Product Information

Tadalafil and Dapoxetine tablet

What is this medicine?

TADALAFIL; DAPOXETINE is proven to help in treatment of impotence and premature ejaculation. Antidepressants like fluoxetine have long been used off-label to delay orgasms. 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:

• eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
• bipolar disorder or mania
• diabetes
• high or low blood pressure
• frequent heartburn or gastroesophageal reflux disease (GERD)
• heart disease, angina, high or low blood pressure, a history of heart attack, or other heart problems
• kidney disease
• liver disease
• psychosis
• seizures
• stroke
• an unusual reaction to tadalafil, dapoxetine, 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 1-2 hours before sexual activity. You can take this medicine with or without food. 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:

• cisapride
• methscopolamine nitrate
• nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• nitroprusside
• other tadalafil products

This medicine may also interact with the following:

• arsenic trioxide
• bosentan
• 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
• chloroquine
• cisapride
• diltiazem
• grapefruit juice
• macrolide antibiotics like clarithromycin, erythromycin, troleandomycin
• medicines for prostate problems
• medicines for fungal infections (fluconazole, itraconazole, ketoconazole, voriconazole)
• methadone
• nicardipine
• pentamidine
• pimozide
• rifabutin, rifampin, or rifapentine

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.

Currently, there are no documented drug-drug interactions associated with dapoxetine. Pharmacokinetic studies have been conducted to determine if dapoxetine has any drug interactions with tadalafil and sildenafil; as well as with ethanol. Both studies demonstrated no significant interactions when the combination was administered. Due to the lack of current information, it is too early to speak about other potential drug interactions.

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.

If you have diabetes, this medicine may affect blood sugar levels. Check your blood sugar. Talk to your doctor or health care professional if you notice changes.

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 can make you more drowsy and dizzy. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

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

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
• muscle aches
• prolonged or painful erection (lasting more than 4 hours)
• skin rash, itching
• seizures
• seizures

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

• flushing
• back pain
• headache
• indigestion
• dizziness
• diarrhea
• dry mouth
• flushing
• indigestion
• muscle aches
• insomnia
• nausea
• stuffy or runny nose

This list may not describe all possible 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.