What is this medicine?

DAPOXETINE has been found to be safe and effective for the treatment of premature ejaculation, according to two major clinical trials. Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI).

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 mania
• diabetes
• liver disease
• psychosis
• seizures
• an unusual or allergic reaction to dapoxetine, other medicines, foods, dyes, or preservatives

How should I use this medicine?

Take this medicine by mouth with a glass of water on an as-needed basis 1 to 3 hours before sexual intercourse. You can take this medicine with or without food.

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?

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.

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, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while taking this medicine?

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.

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.

If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get side effects or have a worsening of your condition. Ask your doctor or health care professional for advice.

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

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

• headache
• diarrhea
• dry mouth
• insomnia
• nausea
• dizziness

This list may not describe all possible side effects.

Where can I keep my medicine?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.