BONJESTA

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

DOXYLAMINE SUCCINATE; PYRIDOXINE (VIT B6) HYDROCHLORIDE

Dostępny od:

TZAMAL BIO-PHARMA LTD

Kod ATC:

R06AA09

Forma farmaceutyczna:

TABLETS EXTENDED RELEASE

Skład:

DOXYLAMINE SUCCINATE 20 MG; PYRIDOXINE (VIT B6) HYDROCHLORIDE 20 MG

Droga podania:

PER OS

Typ recepty:

Required

Wyprodukowano przez:

DUCHESNAY INC., CANADA

Dziedzina terapeutyczna:

DOXYLAMINE

Wskazania:

BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.Limitations of UseBONJESTA has not been studied in women with hyperemesis gravidarum.

Data autoryzacji:

2021-06-17

Ulotka dla pacjenta

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
BONJESTA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pyridoxine hydrochloride 20 mg
Doxylamine succinate 20 mg
For the full list of excipients, see section 12.
3. PHARMACEUTICAL FORM
Extended release tablets.
BONJESTA extended-release tablets are pink, round, film-coated tablets
containing 20 mg doxylamine
succinate and 20 mg pyridoxine hydrochloride, imprinted on one side
with the pink image of a pregnant woman
and a “D” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 (12.3)]._
Swallow tablets whole. Do
not crush, chew, or split BONJESTA tablets.
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Take daily and not on an as needed basis. Reassess the woman for
continued need for BONJESTA as her
pregnancy progresses.
4.3 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)]_
.
5. SPECIAL WARNINGS AND PRECAUTIONS FOR US