Select Safety Information for JALYN®
JALYN® is for men only. Women should not take or touch JALYN® due to risk of a specific birth defect. If a woman comes in contact with leaking JALYN® Capsules, she should wash the contact area immediately with soap and water. Do not take JALYN® if you are allergic to dutasteride, finasteride, tamsulosin, or any of the ingredients in JALYN®.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
- JALYN® is for adult men only. Women should not take or touch JALYN® due to risk of a specific birth defect. If a woman comes in contact with leaking JALYN® Capsules, she should wash the contact area immediately with soap and water.
- Do not take JALYN® if you are allergic to dutasteride, finasteride, tamsulosin, or any of the ingredients in JALYN®.
- JALYN® may cause rare and serious allergic reactions, including:
- swelling of your face, tongue, or throat
- serious skin reactions, such as skin peeling
- JALYN® may cause a sudden drop in blood pressure upon standing, especially when starting treatment, which may cause you to faint, or feel dizzy or lightheaded. Avoid driving or operating hazardous equipment when starting or restarting JALYN®.
- Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. JALYN® and other medicines may affect each other, causing side effects.
- Some types of medicines should not be taken with JALYN®, including:
- ketoconazole, an antifungal medication, which if taken with JALYN® can increase levels of tamsulosin, a component of JALYN®
- alpha-blockers, like tamsulosin, which if taken with JALYN® may cause fainting, dizziness, or feeling lightheaded
- Some types of medicines should be used with caution when taken with JALYN®, including:
- erythromycin, paroxetine, or terbinafine, which when taken with JALYN® can increase levels of tamsulosin, a component of JALYN®
- certain types of medicines that are commonly used to treat erectile dysfunction, which when taken with JALYN® may cause fainting, dizziness, or feeling lightheaded
- Only your healthcare provider can tell if your symptoms are due to BPH or a more serious condition like prostate cancer. See your doctor for regular exams.
- JALYN® may cause serious side effects including a higher chance of a more serious form of prostate cancer.
- Your healthcare provider may check you for other prostate problems, including prostate cancer, before you start and while you take JALYN®. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. JALYN® will reduce the amount of PSA measured in your blood. Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with JALYN® (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.
- Rarely, JALYN ®can cause a painful erection. If this happens get medical help right away.
- Do not donate blood until 6 months after stopping JALYN®.
- Before you take JALYN®, tell your doctor if you:
- have a history of low blood pressure
- plan to have cataract surgery
- are allergic to sulfa medications
- take medicines to treat high blood pressure
- have liver problems
- have any other medical conditions
- The most common side effects include:
- ejaculation problems
- trouble getting or keeping an erection (impotence)
- a decrease in sex drive (libido)
- decreased amount of semen released during sex
- enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider
- runny nose
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
These highlights do not include all the information needed to use JALYN® safely and effectively. See full prescribing information for JALYN®.
Please read the accompanying Medication Guide for JALYN®, including the information about birth defects if taken during pregnancy, and discuss it with your doctor.