Doxpirexel 20 mg/ 20 mg modified-release tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Pyridoxine hydrochloride ; Doxylamine hydrogen succinate

Dostopno od:

Exeltis healthcare S.L.

Koda artikla:

R06AA59

INN (mednarodno ime):

Pyridoxine hydrochloride ; Doxylamine hydrogen succinate

Farmacevtska oblika:

Modified-release tablet

Terapevtsko območje:

doxylamine, combinations

Status dovoljenje:

Not marketed

Datum dovoljenje:

2023-06-30

Navodilo za uporabo

LF-DOXPYR-IE-IE.H.1174.001.P.001
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXPIREXEL 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 Doxpirexel is and what it is used for
2.
What you need to know before you take Doxpirexel
3.
How to take Doxpirexel
4.
Possible side effects
5.
How to store Doxpirexel
6.
Contents of the pack and other information
1.
WHAT DOXPIREXEL IS AND WHAT IT IS USED FOR
WHAT DOXPIREXEL IS
Doxpirexel
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 DOXPIREXEL IS USED FOR
Doxpirexel 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 DOXPIREXEL
DO NOT TAKE DOXPIREXEL 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 medicin

Lastnosti izdelka

Health Products Regulatory Authority
30 June 2023
CRN00CJV5
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxpirexel 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. Doxpirexel
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
Doxpirexel 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 Doxpirexel 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). Doxpirexel should be taken as a daily
prescription and not on an as needed basis. Continued need for
Doxpirexel should be reassessed as the pregnancy pr