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November 8, 2009
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contraceptive cervical cap-device (cont.)

SIDE EFFECTS: Vaginal/cervical discomfort may occur. If this effect persists or worsens, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: vaginal odor or discharge, odor when the device is removed, stomach/abdominal pain. If you notice the following unlikely but serious side effects of Toxic Shock Syndrome (TSS), remove the device and seek immediate medical attention: high fever, at least one other symptom of TSS (e.g., vomiting, diarrhea, dizziness, fainting or lightheadedness, sore throat, muscle weakness, joint pain, sunburn-like rash, eye redness). Promptly tell your doctor if you or your sexual partner experiences any burning/irritation/discomfort during sex while you are using this product. This may mean that you are not properly fitted for this device. An allergic reaction to this product or the spermicide used along with this product is highly unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: This device is not recommended for use if you have the following medical conditions: history of toxic shock syndrome (TSS), abnormal Pap smear(s), history of certain cancers (e.g., cervical or uterine cancer), vaginal or cervical infection, currently experiencing any menstrual bleeding (including your regular menstrual period), recent childbirth, recent miscarriage or abortion. Tell your doctor your medical history, especially of: unusual vaginal bleeding (e.g., irregular periods), any allergies. Prior to using this product, consult your doctor if you are breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially: vaginal medications (e.g., creams, ointments). Do not start or stop any medicine without doctor or pharmacist approval.




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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