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Zazole Cream

Zazole Cream is used for:

Treating vaginal yeast infections in women. It may also be used for certain conditions as determined by your doctor.

Zazole Cream is an antifungal agent. It works by weakening the fungal cell membrane, thereby killing sensitive fungi that cause yeast infections.

Do NOT use Zazole Cream if:

• you are allergic to any ingredient in Zazole Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zazole Cream:

Some medical conditions may interact with Zazole Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of liver disease

Some MEDICINES MAY INTERACT with Zazole Cream. However, no specific interactions with Zazole Cream are known at this time.

Ask your health care provider if Zazole Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zazole Cream:

Use Zazole Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Zazole Cream. Talk to your pharmacist if you have questions about this information.
• Remove cap from tube. Reverse cap and place puncture tip onto tube. Push cap firmly until tube end is punctured.
• Screw applicator onto tube. Squeeze tube forcing contents into barrel until it is full.
• Then remove applicator from tube. Hold tube with attached applicator up. Squeeze tube from bottom until medication fills applicator. Remove applicator from tube.
• Lie on your back with knees drawn up. Hold filled applicator by barrel and gently insert it into the vagina as far as it will go comfortably. Press plunger and deposit material. While keeping plunger depressed, remove the applicator from vagina.
• After each use, pull applicator apart and wash with soap and warm water. An unclean applicator may not function properly. Thoroughly clean the applicator after each use.
• To clear up your infection completely, use Zazole Cream for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Zazole Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Zazole Cream.

Important safety information:

• If your sexual partner has any penile itching, redness, or discomfort, he should consult his health care provider and mention that you are being treated for a yeast infection.
• You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may absorb the medication. Instead, use external pads or napkins until you have finished your medication. You may also wish to wear a sanitary napkin if the vaginal medicine leaks.
• Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast.
• Wipe from front to rear (away from the vagina) after a bowel movement.
• Do not douche unless your doctor specifically tells you to do so. Douching may disturb the vaginal balance.
• Do not scratch the affected area if you can avoid it. Scratching can cause more irritation and spread the infection.
• If you have sexual intercourse during treatment, you may increase the risk of reinfection.
• Zazole Cream may decrease the effectiveness of condoms and diaphragms.
• Be sure to use Zazole Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Use Zazole Cream with caution in the ELDERLY; they may be more sensitive to its effects.
• Zazole Cream should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zazole Cream while you are pregnant. It is not known if Zazole Cream is found in breast milk. Do not breast-feed while taking Zazole Cream.

Possible side effects of Zazole Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Body pain; burning or itching of the vagina; painful menstruation; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; flu-like symptoms (headache; tiredness; muscle aches; fever); vaginal sensitivity or irritation.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Zazole Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zazole Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Zazole Cream, please talk with your doctor, pharmacist, or other health care provider.
• Zazole Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Zazole Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.