Bonjesta® (doxylamine succinate and pyridoxine hydrochloride) 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.
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. You should also not take Bonjesta® in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse central nervous system (CNS) effects of Bonjesta®. Please ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including Marplan, Nardil, Emsam, Eldepryl, Zelapar, and Parnate.
The absorption and action of Bonjesta® may be impacted when tablets are taken with food. Therefore, you should take Bonjesta® on an empty stomach with a glass of water.
The most common side effect of Bonjesta® is drowsiness, which may be severe. 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.
These are not all the possible side effects of Bonjesta®. Call your doctor for medical advice about side effects.
Bonjesta® should be used with caution in women who have certain medical conditions, such as asthma, or eye problems called increased intraocular pressure or narrow angle glaucoma, a stomach problem called stenosing peptic ulcer or pyloroduodenal obstruction, a bladder problem called urinary bladder-neck obstruction, or who are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed, so he/she can assess if Bonjesta® is right for you. Bonjesta® can pass into your breast milk and may harm your baby. You should not breastfeed while using Bonjesta®.
It is not known if Bonjesta® is safe and effective in children under 18 years of age.
Bonjesta® is an extended-release formulation, so signs of overdose may not appear right away. 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. Stop taking Bonjesta®, call your healthcare provider or go to the nearest hospital emergency room right away. If you take too much Bonjesta®, call your poison control center at 1-800-222-1222.
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.
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