Diclegis® is proven safe for you and your baby

When diet and lifestyle changes are not enough to control your morning sickness, there’s Diclegis®!

Morning sickness is a real medical condition. Left untreated, symptoms can get worse, leading to weight loss and dehydration, which may require hospitalization. If diet and lifestyle changes have not helped get your symptoms under control, ask your healthcare provider if Diclegis® is right for you.

Diclegis® is specifically designed to manage morning sickness symptoms all day long

Diclegis® is a combination of an antihistamine (doxylamine succinate) and vitamin B6 (pyridoxine hydrochloride) to help control nausea and vomiting of pregnancy when diet and lifestyle changes are not enough.

Diclegis® delayed-release tablets are designed to take effect 5 to 7 hours after you take them. In other words, taking the minimum recommended daily dose of two tablets at bedtime can help relieve your symptoms the next morning.

Diclegis® is suitable for women with food constraints, as it is lactose free, gluten free and tartrazine free and certified Kosher, Kosher for Passover and Halal.

Diclegis® is safe for you and your baby

Studies have shown that Diclegis® presents no increased risk to an unborn baby, even when taken in the first trimester, and its combination of ingredients:

  • is one of the most studied in pregnancy
  • has a 60+ year record of safety for mother and baby
  • has been used by over 35 million women worldwide to treat morning sickness
  • is recommended by both the American College of Obstetricians and Gynecologists (ACOG) and the Association of Professors of Gynecology and Obstetrics (APGO), when diet and lifestyle changes don’t work.

Diclegis® may cause drowsiness.

Diclegis® has not been studied in women with hyperemesis gravidarum or in children under 18 years of age.

Diclegis® should not be taken while breastfeeding.

Talk to your healthcare provider about Diclegis® today!

How to take Diclegis®

It is important to know that Diclegis® is not a medication that you take “as needed”, as you would, for example, with an over-the-counter medication for a headache or upset stomach.

Instead, in order for Diclegis® to help control your symptoms, you must take it daily, as indicated in the product information leaflet.

2 tablets at bedtime
1 in the morning
1 mid-afternoon

Day 1: Take 2 tablets, by mouth at bedtime.

Day 2: Take 2 tablets at bedtime. If your nausea and vomiting are controlled on Day 2, continue to take 2 tablets every night at bedtime.

Day 3: If you still have 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 are controlled on Day 3, continue to take the 3 tablets as described. If you still have 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 per day (2 at bedtime, 1 in the morning and 1 mid-afternoon).

  • 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.

Most Common Side Effects and Safety Considerations

The most common side effect of Diclegis® is drowsiness.

Do not drive, operate heavy machinery or engage in 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 taking 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 of the possible side effects of Diclegis®.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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