Details for: JELIDO
Company: PENDOPHARM DIVISION OF PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02469146 | JELIDO | LIDOCAINE HYDROCHLORIDE | 20 MG / ML | GEL | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
JELIDO is used to produce a temporary loss of feeling or numbness of the skin in adults and in children 2 years of age and older, and can be used:
- before certain types of examinations done by your doctor;
- to help relieve the pain from inflammation of the urinary bladder and the urethra.
What it does
JELIDO is the brand name for a topical anesthetic that contains
the drug lidocaine. Topical anesthetics are used to produce a
temporary loss of sensation or numbness on the area where they
are applied.
JELIDO should start to work within 5 to 15 minutes after you
apply it. The effect usually lasts 20 to 30 minutes.
When it should not be used
- are allergic to lidocaine, any other “-caine” type anesthetics, or any of the nonmedicinal ingredients in the product (see What the nonmedicinal ingredients are).
What the medicinal ingredient is
Lidocaine Hydrochloride 2%
What the non-medicinal ingredients are
Hydroxypropyl Methylcellulose, Purified Water and Sodium
Hydroxide
Tell your doctor if you think you may be sensitive to any of the
above ingredients.
What dosage form it comes in
JELIDO comes in a single-use syringe, in two package sizes – 6 mL and 11 mL.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JELIDO. Talk about any health conditions or problems you may have, including:
- all health problems you have now or have had in the past;
- 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 (antiarrhythmics);
- if you use JELIDO or any other medicines ending with “- caine”;
- if there is an infection, skin rash, cut or wound at or near the area you want to apply JELIDO;
- if you have a skin condition that is severe or that covers a large area;
- if you have severe heart, kidney or liver disease;
- if you have epilepsy;
- if you are experiencing severe shock;
- if you are pregnant, plan to become pregnant or are breastfeeding.
Interactions with this medication
Tell your healthcare professional about all the medicines you
take, including any drugs, vitamins, minerals, natural
supplements or alternative medicines.
The following may interact with JELIDO:
- drugs you can buy without a prescription;
- antiarrhythmic drugs for heart problems (e.g., mexiletine, amiodarone);
- other anesthetics;
- propranolol for heart problems or cimetidine for gastrointestinal problems, if you are going to use high doses of JELIDO for a long time;
- fluvoxamine for depression, if you are going to use high doses of JELIDO for a long time.
Please inform your doctor/dentist/pharmacist if you are taking or have recently taken any other medicines, even those that can be bought without a prescription. Usage of such medicines at the same time may increase the risk of serious side effects.
Proper use of this medication
The gel is available in two package sizes - 6 mL and 11 mL.
Usually, the complete contents of the size suitable for the
procedure will be used.
Adults: Do not use more JELIDO than the doctor has
recommended. A usual adult dose is one 11 mL syringe, with
possibly an additional syringe of 6 or 11 mL (for men) or one 6
mL syringe of 6 mL (for women). During procedures, the doctor
may use as many as 4 syringes (a total of 40 mL) in one dose. Do
not use more than 4 doses in a period of 24 hours.
Children: The dose depends on the child’s weight. No more than
3 mL of jelly per 10 kilograms of the child’s weight should be
used per dose. For a 10 kg child the dose should be no more than
one tenth of the tube. Do not use more than 4 doses in a period of
24 hours.
For self-catheterization: Follow these directions carefully. Clean
the urethral area before using JELIDO. The syringe is removed
from its sterile package by tearing off the backing paper. Before
removing the blue cap from the end of the syringe, free the plunger by gently pressing it. Remove the cap. Insert the nozzle
into the opening of the urethra and press the plunger slowly to
push out the gel.
The syringe is for single use only. If the complete contents are
not used, the syringe and remaining gel must be thrown away.
This medicine has been prescribed for your current medical
problem only. Do not give it to other people.
Overdose
Avoid contact with your eyes or ears. Numbness in the eyes may prevent you from noticing if you get something in the eye. For symptoms of serious side effects please consult the table entitled, “Serious side effects and what to do about them.”
Side effects and what to do about them
Like any medication, JELIDO may cause side effects in some
people.
Avoid eating or chewing gum when JELIDO 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 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, JELIDO 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
JELIDO, stop using it and check with your doctor or
pharmacist as soon as possible.
| Symptôme / effet | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Rare | |||
| Allergic reaction such as: redness, itching or swelling of your skin, hives, burning, stinging or any other skin problems, swelling of the neck area, or any difficulty with breathing not present before using this medicine | ✔ | ✔ | |
| Very rare | |||
| Overdose: drowsiness, numbness of your tongue, lightheadedness, ringing in your ears, blurred vision, vomiting, dizziness, unusually slow heartbeat, fainting, nervousness, unusual sweating, trembling, or seizures | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking JELIDO contact your doctor or pharmacist
JELIDO can cause serious side effects if too much is applied.
These include: drowsiness, numbness of your tongue, lightheadedness, ringing in your ears, blurred vision, vomiting, dizziness, unusually slow heartbeat, fainting, nervousness, unusual sweating, trembling or seizures.
The above side effects are extremely rare but can occur when too much JELIDO is used at one time and when large amounts are used over a long period of time.
Consult your doctor immediately if any of these symptoms appear.
How to store
Remember to keep JELIDO well out of the reach of children
when you are not using it.
Keep JELIDO between 15°C and 30°C. Do not keep JELIDO in
the bathroom medicine cabinet or other warm, moist places.
Store in the original package.
Do not use JELIDO after the expiry date marked on the package.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full prescribing information, prepared for
healthcare professionals can be obtained by contacting the
sponsor, PENDOPHARM, Division of Pharmascience Inc. at:
http://www.pendopharm.com
By telephone: 1-888-550-6060
By post: PENDOPHARM, Division of Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montreal, QC H4P 2T4
This leaflet was prepared by PENDOPHARM, Division of
Pharmascience Inc.
Date Prepared: October 19, 2017
JELIDOTM is a trademark of FARCO-PHARMA GmbH, 50670
Cologne, Germany, used under license by Pharmascience Inc.