Patient Medication Information: uses, side effects, how to take - Monistat Derm Cream

**What is MONISTAT* Derm Cream used for?**

MONISTAT* Derm Cream is indicated for:

the relief of external vaginal itching and irritation

**How does MONISTAT* Derm Cream work?**

This cream works by relieving the external itching and irritation associated with yeast infection.

**What are the ingredients in MONISTAT* Derm Cream?**

Medicinal ingredients: Miconazole Nitrate

Non-medicinal ingredients: Benzoic Acid, Cetyl Alcohol, Isopropyl Myristate, Polysorbate 60, Potassium Hydroxide, Propylene Glycol, Stearyl Alcohol, Water

**MONISTAT* Derm Cream comes in the following dosage forms:**

Cream, 2%

**Do not use MONISTAT* Derm Cream if:**

Serious Warnings and Precautions

Should not be used for self-medication if vaginal itching or discomfort is occurring for the first time;
Should not be used for self-medication if fever, nausea, unexplained pain in the lower back, lower abdomen, or either shoulder, or foul-smelling vaginal discharge are present;
Discontinue use if sensitization or other signs of irritation not present before therapy occur;
Should not be used by pregnant or nursing women without consulting health professional;
Avoid intercourse during therapy;
Therapy reduces the effectiveness of latex condoms and diaphragms;
Should not be introduced into the eyes;
Blood thinning effect;
Consult a doctor if you do not respond to therapy as the symptoms you are having may be those of a more serious condition.

hypersensitive to this drug or to any ingredient in this formulation, including any non-medicinal ingredient, or component of the container.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MONISTAT* Derm Cream. Talk about any health conditions or problems you may have, including if you:

experience sensitization or marked irritation (rash, burning, blistering, redness) not present before therapy occur
introduce MONISTAT* Derm Cream into the eyes
take oral anticoagulants (blood thinning medication), such as warfarin, as bruising or bleeding may occur

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 MONISTAT* Derm Cream:**

oral anticoagulants (blood thinning medication), such as warfarin

**How to use MONISTAT* Derm Cream:**

Use only in conjunction with MONISTAT^®vaginal OVULE™ and vaginal suppositories.

Apply a thin layer of cream to the itchy or irritated genital area in the morning and evening as needed. Massage gently until the cream disappears.

Usual dose:

Use morning and evening as needed, up to 7 days as long as external symptoms persist.

Overdose:

Monistat* Derm Cream is intended for external application and not for oral use. If swallowed, call a poison control centre or get medical help right away.

If you think you have used too much Monistat* Derm Cream, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

Monistat* Derm Cream contains a cream that is to be used morning and evening for as long as external symptoms persist. If you miss a dose of the cream, you do not need to make up the missed dose. Skip the missed dose and continue with your next dose.

**What are possible side effects from using MONISTAT* Derm Cream?**

These are not all the possible side effects you may have when taking MONISTAT* Derm Cream. If you experience any side effects not listed here, tell your healthcare professional.

On rare occasions it has been reported that patients treated with MONISTAT* Derm Cream experienced mild itchy skin, irritation and burning at the site of application.

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
RARE Mild itchy skin	X
Irritation	X
Burning at the site of application	X

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

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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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.

Storage:

Monistat* Derm Cream should be stored at controlled room temperature (15 °C - 30 °C).

Keep out of reach and sight of children.

**If you want more information about MONISTAT* Derm Cream:**

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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.monistat.ca, or by calling 1-800-891-4857

Rx or OTC	Over-the-counter (OTC)?
DIN	02126567
Schedule(s)	NON-PRESCRIPTION DRUGS
Active ingredient(s)	Miconazole nitrate 2 %
Dosage form(s)	Cream
Route(s) of administration	Topical
Drug class (WHO ATC)	D Dermatologicals D01 Antifungals for dermatological use D01A Antifungals for topical use D01AC Imidazole and triazole derivatives, topical antifungals D01AC02 Miconazole
Company	INSIGHT PHARMACEUTICALS, LLC
Current status	Marketed
Current status date	August 30, 2012

Monistat Derm Cream: Uses, Side Effects and Dosage