What is this medicine?

SILDENAFIL; DULOXETINE is a combination treatment of 2 most disturbing problems in men: impotence and premature ejaculation. Antidepressants of the SSRI (selective serotonin and norepinephrine reuptake inhibitors) class including duloxetine have long been used off-label to treat premature ejaculation. Delayed orgasm is a well known effect of such drugs. The product is fairly new and became available in early 2010.

What should my health care professional know before I take this medicine?

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

• bipolar disorder or a family history of bipolar disorder
• eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
• heart disease, angina, high or low blood pressure, a history of heart attack, or other heart problems
• kidney or liver disease
• narrow- angle glaucoma
• stroke
• suicidal thoughts or a previous suicide attempt
• taken medicines called MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate within 14 days
• an unusual reaction to sildenafil citrate, duloxetine, other medicines, foods, dyes, or preservatives

How should I use this medicine?

Take this medicine by mouth with a glass of water. The dose is usually taken 1 hour before sexual activity. You should not take the dose more than once per day. Do not take your medicine more often than directed. If you have been taking this medicine regularly for some time, do not suddenly stop taking it.

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 may interact with this medicine?

Do not take this medicine with any of the following:

• certain diet drugs like dexfenfluramine, fenfluramine, phentermine, sibutramine
• cisapride
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• methscopolamine nitrate
• nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• nitroprusside
• other sildenafil products (Revatio)
• procarbazine
• SSRIs like citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline
• St. John's Wort
• thioridazine
• tryptophan
• venlafaxine

This medicine may also interact with the following:

• aspirin and aspirin-like medicines
• certain antibiotics like ciprofloxacin and enoxacin
• certain drugs for high blood pressure
• certain drugs for the treatment of HIV infection or AIDS
• certain drugs used for fungal or yeast infections, like fluconazole, itraconazole, ketoconazole, and voriconazole
• cimetidine
• erythromycin
• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• medicines for heart rhythm or blood pressure
• medicines for mental depression, mania, psychosis, or anxiety
• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen
• rifampin

This list may not describe all possible interactions. Give your health care providers 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 taking this medicine?

If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible.

Contact you doctor or health care professional right away if the erection 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 experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking this medicine, you should refrain from further activity and call your doctor or health care professional as soon as possible.

Using this medicine does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

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.

Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks. Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help.

This medicine may cause an increase in blood pressure. Check with your doctor or health care professional, you may be able to measure your own blood pressure and pulse. Find out what your blood pressure and heart rate should be and when you should contact him or her.

What side effects may I notice from this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in hearing
• changes in vision, blurred vision, trouble telling blue from green color
• chest pain
• fast, irregular heartbeat or changes in blood pressure
• fever
• prolonged or painful erection (lasting more than 4 hours)
• seizures
• stomach flu-like symptoms of diarrhea, vomiting
• suicidal thoughts or other mood changes
• unusual bleeding or bruising

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

• blurred vision
• change in appetite
• diarrhea
• flushing
• headache
• indigestion
• nausea
• stuffy or runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects.

Where can 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) away from heat and direct light. Do not freeze. Throw away any unused medicine after the expiration date.