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TA000201642610070011______Dokument1 1 Dok-Nr.: TA000201642610070011 SUMMARY of PRODUCT CHARACTERISTICS

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TA000201642610070011______Dokument1 1 Dok-Nr.: TA000201642610070011 SUMMARY of PRODUCT CHARACTERISTICS 1.3.1 Fachinformation, Beschriftung auf Behältnis und äußerer Umhüllung, Gebrauchsinformation 1.3.1.1 Fachinformation Künftig vorgesehener Wortlaut für die Fachinformation Der Text befindet sich in der Anlage. ___________________________________________________________________________ Dokument1 1 Dok-Nr.: TA000201642610070011___________________________________________________________ ________________ Dokument1 1 Dok-Nr.: TA000201642610070011 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Diclofenac Temmler 75 mg gastro-resistant capsule, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gastro-resistant capsule, hard contains diclofenac as 75 mg of diclofenac sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant capsule, hard, Hard gelatin capsules, size 2, capsule cap and body are red opaque 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Diclofenac Temmler 75 mg gastro-resistant capsule is indicated in adults. Symptomatic treatment of pain and inflammation associated with - arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, - acute musculo-skeletal disorders such as periarthritis, tendinitis, tenosynovitis, bursitis, - painful post-traumatic swellings or inflammations 4.2 Posology and method of administration Posology The dosage of diclofenac depends on the severity of the clinical condition. The recommended dose range for adults is between 50mg and 150 mg of diclofenac sodium daily given on a 1 to 2 divided dose schedule. A single dose comprises not more than 75 mg diclofenac sodium. Age Single dose: Total daily dose: Adults 1 2 (75 mg diclofenac sodium) (150 mg diclofenac sodium) The duration of administration is decided by the treating physician. For rheumatic diseases, it may be necessary to take Diclofenac Temmler 75 mg gastro- resistant capsule over a prolonged period. For long-term use the total daily dose should ___________________________________________________________________________ Dokument1 2 Dok-Nr.: TA000201642610070011___________________________________________________________ ________________ Dokument1 2 Dok-Nr.: TA000201642610070011 be reduced, if possible, to 75 mg diclofenac sodium according to the therapeutic response. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4, Special warnings and precautions for use). Special population Elderly: No specific dose adjustment is required. Because of the potential undesirable effect profile, elderly patients should be monitored with particular care (for elderly see section 4.4). Renal impairment: For patients with mildly to moderately impaired renal function no dose reduction is required (for patients with severe renal impairment see section 4.3). Hepatic impairment (see section 5.2): For patients with mild to moderate hepatic impairment no dose reduction is required (for patients with severe hepatic dysfunction see section 4.3). Paediatric population: Diclofenac Temmler 75 mg gastro-resistant capsule is contraindicated in children and adolescents, see also section 4.3. Method of administration For oral use. Diclofenac Temmler 75 mg gastro-resistant capsule is swallowed whole with plenty of liquid (a glass of water) one to two hours before meals and should be taken on an empty stomach. 4.3 Contraindications hypersensitivity to the active substance or to any of the excipients listed in section 6.1 active gastric or intestinal ulcer, bleeding or perforation history of gastrointestinal bleeding or perforation, related to previous non-steroidal antirheumatic/anti-inflammatory drugs (NSAIDs) therapy. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) cerebrovascular bleeding or other active bleeding disorders known past reactions of bronchospasm, asthma, rhinitis or urticaria after taking acetylsalicylic acid or other NSAIDs unexplained haematopoietic disorders severe hepatic failure or severe renal failure established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. last trimester of pregnancy (see section 4.6) Children and adolescents under the age of 18 years must not take Diclofenac Temmler 75 mg gastro-resistant capsule, because the content of active substance is too high. 4.4 Special warnings and precautions for use General: The concomitant use of Diclofenac with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects. Like other NSAIDs, Diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). Elderly patients: Caution is indicated in the elderly on basic medical grounds. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight. 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 (GI) effects: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, including diclofenac, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. They generally have more serious consequences in the elderly. As with all NSAIDs, including diclofenac, close medical surveillance is imperative and particular caution should be exercised when prescribing diclofenac in patients with symptoms indicative of GI disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8). The risk of GI 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. To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose. 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 section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medicinal products which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5). Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn’s disease, as their condition may be exacerbated (see section 4.8). When GI bleeding or ulceration occurs in patients receiving diclofenac, the treatment should be withdrawn. Skin reactions: 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. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild heart failure (NYHA I) as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment (see section 4.3 and 4.4). Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration. As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re- evaluated periodically. Hepatic effects: Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated. As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase. During prolonged or repeated treatment with diclofenac, regular monitoring of hepatic function is indicated as a precautionary
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