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Indication for JALYN

JALYN is a prescription medicine that contains 2 medicines: dutasteride and tamsulosin. JALYN is used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Indication for AVODART

AVODART is a prescription medicine that contains dutasteride. AVODART is used alone and in combination with the alpha blocker tamsulosin to treat the symptoms of BPH in men with an enlarged prostate.

JALYN and AVODART are not approved for the prevention of prostate cancer.

Important Safety Information About JALYN and AVODART

  • JALYN and AVODART are for adult men only. Women, children, and teenagers should not take JALYN or AVODART. Women should not touch JALYN or AVODART due to risk of a specific birth defect. If a woman comes in contact with leaking JALYN or AVODART capsules, she should wash the contact area immediately with soap and water.
  • Do not take JALYN or AVODART if you are allergic to dutasteride, finasteride, or any of the ingredients in JALYN or AVODART. Do not take JALYN if you are allergic to tamsulosin.
  • JALYN and AVODART may cause rare and serious allergic reactions, including:
  • - swelling of your face, tongue, or throat
    - serious skin reactions, such as skin peeling
    JALYN may also cause:
    - difficulty breathing

    Get medical help right away if you have these serious allergic reactions.

  • 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 or AVODART and other medicines may affect each other, causing side effects.
  • Some types of medicines should be used with caution when taken with AVODART, such as ritonavir.
  • 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
    • cimetidine
    • certain types of medicines that are commonly used to treat erectile dysfunction, which when taken with JALYN may cause fainting, dizziness, or feeling lightheaded
    • warfarin
  • 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 and AVODART 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 or AVODART. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. JALYN or AVODART 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 or AVODART (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.
  • JALYN may cause eye problems during cataract surgery. If you need to have cataract surgery, tell your surgeon if you take or have taken JALYN.
  • Rarely, JALYN can cause a painful erection. If this happens get medical help right away.
  • You should not donate blood while taking JALYN or AVODART or for 6 months after you have stopped JALYN or AVODART. This is important to prevent pregnant women from receiving JALYN or AVODART through blood transfusions.
  • 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
  • Before you take AVODART, tell your doctor if you have liver problems.
  • The most common side effects of JALYN and AVODART include:
    • ejaculation problems*
    • trouble getting or keeping an erection (impotence)*
    • a decrease in sex drive (libido)*
    • enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.
    • *Some of these events may continue after you stop taking JALYN or AVODART.

  • The most common side effects of JALYN also include:
    • dizziness
    • runny nose
  • Depressed mood has been reported in patients receiving dutasteride, an ingredient of JALYN and AVODART.
  • Dutasteride, an ingredient of JALYN and AVODART, has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of JALYN and AVODART on male fertility is not known.

  • Click here for complete Prescribing Information for JALYN

    Click here for complete Prescribing Information for AVODART