Consumer Information for: PHARIXIA
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
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
PHARIXIA provides relief by reducing pain and inflammation. PHARIXIA 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 PHARIXIA;
- 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
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 form it comes in
PHARIXIA 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. PHARIXIA is a clear, yellow-green liquid with a mint-like odour
Warnings and precautions
BEFORE you use PHARIXIA talk to your doctor or pharmacist if:
- if you have experienced allergic reactions to any ingredient in PHARIXIA;
- 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 doses.
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.c
This is not a complete list of side effects. For any unexpected effects while taking PHARIXIA, contact your doctor or pharmacist
How to store
Store at room temperature (15oC to 30oC). Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. 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, PENDOPHARM, Division of Pharmascience Inc., at: 1-888-550-6060.
TMTrademark of Pharmascience Inc.
This leaflet was prepared by PENDOPHARM,
Division of Pharmascience Inc.
Last revised: October 11, 2013.
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