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Jalyn (Dutasteride, Tamsulosin Hydrochloride) capsules 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 (Dutasteride, Tamsulosin Hydrochloride)?

Jalyn in capsules is a prescription medication 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.

Who should not take Dutasteride, Tamsulosin (Jalyn)?

Do not take Jalyn if you are:

  • pregnant or could become pregnant. Dutasteride, Tamsulosin Hydrochloride (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 this medication in her body by swallowing or touching Jalyn (Dutasteride and Tamsulosin), 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 leaflet for a complete list of ingredients in Dutasteride with Tamsulosin (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 (Dutasteride and Tamsulosin HCl)?

    Before you take Jalyn, tell your doctor, pharmacist, or other healthcare professional if you:

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

    Tell your doctor or pharmacist about all the medicines you take, including prescription and non-prescription medicines, herbal supplements, vitamins. Dutasteride with Tamsulosin HCl (Jalyn) and other medicines may affect each other, causing side effects. Jalyn (Dutasteride and Tamsulosin Hydrochloride) may affect the way other medicines work, and other medicines may affect how this drug works.

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

    How should I take Dutasteride with Tamsulosin HCl (Jalyn) capsules?

  • Take this medicine exactly as your physician tells you to take it.
  • Swallow Jalyn (Dutasteride and Tamsulosin HCl) 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 Dutasteride with Tamsulosin Hydrochloride (Jalyn) 1 time each day, about 30 minutes after the same meal every day. For example, you may take this medication 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 (Dutasteride with Tamsulosin) capsules in the same day. If you stop or forget to take this drug for several days, talk with your doctor before starting again.
  • If you take too much Dutasteride and Tamsulosin (Jalyn), call your doctor, pharmacist, or other healthcare professional or go to the nearest hospital emergency room right away.

    What should I avoid while taking Jalyn (Dutasteride with Tamsulosin HCl)?

  • Avoid driving, operating machinery, or other dangerous activities when starting treatment with Dutasteride and Tamsulosin HCl (Jalyn) until you know how this medicine affects you.
  • Jalyn (Dutasteride with Tamsulosin Hydrochloride) 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 Dutasteride and Tamsulosin HCl (Jalyn) capsules or for 6 months after you have stopped this medication. This is important to prevent pregnant women from receiving Jalyn through blood transfusions.

    What are the possible side effects of Jalyn (Dutasteride with Tamsulosin HCl) capsules?

    This drug may cause serious side effects, including:

  • Decreased blood pressure. Dutasteride and Tamsulosin Hydrochloride (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: dizziness, fainting, 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 capsules 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 (Dutasteride, Tamsulosin Hydrochloride) 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 1106 have an erection.

    The most common side effects of Dutasteride, Tamsulosin (Jalyn) include:

  • trouble getting or keeping an erection (impotence)
  • ejaculation problems
  • 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.
  • dizziness
  • runny nose

    Dutasteride, an ingredient of Jalyn, has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of Jalyn (Dutasteride, Tamsulosin Hydrochloride) capsules on male fertility is not known.

    Prostate Specific Antigen (PSA) Test: Your doctor, pharmacist, or other healthcare professional may check you for other prostate problems, including prostate cancer before you start and while you take Dutasteride, Tamsulosin Hydrochloride (Jalyn). A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. Jalyn (Dutasteride and Tamsulosin) will reduce the amount of PSA measured in your blood. Your doctor 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 doctor or pharmacist.

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

    These are not all the possible side effects with Dutasteride with Tamsulosin (Jalyn). For more information, ask your physician or pharmacist.

    Call your healthcare provider for medical advice about side effects. You may report side effects to FDA.

    How should I store Jalyn (Dutasteride and Tamsulosin HCl)?

  • Store Jalyn capsules at room temperature (59° to 86°F or 15° to 30°C).
  • Dutasteride with Tamsulosin HCl (Jalyn) capsules may become deformed and/or discolored if kept at high 1136 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 (Dutasteride and Tamsulosin Hydrochloride) and all medicines out of the reach of children.

    Medicines are sometimes prescribed for purposes other than those listed in a patient leaflet. Do not use this medication for a condition for which it was not prescribed. Do not give Dutasteride with Tamsulosin HCl (Jalyn) capsules to other people, even if they have the same symptoms that you have. It may harm them.

    This medication guide summarizes the most important information about Jalyn (Dutasteride and Tamsulosin HCl) capsules. If you would like more information, talk with your doctor, pharmacist, or other healthcare professional. You can ask your healthcare provider for information about this drug that is written for health professionals.

    What are the ingredients in Dutasteride with Tamsulosin Hydrochloride (Jalyn)?

    Active ingredients: dutasteride and tamsulosin hydrochloride

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

    How does Jalyn (Dutasteride with Tamsulosin) work?

    Jalyn contains 2 medications, dutasteride and tamsulosin. These 2 medicines work in different ways to improve symptoms of BPH.

    Dutasteride shrinks the enlarged prostate 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.

    Manufactured and distributed by GlaxoSmithKline pharmaceutical company and its divisions.

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