Details for: ODAN-BENZYDAMINE
Company: ODAN LABORATORIES LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02463105 | ODAN-BENZYDAMINE | BENZYDAMINE HYDROCHLORIDE | 0.15 % / W/V | MOUTHWASH/GARGLE | BUCCAL |
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
- the relief of pain in sore throat;
- the relief of symptoms related to mouth and throat mucosa inflammation caused by radiation therapy.
What it does
ODAN-BENZYDAMINE provides relief by reducing pain and inflammation. ODAN-BENZYDAMINE acts by preventing the formation of chemical messengers named prostaglandins, which are involved in the inflammation process.
When it should not be used
- if you have experienced allergic reactions to any ingredient in ODAN BENZYDAMINE;
- in children five years of age and younger;
- if you are pregnant;
- if you have renal disease.
What the medicinal ingredient is
Benzydamine hydrochloride.
What the non-medicinal ingredients are
Citric Acid (for pH adjustment), D&C Yellow No.10, Ethyl Alcohol, FD&C Blue No.1, Glycerin, Methylparaben, Peppermint Extract, Polysorbate 80, Propylparaben, Purified Water, Sodium Citrate Dihydrate and Sorbitol.
What dosage form it comes in
ODAN-BENZYDAMINE is a mouthwash containing 1.5 mg/mL (0.15% w/v) of benzydamine hydrochloride. It is supplied in bottles of 250 mL. ODAN-BENZYDAMINE is a clear, yellow-green liquid with a mint-like odour.
Warnings and precautions
BEFORE you use ODAN-BENZYDAMINE talk to your doctor or pharmacist if:
- if you have experienced allergic reactions to any ingredient in ODAN-BENZYDAMINE;
- if you are pregnant;
- if you have renal disease.
Interactions with this medication
As with most medicines, interactions with other drugs are possible. Tell your healthcare professional about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
Proper use of this medication
Usual Adult Dose
Radiation Induced Oro-Pharyngeal Mucositis (ulcers in the mouth caused by radiation therapy)
Rinse and gargle the mouth and throat with 15 ml
(1 tablespoon) for at least 30 seconds, 3-4 times daily beginning the day prior to starting therapy. Continue use while receiving and after stopping the radiation therapy until symptoms disappear. Spit out the solution. Do not swallow.
Acute Sore Throat
Gargle with 15 ml (1 tablespoon) every 1.5 to
3 hours. Spit out the solution. Do not swallow.
In case of burning sensation, you can dilute with an equal volume of lukewarm water.
Take exactly as prescribed by your doctor.
Overdose
Missed Dose
If a dose of this medication is missed, it is not necessary to make up the missed dose. Skip the missed dose and continue with the next scheduled dose. Do not double dose.
Side effects and what to do about them
Side effects include:
- local numbness
- local burning or stinging sensation
- nausea and/or vomiting
- throat irritation
- cough
- dryness of the mouth with thirst
- drowsiness
- headache.
This is not a complete list of side effects. For any unexpected effects while taking ODAN-BENZYDAMINE, contact your doctor or pharmacist.
How to store
Store at room temperature (15°C to 30°C). Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to the Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php)
- Call 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 product monograph, prepared for health professionals can be obtained by contacting the sponsor, Odan Laboratories Limited at: 1-800-387-9342.
This leaflet was prepared by Odan Laboratories Limited.
Last prepared: April 13, 2017.