Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Acemetacin
Merck Serono Ltd
M01AB11
Acemetacin
60mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5013837203068
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Ć +LJKEORRGVXJDUVXJDULQWKHXULQH Ć ,QIODPHGEORRGYHVVHOVRULQIODPHGOXQJWLVVXHQRUPDOO\UHODWHGWRDQDOOHUJLFUHDFWLRQ Ć 0HQWDOGLVRUGHUVGLVRULHQWDWLRQDQ[LHW\QLJKWPDUHVWUHPRUSV\FKRVLV KDOOXFLQDWLRQVGHSUHVVLRQ WHPSRUDU\ORVVRIFRQVFLRXVQHVVZKLFKPD\OHDGWRFRPD Ć :RUVHQLQJRIDQ\SV\FKLDWULFFRQGLWLRQVWKDWDUHDOUHDG\SUHVHQW Ć 6HQVLELOLW\GLVRUGHUVPXVFOHZHDNQHVVLQFUHDVHGVZHDWLQJORVVRIWDVWHPHPRU\ORVV VOHHSGLVRUGHUV VHL]XUHV Ć :RUVHQLQJRIWKHV\PSWRPVRIHSLOHSV\RU3DUNLQVRQ¶VGLVHDVH Ć 0HQLQJLWLV7KLVLVPRUHFRPPRQLQSHUVRQVVXIIHULQJIURPGLVHDVHVOLNHV\VWHPLFOXSXV HU\WKHPDWRVXV6/(RUOXSXVDORQJWHUPGLVHDVHLQYROYLQJWKHERG\¶VLPPXQH V\VWHPDQGPL[HGFRQQHFWLYHWLVVXHGLVHDVHDQRWKHUORQJWHUPLQKHULWHGGLVHDVH LQYROYLQJWKHERG\¶VLPPXQHV\VWHPZKLFKFDXVHVSDLQIXOMRLQWVDQGPXVFOHV 6\PSWRPVRIPHQLQJLWLVWKDWKDYHEHHQFDXVHGE\16$,'VZLOOLQFOXGHVWLIIQHFNKHDGDFKH Ć 5LQJLQJLQWKHHDUVWHPSRUDU\KHDULQJORVV Ć )HHOLQJ\RXUKHDUWEHDWFKHVWSDL Прочитайте повний документ
OBJECT 1 EMFLEX CAPSULES Summary of Product Characteristics Updated 24-May-2016 | Merck 1. Name of the medicinal product Emflex Capsules 2. Qualitative and quantitative composition Each capsule contains Acemetacin 60mg Excipients: Each capsule contains 73.9mg lactose_._ For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gelatine capsule 4. Clinical particulars 4.1 Therapeutic indications Rheumatoid arthritis, osteoarthritis, low back pain, and post-operative pain and inflammation. 4.2 Posology and method of administration Method of administration: For oral administration. To be taken preferably with or after food. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Posology: The recommended starting dose is 120mg/day in divided doses, increasing to 180mg/day in divided doses, depending on patient response. Special populations: _Elderly: _ The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. _Paediatric population: _ The safety in children and adolescents is not established 4.3 Contraindications • Hypersensitivity to the active substance, indomethacin or to any of the excipients listed in section 6.1 • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • NSAIDS are contra-indicated in patients who have previously shown hypersensitivity reactions (e.g., asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti- inflammatory drugs. • Severe heart failure, hepatic failure and renal failure (see section 4.4). • During the last trimester of pregnancy (see section 4.6) • History of gastrointestinal bleeding or perforation, related to previous NSAIDs th Прочитайте повний документ