PMS-Fluconazole (Pharmascience, 150 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

pms-FLUCONAZOLE 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. pms-FLUCONAZOLE 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
• 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

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:

pms-FLUCONAZOLE 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, Gelatin, Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch and Titanium Dioxide.

What dosage forms it comes in:

Capsule: 150 mg

WARNINGS AND PRECAUTIONS

BEFORE you use pms-FLUCONAZOLE 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 pms-FLUCONAZOLE, you should consider using a reliable means of contraception for approximately 1 week after the dose. If you become pregnant while taking pms-FLUCONAZOLE, contact your doctor.

Yeast infections do not cause:

• Fever
• Chills
• Abdominal pain
• Nausea
• Vomiting

IMPORTANT: PLEASE READ

pms-FLUCONAZOLE Product Monograph Page 32 of 32

• 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 pms-FLUCONAZOLE 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 or similar drugs)
• 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)

* 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 pms-FLUCONAZOLE 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 pms-FLUCONAZOLE is taken only once, pms-FLUCONAZOLE 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 pms-FLUCONAZOLE works to cure the infection, symptoms will lessen and eventually disappear.

Overdose:

If you think you have taken too much pms-FLUCONAZOLE, contact your healthcare professional, hospital emergency department or regional 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^oC and 30^oC

Keep out of reach of children.

REPORTING SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Pharmascience Inc., at: 1-888-550-6060

Pharmascience Inc.

Montréal, Québec

H4P 2T4

www.pharmascience.com

Last revised: April 13, 2018