Generic Name: dutasteride/tamsulosin (doo-TAS-ter-ide/tam-SOO-loe-sin)
Brand Name: Jalyn

Jalyn is used for:

Treating symptoms of benign prostatic hyperplasia (BPH) in men who have an enlarged prostate gland.

Jalyn is a 5 alpha-reductase inhibitor and alpha-blocker combination. The 5 alpha-reductase inhibitor (dutasteride) works by lowering levels of a hormone called dihydrotestosterone (DHT), which is a major cause of prostate growth. The alpha-blocker (tamsulosin) works by relaxing muscles in the prostate and bladder. Jalyn helps to decrease the size of the prostate and reduce symptoms of BPH.

Do NOT use Jalyn if:

  • you are allergic to any ingredient in Jalyn or to other 5 alpha-reductase inhibitors (eg, finasteride)
  • the patient is a woman who is pregnant or may become pregnant
  • the patient is a child
  • you are taking another alpha-blocker (eg, prazosin)
  • you are taking certain azole antifungals (eg, itraconazole, ketoconazole, posaconazole), HIV protease inhibitors (eg, ritonavir), certain macrolide antibiotics (eg, clarithromycin), nefazodone, or telithromycin

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Jalyn:

Some medical conditions may interact with Jalyn. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines or other substances
  • if you have heart failure, kidney problems, urinary tract problems, or problems urinating
  • if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any sulfonamide (sulfa) medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), probenecid, sulfamethoxazole, sulfonylureas (eg, glyburide), valdecoxib, or zonisamide
  • if you will be having a certain type of eye surgery (cataract surgery)
  • if you have a history of high or low blood pressure, prostate cancer, increased serum prostate-specific antigen (PSA) levels, abnormal liver function tests, or liver problems
  • if you take medicine for high blood pressure

Some MEDICINES MAY INTERACT with Jalyn. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, fluconazole, itraconazole, ketoconazole, posaconazole), cimetidine, fluoxetine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, paroxetine, telithromycin, or terbinafine because they may increase the risk of Jalyn's side effects
  • Phosphodiesterase type 5 (PDE5) inhibitors (eg, sildenafil) or other medicines that contain alpha-blockers (eg, prazosin) because symptoms of low blood pressure (eg, severe dizziness, light-headedness, fainting) may occur
  • Warfarin because the risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Jalyn may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Jalyn:

Use Jalyn as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Jalyn. Talk to your pharmacist if you have questions about this information.
  • Take Jalyn by mouth about 30 minutes after the same meal each day.
  • Swallow Jalyn whole. Do not break, crush, chew, or open before swallowing. Do not take capsules that are cracked, deformed, discolored, or leaking. Jalyn can irritate your lips, mouth, and throat.
  • Take Jalyn on a regular schedule to get the most benefit from it. Taking Jalyn at the same time each day will help you remember to take it.
  • Continue to take Jalyn even if you feel well. Do not miss any doses.
  • If you miss a dose of Jalyn, you may take the missed dose later that same day, 30 minutes after a meal. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss taking Jalyn for several days, contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use Jalyn.

Important safety information:

  • Jalyn 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 Jalyn with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Jalyn 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.
  • Jalyn 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. Jalyn 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.
  • Jalyn 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 Jalyn. This is to prevent a pregnant woman from being exposed to it through a blood transfusion.
  • Jalyn may increase the risk of a certain type of prostate cancer. Discuss any questions or concerns with your doctor.
  • Jalyn 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 Jalyn, contact your doctor.
  • Jalyn may decrease the amount of semen released during sex. However, the effect of Jalyn 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 Jalyn). 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 Jalyn.
  • Jalyn 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.
  • Jalyn may interfere with certain lab tests, including PSA tests for the screening of prostate cancer . Be sure your doctor and lab personnel know you are taking Jalyn.
  • Tell your doctor or dentist that you take Jalyn before you receive any medical or dental care, emergency care, or surgery (including eye surgery for cataracts).
  • Lab tests and medical exams may be performed while you take Jalyn. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Jalyn should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Jalyn may cause harm to the fetus. It is not known if Jalyn is found in breast milk. Jalyn is not approved for use in women.

Possible side effects of Jalyn:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; cough; decreased amount of semen released during ejaculation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; headache; light-headedness; mild sore throat; runny or stuffy nose; sinus inflammation; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blurred vision; breast enlargement, lumps, pain, or tenderness; chest pain; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; nipple discharge; prolonged, painful erection; red, swollen, blistered, or peeling skin; severe or persistent dizziness or light-headedness; shortness of breath.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe or persistent dizziness or light-headedness.

Proper storage of Jalyn:

Store Jalyn at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Jalyn out of the reach of children and away from pets.

General information:

  • If you have any questions about Jalyn, please talk with your doctor, pharmacist, or other health care provider.
  • Jalyn is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Jalyn or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Jalyn. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Jalyn. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Jalyn.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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