Consumer information leaflet - xylocaine ointment 5%

XYLOCAINE® OINTMENT 5%
WHAT THE MEDICINAL INGREDIENT IS:
WHAT THE IMPORTANT NONMEDICINAL
PART III:
INGREDIENTS ARE:
XYLOCAINE Ointment 5% also contains polyethylene glycol,
CONSUMER INFORMATION
This leaflet is part III of a two-part "Prescribing
Check with your doctor if you think you may be sensitive to any Information" published when XYLOCAINE Ointment
5% was approved for sale in Canada and is designed
specifically for Consumers. This leaflet is a summary
WHAT DOSAGE FORMS IT COMES IN:
and will not tell you everything about XYLOCAINE
Ointment 5%. Contact your doctor or pharmacist if you
have any questions about the drug.
WARNINGS AND PRECAUTIONS
Before using XYLOCAINE Ointment 5%, read this
BEFORE you use XYLOCAINE Ointment 5% tell your doctor, leaflet carefully.
about all health problems you have now or have had in Please keep this leaflet to refer to until you have used up
all your XYLOCAINE Ointment 5%.
about other medicines you take, including ones you can This medicine has been prescribed for you personally
if you are taking other medicines such as drugs used to and you should not pass it on to others. It may harm
treat irregular heart activity (anti-arrhythmics); them, even if their symptoms are the same as yours.
if you have ever had a bad, unusual or allergic reaction to XYLOCAINE Ointment 5% or any other medicines ABOUT THIS MEDICATION
if you think you may be allergic or sensitive to any WHAT THE MEDICATION IS USED FOR:
ingredients in XYLOCAINE Ointment 5% (see above); XYLOCAINE Ointment 5% is used to produce a temporary if you have bleeding hemorrhoids and wish to use the 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 if there is an infection, skin rash, cut or wound at or near the area you want to apply XYLOCAINE Ointment 5%; before certain types of examinations done by your if you have a skin condition that is severe or that covers a to help relieve the pain from minor skin abrasions, if you have a severe heart, kidney or liver disease (see sunburn or other minor burns, sore nipples, insect if you have epilepsy (there is very low risk if used as per WHAT IT DOES:
XYLOCAINE Ointment 5% is the brand name for a topical anesthetic that contains the drug lidocaine. Topical if you are pregnant, plan to become pregnant or are anesthetics are used to produce a temporary loss of feeling or numbness on the area where they are applied. INTERACTIONS WITH THIS MEDICATION
XYLOCAINE Ointment 5% should start to work within 5 minutes after you apply it. The pain relief effect lasts about Tell your doctor or pharmacist about any other drugs you take, 4 hours specifically for wounds caused by burning. When a gauze is used over the cream, it may extend the effect of drugs you can buy without a prescription; anti-arrhythmic drugs for heart problems (e.g. mexiletine, WHEN IT SHOULD NOT BE USED:
Do not use XYLOCAINE Ointment 5% if you: other anesthetics (see PROPER USE OF THIS are allergic to lidocaine, any other "-caine" type anesthetics, or any of the non-medicinal ingredients propranolol for heart problems or cimetidine for in the product (see WHAT THE IMPORTANT
gastrointestinal problems, if you are going to use high NONMEDICINAL INGREDIENTS ARE below).
doses of XYLOCAINE Ointment 5% for a long time; COPYRIGHT 1954, 2006 ASTRAZENECA CANADA INC. fluvoxamine for depression, if you are going to use Conditions where dose adjustments may be required:
high doses of XYLOCAINE Ointment 5% for a long Usage of such medicines at the same time as XYLOCAINE Ointment 5% may increase the risk of serious side effects. patients also treated with other anesthetics or certain antiarrhythmic drugs (such as amiodarone or melixitine) PROPER USE OF THIS MEDICATION
Dose for Adults:
USUAL DOSE:
No more than 10 grams of ointment should be used for any 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 The minimum time between doses should be at least 8 hours. with your doctor or pharmacist if you have any questions The total dose for a 24-hour period should be no more than 20
XYLOCAINE Ointment 5% comes in tube sizes of 35 gram tubes with a special protective seal on the tube opening. If Dose for Children 2-12 Years of Age:
this seal is broken when you buy XYLOCAINE Ointment The dose depends on the child's weight. No more than 1 gram 5%, exchange it at the pharmacy for a new tube. To break of ointment per 10 kilograms of the child's weight. The the protective seal the first time you use XYLOCAINE minimum time between doses should be at least 8 hours. Ointment 5%, firmly press the pointed end of the white cap For use in children under 2 years of age, consult a doctor. If you have any questions about how to measure the The following are general guidelines for the maximum above amounts, be sure to ask your pharmacist. amount of XYLOCAINE Ointment 5% that should be used 10 grams of ointment administered from the 35 g tube is without a doctor's advice. These guidelines apply only to otherwise healthy people. If you have a special skin If you have the impression that the effect of condition or other condition that requires a doctor's XYLOCAINE Ointment 5% is too strong or too weak, supervision ask your doctor about the maximum amount of The ointment can easily be removed from the site of application Do not use more XYLOCAINE Ointment 5%; or more often and from clothing by washing with water. or for a longer period of time than either your doctor ordered or than these package directions recommend as this may If you are treating yourself and your condition does not seem to cause unwanted side effects (see SERIOUS SIDE EFFECTS improve within three to five days, check with your doctor about continuing to use XYLOCAINE Ointment 5%. If possible, clean the affected area well, before each OVERDOSE:
Early signs of overdosage are numbness of the lips and around Use the smallest amount of ointment needed to the mouth, lightheadedness, dizziness and sometimes blurred vision. In the event of a serious overdosage, trembling, seizures Apply a thin layer, using only enough to cover the affected area, and reapply it only when you need it. For broken or burned skin: To avoid touching the If the early signs of overdosage are noticed and no further affected area with your hands, apply the ointment to XYLOCAINE Ointment 5% is given, the risk of serious side a sterile gauze pad. Then secure the gauze pad in effects occurring rapidly decreases. If you think you or anyone else is experiencing any of the above signs, telephone your If used on sore nipples it is essential that you clean doctor or go to the nearest hospital right away. the nipple area completely before each feeding. This will ensure that the baby does not take in any of this SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, XYLOCAINE Ointment 5% may cause Propylene glycol (one of the other ingredients of the ointment) COPYRIGHT 1954, 2006 ASTRAZENECA CANADA INC. Avoid eating or chewing gum when XYLOCAINE Consult your doctor immediately if any of these symptoms Ointment 5% 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 gums HOW TO STORE IT
may also increase the danger of injury due to biting. Remember to keep XYLOCAINE Ointment 5% well out of
Avoid exposure to extreme hot or cold temperatures (e.g. the reach of children when you are not using it.
food, drink) until complete sensation has returned. Keep XYLOCAINE Ointment 5% at room temperature. Protect Avoid contact with the eyes because numbness in the eyes from freezing. Do not keep XYLOCAINE Ointment 5% in the may prevent you from noticing if you get something in your bathroom medicine cabinet or other warm, moist places. Store With the recommended doses, XYLOCAINE Ointment 5% Do not use XYLOCAINE Ointment 5% after the expiry date has no effect on the ability to drive and use machines. Medicines affect different people in different ways. Just REPORTING SUSPECTED SIDE EFFECTS
because side effects have occurred in some patients, does To monitor drug safety, Health Canada collects
not mean that you will get them. If any side effects bother information on serious and unexpected effects of drugs .
you, or if you experience any unusual effects while you are If you suspect you have had a serious or unexpected
using XYLOCAINE Ointment 5%, stop using it and check reaction to this drug you may notify Health Canada by:
with your doctor or pharmacist as soon as possible. Toll-free telephone: 866-234-2345
SERIOUS SIDE EFFECTS, HOW OFTEN THEY
Toll-free fax:
866-678-6789
HAPPEN AND WHAT TO DO ABOUT THEM
By email:
cadrmp@hc-sc.gc.ca
Symptom / effect
Talk with your
Stop taking
doctor or
By regular mail:
pharmacist
call your
National AR Centre
doctor or
Marketed Health Products Safety and Effectiveness
pharmacist
Information Division
Rare Allergic
reaction
Marketed Health Products Directorate
such as: redness,
Tunney’s Pasture, AL 0701C
itching or swelling of your skin, hives, Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should
contact your physician or pharmacist.
MORE INFORMATION
breathing, not present before using this Important Note: This leaflet alerts you to some of the times
you should call your doctor. Other situations which cannot
This is not a complete list of side effects. For any
be predicted may arise. Nothing about this leaflet should
unexpected effects while taking XYLOCAINE Ointment
stop you from calling your doctor with any questions or
5% contact your doctor or pharmacist
concerns you have about using XYLOCAINE Ointment 5%.
XYLOCAINE Ointment 5% can cause serious side effects if NOTE: This CONSUMER INFORMATION leaflet provides too much is used. These include: drowsiness, numbness of you with the most current information at the time of printing. your tongue, light-headedness, ringing in your ears, blurred vision, vomiting, dizziness, unusually slow heart beat, For the most current information, the Consumer Information fainting, nervousness, unusual sweating, trembling or Leaflet plus the full Prescribing Information, prepared for health The above are extremely rare and usually require large or by contacting the sponsor, AstraZeneca Canada Inc. at: amounts of XYLOCAINE Ointment 5% over a long period Customer Inquiries – 1 (800) 668-6000, COPYRIGHT 1954, 2006 ASTRAZENECA CANADA INC. This leaflet was prepared by: AstraZeneca Canada Inc. Mississauga, Ontario L4Y 1M4 XYLOCAINE® and the AstraZeneca logo are trade-marks of the AstraZeneca group of companies. AstraZeneca 1954, 2006 Last revised: December 21, 2006 COPYRIGHT 1954, 2006 ASTRAZENECA CANADA INC.

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