Doxylamine/Pyridoxine Exeltis 10 mg/10 mg gastro-resistant tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Doxylamine; Pyridoxine hydrochloride

Disponible des:

Exeltis healthcare S.L.

Codi ATC:

R06AA59

Designació comuna internacional (DCI):

Doxylamine; Pyridoxine hydrochloride

Dosis:

10/10 milligram(s)

formulario farmacéutico:

Gastro-resistant tablet

Área terapéutica:

doxylamine, combinations

Estat d'Autorització:

Not marketed

Data d'autorització:

2021-12-17

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOXYLAMINE/PYRIDOXINE EXELTIS 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.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Doxylamine/Pyridoxine Exeltis is and what it is used for
2.
What you need to know before you take Doxylamine/Pyridoxine Exeltis
3.
How to take Doxylamine/Pyridoxine Exeltis
4.
Possible side effects
5.
How to store Doxylamine/Pyridoxine Exeltis
6.
Contents of the pack and other information
1.
WHAT DOXYLAMINE/PYRIDOXINE EXELTIS IS AND WHAT IT IS USED FOR
WHAT DOXYLAMINE/PYRIDOXINE EXELTIS IS
Doxylamine/Pyridoxine Exeltis 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 DOXYLAMINE/PYRIDOXINE EXELTIS IS USED FOR
Doxylamine/Pyridoxine Exeltis 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 DOXYLAMINE/PYRIDOXINE EXELTIS
DO NOT TAKE DOXYLAMINE/PYRIDOXINE EXELTIS IF:
•
you are allergic to doxylamine succinate or other antihistamines (such
as diphenhydramine),
pyridoxine hyd

Fitxa tècnica

Health Products Regulatory Authority
22 December 2021
CRN00CNL6
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doxylamine/Pyridoxine Exeltis 10 mg/10 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 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).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet (tablet)
White, round, film-coated tablet with a pink image of a pregnant woman
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxylamine/Pyridoxine Exeltis is indicated for the symptomatic
treatment of nausea and vomiting of pregnancy (NVP) in
women who do not respond to conservative management.
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 is two tablets 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 must
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).
Doxylamine/Pyridoxine Exeltis should be taken as a daily prescription
and not on an as needed basis. Continued need for
Doxylamine/Pyridoxine Exeltis should be reassessed as the pregnancy
progresses.
To
prevent
a
sudden
return
of
nausea
and
vomiting
of
pregnancy
symptoms