BONJESTA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DOXYLAMINE SUCCINATE; PYRIDOXINE (VIT B6) HYDROCHLORIDE

متاح من:

TZAMAL BIO-PHARMA LTD

ATC رمز:

R06AA09

الشكل الصيدلاني:

TABLETS EXTENDED RELEASE

تركيب:

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

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

DUCHESNAY INC., CANADA

المجال العلاجي:

DOXYLAMINE

الخصائص العلاجية:

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.

تاريخ الترخيص:

2021-06-17

نشرة المعلومات

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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