Common
questions
about
Bonjesta logo

    Common questions about Bonjesta®

    What is Bonjesta®?

    Bonjesta® is a new formulation of doxylamine succinate and pyridoxine hydrochloride that is FDA-approved for the treatment of morning sickness when diet and lifestyle changes fail to adequately control symptoms.

    Bonjesta®’s multilayer, extended-release tablets are designed to provide rapid and continuous relief of morning sickness symptoms throughout the day and night.

    What is Bonjesta® indicated for?

    Bonjesta® is specifically indicated to treat nausea and vomiting of pregnancy, commonly known as “morning sickness”, in women whose symptoms are not adequately controlled by diet and lifestyle changes.

    It is important to note that Bonjesta® has not been studied for the treatment of hyperemesis gravidarum, the most severe form of nausea and vomiting of pregnancy. Also, the safety and effectiveness of Bonjesta® have not been studied in patients under 18 years of age.

    Is Bonjesta® FDA-approved?

    Yes. Bonjesta® is FDA-approved to treat nausea and vomiting of pregnancy when diet and lifestyle changes fail to adequately control symptoms.

    Is Bonjesta® safe for me and my unborn baby?

    Yes. Results of controlled studies have shown no increased risk to an unborn baby during pregnancy. The combination of ingredients in Bonjesta® has been prescribed for over 60 years and has been used by over 35 million women worldwide for the safe and effective treatment of morning sickness.

    What is the most common side effect of Bonjesta®?

    The most common side effect of Bonjesta® is drowsiness. That’s why you should not drive, operate heavy machinery, or do other activities that need your full attention unless your healthcare provider says that you may do so.

    Is Bonjesta® suitable for women with dietary restrictions?

    Yes. Bonjesta® is suitable for women with both medical and religious dietary restrictions, as it is lactose free, gluten free and tartrazine free and certified kosher, kosher for Passover and halal.

    How do I take Bonjesta®?

    • Take one Bonjesta® tablet by mouth at bedtime.
    • If your symptoms are adequately controlled the next day, continue taking only one tablet daily at bedtime.
    • If your symptoms are not adequately controlled the next day, add a second daily tablet in the morning so that you are taking two tablets daily: one tablet in the morning and one tablet at bedtime.
    • Do not take more than two tablets per day.
    • Take Bonjesta® on an empty stomach with a glass of water.
    • Take Bonjesta® tablets whole. Do not crush, chew, or break Bonjesta® tablets before swallowing. If you cannot swallow Bonjesta® tablets whole, tell your healthcare provider.
    • If you take too much Bonjesta® (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
      • Sudden and severe kidney problems

    If you have these symptoms and they are severe, they may lead to death. Stop taking Bonjesta® and 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 should I do if I vomit shortly after taking a dose of Bonjesta®?

    Please consult your healthcare provider or pharmacist regarding what to do in the event that you vomit shortly after swallowing a Bonjesta® tablet.

    Should your healthcare provider consider this to be a reaction to the medication, 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.

    Can I get the same results as from Bonjesta® by taking over-the-counter (OTC) products that contain doxylamine and/or pyridoxine?

    The FDA has not studied over-the-counter products for safety or efficacy during pregnancy. In other words, it is not known if these products could pose a risk to your unborn baby or if they are at all effective at treating morning sickness.

    Furthermore, none of these products offer an extended-release formulation and they do not come in the recommended dose. So you would have to guess and divide the tablets yourself.

    Only Bonjesta® is approved, available and proven safe and effective for the treatment of morning sickness.

    How should I store Bonjesta®?

    • Store Bonjesta® between 68°F to 77°F (20°C to 25°C)
    • Keep Bonjesta® tablets dry, in a tightly closed container
    • Safely throw away medicine that is out of date or no longer needed

    Keep Bonjesta® and all medicines out of the reach of children.

    Indication and important safety information

    INDICATION

    BONJESTA® 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 BONJESTA® 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

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

    Do not take BONJESTA® if you:

    • are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in BONJESTA®. 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 BONJESTA®, tell your healthcare provider about all of your medical conditions, including if you: have eye problems called increased intraocular pressure or narrow angle glaucoma; have a stomach problem called stenosing peptic ulcer or pyloroduodenal obstruction; have a bladder problem called urinary bladder-neck obstruction; are breastfeeding or plan to breastfeed. BONJESTA® can pass into your breast milk and may harm your baby. You should not breastfeed while using BONJESTA®.

    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 BONJESTA®?

    • Talk to your healthcare provider about how much and when to take BONJESTA®.
    • Take BONJESTA® everyday as prescribed by your healthcare provider. Do not stop taking BONJESTA® without talking to your healthcare provider first.
    • Do not take more than 2 tablets (1 in the morning and 1 at bedtime) each day.
    • Take BONJESTA® tablets whole on an empty stomach with a glass of water.
    • If you take too much BONJESTA® (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, urination changes and build-up of fluid in the body. If you have these symptoms and they are severe, they may lead to death. If you take too much BONJESTA®, call your poison control center at 1-800-222-1222.

    What are the possible side effects of BONJESTA®?

    • The most common side effect of BONJESTA® 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 BONJESTA®. Severe drowsiness can happen or become worse causing falls or accidents. BONJESTA® 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 BONJESTA®. Call your doctor for medical advice about side effects.

    Keep BONJESTA® and all medicines out of the reach of children. Carefully read the storage instruction as detailed in the BONJESTA® 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

    Indication and important safety information

    INDICATION

    BONJESTA® 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 BONJESTA® 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

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

    Indication and important safety information

    INDICATION

    BONJESTA® 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 BONJESTA® 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.