UBISTESIN 40 mg /0.012 Mg/Ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Ubistesin forte, (40 mg + 0.012 mg)/ml, solution for injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ubistesin forte and what is it used for
4. Important information before using Ubistesin forte
   1. Do not use Ubistesin forte if the patient has any of the following diseases:
   2. Warnings and precautions
   3. Ubistesin forte and other medicines
   4. Ubistesin forte with food
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Ubistesin forte contains sodium and sodium sulfite
5. How to use Ubistesin forte
   1. Using a higher dose of Ubistesin forte than recommended
6. Possible side effects
   1. Tell your dentist, doctor, or pharmacist immediately if the patient experiences any of the following serious side effects:
   2. Common side effects: may occur in up to 1 in 10 patients:
   3. Uncommon side effects: may occur in up to 1 in 100 patients:
   4. Rare side effects: may occur in up to 1 in 1,000 patients:
   5. Very rare side effects: may occur in up to 1 in 10,000 patients:
   6. Frequency not known: frequency cannot be estimated from available data
   7. Reporting side effects
7. How to store Ubistesin forte
8. Contents of the packaging and other information
   1. What Ubistesin forte contains
   2. What Ubistesin forte looks like and what the packaging contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. Date of last revision of the leaflet: 08/2024

Leaflet attached to the packaging: patient information

Ubistesin forte, (40 mg + 0.012 mg)/ml, solution for injection

Articaine hydrochloride + Epinephrine hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your dentist, doctor, or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell your dentist, doctor, or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ubistesin forte and what is it used for

Ubistesin forte is used to anesthetize the oral cavity during dental procedures.
This medicine contains two active substances:

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

Ubistesin forte is administered to the patient by a dentist.
Ubistesin forte is intended for children over 4 years old (approximately 20 kg body weight),
adolescents, and adults.

• Ubistesin forte is more suitable for procedures that take longer or are associated with potentially more severe bleeding.

2. Important information before using Ubistesin forte

Do not use Ubistesin forte if the patient has any of the following diseases:

• the patient is allergic to articaine or epinephrine or any of the other ingredients of this medicine (listed in section 6);
• the patient is allergic to other locally acting anesthetics;
• the patient has uncontrolled epilepsy.

Warnings and precautions

Before starting treatment with Ubistesin forte, discuss with your dentist if the patient has any of the following conditions:

• severe heart rhythm disorders (e.g., atrioventricular block II and III degree);
• acute heart failure [acute heart weakness, e.g., unexpected chest pain at rest or after a heart attack (i.e., myocardial infarction)];
• low blood pressure;
• abnormally fast heart rate;
• heart attack within the last 3-6 months;
• the patient underwent coronary artery bypass grafting within the last 3 months;
• the patient is taking antihypertensive medications called beta-adrenolytics, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe bradycardia (patrz "Ubistesin forte and other medicines");
• very high blood pressure;
• the patient is taking certain medications for depression and Parkinson's disease (tricyclic antidepressants). These medications enhance the effect of epinephrine;
• epilepsy;
• the patient has a natural chemical deficiency in the blood called cholinesterase (cholinesterase deficiency);
• kidney disease;
• severe liver disease;
• a disease called myastheniathat causes muscle weakness ;
• porphyriathat causes neurological complications or skin problems ;
• the patient is using other locally acting anesthetics, medications that cause transient loss of sensation (including inhalation anesthetics, such as halothane);
• the patient is taking antiplatelet or anticoagulant medications to prevent blood vessel narrowing or hardening in the hands and feet;
• the patient is over 70 years old;
• the patient has had or currently has heart disease;
• uncontrolled diabetes;
• severe hyperthyroidism (thyrotoxicosis);
• a tumor called pheochromocytoma;
• a disease called glaucoma, which is an eye disease;
• inflammation or infection at the injection site;
• low oxygen levels in body tissues (hypoxia), high potassium levels (hyperkalemia), and metabolic disorders due to excessive acid components in the blood (metabolic acidosis).

Ubistesin forte and other medicines

Tell your dentist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
It is especially important to inform your dentist if the patient is taking any of the following medications:

• other locally acting anesthetics, medications that cause reversible loss of sensation (including inhalation anesthetics, such as halothane);
• sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before a dental procedure;
• medications that affect the heart and lower blood pressure (such as guanadrel, guanethidine, propranolol, nadolol);
• tricyclic antidepressants used to treat depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline);
• COMT inhibitors used to treat Parkinson's disease (such as entacapone or tolcapone);
• MAO inhibitors used to treat depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid);
• medications used to treat irregular heartbeat (e.g., digitalis, quinidine);
• medications used to treat migraine attacks (such as methysergide or ergotamine);
• sympathomimetic vasoconstrictor medications (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) used to increase blood pressure: if used within the last 24 hours, planned dental treatment should be postponed;
• neuroleptic medications (e.g., phenothiazines).

Ubistesin forte with food

Avoid eating, including chewing gum, until normal sensation returns, due to the risk of biting the lip, cheek, or tongue, especially in children.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her dentist or doctor before using this medicine.
The dentist or doctor will decide whether the patient can use Ubistesin forte during pregnancy.
Breastfeeding can be resumed 5 hours after anesthesia administration.
No effect on fertility is expected after doses used during dental procedures.

Driving and using machines

If side effects occur, including dizziness, blurred vision, or fatigue, do not drive or operate machinery until normal sensation returns (usually within 30 minutes after the dental procedure).

Ubistesin forte contains sodium and sodium sulfite

• This medicine contains sodium sulfite (E221), which can rarely cause severe hypersensitivity reactions and bronchospasm.
• The medicine contains less than 1 mmol (23 mg) of sodium per cartridge, which means the medicine is considered "sodium-free". If there is a risk of an allergic reaction, the dentist will choose another anesthetic.

3. How to use Ubistesin forte

Only doctors or dentists with proper training should use Ubistesin forte.
The dentist will decide whether to use Ubistesin forte and determine the appropriate dose, considering the patient's age, body weight, overall health, and dental procedure.
Use the smallest dose that allows effective anesthesia. This medicine is administered by slow injection into the oral cavity.

Using a higher dose of Ubistesin forte than recommended

It is unlikely that the patient will receive too much of this medicine, but if the patient feels unwell, they should tell the dentist. Symptoms of overdose include severe weakness, pale skin, headache, feeling of excitement or overexcitement, feeling of disorientation, loss of balance, involuntary trembling or convulsions, pupil dilation, blurred vision, problems with focusing vision, speech disorders, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or fast breathing, which can lead to temporary breathing arrest, ineffective heart contractions (cardiac arrest).
If you have any further doubts about using the medicine, consult your dentist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the patient's stay in the dentist's office, the patient will be closely monitored by the dentist for the effect of Ubistesin forte.

Tell your dentist, doctor, or pharmacist immediately if the patient experiences any of the following serious side effects:

• facial swelling, tongue or throat swelling, swallowing problems, hives, or breathing difficulties (angioedema)
• rash, itching, throat swelling, and breathing difficulties: these may be symptoms of an allergic reaction (hypersensitivity)
• drooping eyelid and constricted pupil (Horner's syndrome). These side effects may occur rarely (may affect up to 1 in 1,000 patients).

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

Common side effects: may occur in up to 1 in 10 patients:

• gingivitis
• neuropathic pain - caused by nerve damage
• numbness or weakness of sensation in the mouth and around the mouth
• metallic taste, taste disorders, or loss of taste
• increased, unpleasant, or abnormal sensation
• increased sensitivity to heat
• headache
• abnormally fast heart rate
• abnormally slow heart rate
• low blood pressure
• tongue, lip, and gum swelling.

Uncommon side effects: may occur in up to 1 in 100 patients:

• burning sensation
• high blood pressure
• tongue and mouth inflammation
• nausea, vomiting, diarrhea
• rash, itching
• neck pain or reaction at the injection site.

Rare side effects: may occur in up to 1 in 1,000 patients:

• nervousness (anxiety), anxiety
• facial nerve disorders (facial nerve palsy)
• drowsiness
• involuntary eye movements
• double vision, temporary blindness, decreased visual acuity
• drooping eyelid and constricted pupil (Horner's syndrome)
• displacement with lowering of the eyeball into the orbit (enophthalmia)
• pupil dilation
• eye pain
• ringing in the ears, increased sensitivity to sound
• palpitations
• hot flashes
• pallor
• wheezing (bronchospasm), asthma
• breathing difficulties
• scaling and ulceration of the gums
• scaling at the injection site
• hives
• minor muscle spasms, involuntary muscle spasms,
• fatigue, weakness
• chills.

Very rare side effects: may occur in up to 1 in 10,000 patients:

• transient or permanent loss of sensation, prolonged numbness, or loss of taste

Frequency not known: frequency cannot be estimated from available data

• extremely good mood (euphoria)
• feeling of weakness/fainting
• seizures, including generalized
• heart conduction disorders (conduction disorders, atrioventricular block, cardiac arrest)
• increased blood flow to a part of the body, leading to congestion in blood vessels
• vasodilation or vasoconstriction
• hoarseness
• swallowing difficulties
• cheek and local swelling
• burning mouth syndrome
• skin redness (flushing)
• abnormally increased sweating
• exacerbation of neuromuscular symptoms of Kearns-Sayre syndrome
• feeling of heat or cold
• bruxism.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 Ubistesin forte

Keep the medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the label and outer packaging after EXP. The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Protect from light.
Do not use this medicine if the solution is cloudy or discolored.
To avoid cuts, cartridges should be carefully removed from the container.
Cartridges are for single use. Use immediately after opening the cartridge.
Unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. The dentist knows how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Ubistesin forte contains

• The active substances of the medicine are articaine hydrochloride and epinephrine hydrochloride. Each 1.7 ml cartridge of Ubistesin forte solution for injection contains 68 mg of articaine hydrochloride and 0.0204 mg of epinephrine hydrochloride. 1 ml of Ubistesin forte contains 40 mg of articaine hydrochloride and 0.012 mg of epinephrine hydrochloride.
• Other ingredients are sodium sulfite (E221), sodium chloride, 14% hydrochloric acid (for pH adjustment), and 9% sodium hydroxide solution (for pH adjustment), water for injections.

What Ubistesin forte looks like and what the packaging contains

Ubistesin forte is a clear and colorless solution.
It is packaged in single-dose cartridges made of neutral glass type I, closed with a rubber stopper and aluminum cap.
A metal container contains 50 cartridges of 1.7 ml each.

Marketing authorization holder:

Pierrel S.p.A.
Strada Statale Appia 7bis, 46/48
81043 Capua (CE) – Italy
phone: +39 0823 626 111
fax: +39 0823 626 228

Manufacturer:

Solventum Germany GmbH
ESPE Platz
82229 Seefeld
Germany

Date of last revision of the leaflet: 08/2024

 ---------------------------------------------------------------------------------------------------------------------
Information intended only for healthcare professionals:
Since the product is administered only by dentists, the full text of the Summary of Product Characteristics will be attached to the end of the patient leaflet in the form of a detachable section.