국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Ibuprofen
Teva B.V.
M01AE; M01AE01
Ibuprofen
Film-coated tablet
Propionic acid derivatives; ibuprofen
Marketed
2009-07-03
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUPLEX RX 200 MG FILM-COATED TABLETS ibuprofen 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. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Buplex Rx is and what it is used for 2. What you need to know before you take Buplex Rx 3. How to take Buplex Rx 4. Possible side effects 5. How to store Buplex Rx 6. Contents of the pack and other information 1. WHAT BUPLEX RX IS AND WHAT IT IS USED FOR Buplex Rx belongs to a group of medicines called NSAID (non-steroidal anti-inflammatory drugs) which work by reducing pain, inflammation and fever. Buplex Rx is used to provide relief from mild to moderate pain such as headache, including migraine headache, dental pain, period pain and fever. If you are over 12 years of age your doctor may also prescribe this or higher doses for the treatment of rheumatoid arthritis, osteoarthritis, or other inflammatory or painful joint conditions, as well as for inflammatory and painful conditions of soft tissues such as muscles. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPLEX RX DO NOT TAKE BUPLEX RX: - if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). - if you have had allergic reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid or other drugs for pain and inflammation (NSAIDs). - if you have suffered from an ulcer or bleeding in the stomach or small intestine (duodenum) related to previous use of drugs 전체 문서 읽기
Health Products Regulatory Authority 08 March 2024 CRN00F2J6 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buplex Rx 200 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film‑coated tablet contains 200 mg ibuprofen. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film‑coated tablet. White, oval, biconvex film‑coated tablets with a score on one face. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate pain, such as headache including migraine headache, dental pain. Primary dysmenorrhoea. Fever. Rheumatic conditions such as arthritic diseases (e.g. rheumatoid arthritis including juvenile rheumatoid arthritis), degenerative arthritic conditions (e.g. osteoarthritis), non-articular rheumatic conditions, other muscular and joint disorders, and soft tissue injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). If a child or adolescent requires this medicinal product for more than 3 days, or if symptoms worsen, a doctor should be consulted. The ibuprofen dose depends on the patient's age and body weight. The maximum single dose for adults should not exceed 800 mg of ibuprofen. _MILD TO MODERATE PAIN AND FEVER_ _Adults and adolescents older than 12 years (≥40 kg):_ 200‑400 mg given as a single dose or 3‑4 times a day with an interval of 4 to 6 hours. The dosage in migraine headache should be: 400 mg given as a single dose, if necessary 400 mg with intervals of 4 to 6 hours. The maximum daily dose should not exceed 1200 mg. _Children 6‑12 years (>20 kg):_ Children 6‑9 years (20‑29 kg): 200 mg 1‑3 times a day with intervals of 4 to 6 hours as required. The maximum daily dose should not exceed 600 mg. Children 10‑12 years (30‑40 kg): 200 mg 1‑4 times a day with intervals of 4 to 6 hours as required. The maximum daily dose should not exceed 800 mg. He 전체 문서 읽기