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SUMMARY of PRODUCT CHARACTERISTICS 1. NAME of the MEDICINAL PRODUCT < Invented Name > 60 Mg Capsules, Hard 2. QUALITATIVE

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SUMMARY of PRODUCT CHARACTERISTICS 1. NAME of the MEDICINAL PRODUCT < Invented Name > 60 Mg Capsules, Hard 2. QUALITATIVE SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT < invented name > 60 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule, hard contains 60 mg acemetacin. Excipients with known effects: 55 mg lactose (as monohydrate) per capsule, hard 0,022 mg Azorubine (E122) per capsule, hard For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard Hard gelatine capsule, size 4 (14.3 mm x 53 mm) with an ivory-coloured opaque body and a violet opaque cap. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Symptomatic treatment of pain and inflammation in acute arthritis (including gout) chronic arthritis, particularly in rheumatoid arthritis (chronic polyarthritis) ankylosing spondylitis (Bechterew’s Disease) and other inflammatory rheumatic spinal disorders osteoarthritis soft tissue inflammatory rheumatic disorders painful inflammation and swelling due to trauma 4.2 Posology and method of administration Posology with single and daily doses: Acemetacin is dosed according to the severity of the disease. Adults: The recommended dose range is between 60 and 180 mg per day divided into 1 – 3 three single doses. Age: Single-dose: Daily dose Adults 60 mg Acemetacin 60 - 180 mg Acemetacin The physician should decide on the duration of treatment. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control the symptoms (see section 4.4). Treatment of rheumatic diseases may require intake of < invented name > over a longer period. Acute gout: For the treatment of acute gout a daily dose of 180 mg is recommended until symptoms subside. Higher doses may occasionally be required for the first 24 to 48 hours. Treatment with a daily dose higher than 180 mg should only occur under the close supervision of the prescribing physician. 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: < invented name > is not recommended for use in children and adolescents due to insufficient data on safety and efficacy in this patient-group. Method of administration For oral use. < invented name > should be swallowed unchewed and with a sufficient amount of liquid. < invented name > should not be taken on an empty stomach. For patients with a sensitive stomach it is recommended to take < invented name > during a meal. 4.3 Contraindications hypersensitivity to the active substance, indometacin or to any of the excipients listed in section 6.1. known reactions of bronchospasm, asthma attacks, rhinitis or urticaria in response to acetylsalicylic acid or other non-steroidal anti-inflammatory medicinal products unexplained disturbance of hemopoiesis active, or history of recurrent peptic ulcer/hemorrhage (at least two or more different episodes of proven ulceration or bleeding) a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy cerebrovascular or other active bleeding severe heart failure severe renal and hepatic failure < invented name > is also contraindicated during the third trimester of pregnancy 4.4 Special warnings and precautions for use Gastrointestinal safety: The use of < invented name > in combination with other NSAIDS, including cyclooxygenase-2 selective inhibitors, should be avoided. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and gastrointestinal and cardiovascular risks below). Elderly The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid,, or other medicinal products likely to increase gastrointestinal risk (see below and 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment. Caution is advised in patients receiving concomitant medications, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5), which could increase the risk of ulceration or bleeding. When gastrointestinal bleeding or ulceration occurs in patients receiving < Invented Name >, the treatment should be withdrawn. NSAIDs should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease) as their condition may worsen (see section 4.8). Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a slightly increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for acemetacin. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with acemetacin after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Effects on the skin: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy; the onset of the reaction occurring in the majority of cases within the first month of treatment. < invented name > should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Renal and Hepatic Impairment: The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients (see also section 4.3) < invented name > should only be used after careful consideration of the risk-benefit ratio in patients with acute porphyria with systemic lupus erythematosus (SLE) or mixed connective tissue disease (see section 4.8) Particular supervision by a physician is necessary in patients with renal impairment with hepatic impairment immediately after major surgical intervention with allergic rhinitis, nasal polyps or chronic obstructive pulmonary disease because of a higher risk for allergic reactions, such as acute asthma attack (analgesic induced asthma), Quincke’s edema or urticaria with a history of allergic reaction to other substances because of a higher risk for an allergic reaction to < invented name > Severe allergic reactions, e.g. anaphylactic shock, are very rare. < invented name > must be discontinued at the first appearance of any sign of severe hypersensitivity. Depending on the symptoms, suitable treatment should be initiated by healthcare professionals. < invented name > can induce transitory inhibition of thrombocyte aggregation. Patients with blood clotting disturbance should, therefore, be observed carefully. Patients receiving long-term treatment should be regularly screened for renal and hepatic parameters and blood counts. Particular caution is advised before surgical interventions. Headache may occur due to long-term treatment with analgesics; this should not be treated with higher doses of the offending substance. In general, habitual use of analgesics, especially the combination of different analgesic substances, may lead to irreversible renal impairment with the risk of renal insufficiency (analgesic induced nephropathy). Concomitant intake of NSAIDs and alcohol my increase the risk of acemetacin-related adverse reactions, particularly adverse reactions involving the gastrointestinal tract or the central nervous system. During long-term treatment with indometacin, the main active metabolite of acemetacin, changes to the retina
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