Land: Holland
Tungumál: hollenska
Heimild: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
DOXYLAMINEWATERSTOFSUCCINAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; DOXYLAMINE 13,9 mg/stuk ; PYRIDOXINEHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; PYRIDOXINE 16,5 mg/stuk
DOXYLAMINEWATERSTOFSUCCINAAT 20 mg/stuk SAMENSTELLING overeenkomend met ; DOXYLAMINE 13,9 mg/stuk ; PYRIDOXINEHYDROCHLORIDE 20 mg/stuk SAMENSTELLING overeenkomend met ; PYRIDOXINE 16,5 mg/stuk
Tablet met gereguleerde afgifte
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)
Oraal gebruik
1900-01-01
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 Lestu allt skjalið
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 Lestu allt skjalið