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Indication and Important Safety Information

INDICATION

Diclegis^® is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.

LIMITATIONS OF USE

It is not known if Diclegis^® is safe and effective in women with severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum. Women with this condition may need to be hospitalized.

IMPORTANT SAFETY INFORMATION

Diclegis^® is intended for use in pregnant women. It is not known if Diclegis^® is safe and effective in children under 18 years of age.

Do not take Diclegis^® if you:

are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis^®. Please refer to the Patient Information leaflet for the complete list of ingredients;
take monoamine oxidase inhibitors (MAOIs). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including Marplan, Nardil, Emsam, Eldepryl, Zelapar, and Parnate.

Before taking Diclegis^®, tell your healthcare provider about all of your medical conditions, including if
you: (1) have asthma; (2) have eye problems called increased intraocular pressure or narrow angle glaucoma; (3) have a stomach problem called stenosing peptic ulcer or pyloroduodenal obstruction; (4) have a bladder problem called urinary bladder-neck obstruction; (5) are breastfeeding or plan to breastfeed. Diclegis^® can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis^®.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should you take Diclegis^®?

Talk to your healthcare provider about how much Diclegis^® to take and when to take it.
Take Diclegis^® everyday as prescribed by your healthcare provider. Do not stop taking Diclegis^® without talking to your healthcare provider first.
Do not take more than 4 tablets (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime) in 1 day.Take Diclegis^® on an empty stomach with a glass of water.
Take Diclegis^® tablets whole.

If you take too much Diclegis^® (overdose), you may have the following symptoms: restlessness, dry mouth, the pupils of your eyes become larger (dilated), sleepiness, dizziness, confusion, fast heart rate, seizures, muscle pain or weakness, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking Diclegis^®, call your healthcare provider or go to the nearest hospital emergency room right away. For more information about overdose treatment, call your poison control center at 1-800-222-1222.

What are the possible side effects of Diclegis^®?

The most common side effect of Diclegis^® is drowsiness.
Do not drive, operate heavy machinery, or do other activities that need your full attention unless your healthcare provider says that you may do so.
Do not drink alcohol, or take other CNS depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis^®. Severe drowsiness can happen or become worse causing falls or accidents.
Diclegis^® may cause an incorrect positive result for urine drug screening tests for methadone, opiates and PCP.

These are not all the possible side effects of Diclegis^®. Call your doctor for medical advice about side effects.

Keep Diclegis^® and all medicines out of the reach of children. Carefully read the storage instruction as detailed in the Diclegis Patient Information leaflet.

Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088