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BONJESTA EXTENDED-RELEASE TABLETS 20 MG/20 MG [SIN16865P]
Active ingredients: BONJESTA EXTENDED-RELEASE TABLETS 20 MG/20 MG
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Product Info
BONJESTA EXTENDED-RELEASE TABLETS 20 MG/20 MG
[SIN16865P]
Product information
Active Ingredient and Strength | DOXYLAMINE SUCCINATE - 20 MG |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Manufacturer and Country | DUCHESNAY INC. - CANADA |
Registration Number | SIN16865P |
Licence Holder | UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | R06AA59 |
1. INDICATIONS AND USAGE
BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Limitations of Use
BONJESTA has not been studied in women with hyperemesis gravidarum.
2. DOSAGE AND ADMINISTRATION
2.1 Dosage Information
Initially, take one BONJESTA extended-release tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, increase the daily dose to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets per day, one in the morning and one at bedtime.
Take on an empty stomach with a glass of water [see Clinical Pharmacology (11.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Swallow tablets whole. Do not crush, chew, or split BONJESTA tablets.
Take daily and not on an as needed basis. Reassess the woman for continued need for BONJESTA as her pregnancy progresses.
4. CONTRAINDICATIONS
BONJESTA is contraindicated in women with any of the following conditions:
Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation
Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of BONJESTA [see Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
