Silodosin Oral capsule

What is this medicine?

SILODOSIN (SYE lo DOE sin) is used to treat enlargement of the prostate gland in men, a condition called benign prostatic hyperplasia or BPH. It is not for use in women.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• kidney disease

• liver disease

• low blood pressure

• prostate cancer

• an unusual or allergic reaction to silodosin, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a meal. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. If you have difficulty swallowing the capsules, you may open the capsule and sprinkle the contents over a tablespoon of cool applesauce. Do not use hot applesauce or any other food or liquid. Swallow the dose immediately (within 5 minutes) after preparing it. Do not chew. Follow with an 8 ounce (240 ml) glass of water. Do not take your medicine more often than directed. Do not stop taking your medicine unless your doctor tells you to.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• clarithromycin

• itraconazole

• ketoconazole

• ritonavir

This medicine may also interact with the following medications:

• cyclosporine

• erythromycin

• medicines for erectile dysfunction like sildenafil, tadalafil, vardenafil

• medicines for blood pressure

• other medicines for benign prostatic hyperplasia like alfuzosin, doxazosin, phentolamine, phenoxybenzamine, prazosin, terazosin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Contact your doctor or health care professional right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

If you are having cataract surgery, tell your eye surgeon about your prescription for this medicine even if you are no longer taking it.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or itching, hives, swelling of the lips, mouth, tongue, or throat

• change in vision

• dizziness

• feeling faint or lightheaded

• prolonged or painful erection

• weakness

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance

• constipation

• cough

• diarrhea

• nausea or vomiting

• orgasm with decreased or no semen

• runny or stuffy nose

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.