Patient Medication Information: uses, side effects, how to take - PMS-Benzydamine
ABOUT THIS MEDICATION
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:
pms-BENZYDAMINE provides relief by reducing pain and inflammation. pms-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 pms-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 important nonmedicinal ingredients are:
Alcohol, Citric Acid (for pH adjustment), Glycerin, Methylparaben, Mouthwash Natural and Artificial Flavour and Artificial Colour (contains D&C Yellow No. 10 and FD&C Blue No. 1), Polysorbate 80, Propylparaben, Purified Water, Sodium Citrate Dihydrate (for pH adjustment), Sorbitol.
What dosage forms it comes in:
PMS-BENZYDAMINE is a mouthwash containing 1.5 mg/mL (0.15% w/v) of benzydamine hydrochloride. It is supplied in bottles of 100 mL and 250 mL. pms-BENZYDAMINE is a clear, yellow-green liquid with a mint-like odour.
WARNINGS AND PRECAUTIONS
BEFORE you use pms-BENZYDAMINE talk to your doctor or pharmacist if:
- if you have experienced allergic reactions to any ingredient in pms-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:
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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 doses.
Product Monograph pms-BENZYDAMINE Page 13 of 13
IMPORTANT: PLEASE READ
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 pms-BENZYDAMINE, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15oC to 30oC). 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
Health Canada by:
Visiting the Web page on Adverse Reaction
Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/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 product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.
Pharmascience Inc.
Montréal, CANADA
H4P 2T4
www.pharmascience.com