País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Pyridoxine hydrochloride ; Doxylamine hydrogen succinate
Exeltis healthcare S.L.
R06AA59
Pyridoxine hydrochloride ; Doxylamine hydrogen succinate
Modified-release tablet
doxylamine, combinations
Not marketed
2023-06-30
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 Leer el documento completo
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 Leer el documento completo