DICLECTIN DELAYED RELEASE TABLETS 10MG10MG

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Doxylamine Succinate; Pyridoxine Hydrochloride

Διαθέσιμο από:

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Φαρμακολογική κατηγορία (ATC):

R06AA59

Φαρμακοτεχνική μορφή:

TABLET, DELAYED RELEASE

Σύνθεση:

Doxylamine Succinate 10mg; Pyridoxine Hydrochloride 10mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Duchesnay Inc.

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2017-07-20

Αρχείο Π.Χ.Π.

HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLECTIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DICLECTIN.
DICLECTIN (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE,
10MG/10MG) DELAYED-RELEASE TABLETS, FOR ORAL USE. --------------------------- RECENT MAJOR CHANGES
-------------------------
Warnings and Precautions, Interference with Urine Screen for
Methadone,
Opiates and Phencyclidine Phosphate (PCP) (5.3)
07/2018 ---------------------------- INDICATIONS AND USAGE
--------------------------
DICLECTIN is a fixed dose combination drug product of doxylamine
succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin
B6
analog, indicated for the treatment of nausea and vomiting of
pregnancy in
women who do not respond to conservative management. (1) ----------------------- DOSAGE AND ADMINISTRATION
----------------------
Take two tablets daily at bedtime. If symptoms are not adequately
controlled,
the dose can be increased to a maximum recommended dose of four
tablets
daily (one in the morning, one mid-afternoon and two at bedtime) as
described
in the full prescribing information. (2) ---------------------- DOSAGE FORMS AND STRENGTHS -------------------
Delayed-release tablets containing 10 mg doxylamine succinate and 10
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
---------------------
•
Activities requiring mental alertness: Avoid engaging in activities
requiring complete mental alertness, such as driving or operating
heavy
machinery, while using DICLECTIN until cleared to do so by a
healthcare provider (5.1)
•
Central nervous system (CNS) depressants: Concurrent use with alcohol
or other C