Jalyn

What is Jalyn used for?

• In men, it is used to treat the signs of an enlarged prostate.
• Jalyn may be given to you for other reasons. Talk to your doctor.

Before taking Jalyn, tell your doctor:

For all patients taking Jalyn:

• If you have a sulfa allergy.
• If you are allergic to Jalyn; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Jalyn, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with Jalyn. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with Jalyn.
• If you are a woman. This medicine is not approved for use in women. If you are a woman using Jalyn, talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

Children:

• If the patient is a child. Do not give Jalyn to a child.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Jalyn with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Jalyn?

• Tell all of your health care providers that you take Jalyn. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Jalyn affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not donate blood while using Jalyn and for 6 months after stopping.
• A serious form of prostate cancer was seen more often in certain men taking drugs like this one than in those who were not. This was seen in a trial of men taking these drugs to lower the chance of prostate cancer. Talk with your doctor.
• Pregnant women or females of childbearing age must not touch the capsules. Talk with the doctor.
• If a woman who is pregnant or may get pregnant touches a leaking capsule, the area must be washed right away with soap and water. Tell your doctor right away.
• If you are having cataract surgery or other eye procedure, talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Check your blood pressure as you have been told.
• Have a rectal exam (to check prostate gland) and blood work (PSA test). Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Jalyn.
• Talk with your doctor before you drink alcohol.
• This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.

How is Jalyn best taken?

Use Jalyn as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Jalyn as you have been told by your doctor or other health care provider, even if you feel well.
• Take 30 minutes after the same meal every day.
• Swallow whole. Do not chew, break, or crush.
• Do not open the capsules.
• Do not take or touch the capsule if it is deformed, changes color, or is leaking.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, after a meal.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you miss taking Jalyn for a few days in a row, call your doctor before you start taking it again.

What are the side effects of Jalyn that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.
• A lump in the breast, breast pain or soreness, or nipple discharge.
• Enlarged breasts.
• Breast pain.
• Low mood (depression).
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

What are some other side effects of Jalyn?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Runny nose.
• This medicine may cause a change in sex ability in men or lowered interest in sex. This could go on after you stop Jalyn. Talk with your doctor if these effects go on or bother you.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Jalyn?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Jalyn, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Jalyn or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 Jalyn. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.