Patient Medication Information: uses, side effects, how to take - Co Fluconazole-150
ABOUT THIS MEDICATION
What the medication is used for:
CO Fluconazole-150 is indicated for the treatment of vaginal yeast (fungal) infections. It can be taken anytime, anywhere to relieve itching, burning and discharge associated with vaginal yeast infections. CO Fluconazole-150 is a clinically proven, effective single-dose cure for most vaginal yeast infections that starts to work in 1 day.
What is a Yeast Infection
A “yeast infection” may occur any time there is an overgrowth of yeast organisms in the vagina. The vagina normally has bacteria and yeast organisms present. Under some conditions, the number of yeast organisms rises, irritating the tissues of the vagina and vaginal opening.
Conditions that make this more likely to occur:
- Illness
- Use of antibiotics
- Change in hormone levels
Pregnancy
- Use of oral contraceptive pills
- Just before a woman’s period
- Diabetes
- Hot humid weather
- Continuous use of panty liners
- Tight, non-breathing clothing
Nylon underwear, pantyhose, wet bathing suits or damp
workout wear
Perfumed soaps, bubble baths or douching may cause
vaginal irritation and upset the normal balance
Refrain from vaginal intercourse when you have a yeast infection to avoid infecting your partner and to minimize additional discomfort. If your partner has any genital itching, redness or discomfort, they should talk to their doctor and mention that you are treating a yeast infection.
When a “yeast infection” occurs, the body responds with:
- An increase in vaginal secretions.
Secretions are generally thick and sticky (cheesy or curd-
like, similar to cottage cheese), but odourless.
Secretions that are irritating to the tissues of the vaginal
area
- Itching, redness and swelling of the vaginal area
Red spots or sores may develop, especially if the area has
been scratched
- Soreness in the vagina
- Pain during sexual relations is common
What it does:
CO Fluconazole-150 is an antifungal medication. The active ingredient fluconazole works by stopping the growth of the fungi that cause vaginal yeast infections.
When it should not be used:
Do not use if you are:
- Pregnant
- Nursing
- Allergic to fluconazole, related azoles (e.g. clotrimazole / miconazole) or other ingredients in the product
- Taking allergy drugs (e.g. astemizole* / terfenadine*)
- Taking cisapride*
*not marketed in Canada
What the medicinal ingredient is:
Fluconazole 150 mg (Oral Capsule)
What the important nonmedicinal ingredients are:
Lactose, maize starch, colloidal silicon dioxide, magnesium stearate and sodium lauryl sulphate; the capsule shell contains gelatin and titanium dioxide.
What dosage forms it comes in:
CO Fluconazole-150 Capsules are available as hard white gelatin capsules. The body of the capsule has “FZ 150” and the cap has “ ”, both printed in black. Each capsule contains 150 mg of fluconazole. Supplied as a unit dose blister (PVC) pack of 1 capsule.
WARNINGS AND PRECAUTIONS
BEFORE USING CO Fluconazole-150 talk to your doctor or pharmacist if:
- You are having your first yeast infection
- You have frequent vaginal infections
- You are at increased risk for sexually transmitted diseases, have multiple sexual partners or change partners often
- You have heart disease
Using in children less than 12 years old
If you could become pregnant while taking CO Fluconazole-150, you should consider using a reliable means of contraception, because the possible effects of this medication on a developing fetus are not known.
Yeast infections do not cause:
- Fever
- Chills
- Abdominal pain
- Nausea
- Vomiting
- Diarrhea
- Pain upon urination
- Unexplained pain in your lower back or either shoulder IMPORTANT: PLEASE READ
CO Fluconazole 150 (Fluconazole) Product Monograph Page 30 of 30
- Foul-smelling discharge
Consult your doctor immediately if you have these symptoms, as
they could be signs of a more serious condition.
INTERACTIONS WITH THIS MEDICATION
BEFORE you use CO Fluconazole-150 talk to your doctor or pharmacist if you are taking any other drug especially drugs for:
- AIDS/HIV (zidovudine)
- Allergies (Astemizole*, Terfenadine*)
- Asthma (theophylline)
- Antibiotics (rifabutin, rifampicin)
- Blood Thinners (warfarin)
- Diabetes (glyburide, glipizide, tolbutamide)
- Diuretics (hydrochlorothiazide)
- Epilepsy (phenytoin)
- Immune System suppression (cyclosporine, tacrolimus)
- Stomach (cimetidine, cisapride*)
- Sedation (midazolam, triazolam)
*not marketed in Canada
PROPER USE OF THIS MEDICATION
Consult your doctor if this is your first yeast infection, or if you have a second yeast infection in less than 2 months after treating a prior infection.
Usual dose:
Adults (≥12 years old): Take CO Fluconazole-150, by mouth as a one-time only dose, with or without food, or as directed by your doctor. DO NOT take more than one dose for this infection. If your symptoms have not improved within 3 days and disappeared in 7 days, contact your doctor.
Clearing a yeast infection does take time. Although CO Fluconazole-150 is taken only once, CO Fluconazole-150 therapy does not cure the infection in just one day, the medication remains active in your body for several days. Most patients can expect to see symptom relief begin within 24 hours after taking the capsule. As CO Fluconazole-150 works to cure the infection, symptoms will lessen and eventually disappear.
Overdose:
In case of accidental overdose call a doctor or poison control centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects in clinical studies were headache, nausea, abdominal pain and diarrhea. Most reported side effects were mild to moderate in nature.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Stop use and contact a doctor or pharmacist if you: develop skin
eruptions, experience new rash or irritations or allergy symptoms such as hives. Rarely, severe allergic reactions (swelling of face, eyes, mouth, hands and feet) have occurred.
HOW TO STORE IT
Store between 15-30°C.
Keep out of reach of children.
REPORTING SUSPECTED 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:
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- 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 0701D
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 found by contacting the sponsor, Cobalt Pharmaceuticals Company, at:
1-866-254-6111.
Cobalt Pharmaceuticals Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5
Date revised: October 22, 2014