JALYN -
Side Effects & Risks
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JALYN - Side Effects & Risks

JALYN - Side Effects & Risks

JALYN is for use by men only.

Read this patient information before you start taking JALYN and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is JALYN?

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

Who should not take JALYN?

Do Not Take JALYN if you are:

  • pregnant or could become pregnant. JALYN may harm your unborn baby. Pregnant women should not touch JALYN Capsules. If a woman who is pregnant with a male baby gets enough JALYN in her body by swallowing or touching JALYN, the male baby may be born with sex organs that are not normal. 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.
  • a child or teenager.
  • allergic to dutasteride, tamsulosin, or any of the ingredients in JALYN. See the end of this section for a complete list of ingredients in JALYN.
  • taking another medicine that contains an alpha-blocker.
  • allergic to other 5 alpha-reductase inhibitors, for example, PROSCAR® (finasteride) Tablets.

What should I tell my healthcare provider before taking JALYN?

Before you take JALYN, tell your healthcare provider if you:

  • have a history of low blood pressure
  • take medicines to treat high blood pressure
  • plan to have cataract surgery
  • have liver problems
  • are allergic to sulfa medications
  • have any other medical conditions

Tell your healthcare provider 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. JALYN may affect the way other medicines work, and other medicines may affect how JALYN works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take JALYN?

  • Take JALYN exactly as your healthcare provider tells you to take it.
  • Swallow JALYN Capsules whole. Do not crush, chew, or open JALYN Capsules because the contents of the capsule may irritate your lips, mouth, or throat.
  • Take your JALYN 1 time each day, about 30 minutes after the same meal every day. For example, you may take JALYN 30 minutes after dinner every day.
  • If you miss a dose, you can take it later that same day, 30 minutes after a meal. Do not take 2 JALYN capsules in the same day. If you stop or forget to take JALYN for several days, talk with your healthcare provider before starting again.
  • If you take too much JALYN, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking JALYN?

  • Avoid driving, operating machinery, or other dangerous activities when starting treatment with JALYN until you know how JALYN affects you. JALYN can cause a sudden drop in your blood pressure, especially at the start of treatment. A sudden drop in blood pressure may cause you to faint, feel dizzy or lightheaded.
  • You should not donate blood while taking JALYN or for 6 months after you have stopped JALYN. This is important to prevent pregnant women from receiving JALYN through blood transfusions.

What are the possible side effects of JALYN?

JALYN may cause serious side effects, including:

  • Decreased blood pressure. JALYN may cause a sudden drop in your blood pressure upon standing from a sitting or lying position, especially at the start of treatment. Symptoms of low blood pressure may include:
    • fainting
    • dizziness
    • feeling lightheaded
  • Rare and serious allergic reactions, including:
    • swelling of your face, tongue, or throat
    • serious skin reactions, such as skin peeling
    Get medical help right away if you have these serious allergic reactions.
  • Higher chance of a more serious form of prostate cancer.
  • Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken JALYN in the past. If you need to have cataract surgery, tell your surgeon if you take or have taken JALYN.
  • A painful erection that will not go away. Rarely, JALYN can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, there could be lasting damage to your penis, including not being able to have an erection.
The most common side effects of JALYN include:
  • ejaculation problems
  • trouble getting or keeping an erection (impotence)
  • a decrease in sex drive (libido)
  • dizziness
  • enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.
  • runny nose
Dutasteride, an ingredient of JALYN, has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of JALYN on male fertility is not known.
Prostate-Specific Antigen (PSA) Test: 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.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects with JALYN. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store JALYN?

  • Store JALYN Capsules at room temperature (59° to 86°F or 15° to 30°C).
  • JALYN Capsules may become deformed and/or discolored if kept at high temperatures.
  • Do not use or touch JALYN if your capsules are deformed, discolored, or leaking.
  • Safely throw away medicine that is no longer needed.

Keep JALYN and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a patient section. Do not use JALYN for a condition for which it was not prescribed. Do not give JALYN to other people, even if they have the same symptoms that you have. It may harm them.

This patient information section summarizes the most important information about JALYN. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about JALYN that is written for health professionals.

For more information, go to www.JALYN.com or call 1-888-825-5249.

What are the ingredients in JALYN?

Active ingredients: dutasteride and tamsulosin hydrochloride
Inactive ingredients: black ink, butylated hydroxytoluene, carrageenan, FD&C yellow 6, ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, hypromellose, iron oxide red, methacrylic acid copolymer dispersion, microcrystalline cellulose, mono-di-glycerides of caprylic/capric acid, potassium chloride, talc, titanium dioxide, and triethyl citrate.

How does JALYN work?

JALYN contains 2 medications, dutasteride and tamsulosin. These 2 medications work in different ways to improve symptoms of BPH. Dutasteride shrinks the enlarged prostate over time and tamsulosin relaxes muscles in the prostate and neck of the bladder. These 2 medications, when used together, can improve symptoms of BPH better than either medication when used alone.

PROSCAR is a registered trademark of Merck & Co., Inc.

Important Safety
Information About JALYN

  • 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.

Additional Important Safety Information continued below.

Important Safety Information About JALYN

  • 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

      • 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 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
    • 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 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
    • dizziness
    • enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider
    • runny nose

Click here for complete Prescribing Information for JALYN

Complete Prescribing Information for JALYN is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader; if you do not have it, follow the link to download a copy.

If you are unable to or do not wish to download Acrobat Reader, but still wish to receive complete Prescribing Information, please click here.

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.