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Important safety information:

• Dutasteride/tamsulosin may cause drowsiness, dizziness, blurred vision, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use dutasteride/tamsulosin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Dutasteride/tamsulosin may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Dutasteride/tamsulosin may increase the risk of certain birth defects, including abnormal formation of the genitals in male fetuses. Women who are pregnant or may become pregnant must NOT handle the capsules. Dutasteride/tamsulosin is absorbed through the skin and could result in unintended fetal exposure. If a woman who is pregnant or may become pregnant comes in contact with leaking capsules, the contact area should be washed immediately with soap and water. If contact occurs, tell your doctor at once.
• Dutasteride/tamsulosin stays in the bloodstream for 4 to 6 months after you stop taking it. Do not donate blood for at least 6 months after your last dose of dutasteride/tamsulosin. This is to prevent a pregnant woman from being exposed to it through a blood transfusion.
• Dutasteride/tamsulosin may increase the risk of a certain type of prostate cancer. Discuss any questions or concerns with your doctor.
• Dutasteride/tamsulosin may cause decreased sexual desire or ability (eg, decrease in sex drive, problems with ejaculation, difficulty in achieving or keeping an erection). If you develop decreased sexual desire or ability that continues or becomes bothersome, check with your doctor. If this effect continues after you stop dutasteride/tamsulosin, contact your doctor.
• Dutasteride/tamsulosin may decrease the amount of semen released during sex. However, the effect of dutasteride/tamsulosin on fertility is not known. Discuss any questions or concerns with your doctor.
• Rarely, there have been cases of male breast cancer reported in patients taking dutasteride (a component of dutasteride/tamsulosin). Discuss any questions or concerns with your doctor. Tell your doctor right away if you develop breast changes, such as lumps, pain, or nipple discharge.
• Check with your doctor about whether you should use a barrier method of birth control (eg, condoms) if you have sex with a pregnant woman while taking dutasteride/tamsulosin.
• Dutasteride/tamsulosin may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
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• Lab tests and medical exams may be performed while you take dutasteride/tamsulosin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Dutasteride/tamsulosin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Dutasteride/tamsulosin may cause harm to the fetus. It is not known if Jalyn is found in breast milk. Dutasteride/tamsulosin is not approved for use in women.

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