Orabloc

Package Leaflet: Information for the Patient

Orabloc, (40 mg + 0.01 mg)/ml, Solution for Injection

Articaine Hydrochloride + Adrenaline

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 pack 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 at 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:

• oral mucosa or bone surgery to reduce blood flow,
• pulp surgery,
• removal of broken teeth,
• prolonged surgical interventions,
• bone surgery with opening of the gums,
• removal of cysts (periapical cysts filled with fluid),
• periodontal and periapical surgery,
• removal of tooth roots.

2. Important information before using Orabloc

When not to use Orabloc

• in patients with severe heart rhythm disorders (e.g., second- and third-degree atrioventricular block),
• 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 the following cases:

• anesthesia that only affects an area supplied by a single arterial 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 medications for depression or Parkinson's disease (tricyclic antidepressants, MAO inhibitors). These medications 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 should not be administered intravenously.

Warnings and precautions

Before using Orabloc, inform your dentist 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 should only be used after a thorough medical examination if:

• the patient has bleeding disorders,
• the patient has severe kidney or liver dysfunction (e.g., nephritis 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, and the dentist should consider using Orabloc 40 mg/ml + 0.005 mg/ml instead of Orabloc 40 mg/ml + 0.01 mg/ml due to the lower adrenaline content:

• 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
• arrhythmias (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 treatment 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 damage to soft tissues.

Orabloc and other medicines

Tell your dentist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
If other local anesthetics are used concomitantly, their effect on the cardiovascular 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 medications used to treat depression and Parkinson's disease (do not use concomitantly with tricyclic antidepressants and MAO inhibitors). (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 medications.
Concomitant use of Orabloc and certain inhalation anesthetics (e.g., halothane) may cause arrhythmias.
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 medications ("blood thinners" such as heparin or acetylsalicylic acid), accidental intravascular injection 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-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 in the uterus.
In pregnant women, Orabloc 40 mg/ml + 0.005 mg/ml should be used instead of Orabloc 40 mg/ml + 0.01 mg/ml due to the lower adrenaline content.
The active substances of Orabloc are rapidly metabolized 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, discontinuation of breastfeeding is usually not necessary.

Driving and using machines

The dentist should decide when the patient can drive or operate machinery 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 rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains less than 1 mmol of sodium chloride (23 mg) per dose, which means that the medicine 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 tooth extraction procedures. 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 remove an adjacent 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 removing 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 mandibular nerve block.
In the case of maxillary surgery, the dentist will use a dose of Orabloc 40 mg/ml + 0.01 mg/ml solution for injection suitable for the complexity and duration of the procedure.
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., nephritis 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 amount of the solution should be disposed of.
The medicine should not be used if it is discolored or cloudy.

Use of a higher dose of Orabloc than recommended

In case of use of 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 a decrease or increase in blood pressure, may also occur. Such disorders require observation and appropriate management by the dentist.
In case of any further doubts about the use of this medicine, 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), decreased sensation in the mouth and face area (hypoesthesia); headache, 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)

• Arrhythmias, increased blood pressure, decreased blood pressure, slow heart rate (bradycardia), heart failure, and shock (which 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 decreased 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 rarely 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 the connective tissue,
• common cold,
• facial swelling (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,
• difficulty breathing 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 damage to the soft tissues of the mouth.
In case of sudden and severe side effects, inform your doctor immediately. This is very important because some side effects (e.g., decreased blood pressure or respiratory disorders) may be life-threatening.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this 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.
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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 0.01 mg of adrenaline (epinephrine) in the form of adrenaline bitartrate.
• One cartridge of solution for injection with a capacity of 1.8 ml contains 72 mg of articaine hydrochloride and 0.018 mg of adrenaline (epinephrine) in the form of adrenaline bitartrate.
• The other ingredients are: sodium metabisulfite (E223), sodium chloride, hydrochloric acid 2% (for pH adjustment), water for injection.

What Orabloc looks like and contents of the pack

Orabloc is a clear and colorless solution for injection in cartridges made of colorless glass type I, 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: [email protected]

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:

Germany:
Orabloc Forte 40 mg/ml + 0.01 mg/ml Injektionslösung
Austria:
Orabloc 40 mg/ml + 10 Mikrogramm/ml Injektionslösung
France:
Orabloc 40 mg/ml adrénalinée au 1/100 000, solution injectable
Greece:
Orabloc (40+0,01) mg/ml ενέσιμο διάλυμα
Poland:
Orabloc
Romania:
Orabloc 1:100.000 40 mg/ml + 0.01 mg/ml soluție injectabilă
Slovakia:
Orabloc forte, 40 mg/ml + 0,01 mg/ml injekčný roztok
United Kingdom (Northern Ireland):
Orabloc 1:100,000

Date of last revision of the package leaflet: