BONJESTA EXTENDED-RELEASE TABLETS 20 MG20 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Doxylamine Succinate; Pyridoxine HCl

Available from:

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

ATC code:

R06AA59

Pharmaceutical form:

TABLET, FILM COATED, EXTENDED RELEASE

Composition:

Doxylamine Succinate 20.0mg; Pyridoxine HCl 20.00mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Duchesnay Inc.

Authorization status:

ACTIVE

Authorization date:

2023-09-18

Summary of Product characteristics

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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BONJESTA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BONJESTA.
BONJESTA
(DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE),
EXTENDED-RELEASE TABLETS, FOR ORAL USE. ---------------------------- INDICATIONS AND USAGE
--------------------------
BONJESTA
is a fixed dose combination drug product of 20 mg doxylamine
succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a
Vitamin
B
6
analog, indicated for the treatment of nausea and vomiting of
pregnancy in
women who do not respond to conservative management. (1) ----------------------- DOSAGE AND ADMINISTRATION
----------------------
On Day 1, take one tablet at bedtime. On Day 2, if symptoms are not
adequately controlled, the dose can be increased to one tablet in the
morning
and one tablet at bedtime. The maximum recommended dose is two tablets
daily, one in the morning and one at bedtime, as described in the full
prescribing information. (2) ---------------------- DOSAGE FORMS AND STRENGTHS -------------------
Extended-release tablets containing 20 mg doxylamine succinate and 20
mg
pyridoxine hydrochloride. (3) ------------------------------- CONTRAINDICATIONS
-----------------------------
•
Known hypersensitivity to doxylamine succinate, other ethanolamine
derivative antihistamines, pyridoxine hydrochloride or any inactive
ingredient in the formulation (4)
•
Monoamine oxidase (MAO) inhibitors (4, 7) ------------------------ WARNINGS AND PRECAUTIONS
---------------------
•
Somnolence: BONJESTA may cause somnolence. Avoid engaging in
activities requiring complete mental alertness, such as driving or
operating heavy machinery, while using BONJESTA until cleared to do
so by a healthcare provider (5.1)
•
Central nervous system (CNS) depressants: Concurrent use with alcohol
or other CNS depressants is not recommended (5.1)
•
Anticholinergic actions: Use with caution in patients with asthma,
increased intrao