoliation at the injection site
• Urticarial rash
• Involuntary muscle contractions
• Fatigue, weakness
• Chills

Very rare adverse effects: may affect up to 1 in 10,000 people:

• Persistent loss of sensation, extensive numbness, and loss of taste

Frequency not known: cannot be estimated from available data

• Extreme sense of well-being (euphoria)
• Heart rhythm coordination problems (conduction disorders, atrioventricular block)
• Increased blood volume in a part of the body leading to congestion of blood vessels
• Widening or narrowing of blood vessels
• Hoarseness
• Difficulty swallowing
• Swelling of the cheeks and local swelling
• Burning mouth syndrome
• Redness of the skin (erythema)
• Abnormal increase in sweating
• Worsening of neuromuscular symptoms in Kearns-Sayre syndrome
• Sensation of heat or cold
• Jaw locking

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection

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

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

Store below 25°C.

Do not freeze.

Keep cartridges in their tightly closed outer packaging to protect from light.

Do not use this medicine if you notice that the solution is cloudy or has changed colour.

Cartridges are for single use only. Use immediately after opening the cartridge. Any unused solution must be discarded.

Medicines should not be disposed of via wastewater or household waste. Your dentist will know how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection

• The active substances are articaine hydrochloride and epinephrine (adrenaline).

  • Each 1.7 ml cartridge of Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection contains: 68 mg of articaine hydrochloride and 17 micrograms of epinephrine (adrenaline).
  • Each millilitre of Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection contains: 40 mg of articaine hydrochloride and 10 micrograms of epinephrine (adrenaline).

• The other components are: sodium metabisulfite (E-223), sodium chloride, 0.1 N hydrochloric acid and water for injections.

Appearance of the product and contents of the pack

Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection is colourless.

It is packaged in single-use glass cartridges, sealed at the base with a movable rubber plunger and at the top with a rubber seal secured by an aluminium cap.

Pack containing one cartridge and one leaflet.

Pack containing 100 cartridges (clinical pack) in 10 PVC blisters with 10 cartridges each and one leaflet.

Other presentations:

Ultracain with adrenaline 40 mg/ml + 5 micrograms/ml solution for injection.

Marketing Authorisation Holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

or

LABORATORIOS NORMON, S.A.

Avenida de los Artesanos, 28 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: October 2024.

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/55033/P_55033.html

This information is intended for healthcare professionals only:

Posology

For all populations, the lowest effective dose required to achieve adequate anaesthesia should be used. The required dose must be determined individually.

For routine procedures, the normal dose for adult patients is 1 cartridge, although less than one cartridge may be sufficient for effective anaesthesia. According to the dentist's judgement, additional cartridges may be required for more extensive procedures, without exceeding the recommended maximum dose.

For most routine dental procedures, Ultracain with adrenaline 40 mg/ml + 5 micrograms/ml solution for injection is preferred.

For more complex procedures, such as when pronounced haemostasis is required, Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection is preferred.

Concomitant use of sedatives to reduce patient anxiety:

The maximum safe dose of local anaesthetic may be reduced in sedated patients due to an additive effect on central nervous system depression.

Adults and adolescents (aged 12 to 18 years)

In adults and adolescents, the maximum dose of articaine is 7 mg/kg, with an absolute maximum dose of articaine of 500 mg. The maximum articaine dose of 500 mg corresponds to a healthy adult weighing more than 70 kg.

Children (aged 4 to 11 years)

The safety of Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection has not been established in children aged 4 years and younger. No data are available.

The amount to be injected should be determined based on the child's age, weight and the extent of the procedure. The effective mean dose is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively. The lowest dose providing effective dental anaesthesia should be used. In children aged 4 years (or from 20 kg (44 lbs) body weight) and older, the maximum dose of articaine is only 7 mg/kg, with an absolute maximum dose of 385 mg of articaine for a healthy child weighing 55 kg.

Special populations

Elderly patients and patients with renal disorders:

Due to the absence of clinical data, special precautions should be taken to administer the lowest dose providing effective anaesthesia in elderly patients and in patients with renal disorders.

Elevated plasma levels of the drug may occur in these patients, especially after repeated use. If re-injection is required, the patient should be closely monitored for any signs of relative overdose.

Patients with hepatic impairment

Special precautions should be taken to administer the lowest dose providing effective anaesthesia in patients with hepatic impairment, particularly after repeated use, although 90% of articaine is initially inactivated by nonspecific plasma esterases in tissues and blood.

Patients with plasma cholinesterase deficiency

Elevated plasma levels of the drug may occur in patients with cholinesterase deficiency or those receiving acetylcholinesterase inhibitors, as the product is inactivated by plasma esterases by 90%. Therefore, the lowest dose providing effective anaesthesia should be used.

Method of administration

Infiltration and perineural use in the oral cavity.

If inflammation and/or infection is present at the injection site, local anaesthesia should be administered with caution. The injection rate should be very slow (1 ml/min).

Precautions to be taken before handling or administering the medicine

This medicine should only be used by a physician or dentist with adequate training and familiar with the diagnosis and treatment of systemic toxicity, or under their supervision. Before inducing regional anaesthesia with local anaesthetics, availability of resuscitation equipment and appropriate medication must be ensured to allow immediate treatment of any respiratory or cardiovascular emergency. The patient's level of consciousness should be monitored after each local anaesthetic injection.

When using Ultracain with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection for infiltration or regional anaesthetic block, the injection must always be administered slowly and with prior aspiration.

Special warnings

Adrenaline reduces blood flow in the gums, potentially causing local tissue necrosis.

Very rare cases of prolonged or irreversible nerve injury and taste disturbance have been reported following mandibular nerve block anaesthesia.

Precautions for use

Risk associated with accidental intravascular injection:

Accidental intravascular injection may result in high systemic levels of adrenaline and articaine. This may be associated with serious adverse reactions such as seizures, followed by central nervous system and cardiopulmonary depression and coma, progressing to respiratory and circulatory arrest.

Therefore, to ensure that the needle does not enter a blood vessel during injection, aspiration must be performed before injecting the local anaesthetic. However, the absence of blood in the syringe does not guarantee that intravascular injection has not occurred.

Risk associated with accidental intraneural injection:

Accidental intraneural injection may cause the drug to travel retrogradely along the nerve.

To avoid intraneural injection and prevent nerve injury during nerve blocks, the needle should be slightly withdrawn whenever the patient experiences an electric shock sensation during injection or if the injection is particularly painful. If nerve injury occurs from the needle, the neurotoxic effect may be worsened by the potential chemical neurotoxicity of articaine and the presence of adrenaline, which may reduce perineural blood flow and impair local elimination of articaine.

Treatment of overdose

Before administering regional anaesthesia with local anaesthetics, resuscitation equipment and appropriate medication must be available to allow immediate treatment of any respiratory or cardiovascular emergency.

Depending on the severity of overdose symptoms, the physician or dentist should implement protocols that include the need to protect airways and provide assisted ventilation.

The patient's level of consciousness should be monitored after each local anaesthetic injection.

If signs of acute systemic toxicity occur, injection of the local anaesthetic must be stopped immediately. If necessary, place the patient in the supine position.

Symptoms of CNS toxicity (seizures, CNS depression) should be treated immediately with appropriate airway/respiratory support and administration of anticonvulsant drugs.

Optimal oxygenation and ventilation, together with circulatory support and treatment of acidosis, may prevent cardiac arrest.

If cardiovascular depression (hypotension, bradycardia) occurs, appropriate treatment with intravenous fluids, vasopressors or inotropic agents should be considered. Children should receive doses appropriate to their age and weight.

In case of cardiac arrest, immediate cardiopulmonary resuscitation must be performed.

Special precautions for disposal and other handling

This medicine should not be used if the solution is cloudy or has changed colour.

To avoid the risk of infection (e.g., transmission of hepatitis), the syringe and needles used to prepare the solution must always be new and sterile.

Cartridges are for single use only. If only part of the cartridge is used, the remainder must be discarded.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.