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Discover Diclegis®


Now available for Nausea and Vomiting of Pregnancy (NVP), commonly called morning sickness1


is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.


Indication Diclegis®


Limitations of Use


Diclegis has not been studied in women with hyperemesis gravidarum.


Important Safety Information Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse CNS eff ects of Diclegis. Use of MAOIs may also prolong and intensify the anticholinergic (drying) eff ects of antihistamines.


The most common side eff ect of Diclegis is drowsiness. You should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Diclegis until cleared to do so by your healthcare provider.


Do not take Diclegis with alcohol or sedating medicines, including other


antihistamines (present in some cough and cold medications), opiates, or sleep aids, because severe drowsiness can happen or become worse, causing falls or accidents.


Diclegis should be used with caution in women who have: (1) asthma, (2) increased pressure in the eye, (3) an eye problem called narrow angle glaucoma, (4) a stomach problem called stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) a bladder problem called bladder- neck obstruction.


Fatalities have been reported from doxylamine overdose in children. Chil- dren appear to be at a high risk for cardiorespiratory arrest. However, the safety and eff ectiveness of Diclegis in children younger than 18 years have not been established.


Diclegis is a delayed-release formulation; therefore, signs and symptoms of intoxi- cation may not be apparent imme- diately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia. If you suspect an overdose or seek additional


overdose information, you can contact a poison control center at 1-800-222-1222.


The FDA granted Diclegis Pregnancy Category A status, which means that the results of controlled studies have not shown increased risk to an unborn baby during pregnancy.


Women should not breast-feed while using Diclegis because the antihistamine component (doxylamine succinate) in Diclegis can pass into breast milk. Excitement, irritability, and sedation have been reported in nursing infants presum- ably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative eff ects of Diclegis resulting in worsening of their apnea or respiratory conditions.


You are encouraged to report negative side eff ects of prescription drugs to the FDA. Visit www.fda.gov/ medwatch or call 1-800-FDA-1088.


Please see Patient Information on adjacent page.


Please see full Prescribing Information at www.Diclegis.com.


Tablet(s) shown are not actual size.


Reference: 1. ACOG Committee on Practice Bulletins – Obstetrics. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 52, April 2004. Nausea and vomiting of pregnancy. Obstet Gynecol. 2004;103(4):803-815.


©2013 Duchesnay USA. All rights reserved. 2013-0094-01 Jun 2013 Printed in the USA.


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