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Patient Information DICLEGIS (dye-CLEE-gis) (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets

What is DICLEGIS? • 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.

• It is not known if DICLEGIS is safe and effective in children under 18 years of age.

Who should not take DICLEGIS? Do not take DICLEGIS if you: • are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in DICLEGIS. See below for a complete list of ingredients in DICLEGIS.

• take monoamine oxidase inhibitors (MAOIs) (Marplan, Nardil, Emsam, Eldepryl, Zelapar, Parnate)

Before taking DICLEGIS, tell your healthcare provider about all of your medical conditions, including; • if you 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 or over-the-counter medicines, vitamins, or herbal supplements.

How should I take DICLEGIS? • Talk to your healthcare provider about how much DICLEGIS to take and when to take it.

• Take DICLEGIS every day as prescribed by your healthcare provider. Do not stop taking DICLEGIS without talking to your healthcare provider first.

• See the following schedule for the usual way you should start taking DICLEGIS: • Day 1- Take 2 tablets, by mouth at bedtime. • Day 2- Take 2 tablets at bedtime. If your nausea and vomiting is better or controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be your usual dose unless your healthcare provider tells you otherwise.

• Day 3- If you still had nausea and vomiting on Day 2, take 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime).

• Day 4- If your nausea and vomiting was better or controlled on Day 3, continue to take 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). If you still had nausea and vomiting on Day 3, start taking 4 tablets each day (1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime).

• 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. Do not crush, chew, or break DICLEGIS tablets before swallowing. If you cannot swallow DICLEGIS tablets whole, tell your healthcare provider.

• 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? DICLEGIS may cause serious side effects, including drowsiness. • Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so.

• Do not drink alcohol, or take other central nervous system 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.

These are not all the possible side effects of DICLEGIS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store DICLEGIS? • Store DICLEGIS between 68°F to 77°F (20°C to 25°C). • Keep DICLEGIS tablets dry, in a tightly closed container, and out of the light.

• Safely throw away medicine that is out of date or no longer needed.

Keep DICLEGIS and all medicines out of the reach of children.

General information about the safe and effective use of DICLEGIS.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.You can ask your pharmacist or healthcare provider for information about DICLEGIS that is written for health professionals. Do not use DICLEGIS for a condition for which it was not prescribed. Do not give DICLEGIS to other people, even if they have the same symptoms that you have. It may harm them.

Inactive ingredients: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue #2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, talc, titanium dioxide.

What are the ingredients in DICLEGIS? Active ingredient: doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6


Distributed by: Duchesnay USA, Inc., Bryn Mawr, PA, 19010, or call 1-855-722-7734.

Visit for full Prescribing Information and additional information.

©2013 Duchesnay USA. All rights reserved. 2013-0095-02 Jul 2013 Printed in the USA.

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