País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aprepitant
Merck Sharp & Dohme Ltd
A04AD12
Aprepitant
80mg
Capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5013945196269
PACKAGE LEAFLET: INFORMATION FOR THE USER EMEND® 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 EMEND, 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 EMEND is and what it is used for 2. What you need to know before you take or give EMEND 3. How to take EMEND 4. Possible side effects 5. How to store EMEND 6. Contents of the pack and other information 1. WHAT EMEND IS AND WHAT IT IS USED FOR EMEND contains the active substance aprepitant and belongs to a group of medicines called “neurokinin 1 (NK 1 ) receptor antagonists”. The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area, thereby reducing nausea and vomiting. EMEND 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 EMEND DO NOT TAKE EMEND: - if you or the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6). - with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell the doctor if you or the Leia o documento completo
OBJECT 1 EMEND 80MG, 125MG HARD CAPSULES Summary of Product Characteristics Updated 07-Jun-2018 | Merck Sharp & Dohme Limited 1. Name of the medicinal product EMEND® 125 mg hard capsules EMEND® 80 mg hard capsules 2. Qualitative and quantitative composition Each 125 mg capsule contains 125 mg of aprepitant. Each 80 mg capsule contains 80 mg of aprepitant. Excipient with known effect Each capsule contains 125 mg of sucrose (in the 125 mg capsule). Excipient with known effect Each capsule contains 80 mg of sucrose (in the 80 mg capsule). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule. The 125 mg capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body. The 80 mg capsules are opaque with a white body and cap with “461” and “80 mg” printed radially in black ink 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. EMEND 125 mg/80 mg is given as part of combination therapy (see section 4.2). 4.2 Posology and method of administration Posology _Adults _ EMEND 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. 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 EMEND 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 chemothe Leia o documento completo