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JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): PATIENT COUNSELING INFORMATION

Orthostatic Hypotension

Physicians should inform patients about the possible occurrence of symptoms related to orthostatic hypotension, such as dizziness and vertigo, and the potential risk of syncope when taking Jalyn (Dutasteride with Tamsulosin HCl). Patients starting treatment with Jalyn should be cautioned to avoid situations where injury could result should syncope occur (e.g., driving, operating machinery, performing hazardous tasks). Patients should sit or lie down at the first signs of orthostatic hypotension.

PSA Monitoring

Physicians should inform patients that Jalyn (Dutasteride with Tamsulosin Hydrochloride) reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. For patients undergoing PSA screening, increases in PSA levels while on treatment with Jalyn may signal the presence of prostate cancer and should be evaluated by a healthcare provider.

Risk of High-grade Prostate Cancer

Physicians should inform patients that there was an increase in high-grade prostate cancer in men treated with 5-alpha-reductase inhibitors (which are indicated for BPH treatment), including dutasteride, which is a component of Jalyn (Dutasteride with Tamsulosin HCl) capsules, compared with those treated with placebo in studies looking at the use of these drugs to reduce the risk of prostate cancer.

Exposure of Women - Risk to Male Fetus

Physicians should inform patients that Jalyn (Dutasteride and Tamsulosin HCl) capsules should not be handled by a woman who is pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a pregnant woman or woman of childbearing potential comes in contact with leaking Jalyn capsules, the contact area should be washed immediately with soap and water.

Instructions for Use

Dutasteride with Tamsulosin Hydrochloride (Jalyn) should be swallowed whole and not chewed, crushed, or opened. Jalyn capsules may become deformed and/or discolored if kept at high temperatures. If this occurs, capsules should not be used.

Priapism

Physicians should inform patients about the possibility of priapism as a result of treatment with Jalyn (Dutasteride with Tamsulosin) or other alpha adrenergic antagonist-containing medications. Patients should be informed that this reaction is extremely rare, but can lead to permanent erectile dysfunction if not brought to immediate medical attention.

Blood Donation

Physicians should inform men treated with Dutasteride and Tamsulosin (Jalyn) that they should not donate blood until at least 6 months following their last dose to prevent pregnant women from receiving dutasteride through blood transfusion. Serum levels of dutasteride are detectable for 4 to 6 months after treatment ends.

Intraoperative Floppy Iris Syndrome (IFIS)

Physicians should advise patients considering cataract surgery to tell their ophthalmologist that they take or have taken Jalyn (Dutasteride with Tamsulosin HCl), an alpha adrenergic antagonist-containing product.

Manufactured and distributed by GlaxoSmithKline pharmaceutical company and its divisions.

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