País: Malta
Idioma: inglés
Fuente: Medicines Authority
APREPITANT
Rontis Hellas Medical and Pharmaceutical Products S.A. 38, Sorou Str., Athens, Maroussi, 15125, Greece
A04AD12
APREPITANT 80 mg APREPITANT 125 mg
HARD CAPSULE
APREPITANT 80 mg APREPITANT 125 mg
POM
ANTIEMETICS AND ANTINAUSEANTS
Withdrawn
2018-04-24
PACKAGE LEAFLET: INFORMATION FOR THE USER APREPITANT RONTIS 80 MG HARD CAPSULES APREPITANT RONTIS 125 MG HARD CAPSULES APREPITANT RONTIS 125 MG HARD CAPSULES + APREPITANT RONTIS 80 MG HARD CAPSULES aprepitant 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 RONTIS, PLEASE READ THIS INFORMATION CAREFULLY. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask the 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. - 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. WHAT IS IN THIS LEAFLET 1. What Aprepitant Rontis is and what it is used for 2. What you need to know before you take or give Aprepitant Rontis 3. How to take Aprepitant Rontis 4. Possible side effects 5. How to store Aprepitant Rontis 6. Contents of the pack and other information 1. WHAT APREPITANT RONTIS IS AND WHAT IT IS USED FOR Aprepitant Rontis contains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists". The brain has a specific area that controls nausea and vomiting. Aprepitant Rontis works by blocking signals to that area, thereby reducing nausea and vomiting. Aprepitant Rontis capsules are used in adults and adolescents from the age of 12 years IN COMBINATION WITH OTHER MEDICINES to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OR GIVE APREPITANT RONTIS DO NOT TAKE APREPITANT RONTIS: - if you or the child is allergic to aprepitant or any of the other ingredients of this medicine (lis Leer el documento completo
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aprepitant Rontis 80 mg hard capsules Aprepitant Rontis 125 mg hard capsules Aprepitant Rontis 125 mg hard capsules + Aprepitant Rontis 80 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Aprepitant Rontis 80 mg hard capsules _ Each hard capsule contains 80 mg of aprepitant. Excipient with known effect Each capsule contains 80 mg of sucrose (in the 80 mg capsule). _Aprepitant Rontis 125 mg hard capsules _ Each hard capsule contains 125 mg of aprepitant. Excipient with known effect Each capsule contains 125 mg of sucrose (in the 125 mg capsule). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. _Aprepitant Rontis 80 mg hard capsules _ Opaque, size 2 hard gelatin capsules with a white body and cap, containing white to off-white pellets. _Aprepitant Rontis 125 mg hard capsules _ Opaque, size 1 hard gelatin capsules with a white body and pink cap, containing white to off-white pellets. 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 Rontis 125 mg/80 mg is given as part of combination therapy (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Aprepitant Rontis is 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. Page 2 of 18 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 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 Leer el documento completo