Orabloc

Package leaflet: Information for the patient

Orabloc, (40 mg + 0.01 mg)/ml, solution for injection
Articaini hydrochloridum + Adrenalinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Orabloc is and what it is 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 Orabloc is and what it is used for

Orabloc is a medicine used in dentistry for local anaesthesia.
It contains articaine (a local anaesthetic agent) and adrenaline. Adrenaline
constricts blood vessels. This reduces blood flow at the injection site (local ischaemia).
As a result, bleeding during the procedure is reduced and the local anaesthetic effect is enhanced.
Orabloc is used for local anaesthesia during dental procedures in adults, adolescents, and children over 4 years of age:

• Surgery of the oral mucosa or bone, to reduce blood flow,
• Pulp surgery,
• Removal of broken teeth,
• Prolonged surgical interventions,
• Bone surgery involving gingival incision,
• Removal of cysts (fluid-filled jaw cavities),
• Surgery involving gingiva and periodontium,
• Removal of tooth root tips.

2. Important information before using Orabloc

When not to use Orabloc

• if the patient is allergic to articaine or other local anaesthetics of the amide type, adrenaline, or any of the other components of this medicine (listed in section 6),
• in patients with severe cardiac arrhythmias (e.g. second- or third-degree atrioventricular block),
• if the patient has a very slow heartbeat,
• if the patient has acute heart failure (e.g. following myocardial infarction),
• if the patient has very low blood pressure,
• in patients with bronchial asthma and sulfite sensitivity (asthma attacks triggered by sulfites),
• in children under 4 years of age.

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

• anaesthesia of an area supplied by a single arterial branch only,
• increased intraocular pressure (glaucoma),
• hyperthyroidism,
• paroxysmal tachycardia,
• atrial fibrillation with rapid ventricular response,
• myocardial infarction within the last 3 to 6 months,
• coronary artery bypass grafting within the last 3 months,
• concomitant use of certain beta-blockers such as propranolol; there is a risk of hypertensive crisis or severe bradycardia,
• pheochromocytoma (adrenaline-producing tumour of the adrenal medulla),
• severe arterial hypertension,
• concomitant use of certain medicines used in the treatment of depression or Parkinson's disease (tricyclic antidepressants, MAO inhibitors). These medicines may enhance the effects 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, inform your dentist:

• about enzyme deficiencies (e.g. cholinesterase deficiency); the effect of Orabloc may be prolonged or intensified.
• about inflammation or infection at the site of injection; the effect of Orabloc may be reduced due to increased systemic absorption.

Orabloc may be used only after thorough medical evaluation if:

• the patient has blood coagulation disorders,
• the patient has severe renal or hepatic impairment (e.g. in case of nephritis or liver cirrhosis),
• the patient is concurrently treated with halogenated inhaled anaesthetics (see Orabloc and other medicines),
• the patient has epilepsy (see section 4).

In any of the following conditions, Orabloc should be administered only after thorough medical evaluation, 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 its lower adrenaline content:

• cardiovascular diseases, e.g.:
• angina pectoris (chest pain and pressure caused by myocardial ischaemia)
• atherosclerosis (narrowing of arteries due to deposits, e.g. fats from blood)
• heart failure
• coronary artery disease (narrowing of coronary arteries)
• previous myocardial infarction
• cardiac arrhythmias (irregular pulse)
• arterial hypertension
• impaired cerebral blood flow
• previous stroke
• chronic bronchitis, pulmonary emphysema,
• diabetes mellitus,
• severe anxiety disorders.

To avoid adverse effects, the dentist should:

• review the patient's medical history and concomitant medications,
• perform a test injection if there is a risk of hypersensitivity,
• use the lowest possible dose,
• carefully aspirate before injection to ensure the needle is not in a blood vessel.

After administration of Orabloc, prolonged numbness in the anaesthetized area may occur:
in young children, care should be taken to prevent self-biting, which could cause injury to soft tissues.
Orabloc and other medicines
Inform your dentist about all medicines currently taken, recently used, or planned for use.
If other local anaesthetics are used concomitantly, their effects on the cardiovascular and nervous systems may be enhanced.
Orabloc contains adrenaline, which constricts blood vessels and increases blood pressure. The effect of adrenaline may be increased by certain medicines used in the treatment of 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 section "When not to use Orabloc" regarding concomitant use of beta-blockers (e.g. propranolol).
Epinephrine (adrenaline) may inhibit insulin release from the pancreas, thereby reducing the effectiveness of oral antidiabetic agents.
Concomitant use of Orabloc and certain inhaled anaesthetics (e.g. halothane) may cause cardiac arrhythmias.
Phenothiazines may influence the blood pressure increase caused by epinephrine (adrenaline). Therefore, concomitant use of these medicines should be avoided. If concomitant use is necessary, patients should remain under continuous monitoring.
Note: in patients taking anticoagulant medicines ("blood thinners" such as heparin or acetylsalicylic acid), accidental intravascular injection during local anaesthesia may lead to serious bleeding and increased bleeding tendency.
Orabloc with food and drink
After administration of Orabloc, patients should refrain from eating until the anaesthesia wears off.
Pregnancy and breastfeeding
In pregnant women, the dentist should use Orabloc only after careful benefit-risk assessment.
There is limited experience with the use of articaine in pregnant women, except during labour. Animal studies have shown that epinephrine (adrenaline), at doses higher than the maximum recommended dose in dentistry, has toxic effects on offspring. Accidental intravascular injection in the mother may reduce uterine blood flow due to adrenaline.
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 its lower adrenaline content.
The active substances in Orabloc are rapidly metabolized in the patient's body. This means that active substances posing a risk to breastfed infants do not pass into breast milk. In cases of short-term use of Orabloc, interruption of breastfeeding is usually not necessary.
Driving and operating machinery
The dentist should decide when the patient may resume driving or operating machinery after the procedure. No significant impairment of the ability to drive has been observed after anaesthesia with articaine.
Orabloc contains sodium metabisulfite (E223) and sodium chloride
Sodium metabisulfite (E223) may in rare cases cause severe hypersensitivity reactions and bronchospasm.
This medicine contains less than 1 mmol of sodium chloride (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to use Orabloc

The dentist determines the dosage and method of administration of Orabloc. For this purpose, the following recommendations are usually followed:

Dosage

An injection of 1.8 ml of Orabloc per tooth is usually sufficient for simple removal of upper teeth not affected by inflammation. In some cases, an additional injection of 1–1.8 ml may be necessary to achieve complete anaesthesia.

Usually, not every tooth requires full-dose anaesthesia with Orabloc. In certain cases, adjacent teeth may be removed without additional injections.

If incision or suturing of the palate is required, a dose of approximately 0.1 ml per injection site is sufficient. During surgical removal of mandibular molars without inflammation, a dose of 1.8 ml per tooth is usually adequate. If sufficient anaesthetic effect is not achieved, the dentist may administer an additional injection of 1–1.8 ml. If complete anaesthesia is not obtained after the second dose, the dentist may perform a mandibular nerve block.

In maxillary surgery, the dentist will use an appropriate dose of Orabloc 40 mg/ml + 0.01 mg/ml solution for injection, depending on 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 injection solution) are well tolerated.

Elderly patients and patients with severe hepatic or renal impairment
In elderly patients and in patients with severe impairment of liver or kidney function (e.g. in cases of nephritis or liver cirrhosis), blood concentrations of articaine may be higher. The dentist should exercise particular caution in these patient groups and use the smallest possible dose required to achieve adequate anaesthesia.

Use in children and adolescents
When using Orabloc in children and adolescents, the smallest effective dose should be used to achieve adequate anaesthesia. The injection volume should be individually adjusted according to the child's age and body weight. The maximum recommended dose of 5 mg of articaine per kg of body weight must not be exceeded.

This medicine has not been studied in children under one year of age.

Method of administration
Orabloc is intended for oral use (dental application). To prevent infections (e.g. transmission of hepatitis virus), single-use syringes and needles should be used for each injection.

For single use only. Any unused solution should be discarded.
Do not use the medicine if it is discoloured or cloudy.

Overdose of Orabloc
If a higher than recommended dose of Orabloc is administered, the following nervous system disturbances may occur:

• headache,
• dizziness,
• nausea,
• disturbances of consciousness,
• episodes of breathlessness and respiratory disturbances.

Cardiovascular disturbances may also occur, such as hypotension or hypertension. These symptoms require observation and appropriate management by the dentist.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.

Common (may affect up to 1 in 10 patients):
Nausea, vomiting, disturbances in tooth sensation (numbness), reduced sensation in the mouth and facial area (hypoesthesia); headache, probably caused by epinephrine.

Uncommon (may affect up to 1 in 100 patients):
Very fast heartbeat (tachycardia), dizziness.

Frequency not known (frequency cannot be estimated from the available data):

• Heart rhythm disturbances, increased blood pressure, decreased blood pressure, slow heart rate (bradycardia), heart failure, and shock (may be life-threatening).
• Depending on the dose (particularly in cases of overdose or accidental intravascular injection), nervous system disturbances may occur, for example:
  • restlessness, nervousness,
  • dizziness sometimes progressing to loss of consciousness, coma,
  • breathing disturbances leading to respiratory arrest,
  • muscle tremors, muscle spasms, and even seizures.
• During or shortly after injection of local anaesthetics in the head area, transient visual disturbances may occur (blurred vision, loss of vision, double vision).
• Nerve damage (e.g. facial nerve paralysis) and reduced taste sensitivity are not specific to articaine. However, such reactions may occur during dental procedures due to the anatomical course of nerves in the injection area or incorrect injection technique.
• Accidental intravascular injection may occasionally lead to ischemic areas at the injection site and, in some cases, even tissue necrosis.
• Hypersensitivity reactions (allergy or allergic-type reactions). These may manifest as swelling or inflammation at the injection site. Hypersensitivity reactions may occur independently of the injection site and present as:
  • skin redness,
  • itching,
  • connective tissue inflammation,
  • cold-like symptoms,
  • facial swelling (angioedema) with swelling of the upper and/or lower lip and/or cheeks,
  • laryngeal edema with a sensation of tightness in the throat and difficulty swallowing,
  • urticaria,
  • difficulty breathing, and even anaphylactic shock.
• Due to the presence of sodium metabisulfite, the medicine may cause hypersensitivity reactions, particularly in patients with bronchial asthma. These reactions may present as vomiting, diarrhea, wheezing, acute asthma attacks, disturbances of consciousness, or shock.
• Breathing disturbances (rapid breathing, slowed breathing), which may lead to respiratory arrest.

Additional adverse reactions in children
In young children, unlike adults, prolonged numbness around the mouth after a dental procedure carries a risk of self-biting, which may cause trauma to the soft tissues of the oral cavity.

If a sudden and severe adverse reaction occurs, inform a doctor immediately. This is very important because some adverse reactions (e.g. low blood pressure or breathing disturbances) may be life-threatening.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Orabloc

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
Store below 25 °C. Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Orabloc contains

• The active substances in this medicinal product are articaine hydrochloride and adrenaline. 1 ml of injection solution contains 40 mg of articaine hydrochloride and 0.01 mg of adrenaline (epinephrine) as adrenaline bitartrate.
• One vial containing 1.8 ml of injection solution contains 72 mg of articaine hydrochloride and 0.01 mg of adrenaline (epinephrine) as adrenaline bitartrate.
• Other components: sodium metabisulfite (E 223), sodium chloride, hydrochloric acid 2% (for pH adjustment), water for injections.

What Orabloc looks like and contents of the pack
Orabloc is a sterile, clear and colourless injection solution contained in cartridges made of colourless
type I glass, sealed at both ends with bromobutyl rubber stoppers (one of which acts as a plunger) and an aluminium seal.
The cartridges are packed in PVC blisters (10 cartridges/blisters). Blisters are packed into cardboard boxes containing 5 x 10 or 10 x 10 cartridges.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the European Economic Area and 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 microgram/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