Lignospan Forte: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

LIGNOSPAN is used to anesthetize part of the mouth for surgical operations and also for pain relief.

WHAT IT DOES:

LIGNOSPAN acts by preventing the nerves in the injected area from transmitting sensations of pain, heat or cold. However, you may still experience sensations such as pressure and touch. In this way the nerve(s) is anaesthetized in the part of the mouth, which will be subjected to surgery. In many cases this means that the nerves to the muscles in the area will also be blocked, causing temporary weakness or paralysis.

WHEN IT SHOULD NOT BE USED:

LIGNOSPAN should not be used in patients who:

• are allergic to lidocaine, any other “-caine” type anesthetics, or any of the non-medicinal ingredients in the product (see NON-MEDICINAL INGREDIENTS below)
• are allergic to sodium metabisulfite

WHAT THE MEDICINAL INGREDIENTS ARE:

Lidocaine hydrochloride 2% with epinephrine 0.010 mg/mL (1:100,000) or 0.02 mg/mL (1:50,000)

NON-MEDICINAL INGREDIENTS:

LIGNOSPAN with epinephrine contains sodium chloride, potassium metabisulfite, disodium edetate, water for injection, and sodium hydroxide and/or, hydrochloric acid.

Check with your doctor if you think you may be sensitive to any of the above ingredients.

WHAT DOSAGE FORMS IT COMES IN:

LIGNOSPAN is available in single –dose glass cartridges.

WARNINGS AND PRECAUTIONS

You should talk to your doctor prior to surgery:

• about all health problems you have now or have had in the past;
• about other medicines you take, including ones you can buy without prescription;
• if you are taking other medicines such as drugs used to treat irregular heart activity (anti-arrhythmics);
• if you think you may be allergic or sensitive to any ingredients in LIGNOSPAN (see above). Sodium metabisulfite might cause allergic reactions (e.g. facial swelling and respiratory difficulties) in susceptible people, especially those with a history of asthma or allergy;
• if you have a severe heart, liver or kidney disease;
• if you have poorly controlled hyperthyroidism and diabetes;
• if you have epilepsy;
• if you or someone in your family has been diagnosed with porphyria;
• if you are experiencing severe shock;

• if you are pregnant, plan to become pregnant or are breastfeeding;

• if you are planning to drive or operate any tools or machinery on the day of surgery, because LIGNOSPAN may temporarily interfere with your reactions and muscular coordination.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor/dentist/pharmacist if you are taking or have recently taken any medicines, even those that can be bought without a prescription.

Drugs that may interact with LIGNOSPAN include:

• anti-arrhythmic drugs for heart problems (e.g. mexiletine, amiodarone);
• other anesthetics;
• proranolol for heart problems or cimetidine for gastrointestinal problems;
• fluvoxamine for depression, if using high doses of LIGNOSPAN for long time and other medicines for depression;
• antimigraine therapy;
• antipsychotic therapy;
• medicines for high blood pressure.

Usage of such medicines at the same time as LIGNOSPAN may increase the risk of serious side effects.

PROPER USE OF THIS MEDICATION

USUAL DOSE:

LIGNOSPAN should be administered by a doctor. The dose given is decided by the doctor based on the clinical need and your physical condition.

Overdose:

Serious adverse effects resulting from getting too much LIGNOSPAN need special treatment and the doctor treating you is trained to deal with these situations. Early signs that too much LIGNOSPAN^® Parenteral Solution has been given include:

• numbness of the lips and around the mouth;
• lightheadedness or dizziness;
• blurred vision;
• hearing problems;
• tingling in the ears

In the event of a serious overdosage, trembling, seizures or unconsciousness may occur.

If the early signs of overdosage are noticed and no further LIGNOSPAN is given, the risk of serious side effects occurring rapidly decreases. If you have any of these symptoms, or you think you have received too much LIGNOSPAN, tell your doctor immediately.

In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like any medication, LIGNSOSPAN may cause side effects in some people.

Medicines affect different people in different ways. Just because side effects have occurred in some patients, does not mean that you will get them. If any side effects bother you, or if you experience any unusual effects after exposure to LIGNOSPAN, check with your doctor as soon as possible.

LIGNOSPAN may temporarily interfere with your reactions and muscle co-ordination; therefore do not drive or use machines on the day of surgery.

This is not a complete list of side effects. Consult your doctor immediately if any of these symptoms or any unexpected effects appear.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

Important Note: This leaflet alerts you to some of the times you should call your doctor. Other situations which cannot be predicted may arise. Nothing about this leaflet should stop you from calling your doctor with any questions or concerns you have about using LIGNOSPAN Parenteral Solutions.

NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.

For the most current information, the Consumer Information Leaflet plus the full Package Insert, prepared for health professionals can be found by contacting the sponsor, Septodont

at 1-800-647-0643

Novocol Pharmaceutical of Canada, Inc.

25 Wolseley Court.

Cambridge ON

NIR 6X3

Last revised: June 30, 2015