Xonvea MR 20 mg/20 mg modified-release tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Doxylamine hydrogen succinate; Pyridoxine hydrochloride

थमां उपलब्ध:

Exeltis healthcare S.L.

ए.टी.सी कोड:

R06AA59

INN (इंटरनेशनल नाम):

Doxylamine hydrogen succinate; Pyridoxine hydrochloride

फार्मास्यूटिकल फॉर्म:

Modified-release tablet

चिकित्सीय क्षेत्र:

doxylamine, combinations

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2023-06-30

सूचना पत्रक

LF-DOXPYR-IE-IE/H/1167/001/IB/001/G-D0
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
XONVEA MR 20 MG/20 MG MODIFIED-RELEASE TABLETS
doxylamine hydrogen succinate/pyridoxine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xonvea MR is and what it is used for
2.
What you need to know before you take Xonvea MR
3.
How to take Xonvea MR
4.
Possible side effects
5.
How to store Xonvea MR
6.
Contents of the pack and other information
1.
WHAT XONVEA MR IS AND WHAT IT IS USED FOR
WHAT XONVEA MR IS
XONVEA MR 20 MG/20 MG
modified-release tablets contains two medicines (‘active
substances’)
called: ‘doxylamine hydrogen succinate’ and ‘pyridoxine
hydrochloride’.
•
Doxylamine hydrogen succinate belongs to a group of medicines called
‘antihistamines’.
•
Pyridoxine hydrochloride is another name for Vitamin B
6
.
WHAT XONVEA MR IS USED FOR
Xonvea MR is used in pregnant women, to help stop them feeling sick
(nausea) and being sick
(vomiting). It is used when changes in diet or other non-medicine
treatments have not worked.
Women suffering from severe nausea and vomiting of pregnancy, a
condition called hyperemesis
gravidarum, have to be treated by a specialist.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XONVEA MR
DO NOT TAKE XONVEA MR IF:
•
you are allergic to doxylamine hydrogen succinate or other
antihistamines (such as
diphenhydramine), pyridoxine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)
•
you are taking medicines for

उत्पाद विशेषताएं

Health Products Regulatory Authority
18 July 2023
CRN00DQ6R
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xonvea MR 20 mg/20 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 20 mg doxylamine hydrogen
succinate and 20 mg pyridoxine hydrochloride. Xonvea MR
is comprised of an enteric-coated core containing 10 mg doxylamine
hydrogen succinate and 10 mg pyridoxine hydrochloride
and an immediate-release multilayer coating containing 10 mg
doxylamine hydrogen succinate and 10 mg pyridoxine
hydrochloride.
Excipient(s) with known effect
Each tablet contains 0.008 mg of Allura Red AC aluminium lake (E129),
an azo colouring agent.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet
Pink, round, film-coated tablet with a pink image of a pregnant woman
on one side and the letter "D" on the other side. The
tablet size is approximately 9mm in diameter and 4mm thick.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vombee is indicated for the symptomatic treatment of nausea and
vomiting of pregnancy (NVP) in pregnant women ≥18 years
who do not respond to conservative management (i.e., lifestyle and
diet change).
Limitations of use: The combination doxylamine/pyridoxine has not been
studied in case of hyperemesis gravidarum (see
section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose of Xonvea MR is one tablet (20mg/20mg)
at bedtime on Day 1 and on Day 2. If symptoms
are not adequately controlled on Day 2, the dose can be increased on
Day 3 to one additional tablet (20mg/20mg) in the
morning and one tablet (20mg/20mg) at bedtime (for a total of two
tablets per day). The maximum recommended dose is two
tablets daily, one in the morning and one at bedtime (for a maximum
daily dose of 40mg/40mg). Xonvea MR should be taken
as a daily prescription and not on an as needed basis. Continued need
for Xonvea MR should be reassessed as the pregnancy
progresses.
S