Details for: APO-FLUCONAZOLE-150
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02241895 | APO-FLUCONAZOLE-150 | FLUCONAZOLE | 150 MG | CAPSULE | ORAL |
Summary Reports
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
APO-FLUCONAZOLE-150 is indicated for the treatment of
vaginalyeast (fungal) infections. It can be taken anytime,
anywhere to relieve itching, burning and discharge associated
with vaginal yeast infections. APO-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
vaginalopening.
Conditions that make this more likely to occur:
- illness
- use of antibiotics
- changes 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.
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
APO-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
- trying to become 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
What the non-medicinal ingredients are
Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, stearic acid and talc. Capsule shell contains: gelatin, pharmaceutical ink and titanium dioxide.
What dosage form it comes in
APO-FLUCONAZOLE-150 is available in a capsule containing 150 mg (white) fluconazole.
Warnings and precautions
BEFORE you use APO-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
There have been reports of spontaneous abortion of the fetus or
birth defects. If you could become pregnant while taking this
medicine, you should consider using a reliable means of
contraception for approximately 1 week after the dose. If you
become pregnant while taking this medicine, contact your doctor.
Yeast infections do not cause:
- Fever
- Chills
- Abdominal pain
- Nausea
- Vomiting
- Diarrhea
- Pain upon urination
- Unexplained pain in your lower back or either shoulder
- 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 APO-FLUCONAZOLE-150 talk to your doctor or pharmacist if you are taking any other drug especiallydrugs for:
- AIDS/HIV (zidovudine)
- Allergies (Astemizole*, Terfenadine*)
- Asthma (theophylline)
- Antibiotics (rifabutin, rifampicin)
- Blood Thinners(warfarin or similar drugs)
- Cancer (ibrutinib)
- Diabetes (glyburide, glipizide, tolbutamide)
- Diuretics (hydrochlorothiazide)
- Epilepsy (phenytoin)
- Immune System suppression (cyclosporine, tacrolimus)
- Stomach (cimetidine, cisapride*)
- Sedation (midazolam, triazolam)
- Steroid used to treat skin, stomach, blood or breathing
- disorders (prednisone)
- Treating low blood sodium (tolvaptan)
Proper use of this medication
Consult your doctor if this is your first yeast infection, orif you have a second yeast infection in less than 2 months after treating a prior infection.
Usual Dose:
Adults (≥12 years old): Take APO-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 APOFLUCONAZOLE-150 is taken only once, APOFLUCONAZOLE-150 therapy does not cure the infection in just
one day; the medication remains active in your body forseveral
days. Most patients can expect to see symptomrelief begin within
24 hours after taking the capsule. As APO-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. Mostreported 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
Store APO-FLUCONAZOLE-150 at room temperature (15°C to 30°C). Keep out of reach of children.
Reporting side effects
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
If you want more information about APO-FLUCONAZOLE 150:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp).Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products) or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9. Last revised: August 18, 2021