Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Aprepitant
Accord Healthcare Ireland Ltd.
A04AD12
Aprepitant
125 milligram(s)
Capsule, hard
aprepitant
Marketed
2019-03-22
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details APREPITANT 80MG, 125MG & 125MG/80MG HARD CAPSULES PIL - UK/EIRE Black BBBA3644 S.Anson 19.12.18 21/12/18 R.Wrey 170 x 500 10pt Pharmathen 19.12.18 20.12.18 5 Version 2 01.11.2017 _Continued top of next column _ BBBA3644 APREPITANT 125MG HARD CAPSULES APREPITANT 80MG HARD CAPSULES APREPITANT 125MG/80MG HARD CAPSULES aprepitant PACKAGE LEAFLET: INFORMATION FOR THE USER _Continued over page_ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. IF YOU ARE THE PARENT OF A CHILD TAKING APREPITANT HARD CAPSULES , PLEASE READ THIS INFORMATION CAREFULLY. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you or the child 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 or the child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • The full name of this medicine is Aprepitant Hard Capsules but within this leaflet it will be referred to as Aprepitant Capsules. WHAT IS IN THIS LEAFLET 1 WHAT APREPITANT CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE OR GIVE APREPITANT CAPSULES 3 HOW TO TAKE APREPITANT CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE APREPITANT CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMA Les hele dokumentet
Health Products Regulatory Authority 06 November 2023 CRN00DH0D Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aprepitant Accord 125 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 125 mg capsule contains 125 mg of aprepitant. Excipient with known effect Each 125 mg capsule contains 125 mg of sucrose and 0.00026 mmol (0.006 mg) of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule (capsule) The 125 mg hard capsules are presented as opaque hard gelatin capsules of size No 1, with a pink cap and white body, imprinted in black ink with "125mg" on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12. Aprepitant 125 mg/80 mg capsules are given as part of combination therapy (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Aprepitant capsules are given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT 3 antagonist. The recommended dose is 125 mg orally once daily one hour before start of chemotherapy on Day 1 and 80 mg orally once daily on Days 2 and 3 in the morning. The following regimens are recommended in adults for the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy: _Highly Emetogenic Chemotherapy Regimen_ Day 1 Day 2 Day 3 Day 4 Aprepitant capsules 125 mg orally 80 mg orally 80 mg orally none Dexamethasone 12 mg orally 8 mg orally 8 mg orally 8 mg orally 5-HT 3 antagonists Standard dose of 5-HT 3 antagonists. See the product information for the selected 5-HT 3 antagonist for appropriate dosing information none none none DEXAMETHASONE should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 to 4. The dose of dexamethasone accounts for active substance interactions. Health Products Regulatory Authority 06 November 2023 CRN00DH0D Page 2 of Les hele dokumentet