Package leaflet: Information for the patient [Invented Name] 60 mg capsules, hard Acemetacin 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 [Invented Name] is and what it is used for 2. What you need to know before you take [Invented Name] 3. How to take [Invented Name] 4. Possible side effects 5. How to store [Invented Name] 6. Contents of the pack and other information 1. What [Invented Name] is and what it is used for [Invented Name] is a medicine for the relief of inflammation and pain, and belongs to the group of the so-called non-steroidal anti-inflammatory medicinal products (NSAID). [Invented Name] is used to relieve pain and inflammation in patients suffering from 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 2. What you need to know before you <take> <use> X Do not take [Invented Name] - if you are allergic to acemetacin, indometacin or any of the other ingredients of this medicine (listed in section 6). if you have a history of wheezing or asthma attacks, swelling of the nasal mucosa (hayfever) or hives in response to acetylsalicylic acid or other NSAIDs. if you suffer from unexplained disturbance of formation of blood cells. if you suffer from active peptic ulcer/haemorrhage, or if you have a history of recurrent peptic ulcer/haemorrhage (at least two or more different episodes of proven ulceration or bleeding). if you have a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. if you suffer from cerebrovascular or other active bleeding. if you suffer from severe heart failure. if you suffer from kidney or liver impairment 1 if you are pregnant in the third trimester. Warnings and precautions Talk to your doctor or pharmacist before taking [Invented Name]. You should avoid the use of [Invented Name] in combination with other NSAIDs, including cyclooxygenase-2 selective inhibitors. Elderly patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have 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 is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, in patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease) and in elderly patients. If you belong to one of these patient groups your doctor may decide to prescribe medicinal products which help to protect the tissue of your stomach and intestine. Please report any unusual abdominal symptoms (especially gastrointestinal bleeding) to your doctor. If you experience gastrointestinal bleeding or ulceration during the treatment with [Invented Name], the treatment should be withdrawn. Please inform your doctor if you receive concomitant medications, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid, which could increase the risk of ulceration or bleeding. The use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a slightly increased risk of arterial blood clots (for example heart attack or stroke). There are insufficient data to exclude such a risk for [Invented Name]. If you suffer from uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease you 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). Serious skin reactions (e.g. exfoliative dermatitis, Stevens-Johnson-Syndrome and toxic epidermal necrolysis) are very rare during the use of NSAIDs. You must discontinue the use of [Invented Name] at the first appearance of any sign of severe hypersensitivity, skin rash, mucosal lesions or any other sign of allergic reaction. Headache may occur as a result of long-term treatment with analgesics. You should not treat this headache with higher doses of analgesics. In general, habitual use of analgesics, especially the combination of different analgesic substances, may lead to irreversible kidney impairment with the risk of kidney insufficiency (analgesic induced nephropathy). Further information: 2 You should [Invented Name] only use after careful consideration of the risk-benefit ratio if you suffer from - acute porphyria - systemic lupus erythematosus (SLE) or mixed connective tissue disease. Particular supervision by a doctor is necessary - if you suffer from kidney impairment - if you suffer from severe liver impairment - immediately after major surgical intervention - if you suffer from hayfever, 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 hives - if you have 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. You must discontinue the use of [Invented Name] at the first appearance of any sign of severe hypersensitivity and immediately seek for medical advice. [Invented Name] can induce transitory inhibition of the function of platelets (blood components involved in clotting). If you suffer from blood clotting disturbances your doctor will induce measures for monitoring. During long-term treatment with [Invented Name], changes to the retina of the eye (pigmentary degeneration) and cataract were occasionally observed. Please report any sign of blurred vision to your doctor as it may be a sign of this and requires a thorough ophthalmological examination. Children and adolescents [Invented Name] is not recommended for use in children and adolescents as there are no sufficient data on safety and efficacy in this patient-group. Other medicines and [Invented Name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Acemetacin, the active substance of [Invented Name], should – like other NSAIDs – only be used with caution concomitantly with the following substances: Concomitant use of more than one NSAID may increase the risk for gastrointestinal ulceration and bleedings due to synergistic effects. Therefore you should avoid concomitant use of [Invented Name] with other NSAIDs. Concomitant use of [Invented Name] with digoxin, phenytoin or lithium may increase the plasma levels of these compounds. NSAIDs may diminish the effect of diuretics and antihypertensives (e.g. ACE-inhibitors and angiotensin 2 antagonists). In patients with impaired kidney function (e.g. dehydrated patients or elderly patients) concomitant intake of ACE-inhibitors or angiotensin-2- antagonists with a NSAID may lead to further impairment of kidney function including potential acute kidney failure (usually reversible). Therefore, this combination should be used with caution, especially by elderly patients. If you use such a combination please be careful to ensure adequate liquid intake. Your doctor may wish to check your renal parameters regularly. 3 Concomitant intake of [Invented Name] and potassium-sparing diuretics may lead to hyperkalaemia (elevated blood potassium levels). Concomitant use of Glucocorticosteroids, platelet aggregation inhibitors (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (SSRIs) may increase the risk of gastrointestinal ulceration or bleeding. When taken within 24 hours before or after administration of methotrexate, [Invented Name] may increase methotrexate blood concentration and therefore increase the toxic effects of methotrexate. The risk of kidney damage due to cyclosporine is increased by concomitant administration of certain NSAIDs. This effect can also not be excluded for the combination of cyclosporine and acemetacin. NSAIDs such as [Invented Name] may increase the effects of anti-coagulants (anti-clotting medicinal products, e.g. warfarin) Interactions between certain NSAIDs and oral antidiabetic agents have been observed. Although such interactions have not been described for acemetacin and sulfonylureas your f blood glucose should be monitored during concomitant use. Medicinal products containing probenecid or sulfinpyrazone may delay the elimination of acemetacin. Furosemide (a diuretic agent) accelerates the elimination