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Septocaine Forte

Document: Septocaine forte, Septocaine solution for injection ENG PL change



Package leaflet: Information for the user


Septocaine: 40 mg/ml + 5 micrograms/ml, solution for injection

Septocaine forte: 40 mg/ml + 10 micrograms/ml, solution for injection


Articaine hydrochloride/adrenaline


Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.


What is in this leaflet


What Septocaine is and what it is used for

What you need to know before Septocaine is used

How Septocaine is used

Possible side effects

How to store Septocaine

Contents of the pack and other information


1. What Septocaine is and what it is used for


Septocaine is used to numb (anaesthetise) your oral cavity during dental procedures.

This medicine contains two active ingredients:


You will be given Septocaine by a dentist.

Septocaine is for children over 4 years of age, adolescents and adults.


Dependingonthekindofdentalprocedureperformed, the dentist will choose:


2. What you need to know before Septocaine is used


Septocaine must not be used:


Warnings and precautions

Talk to your dentist before using Septocaine


Children

Septocaine should not be usedinchildren under 4 years of age.


Other medicines and Septocaine

Tell your dentist if you are taking,haverecentlytaken or might takeanyothermedicines.


Yourdentistshouldtakespecialattentionifyouaretakingthe following medicines:


If sympathomimetic vasopressor such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline have been used within the past 24 hours, the planned dental treatment has to be postponed.


Septocainewith food

You should avoid chewing gum or eating until normal sensation is restored after using this medicine. Otherwise there is a risk that you will bite your lips, cheeks or tongue.


Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your dentist or doctor for advice before using this medicine.


Your dentist or doctor will decide if you can use Septocaine during pregnancy or breast-feeding.


If Septocaine is used during breast-feeding, the nursing mother is advised to express and discard the first milk after using Septocaine.


Driving and using machines

If you experience side effects, including dizziness, blurred vision or fatigue,youshouldnotdriveoroperatemachineryuntiltheseeffectshavedisappeared.


Septocaine contains sodium and sodium metabisulfite.


3. How Septocaine is used


Your dentist will choose between Septocaine and Septocaine Forte and adjust the dosage according to your age, your health and the dental procedure. The lowest dose leading to efficient anaesthesia should be used.

Septocaine is given as an injection in the oral cavity.


If your dentist uses more Septocaine than he or she should

If you think you may have been given too much of this injection and feel unwell, tell your dentist. Symptoms of overdose include loss of consciousness, severe weakness, headache, feeling restless, feeling disorientated, dizziness, involuntary trembling or quivering, coma, convulsions, speech disorders, losing your balance, dilation of the pupil, blurred vision, problems clearly focusing an object (accommodation disorder), paleness of the skin, abnormally slow or rapid breathing rate which could lead to temporarily stopping breathing, yawning, and failure of the heart to contract effectively (called cardiac arrest).

If you have any further questions on the use of this product, ask your dentist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


While you are in your dentist’s office, your dentist will carefully follow the effects ofSeptocaine.


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


These side effects happen rarely (may affect up to 1 in 1,000 people ).


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

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


Uncommonside effects: may affect up to 1 in 100 people:


Rareside effects: may affect up to 1 in 1,000 people:


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

persistent loss of sensitivity, extended numbness and loss of taste


Not known: frequency cannot be estimated from the available data


Reporting of side effects

If you get any side effects, talk to your dentist, doctor or pharmacist. This includes any possible side effects not listed in this leaflet.


You can also report side effects directly via the the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Septocaine


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


Your dentist will not use this medicine after the expiry date whichisstatedonthecarton.Theexpirydaterefersto the last day of that month.


Yourdentistwillnot store it above25°C.


He/she will keep the cartridges intheouter carton in order to protect from light and moisture. This medicine should not be refrigerated or frozen.


Before giving you Septocaine, your dentist will check if it does not contain a precipitate.


Septocaine should not be thrown away via wastewater or household waste. Your dentist knows how to throw away medicines no longer used. These measures will help protect the environment.


6. Contents of the pack and other information


What Septocaine contains

Active substances:


The other ingredients are:


What Septocainelooks like and contents of the pack

Septocaine/Septocaine forte isaclearandcolourlesssolution.

Cylindrical class I glass cartridge sealed at its base by a mobile rubber plunger and at the top by a rubber seal kept in place by a metal cap.


Box containing glass cartridges 50 x 1.7 ml.

Box containing glass cartridges, self-aspirating 50 x 1.7 ml.

Pack of 4 boxes containing glass cartridges 50 x 1.7 ml.

Pack of 8 boxes containing glass cartridges 50 x 1.7 ml.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer

Specialites Septodont.

58, rue du Pont de Créteil

94100Saint-Maur-des-Fossés

FRANCE


This leaflet was last revised in: 2014-11-19


Detailed information on this medicine is available on the website of {MS/Agency to be completed nationally}


The following information is intended for healthcare professionals only:


Method of Administration

Infiltration and perineural use in oral cavity.

Before injection, aspiration is always recommended to avoid intravascular injection.

To avoid intraneural injection, the needle should always be slightly withdrawn if electric shock sensation is felt by the patient during injection or if the injection is particularly painful.


The rate of injection should not exceed 1 ml of solution per minute.


Posology

The lowest dose leading to efficient anaesthesia should be used. The necessary dosage must be determined on an individual basis.


Adults and adolescents (12-18 years old)

In adults and adolescents, the maximum dose is 7 mg/kg with an absolute maximum dose of 500 mg for an healthy adult of 70 kg body weight.


Children (4 to 11 years)

Due to lack of clinical data, this product should not be used in children under 4 years of age. In children aged 4 years (or from 20 kg (44 lbs) of body weight) and above, the maximum dose is 5 mg/kg only with an absolute maximum dose of 275 mg articaine for a healthy child of 55 kg body weight.


Special populations

Due to the lack of clinical data, particular precaution should be used in order to administer the lowest dose leading to efficient anaesthesia in elderly patients over 70 years old and in patients with renal or hepatic impairment.


Overdose

Types of overdose

Local anaesthetic overdose in the largest sense is often used to describe:

absolute overdose,

relative overdose such as:

- inadvertent injection into a blood vessel, or

- abnormal rapid absorption into the systemic circulation, or

- delayed metabolism and elimination of drug.


Symptomatology

Due to an overdose (absolute or relative), since excitement may be transient or absent, the first manifestations may be drowsiness merging into unconsciousness and respiratory arrest.


Due to articaine:

The symptoms are dose-dependent and have progressive severity in the realm of neurological manifestations (presyncope, syncope, headache, restlessness, agitation, confusional state, disorientation, dizziness (lightheadedness), tremor, deep CNS depression, loss of consciousness, coma, convulsion (including tonic-clonic seizure), speech disorder (e.g., dysarthria, logorrhea), vertigo, balance disorder (disequilibrium)), eyes manifestations (mydriasis, vision blurred, accommodation disorder) followed by vascular (pallor (local, regional, general)), respiratory (apnoea (respiratory arrest), bradypnoea, tachypnoea, yawning, respiratory depression), and finally cardiac (cardiac arrest, myocardial depression) toxicity.


Due to adrenaline:

The symptoms are dose-dependent and have progressive severity in the realm of neurological manifestations (restlessness, agitation, presyncope, syncope) followed by vascular (pallor (local, regional, general)), respiratory (apnoea (respiratory arrest), bradypnoea, tachypnoea, respiratory depression), and finally cardiac (cardiac arrest, myocardial depression) toxicity.


Treatment of overdose

The availability of resuscitation equipment should be ensured before the onset of dental anaesthesia with local anaesthetics.

If signs of acute toxicity are suspected, the injection of Septocaine must immediately be stopped.

Oxygen should rapidly be administered, if necessary by assisted ventilation.

Change patient position to supine position if necessary.

If seizures do not stop spontaneously within 15 – 20 seconds an anticonvulsant drug must be administered. Muscle relaxing agents may be necessary but requires tracheal intubation.

Hypotension and/or bradycardia may be treated with ephedrine.

In case of cardiac arrest, immediate initiation of cardiopulmonary resuscitation should be performed with the combination of epinephrine and atropine.


Special precautions for disposal and other handling

This medicine should not be used if the solution is cloudy or discoloured.

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

The cartridges are for single use. If only a portion of a cartridge is used, the remainder must be discarded.

Any unused product or waste material should be disposed of in accordance with local requirements.