Patient Medication Information: uses, side effects, how to take - Terazol 3 Dual Pak
ABOUT THIS MEDICATION
What the medication is used for:
TERAZOL® Vaginal Ovules and Vaginal Cream are used for the local treatment of yeast infections caused by an organism called candidiasis (moniliasis).
What it does:
TERAZOL® is a synthetic antifungal agent which is active against various strains of Candida albicans by interfering with the fungal cell membrane to stop growth of the fungus and help stop the infection.
When it should not be used:
You should not take TERAZOL® if you are allergic to terconazole, or to any of the non-medicinal ingredients in the product (see What the nonmedicinal ingredients are).
What the medicinal ingredient is:
Terconazole
What the nonmedicinal ingredients are:
TERAZOL® 3 DUAL-PAK®:
TERAZOL® 3 Vaginal Ovules: butylated hydroxyanisole and vegetable oil.
TERAZOL® 3 Vaginal Cream: butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water and stearyl alcohol.
TERAZOL® 7 Vaginal Cream: butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water and stearyl alcohol
What dosage forms it comes in:
TERAZOL® 3 DUAL-PAK®:
TERAZOL® 3: 80 mg Vaginal Ovules and
TERAZOL® 3: 0.8% w/w Vaginal Cream
TERAZOL® 7: 0.4% w/w Vaginal Cream
WARNINGS AND PRECAUTIONS
BEFORE you use TERAZOL® talk to your doctor or pharmacist if:
you are pregnant, or think you may be; this medication should not be used in the first trimester of pregnancy;
- you are breastfeeding or planning to breastfeed;
- you are a diabetic.
For topical use on the vulva and inside the vagina only. TERAZOL® is not for ophthalmic or oral use.
Stop TERAZOL® use and contact your doctor immediately if irritation, fever, chills or flu-like symptoms occur.
Components of the ovule formulation may interact with certain natural rubber products, such as those used in vaginal contraceptive diaphragms or condoms. Concurrent use is not recommended.
INTERACTIONS WITH THIS MEDICATION
TERAZOL® is not affected by oral contraceptive usage.
PROPER USE OF THIS MEDICATION
Usual Adult Dose:
TERAZOL® 7 Vaginal Cream:
One applicatorful (5 g) of TERAZOL® 7 Vaginal Cream is administered intravaginally once daily at bedtime for seven consecutive days. In addition, a thin layer of TERAZOL® 7 Vaginal Cream is applied for seven consecutive days directly to the vulva and massaged in gently.
TERAZOL® 3 DUAL-PAK® terconazole 80 mg Vaginal Ovules/0.8% Vaginal Cream Package:
One TERAZOL® 3 Vaginal Ovule is administered intravaginally once daily at bedtime for three consecutive days. In addition, a thin layer of TERAZOL® 3 Vaginal Cream is applied for three consecutive days directly to the vulva and massaged in gently.
Administration
Insertion of ovule:
- Remove one ovule from the package. Place ovule in the receptacle of applicator as shown. The unit is now ready for insertion.
- Hold the filled applicator by the cylinder and gently insert it into the vagina as far as it will go comfortably. Press the plunger and deposit ovule. While keeping the plunger depressed, remove the applicator from the vagina.
Following insertion of the ovule:
Rub a thin layer of cream directly onto the vulva for 3
consecutive days.
Directions for using the ORTHO® vaginal cream applicator
Filling the applicator: Remove cap from tube. Reverse cap to puncture seal. Screw applicator to tube. Squeeze tube until applicator plunger is fully extended, then remove applicator from tube.
Hold the filled applicator by the cylinder and gently insert it into the vagina as far as it will go comfortably.
Press plunger and deposit the cream. While keeping plunger depressed, remove the applicator from the vagina.
Care of applicator:
After each use, clean the applicator: hold the cylinder
of the applicator with one hand and remove the plunger with the other hand by pulling in the opposite direction. Wash with soap and warm water. To reassemble, gently push the plunger back into the cylinder as far as it will go.
Complete the prescribed course of treatment to reduce the chance of re-infection.
Avoid tight-fitting undergarments, pants, pantyhose, etc.
Overdose:
In the event of oral ingestion of vaginal ovule or cream, your doctor will provide supportive and symptomatic measures. If the cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Along with its intended action, any medication may cause unwanted effects. Some of the side effects that have been reported include:
- headache
- burning
- pain
- itching
- irritation
severe allergic reaction that may include:
- a swollen face, lips, mouth, tongue or throat
- difficulty swallowing or breathing
- life-threatening rash with blisters and peeling skin over much of the bodyfever
- chills.
This is not a complete list of side effects. For any unexpected effects while taking TERAZOL®, contact your doctor or pharmacist.
HOW TO STORE IT
TERAZOL® 7 Vaginal Cream, TERAZOL® 3 Vaginal Ovules, and TERAZOL® 3 Vaginal Cream should be stored at room temperature (15 - 30°C).
Keep out of the 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 0701E
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 at:
http://www.janssen.ca
or by contacting the sponsor, Janssen Inc., at: 1-800-567-3331 or 1-800-387-8781.
Janssen Inc.
Toronto, Ontario M3C 1L9