Xonvea 10 mg/10 mg gastro-resistant tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Doxylamine hydrogen succinate; Pyridoxine hydrochloride

Dostępny od:

Exeltis healthcare S.L.

Kod ATC:

R06AA59

INN (International Nazwa):

Doxylamine hydrogen succinate; Pyridoxine hydrochloride

Forma farmaceutyczna:

Gastro-resistant tablet

Dziedzina terapeutyczna:

doxylamine, combinations

Status autoryzacji:

Not marketed

Data autoryzacji:

2019-04-05

Ulotka dla pacjenta

LF-DOXPYR-IE-IE.H.0963.001.II.011-EoP
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
XONVEA 10 MG/10 MG GASTRO-RESISTANT TABLETS
doxylamine 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 is and what it is used for
2.
What you need to know before you take Xonvea
3.
How to take Xonvea
4.
Possible side effects
5.
How to store Xonvea
6.
Contents of the pack and other information
1.
WHAT XONVEA IS AND WHAT IT IS USED FOR
WHAT XONVEA IS
Xonvea contains two medicines (‘active substances’) called:
‘doxylamine succinate’ and ‘pyridoxine
hydrochloride’.
•
Doxylamine succinate belongs to a group of medicines called
‘antihistamines’.
•
Pyridoxine hydrochloride is another name for Vitamin B
6
.
WHAT XONVEA IS USED FOR
Xonvea is used in pregnant women aged 18 years and older, 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XONVEA
DO NOT TAKE XONVEA IF:
•
you are allergic to doxylamine 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 depression called ‘monoamine oxidase
inhibitors’ (MAOIs)
Do not take Xonvea if any of the above apply to you. If you are not
sure, talk to your doctor,
pharmacist or nurse before taking Xonvea.
WARNINGS AND PRECAUTIONS
Tal

Charakterystyka produktu

Health Products Regulatory Authority
06 March 2024
CRN00DC63
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xonvea 10 mg/10 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 10 mg doxylamine succinate and
10 mg pyridoxine hydrochloride.
Excipients with known effect
Each gastro-resistant tablet contains 6.04 micrograms of the azo
colouring agent Allura red AC aluminium lake (E 129) and 0.02
micrograms of benzoic acid (E 210).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
White, round, film-coated tablet with a pink image of a pregnant woman
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Xonvea is indicated for the 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).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose is two tablets (Total dose: 20 mg
doxylamine succinate/20 mg pyridoxine hydrochloride) at
bedtime (Day 1). If this dose adequately controls symptoms the next
day, the patient can continue taking two tablets at
bedtime. However, if symptoms persist into the afternoon of Day 2, the
patient should continue the usual dose of two tablets
at bedtime (Day 2) and on Day 3 take three tablets (one tablet in the
morning and two tablets at bedtime). If these three
tablets do not adequately control symptoms on Day 3, the patient can
take four tablets starting on Day 4 (one tablet in the
morning, one tablet mid-afternoon and two tablets at bedtime).
The maximum recommended daily dose is four tablets (one in the
morning, one in the mid-afternoon and two at bedtime).
Xonvea should be taken as a daily prescription and not on an as needed
basis. Continued need for Xonvea should be
reassessed as the pregnancy progresses.
To prevent a sudden return of nausea and vomiting of pregnancy
symptoms, a gradual tapering dose of Xonvea i