Orabloc

Leaflet accompanying the packaging: Patient information

Orabloc, (40 mg + 0.005 mg)/ml, solution for injection

Articaine hydrochloride + Adrenaline

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Orabloc and what is it used for
• 2. Important information before using Orabloc
• 3. How to use Orabloc
• 4. Possible side effects
• 5. How to store Orabloc
• 6. Contents of the packaging and other information

1. What is Orabloc and what is it used for

Orabloc is a medicine used in dentistry for local anesthesia.
It contains articaine (a substance with local anesthetic effect) and adrenaline. Adrenaline narrows blood vessels. This reduces blood flow to the injection site (local hypoperfusion). As a result, bleeding during the procedure is reduced and the local anesthetic effect is enhanced.
Orabloc is used for local anesthesia during dental procedures in adults, adolescents, and children over 4 years old:

• simple single or serial tooth extractions,
• removal of dental tartar,
• preparation for dental crowns.

2. Important information before using Orabloc

When not to use Orabloc

• if the patient is allergic to articaine or other local anesthetics of the amide group, adrenaline, or any other component of this medicine (listed in section 6),
• in patients with severe heart rhythm disorders (e.g., second- or third-degree atrioventricular block),
• if the patient has a very slow heart rate,
• if the patient has acute heart failure (e.g., after a heart attack),
• if the patient has very low blood pressure,
• in patients with asthma and sulfite sensitivity (sulfite-induced asthma attacks)
• in children under 4 years of age.

Due to the presence of adrenaline, Orabloc should not be used in cases of:

• anesthesia that affects an area supplied by only one artery branch,
• increased intraocular pressure (glaucoma),
• hyperthyroidism,
• paroxysmal tachycardia,
• atrial fibrillation with rapid heart action,
• heart attack in the last 3 to 6 months,
• coronary artery bypass grafting in the last 3 months,
• taking certain beta-adrenergic blockers, such as propranolol; there is a risk of hypertensive crisis or severe bradycardia,
• pheochromocytoma (a tumor of the adrenal gland that produces adrenaline),
• severe hypertension,
• concomitant use of certain drugs used to treat depression or Parkinson's disease (tricyclic antidepressants, MAO inhibitors). These drugs may enhance the effect of adrenaline on the heart and blood vessels. This effect may persist for up to 14 days after discontinuation of MAO inhibitors.

Orabloc must not be administered intravenously.

Warnings and precautions

Before using Orabloc, the dentist should be informed about:

• deficiency of certain enzymes (cholinesterase deficiency); the effect of Orabloc may be prolonged or enhanced.
• inflammatory or infectious conditions at the injection site; the effect of Orabloc may be reduced due to increased absorption of the medicine.

Orabloc may only be used after a thorough medical examination if:

• the patient has blood coagulation disorders,
• the patient has severe kidney or liver dysfunction (e.g., kidney inflammation or liver cirrhosis)
• the patient is being treated with halogenated inhalation anesthetics (see Orabloc and other medicines)
• the patient has epilepsy (see section 4).

In case of any of the following conditions, Orabloc should be administered only after a thorough medical examination:

• cardiovascular diseases, such as:
• angina pectoris (chest pain and feeling of pressure in the chest caused by myocardial ischemia)
• atherosclerosis (narrowing of arteries caused by deposits, e.g., fats from the blood)
• heart failure
• coronary artery disease (narrowing of the coronary arteries)
• previous heart attack
• heart rhythm disorders (irregular pulse)
• hypertension
• disorders of blood flow to the brain
• previous stroke
• chronic bronchitis, emphysema,
• diabetes,
• severe anxiety disorders.

To avoid side effects, the dentist should:

• check the patient's medical history and concomitant medications
• perform a test injection if there is a risk of allergy to the medicine
• choose the smallest possible dose
• check carefully before injection to avoid injecting into a blood vessel.

After using Orabloc, prolonged numbness may occur in the anesthetized area:
in small children, caution should be exercised to avoid self-biting, which could cause soft tissue damage.

Orabloc and other medicines

The patient should inform the dentist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If other local anesthetics are used concomitantly, their effect on the circulatory and nervous systems may be enhanced.
Orabloc contains adrenaline, which narrows blood vessels and increases blood pressure. The effect of adrenaline may be enhanced by certain medicines used to treat depression and Parkinson's disease (tricyclic antidepressants and MAO inhibitors should not be used concomitantly). (See section 2. Important information before using Orabloc).
See also the section "When not to use Orabloc" regarding concomitant use of beta-adrenergic blockers (such as propranolol).
Adrenaline may inhibit the release of insulin from the pancreas, reducing the effect of oral diabetes medicines.
Concomitant use of Orabloc and certain inhalation anesthetics (e.g., halothane) may cause heart rhythm disorders.
Phenothiazines may affect the increase in blood pressure caused by adrenaline. Therefore, concomitant use of these medicines should be avoided. If concomitant use is necessary, patients should be under constant supervision.
Note: In patients taking anticoagulant medicines ("blood thinners" such as heparin or acetylsalicylic acid), accidental injection into a blood vessel during local anesthesia may cause severe bleeding and increase the tendency to bleed.

Orabloc with food and drink

After using Orabloc, patients should avoid eating until the anesthesia has worn off.

Pregnancy and breastfeeding

In pregnant women, the dentist should use Orabloc only after a thorough analysis of the benefit-to-risk ratio.
There is no experience with the use of articaine in pregnant women, except during labor. Animal studies have shown that adrenaline in doses higher than the maximum recommended dose in dentistry has toxic effects on the offspring. In case of accidental intravascular injection in the mother, adrenaline may reduce blood flow to the uterus.
The active substances of Orabloc are rapidly degraded in the patient's body. This means that the active substances that pose a risk to breastfed infants do not pass into breast milk. In case of short-term use of Orabloc, interruption of breastfeeding is usually not necessary.

Driving and using machines

The dentist should decide when the patient can drive or operate machines after the procedure. No significant impairment of driving ability has been observed after anesthesia with articaine.

Orabloc contains sodium metabisulfite (E223) and sodium chloride

Sodium metabisulfite (E223) may occasionally cause severe hypersensitivity reactions and bronchospasm.
This medicine contains less than 1 mmol of sodium chloride (23 mg) per dose, which means it is considered "sodium-free".

3. How to use Orabloc

The dentist determines the dose and method of administration of Orabloc. For this purpose, the following recommendations will usually be followed:
Dosage
Injection of 1.8 ml of Orabloc per tooth is usually sufficient for simple procedures of extracting upper teeth without inflammation. In some cases, a second injection of 1-1.8 ml may be necessary to achieve full anesthesia.
Not every tooth requires anesthesia with a full dose of Orabloc. In some cases, it is possible to extract a neighboring tooth without additional injection.
If incision or suture is necessary on the palate, a dose of about 0.1 ml per injection is sufficient. During procedures for extracting lower molars without inflammation, a dose of 1.8 ml per tooth is usually sufficient. If sufficient anesthetic effect is not achieved, the dentist may perform a second injection of 1-1.8 ml. If, after the second dose, complete anesthesia is not achieved, the dentist may perform a conduction anesthesia of the mandibular nerve.
Depending on the duration of the procedure, a dose of 0.5-1.8 ml of Orabloc 40 mg/ml + 0.005 mg/ml solution for injection is sufficient for removing decay for filling a tooth and for polishing a tooth crown. However, this does not apply to lower molars.
Adults may receive up to 7 mg of articaine per kg of body weight during the procedure. Doses up to 500 mg (corresponding to 12.5 ml of solution for injection) are well tolerated.
Elderly patients and patients with severe liver and kidney dysfunction
In elderly patients and patients with severe liver and kidney dysfunction (e.g., kidney inflammation or liver cirrhosis), the concentration of articaine in the blood may be higher.
In these patient groups, the dentist should exercise particular caution and use the smallest possible dose to achieve adequate anesthesia.

Use in children and adolescents

When using Orabloc in children and adolescents, the smallest dose should be used to achieve adequate anesthesia. The dose of the solution for injection should be individually adjusted according to the child's age and body weight. The maximum allowed dose of 5 mg of articaine per kg of body weight should not be exceeded.
This medicine has not been studied in children under one year of age.
Method of administration
Orabloc is intended for administration in the oral cavity (dental use).
To prevent infections (e.g., transmission of hepatitis virus), disposable syringes and needles should be used for each injection.
For single use only. Any unused amounts of the solution should be disposed of.
The medicine should not be used if it is discolored or cloudy.

Using a higher dose of Orabloc than recommended

In case of using a higher dose of Orabloc than recommended, the following nervous system disorders may occur:

• headache,
• dizziness,
• nausea,
• disorders of consciousness,
• shortness of breath and respiratory disorders.

Cardiovascular disorders, such as decreased or increased blood pressure, may also occur. Such disorders require observation and appropriate action by the dentist.
In case of any further doubts regarding the use of this medicine, the patient should consult a doctor.

4. Possible side effects

Like all medicines, Orabloc can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
Nausea, vomiting, disorders of tooth sensation (numbness), reduced sensation in the mouth and face area (hypoesthesia); headaches, probably caused by adrenaline.
Uncommon (may affect up to 1 in 100 people)
Very rapid heart rate (tachycardia), dizziness.
Frequency not known (frequency cannot be estimated from the available data)

• Heart rhythm disorders, increased blood pressure, decreased blood pressure, slow heart rate (bradycardia), heart failure, and shock (can be life-threatening).
• Depending on the dose (especially in case of overdose or accidental intravascular injection), nervous system disorders may occur, such as:
• excitement, nervousness,
• transient confusion sometimes leading to loss of consciousness, coma,
• respiratory disorders leading to respiratory arrest,
• muscle tremors, muscle cramps, and even convulsions.
• During injection or shortly after injection of anesthetics in the head area, transient visual disturbances (blurred vision, loss of vision, double vision) may occur.
• Nerve damage (e.g., facial nerve paralysis) and reduced taste sensation are not specific to articaine. However, the occurrence of such reactions is possible during dental procedures due to the course of nerves in the injection area or improper injection technique.
• Accidental intravascular injection may occasionally lead to the formation of areas of hypoperfusion at the injection site, and sometimes even tissue necrosis.
• Hypersensitivity reactions (allergy or allergic reactions). They may manifest as swelling or inflammation at the injection site. Hypersensitivity reactions may occur regardless of the injection site in the form of:
• skin redness,
• itching,
• inflammation of connective tissue,
• cold
• facial edema (angioedema) with swelling of the upper and/or lower lip and/or cheeks,
• laryngeal edema with a feeling of constriction in the throat and difficulty swallowing,
• hives,
• breathing difficulties and even anaphylactic shock.
• Due to the presence of sodium metabisulfite, the medicine may cause hypersensitivity reactions, especially in patients with asthma. These reactions may manifest as vomiting, diarrhea, wheezing, acute asthma attacks, disorders of consciousness, or shock.
• Respiratory disorders (accelerated breathing, slowed breathing), which may lead to apnea.

Additional side effects in children

In small children, unlike adults, due to prolonged numbness of the mouth area after the dental procedure, there is a risk of self-biting, which may cause soft tissue damage.
In case of sudden and severe side effects, the patient should immediately inform their doctor. This is very important because some side effects (e.g., decreased blood pressure or respiratory disorders) may be life-threatening.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Orabloc

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after:
Expiry date (EXP). The expiry date refers to the last day of the month stated.
Store at a temperature below 25 °C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Orabloc contains

• The active substances of Orabloc are articaine hydrochloride and adrenaline. 1 ml of solution for injection contains 40 mg of articaine hydrochloride and 0.005 mg of adrenaline (epinephrine) in the form of adrenaline bitartrate.
• One cartridge with a capacity of 1.8 ml of solution for injection contains 72 mg of articaine hydrochloride and 0.009 mg of adrenaline (epinephrine) in the form of adrenaline bitartrate.
• The other ingredients are: sodium metabisulfite (E 223), sodium chloride, hydrochloric acid 2% (for pH adjustment), water for injections.

What Orabloc looks like and what the packaging contains

Orabloc is a clear and colorless solution for injection in cartridges made of type I glass, closed at both ends with a bromobutyl rubber stopper (one of which serves as a piston) and an aluminum seal.
The cartridges are packaged in PVC blisters (10 cartridges/blister). The blisters are packaged in cardboard boxes containing 5 x 10 or 10 x 10 cartridges.
Not all pack sizes may be marketed.

Marketing authorization holder

PIERREL S.p.A. Strada Statale Appia 7 BIS 46/48, 81043 Capua (CE), Italy
tel: +39 0823 626 111
fax: +39 0823 626 228

Manufacturer

PIERREL S.p.A. Strada Statale Appia 7 BIS 46/48, 81043 Capua (CE), Italy
tel: +39 0823 626 111
fax: +39 0823 626 228
e-mail: manufacturing@pierrelgroup.com

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria:
Orabloc 40 mg/ml + 5 Mikrogramm/ml Injektionslösung
Germany:
Orabloc 40 mg/ml + 0.005 mg/ml Injektionslösung
France:
Orabloc 40 mg/ml adrénalinée au 1/200 000, solution injectable
Greece:
Orabloc (40+0,005) mg/ml ενέσιμο διάλυμα
Poland:
Orabloc
Romania:
Orabloc 1:200.000 40 mg/ml + 0.005 mg/ml soluție injectabilă
Slovakia:
Orabloc, 40 mg/ml + 0,005 mg/ml injekčný roztok
United Kingdom (Northern Ireland):
Orabloc 1:200,000

Date of last revision of the leaflet: