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XYLOCAINE® VISCOUS 2%
(lidocaine hydrochloride solution)

This leaflet is part III of a two-part “Prescribing Information” published when XYLOCAINE Viscous (lidocaine hydrochloride solution) 2% was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%. Contact your doctor or pharmacist if you have any questions about the drug.

Before using XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%, read this leaflet carefully.

Please keep this leaflet to refer to until you have used up all your XYLOCAINE Viscous 2%.

This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

ABOUT THIS MEDICATION

WHAT THE MEDICATION IS USED FOR:

XYLOCAINE Viscous (lidocaine hydrochloride solution) 2% is used to produce a temporary loss of feeling or numbness of the area where it is applied in adults and children 2 years of age and older, and can be used:

• before certain types of examinations done by your doctor.

XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%could also:

• relieve the pain and discomfort of a sore throat, such as after the tonsils are removed;
• provide relief in other painful diseases of the mouth, throat or esophagus;
• cause a loss of feeling in the throat area, before certain types of examinations are performed by your doctor.

WHAT IT DOES:

XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%is the brand name for a topical anesthetic that contains the drug lidocaine. Topical anesthetics are used to produce a temporary loss of feeling or numbness on the area where they are applied.

XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%should start to work within 5 minutes after you apply it. The effect usually lasts 20 to 30 minutes.

WHEN IT SHOULD NOT BE USED:

Do not use XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%if you:

• are allergic to lidocaine, any other “-caine” type anesthetics, or any of the non-medicinal ingredients in the product (see NONMEDICINAL INGREDIENTS below)
• are allergic to methylparaben and/or propylparaben (preservatives used in XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%) or PABA.

WHAT THE MEDICINAL INGREDIENT IS:

lidocaine hydrochloride 2%

NONMEDICINAL INGREDIENTS:

XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%also contains sodium carboxymethylcellulose, methylparaben, propylparaben, cherry essence, saccharin sodium, purified water and sodium hydroxide.

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

WHAT DOSAGE FORMS IT COMES IN:

XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%, 100 mL bottles.

BEFORE you use XYLOCAINE Viscous (lidocaine hydrochloride solution) 2% tell your doctor or pharmacist:

• about all health problems you have now or have had in the past;
• about other medicines you take, including ones you can buy without a prescription;
• if you are taking other medicines such as drugs used to treat irregular heart activity (anti-arrhythmics);
• if you have ever had a bad, unusual or allergic reaction to XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%or any other medicines ending with “caine”;
• if you think you may be allergic or sensitive to any ingredients in XYLOCAINE Viscous 2%(see above);
• if there is an infection, skin rash, cut or wound at or near the area you want to apply XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%;
• if you have a skin condition that is severe or that covers a large area;
• if you have a severe heart, kidney or liver disease (see PROPER USE OF THIS MEDICATION);
• if you have epilepsy (there is very low risk if used as per PROPER USE OF THIS MEDICATION section);
• 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.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about any other drugs you take, or have recently taken, including:

• drugs you can buy without a prescription;
• anti-arrhythmic drugs for heart problems (e.g. mexiletine, amiodarone) (see PROPER USE OF THIS MEDICATION);
• other anesthetics (see PROPER USE OF THIS MEDICATION);
• propranolol for heart problems or cimetidine for gastrointestinal problems, if you are going to use high doses of XYLOCAINE Viscous (lidocaine hydrochloride solution) 2% for a long time;
• fluvoxamine, for depression, if you are going to use high doses of XYLOCAINE Viscous 2% for a long time.

Usage of such medicines at the same time as XYLOCAINE Viscous (lidocaine hydrochloride solution) 2% may increase the risk of serious side effects.

PROPER USE OF THIS MEDICATION

This medication is for topical use only.

USUAL DOSE:

If this medicine is recommended by your doctor, be sure to follow the directions for use that have been given. If you are treating yourself, follow the directions below. Check with your doctor or pharmacist if you have any questions about your directions.

The following are general guidelines for the maximum amount of XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%that should be used without a doctor's advice. These guidelines apply only to otherwise healthy people. If you have a special skin condition or other condition that requires a doctor's supervision, ask your doctor about the maximum amount of XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%that you should use.

Do not use more XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%; or more often or for a longer period of time than either your doctor ordered or than these package directions recommend as this may cause unwanted side effects (see SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM).

Shake the bottle well before using this medicine, so that you get an even dose each time you use it.

• Use the smallest amount needed to control your symptoms.
• When used in the mouth or throat try to increase the length of time XYLOCAINE Viscous 2%is in contact with the affected area. For example, if you are treating mouth sores, swish the liquid around in your mouth and then spit it out. For a sore throat, roll the liquid around at the back of your throat or gargle, and then swallow the liquid.
• Do not drink water or other liquids right after you use XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%, as this will decrease the amount of relief you get from the medicine.
• Avoid contact with your eyes.

Use only an accurate measuring device, such as a measured cup or a measured teaspoon to dose this medicine.

Conditions where dose adjustments may be required:

• elderly patients
• acutely ill patients
• patients with severe liver disease
• patients with severe kidney disease
• patients also treated with other anesthetics or certain antiarrhythmic drugs (such as amiodarone or mexiletine)

Dose for Adults

The usual effective dose for adults is 5 - 10 mL at a time. Do not use this amount more than six times in a 24-hour period.

The total dose for a 24-hour period should be no more than 60 mL.

Dose for Children 2-12 Years of Age

The dose depends on the child's weight. No more than 1 mL per 5 kilogram of the child's weight should be used per dose. Excess solution should be spat out. No more than four doses should be given during a 24-hour period.

Dose for Children Under 3 Years of Age

There may be special considerations for children under 3 years of age. DO NOT use XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%for children in this age group without a doctor's supervision. The solution should be applied to the affected area with a cotton tip applicator. No more than four doses should be given during a 24-hour period.

• For use in children under 2 years of age, consult a doctor.
• If you have any questions about how to measure the above amounts, be sure to ask your pharmacist.
• If you are treating yourself and your condition does not seem to improve within three to five days, check with your doctor about continuing to use XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%.

OVERDOSE:

Early signs of overdosage are numbness of the lips and around the mouth, lightheadedness, dizziness and sometimes blurred vision. In the event of a serious overdosage, trembling, seizures or unconsciousness may occur.

If the early signs of overdosage are noticed and no further XYLOCAINE Viscous (lidocaine hydrochloride solution) 2% is given, the risk of serious side effects occurring rapidly decreases. If you think you or anyone else is experiencing any of the above signs, telephone your doctor or go to the nearest hospital right away.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like any medication, XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%may cause side effects in some people.

Avoid eating or chewing gum when XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%is used in the mouth or throat since numbness in these areas may interfere with swallowing and could potentially cause choking. Numbness of the tongue or gum may also increase the danger of injury due to biting.

Avoid exposure to extreme hot or cold temperatures (e.g. food, drink) until complete sensation has returned.

Avoid contact with the eyes because numbness in the eyes may prevent you from noticing if you get something in your eye.

With the recommended doses, XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%has no effect on the ability to drive and use machines.

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 while you are using XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%, stop using it and check with your doctor or pharmacist as soon as possible.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

This is not a complete list of side effects. For any unexpected effects while taking XYLOCAINE Viscous (lidocaine hydrochloride solution) 2% contact your doctor or pharmacist.

XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%can cause serious side effects if too much is used. These include: drowsiness, numbness of your tongue, light-headedness, ringing in your ears, blurred vision, vomiting, dizziness, unusually slow heart beat, fainting, nervousness, unusual sweating, trembling or seizures.

The above are extremely rare and usually require large amounts of XYLOCAINE Viscous 2%over a long period of time.

Consult your doctor immediately if any of these symptoms appear.

HOW TO STORE IT

Remember to keep XYLOCAINE Viscous (lidocaine hydrochloride solution) 2% well out of the reach of children when you are not using it.

Keep XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%at room temperature. Protect from freezing. Do not keep XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%in the bathroom medicine cabinet or other warm, moist places. Store in the original package.

Do not use XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%after the expiry date marked on the package.

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 XYLOCAINE Viscous (lidocaine hydrochloride solution) 2%.

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 Prescribing Information, prepared for health professionals can be found at: www.astrazeneca.ca or by contacting the sponsor, AstraZeneca Canada Inc. at: Customer Inquiries - 1 (800) 668-6000, Renseignements - 1 (800) 461-3787.

Last reviewed on RxList: 5/8/2008
This monograph has been modified to include the generic and brand name in many instances.