M-Fluconazole-150: Uses, Side Effects and Dosage

What is M-FLUCONAZOLE-150 used for?

M-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. M-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;
• 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.

How does M-FLUCONAZOLE-150 work?

M-FLUCONAZOLE-150 is an antifungal medication. The active ingredient fluconazole works by stopping the growth of the fungi that cause vaginal yeast infections.

What are the ingredients in M-FLUCONAZOLE-150?

Medicinal ingredient: Fluconazole

Capsule contains the following non-medicinal ingredients: Colloidal anhydrous silica, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. Capsule shell contains: gelatin and titanium dioxide.

M-FLUCONAZOLE-150 comes in the following dosage forms:

Capsules are available as hard white gelatin capsules, marked with ‘FL’ on cap and ‘150’ on body. Each capsule contains 150 mg of fluconazole. Supplied as a unit dose blister pack of 1 capsule.

Do not use M-FLUCONAZOLE-150 if:

• you are allergic to fluconazole, related azoles (e.g. clotrimazole / miconazole) or other ingredients in the product (see What the nonmedicinal ingredients are);
• you are taking allergy drugs (e.g. astemizole³ / terfenadine³);
• you are taking cisapride³, quinidine, erythromycin, pimozide or amiodarone.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M-FLUCONAZOLE-150. Talk about any health conditions or problems you may have, including 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.

• ³ Not marketed in Canada

Other warnings you should know about:

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.

Pregnancy and Breastfeeding:

• You should not use M-FLUCONAZOLE-150 if you are pregnant or trying to become pregnant.
• You should not use M-FLUCONAZOLE-150 if you are breastfeeding.

There have been reports of spontaneous abortion of the foetus 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.

Driving and using machines: M-FLUCONAZOLE-150 can cause dizziness and seizures. Do not drive or operate machinery until you know how M-FLUCONAZOLE-150 affects you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with M-FLUCONAZOLE-150:

• antibiotics (rifabutin or rifampin);
• astemizole⁴ or terfenadine⁴(used to treat allergies);
• blood thinners (warfarin or similar drugs);
• cimetidine or cisapride⁴ (for control of heartburn);
• cyclosporine or tacrolimus (used to prevent organ transplant rejection);
• glyburide, glipizide or tolbutamide (medicines for diabetes);
• ibrutinib (used to treat cancer);
• ivacaftor (used to treat cystic fibrosis);
• lemborexant (used to treat insomnia);
• ⁴ Not marketed in Canada
• lurasidone (used to treat brain disorder);
• midazolam or triazolam (used to help you sleep or for anxiety);
• oral contraceptives;
• phenytoin (used to control epilepsy);
• prednisone (steroid used to treat skin, stomach, blood or breathing disorders);
• statins (cholesterol lowering agents);
• theophylline (used to control asthma);
• tolvaptan (used to treat low blood sodium);
• water pills (diuretics), such as hydrochlorothiazide;
• zidovudine (used to treat AIDS/HIV).

How to take M-FLUCONAZOLE-150:

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 M-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 M-FLUCONAZOLE-150 is taken only once, M-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 M-FLUCONAZOLE-150 works to cure the infection, symptoms will lessen and eventually disappear.

Overdose:

What are possible side effects from using M-FLUCONAZOLE-150?

These are not all the possible side effects you may have when taking M-FLUCONAZOLE-150. If you experience any side effects not listed here, tell your healthcare professional.

Like all medicines, M-FLUCONAZOLE-150 may cause some side effects. The most common side effects are:

• headache;
• abdominal pain;
• diarrhea;
• nausea;
• vomiting.

Most reported side effects were mild to moderate in nature.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature (15°C - 30°C). Do not freeze. Keep out of reach and sight of children.

If you want more information about M-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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug- product-database.html; or by contacting Mantra Pharma Inc. at medinfo@mantrapharma.ca or at 1-833-248-7326.

Mantra Pharma Inc.

1000 rue Du Lux, Suite 201

Brossard, Quebec

J4Y 0E3

Date of Authorization: DEC 03, 2024