Details for: ORO CLEAR
Company: GERMIPHENE CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02291096 | ORO CLEAR | CHLORHEXIDINE GLUCONATE | 0.12 % | MOUTHWASH | 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
ORO CLEAR (0.12% w/v Chlorhexidine Gluconate Oral Rinse, House Standard) is indicated for use as part of a professional program for the treatment of moderate to severe gingivitis, and for management of associated gingival bleeding and inflammation according to the recommended dosage and frequency under supervision of a dentist.
What it does
Chlorhexidine weakens the bacterial cell wall, disrupting cell contents, thereby killing bacteria and reducing gingivitis and the associated bleeding and inflammation of the gums.
When it should not be used
ORO CLEAR should not be used by the persons who are known to be hypersensitive to Chlorhexidine Gluconate, Chlorhexidine compounds or other ingredients. (nonmedicinal ingredients specified below).
What the medicinal ingredient is
Chlorhexidine Gluconate 0.12% w/v
What the non-medicinal ingredients are
Purified water, glycerine, sodium saccharin, FD&C Blue #1, methyl salicylate, polysorbate 80, D&C Yellow # 10, spearmint IC5-30379.
What dosage form it comes in
ORO-CLEAR (0.12% w/v Chlorhexidine Gluconate Oral Rinse, House Standard) mouthwash is available in 500 mL and 4L containers.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ORO CLEAR. Talk about any health conditions or problems you have.
ORO CLEAR can cause staining to tooth surfaces, restorations, and the tongue in prolonged use. This staining does not affect health and staining can be removed from most tooth surfaces by your dentist. This product may also cause a change in your taste perception which typically becomes less noticeable with continued use. Parotitis (inflammation of the parotid, one of the salivary glands) and inflammation of the salivary glands have been reported in some patients using Chlorhexidine Gluconate oral rinses. There is potential for sensitization, development of a local reaction in the mouth (e.g. irritation) to the active ingredient Chlorhexidine Gluconate.
If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach, or diarrhea, seek medical attention immediately.
Use in Pregnancy: No clinical studies with Chlorhexidine Gluconate in pregnant women have been conducted. You and your doctor need to decide if this is appropriate for you.
Nursing Women: It is not known whether Chlorhexidine gluconate is excreted in human milk. You and your doctor need to discuss this issue.
Pediatrics (less than 18 years of age): The use of ORO CLEAR in pediatric patients is not recommended.
Geriatrics (greater than 65 years of age): Clinical studies of ORO CLEAR did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. You and your doctor need to decide if this is appropriate for you.
Interactions with this medication
There are no known interactions with ORO CLEAR and other substances. Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
Proper use of this medication
ORO CLEAR is to be administered under the supervision of a dentist.
Usual Adult Dose
Rinse with 15 mL ORO CLEAR for 30 seconds, then spit it out. Use twice daily: after breakfast and before bedtime, or as prescribed by the doctor. Do not swallow. Avoid rinsing the mouth, eating, or drinking for at least 30 minutes after using ORO CLEAR.
Overdose
In case of accidental oral ingestion (more than 100 mL), contact your doctor or local poison control center.
Missed Dose
If a dose of ORO CLEAR is missed, take it as soon as you remember. If it is almost time for the next dose, wait until time, take the dose and resume the normal dosing schedule. Do not double the next dose.
Side effects and what to do about them
Common side effects include staining of teeth, mouth, or tongue, change in taste perception, mouth irritation, and shedding of mouth cells. Other side effects include local irritation. If these side effects become bothersome, contact your doctor.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Parotitis (inflammation of the parotid gland, one of the salivary glands) | ✔ | ||
| Rare | |||
| Serious allergic reaction: symptoms such as swelling of the mouth, lips, throat, difficulty in breathing, rapid heartbeat, light headedness, skin rash, itching, upset stomach or diarrhea. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while using ORO-CLEAR, contact your doctor or pharmacist. Please also see Warnings and Precautions.
How to store
ORO CLEAR must be stored between 15º and 25º C. Protect from freezing. Keep out of reach and sight of children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 found by contacting Germiphene Corporation at: 1-800-265-9931.
Germiphene Corporation, Brantford Canada
Local: 519-759-7100 Fax: 519-759-1625
Toll Free: 1-800-265-9931
This leaflet was prepared by Germiphene Corporation.
Last revised: November 2, 2015