Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Fibristal (Ulipristal).
HEALTH CANADA ADVISORY
January 11, 2019
Health Canada has issued new restrictions concerning the use of Fibristal (Ulipristal). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Asthma: If you have uncontrolled asthma, discuss with your doctor how Fibristal (Ulipristal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fibristal (Ulipristal), and whether any special monitoring is needed.
Birth control: Effective birth control should be practiced while using Fibristal (Ulipristal) as Fibristal (Ulipristal) may harm the baby if used during pregnancy. Birth control pills may be affected by Fibristal (Ulipristal). For this reason, a different method of birth control, such as condoms or a diaphragm should be used. If you become pregnant while taking Fibristal (Ulipristal), contact your doctor immediately.
Liver function: Liver disease or reduced liver function may cause Fibristal (Ulipristal) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Fibristal (Ulipristal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fibristal (Ulipristal), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Fibristal (Ulipristal).
Fibristal (Ulipristal) may cause serious liver damage and in rare cases has led to the need for liver transplant. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately
Menstrual changes: Fibristal (Ulipristal) usually causes a decrease in menstrual bleeding and may cause menstrual bleeding to stop altogether while you are taking Fibristal (Ulipristal). If heavy bleeding continues beyond 10 days of treatment with Fibristal (Ulipristal), contact your doctor. Menstrual periods usually return within 4 weeks of stopping Fibristal (Ulipristal).
Thickened endometrium: Fibristal (Ulipristal) may cause an increase in the thickness of the lining of the uterus (endometrium). Although this thickening usually goes away within several months of stopping treatment, occasionally, it may continue. Your doctor may recommend an ultrasound of your uterus to monitor for any changes.
Pregnancy: If you take Fibristal (Ulipristal) while pregnant, it may cause harm to the developing baby. Do not take Fibristal (Ulipristal) if you are pregnant or not using effective birth control. If you become pregnant while taking Fibristal (Ulipristal), contact your doctor immediately.
Breast-feeding: It is not known if Fibristal (Ulipristal) passes into breast milk. If you are a breast-feeding mother and are taking Fibristal (Ulipristal), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Fibristal (Ulipristal) have not been established for children.
Seniors: The safety and effectiveness of using Fibristal (Ulipristal) have not been established for adults over the age of 65.
