Doxylamine/Pyridoxine Exeltis Healthcare 20mg/ 20mg modified-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Doxylamine hydrogen succinate; Pyridoxine hydrochloride

Available from:

Exeltis healthcare S.L.

ATC code:

R06AA59

INN (International Name):

Doxylamine hydrogen succinate; Pyridoxine hydrochloride

Pharmaceutical form:

Modified-release tablet

Therapeutic area:

doxylamine, combinations

Authorization status:

Not marketed

Authorization date:

2023-06-30

Patient Information leaflet

LF-DOXPYR-IE-IE.H.1175.001.P.001
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXYLAMINE/PYRIDOXINE EXELTIS HEALTHCARE 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 Doxylamine/Pyridoxine Exeltis Healthcare is and what it is used
for
2.
What you need to know before you take Doxylamine/Pyridoxine Exeltis
Healthcare
3.
How to take Doxylamine/Pyridoxine Exeltis Healthcare
4.
Possible side effects
5.
How to store Doxylamine/Pyridoxine Exeltis Healthcare
6.
Contents of the pack and other information
1.
WHAT DOXYLAMINE/PYRIDOXINE EXELTIS HEALTHCARE IS AND WHAT IT IS USED
FOR
WHAT DOXYLAMINE/PYRIDOXINE EXELTIS HEALTHCARE IS
Doxylamine/Pyridoxine Exeltis Healthcare
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 DOXYLAMINE/PYRIDOXINE EXELTIS HEALTHCARE IS USED FOR
Doxylamine/Pyridoxine Exeltis Healthcare 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.
WHA

Summary of Product characteristics

Health Products Regulatory Authority
30 June 2023
CRN00CK84
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxylamine/Pyridoxine Exeltis Healthcare 20mg/ 20mg modified-release
tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
modified-release
tablet
contains
20
mg
doxylamine
hydrogen
succinate
and
20
mg
pyridoxine
hydrochloride.
Doxylamine/Pyridoxine Exeltis Healthcare 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
Doxylamine/Pyridoxine Exeltis Healthcare
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 Doxylamine/Pyridoxine Exeltis
Healthcare 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).
Doxylamine/Pyridoxine Exeltis Heal