Consumer medicine information

ATO MEPIVACAINE 3%

ATO MEPIVACAINE 3%


Consumer Medicine Information

WHAT’S IN YOUR MEDICINE

ATO Mepivacaine contains a local anaesthetic, Mepivacaine hydrochloride.

ATO MEPIVACAINE 3%

Active ingredients

Cartridge 2.2 mL

Mepivacaine hydrochloride 66 mg

Other ingredients:

Sodium chloride, Sodium hydroxide solution, water for injections.

Presentation:

Box of 50 cartridges for single use, containing each 2.2 mL.

WHAT YOUR MEDICINE IS USED FOR AND HOW IT WORKS

ATO MEPIVACAINE 3% contains one active ingredient, Mepivacaine hydrochloride, a local anaesthetic to prevent the pain and is given by injection to cause loss of feeling before and during dental procedures.

ADVICE BEFORE USING THE MEDICINAL PRODUCT

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your dentist will make before treatment.

This product should not be used if any of the following apply to you:

  • You are allergic to mepivacaine, or any local anaesthetic and any other ingredient included in the product
  • You have arterial hypertension (high blood pressure), coronary disease or valvular cardiac disease (heart or circulation problems).
  • You have an over active thyroid gland, whether or not you are treated for this.
  • You have cerebral arteriosclerosis (hardening in the brain arteries).
  • You have inflammation (pain, swelling, redness and heat) or infection in the region of the proposed injection
  • Children under the age of 3 years old.

You must tell your dentist if you have the following conditions:

  • You have problems with your heart, blood vessels, circulation and heart rhythm.
  • You are taking any medicine
  • You have epilepsy.
  • You have hepatic (liver) or renal (kidney) diseases.
  • You have malignant hyperthermia (history or experience of a rapid rise in body temperature to a dangerously high level brought on by general anaesthesia.
  • You have prostatic hypertrophy (enlarged prostate).
  • You are pregnant or breast-feeding. If ATO MEPIVACAINE is used while you are breast-feeding you should not breast-feed for at least 48 hours following use of ATO MEPIVACAINE.
  • You have any other medical conditions.

ATO MEPIVACAINE MAY INTERACT WITH OTHER MEDICINES

It should be used with caution if you are taking:

  • Beta-blockers or Guanethidine (medicines used to lower high blood pressure and/or treat heart problems).
  • Hypoglycaemics (medicine used to treat high blood sugar).
  • Anti-arrhythmic drugs and amiodarone (medicines used to treat irregular heartbeats).
  • Anti-epileptic drugs (medicines used to treat epilepsy).
  • Cardiac glycosides (medicines used to treat heart failure).
  • Cimetidine (medicine used to treat reflux and stomach or duodenal ulcers).
  • Thyroid hormone
  • Inhalational anaesthetics

These medicines may be affected by ATO MEPIVACAINE, or may affect how well it works.

Please make sure that you tell your dentist about all medicines which you are taking, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Your dentist will advise you what to do if you are taking any of these medicines.

HOW THIS MEDICINE WILL BE USED

Your dentist will explain to you why you are being treated with ATO MEPIVACAINE 3% and what dose you will be administered.

Your dentist will inject ATO Mepivacaine into your oral (mouth) cavity. This will result in an area of numbness at the site of injection. One cartridge is usually sufficient but your dentist may give you a greater quantity. He will adjust the dosage according to your age, your health and the dental work to be performed. If only a portion of a cartridge is used the remainder must be discarded.

WHILE YOU ARE affected by ATO MEPIVACAINE

Things you must not do:

  • Do not eat or drink any thing hot until the feeling has returned to your mouth. You may burn or bite yourself.

Things to be careful of:

  • Be careful driving or operating machinery until you know how ATO Mepivacaine affects you. You may be drowsy and your reflexes may be slow.
  • Do not drink alcohol immediately before or after you are given ATO Mepivacaine.
  • If you drink alcohol while you are being given ATO Mepivacaine, your blood pressure may drop making you feel dizzy and faint.
  • Please talk to your dentist or pharmacist about these possibilities if you think they may bother you.

SIDE EFFECTS

ATO Mepivacaine like most other medicines may cause side effects in some patients.

Although not all of these side effects may occur, if they do occur they may need medical attention. While you are in your dentist’s office, your dentist will carefully follow the effects of ATO Mepivacaine.

However, some effects may not be noticed or appear later. Check with your dentist if any of the following side effects occur:

Common reactions:

  • Infection and pain in the injection site.
  • Tingling and numbness of the hands and feet or increased feeling or sensitivity of the skin.
  • You are feeling nervous, nauseous or dizzy
  • You have a headache
  • You are trembling, have buzzing in the ears, blurred vision or have any abnormal feeling
  • Your breathing is difficult
  • Your heart is beating slowly or irregularly
  • You have facial swelling or inflammation of gums
  • You have skin rash, hives or itching
  • You may have a loss of sensation and muscle function following the injection of ATO Mepivacaine. Resolution occurs generally within two weeks.

Very rare reactions:

There are some serious unwanted reactions, which may happen if ATO Mepivacaine is given into the veins or you are very sensitive to it. It may cause:

  • Fits.
  • Unconsciousness.
  • Breathing problems.
  • Low blood pressure.
  • Slow heart beat.
  • Collapse.

If experiencing any of these, you may have had a serious (allergic) reaction to ATO Mepivacaine.

You may need urgent medical attention or hospitalisation.

Tell your dentist if you notice anything else that is making you feel unwell.

Some people may get other side effects while using ATO Mepivacaine.

IN CASE OF OVERDOSE

Your dentist will determine the amount of solution, which is needed to provide pain control during your treatment, and it is very unlikely that you would receive too much ATO Mepivacaine.

However, some persons tolerate mepivacaine less well than others and the signs and symptoms of too much of this substance in your blood include: nervousness, dizziness, blurred vision, nausea, trembling, convulsions, slow or irregular heart beat, troubled breathing.

Tell your dentist immediately if you experience any of these symptoms during or shortly after your treatment.or contact the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766

Whenever you are given ATO Mepivacaine, equipment will be available to care for you if an overdose happens.

STORAGE CONDITIONS

It is most unlikely that you will be asked to look after this medicine.

Your dentist will keep it below 25°C and protected from light.

He will not use this medicine after the expiry date printed on the package.

All medicines must be kept in a safe place out of the reach of children.

FURTHER INFORMATION

Only a dentist can administer this product. This leaflet provides only a summary of the information known about ATO Mepivacaine.

If you have any questions, want to know more about this medicine, or have some doubts, ask your dentist.

SPONSOR

Specialites Septodont T/A ATO Zizine, 14 Cliffbrook Crescent, EMU PLAINS, NSW 2750, Australia.

DATE OF INFORMATION

25 Aug 2008

ATO Mepivacaine 3% INJECTION

  • 50 cartridges of 2.2 mL of solution : AUST R 150494

CMI version: 4.0

Published by MIMS February 2022