Embagyn 20 mg/20 mg tabletten met gereguleerde afgifte

Riik: Holland

keel: hollandi

Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Toimeaine:

DOXYLAMINEWATERSTOFSUCCINAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; DOXYLAMINE 13,9 mg/stuk ; PYRIDOXINEHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; PYRIDOXINE 16,5 mg/stuk

INN (Rahvusvaheline Nimetus):

DOXYLAMINEWATERSTOFSUCCINAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; DOXYLAMINE 13,9 mg/stuk ; PYRIDOXINEHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; PYRIDOXINE 16,5 mg/stuk

Ravimvorm:

Tablet met gereguleerde afgifte

Koostis:

ALLURAROOD AC ALUMINIUM LAK (E 129) ; AMMONIA (E 527) ; CARNAUBAWAS (E 903) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAGNESIUMTRISILICAAT (E 553A II)) ; NATRIUMLAURILSULFAAT ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POLYVINYLALCOHOL (E 1203) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; SIMETICON ; SIMETICON EMULSIE ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), ALLURAROOD AC ALUMINIUM LAK (E 129) ; AMMONIA (E 527) ; CARNAUBAWAS (E 903) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAGNESIUMTRISILICAAT (E 553A II)) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POLYVINYLALCOHOL (E1203) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; SIMETICON ; SIMETICON EMULSIE ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505)

Manustamisviis:

Oraal gebruik

Loa andmise kuupäev:

1900-01-01

Infovoldik

LF-DOXYPYR-NL-IE.H.1167.001.IB.001.G
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
EMBAGYN 20 MG/20 MG TABLETTEN MET GEREGULEERDE AFGIFTE
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 Embagyn is and what it is used for
2.
What you need to know before you take Embagyn
3.
How to take Embagyn
4.
Possible side effects
5.
How to store Embagyn
6.
Contents of the pack and other information
1.
WHAT EMBAGYN IS AND WHAT IT IS USED FOR
WHAT EMBAGYN IS
Embagyn 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 EMBAGYN IS USED FOR
Embagyn 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 EMBAGYN
DO NOT TAKE EMBAGYN 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 depression called

Toote omadused

SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Embagyn 20 mg/20 mg tabletten met gereguleerde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 20 mg doxylamine hydrogen
succinate and 20
mg pyridoxine hydrochloride. Embagyn 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
Embagyn 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 Embagyn 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). Embagyn should be taken as a daily
prescription and not on an as needed basis. Continued need for Embagyn
should be
reassessed as the pregnancy progresses.
Some women may achieve symptom control at intermediatory doses of