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Package Leaflet: Information for the User PACKAGE LEAFLET 1 Package Leaflet: Information for the user <Invented Name> 500 mg tablets metamizole sodium 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> belongs to the pyrazolone group of medicines and has pain-killing and fever reducing properties. <Invented Name> 500 mg tablets are indicated in adults and children aged 10 years and older and may be applied for the treatment of - acute, severe pain following injuries or surgery, - griping abdominal pain (colic), - cancer-related pain (tumour pain), - other acute or chronic severe pain, where other therapeutic measures are not indicated, - high fever that does not respond to other measures. 2. What you need to know before you take <Invented Named> Do not use <Invented Name> - if you are allergic to metamizole sodium or other pyrazolones (e.g. phenazone, propyphenazone) or pyrazolidines (e.g. phenylbutazone, oxyphenbutazone) - this also includes patients who have experienced e.g. a marked decrease of certain white blood cells (agranulocytosis) after using these agents - if you are allergic to any of the other ingredients of this medicine (listed in section 6), - if you have a known intolerance to painkillers (analgesic asthma syndrome or urticaria/angio- oedema-type analgesic intolerance). This applies to patients who experience bronchospasm (sudden constriction of the lower airways) or other hypersensitivity reactions such as itching, runny nose and swelling (urticaria, rhinitis, angioedema) when exposed to painkillers such as salicylates and paracetamol, or diclofenac, ibuprofen, indomethacin, naproxen etc., - if you have bone marrow dysfunction (e.g. after treatment with cytostatics given to treat cancer) or if you have blood formation disorders (of the haematopoietic system), - if you have congenital glucose-6-phosphate dehydrogenase deficiency (a hereditary disease associated with a risk of red blood cell disintegration), - if you have acute intermittent hepatic porphyria (a hereditary disease associated with disturbances of hemoglobin formation), - in the last three months of pregnancy, - if you are breast-feeding - in children below 10 years of age. Warnings and precautions Talk to your doctor or pharmacist before taking <Invented Name> - if you show hypersensitivity (anaphylactic reactions) to <Invented Name>; you are also at particular risk of responding in the same way to other painkillers. - if you show allergic or any other (immunologically-mediated) defence reactions to <Invented Name> (e.g. agranulocytosis), you are also at particular risk of responding in the same way to other pyrazolones and pyrazolidines (chemically related substances). - if you experience signs of agranulocytosis, pancytopenia or thrombocytopenia, you must stop using <Invented Name> film-coated tablets immediately and visit your doctor immediately (see section 4. Possible side effects). <Invented Name> contain metamizole, a pyrazolone derivative, and carry rare but life-threatening risks of shock (sudden circulatory failure) and agranulocytosis (severe disease due to a marked decrease of certain white blood cells). Severe hypersensitivity reactions (anaphylactoid or anaphylactic reactions) If you have any of the following disorders/intolerances, the risk of severe hypersensitivity reactions to <Invented Name> may be significantly increased: - Intolerance to non-steroidal anti-inflammatory drugs (used to treat pain and rheumatism), with symptoms such as itching and swelling (urticaria, angio-oedema), so called analgesic asthma syndrome or urticaria/angio-oedema-type analgesic intolerance, see section 2 Do not use <Invented Name> film-coated tablets). - Attacks of breathlessness due to constriction of the bronchioles (bronchial asthma), particularly if you are also suffering from nasal and sinus inflammation (rhinosinusitis) and nasal polyps. - Chronic nettle rash (urticaria). - Hypersensitivity to colouring agents (e.g. tartrazine) or preserving agents (e.g. benzoates). - Alcohol intolerance, whereby you react to even small amounts of alcohol with sneezing, streaming eyes and severe facial redness. Such alcohol intolerance may be a sign of an as-yet undiagnosed intolerance to painkillers (see section 2 Do not use <Invented Name> film-coated tablets). Before using <Invented Name> the patient must be asked whether any of the above apply. In patients at increased risk of hypersensitivity reactions, <Invented Name> may only be used after careful consideration of the possible risks and the expected benefits. If <Invented Name> is given in such cases, the patient must be kept under close medical surveillance, with emergency facilities readily available. Anaphylactic shock particularly may occur in sensitive patients (see section 4 Possible side-effects). Therefore, special care has to be taken in patients with asthma or a certain disposition to hypersensitivity (atopy). Severe skin reactions Life-threatening skin reactions (Stevens-Johnson-syndrome, toxic epidermal necrolysis) have been reported following use of Metamizole sodium. If you experience rash, frequently associated with blisters or mucosal damage, you must immediately stop treatment with <Invented Name> film-coated tablets. You must not restart treatment with metamizole sodium at any time (see section 4. Possible side effects). Fall in blood pressure (isolated hypotensive reaction) <Invented Name> tablets may trigger falls in blood pressure (isolated hypotensive reactions see section 4. Possible side effects). This risk is increased: - if you suffer from low blood pressure (pre-existing hypotension), if you are severely dehydrated or have poor blood circulation, or in the early stages of circulatory failure (e.g. in cases of heart attack or severe injuries), - if you have a high fever. Your doctor will carefully weigh up the use and will closely monitor you. Preventive measures (stabilisation of blood circulation) may be taken if necessary, in order to reduce the risk of any drop in blood pressure. If it is crucial that you avoid any fall in blood pressure (e.g. if you have severe coronary heart disease or any relevant narrowing [stenosis] of the blood vessels, i.e. restricting the blood supply to the brain), <Invented Name> may only be used under careful monitoring of your blood circulation. Patients with impaired kidney or liver dysfunction If you have kidney or liver dysfunction, <Invented Name> should only be used after careful consideration of the benefits and risks, together with appropriate precautions (see section 3 Impaired kidney or liver function). Older People In the case of elderly patients, excretion of the metabolic products of <Invented Name> may be delayed (see section 3 Older People). Other medicines and Metamizole sodium Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines: <Invented Name> film-coated tablets may lead to a decrease of cyclosporin serum levels (used to supress the immune system). These levels must therefore be monitored if metamizole tablets are taken at the same time. Simoultaneous use of metamizole sodium and methotrexate (used to treat cancer or certain rheumatic diseases) may intensify the potential of methotrexate to damage blood formation, especially in older patients. This combination therefore should be avoided. Metamizole may decrease the effect of acetylsalicylic acid (ASA) on platelets. If you apply acetylsalicylic acid in low doses for heart protection, metamizole film-coated tablets should be applied with caution. Metamizole may decrease blood levels of bupropion (used to treat depression and for smoking cessation). Caution should be exercised if bupropion and metamizole film-coated tablets are applied simultaneously. Excessively low body temperature (hypothermia) may occur if metamizole film-coated tablets and chlorpromazine (used to treat symptoms of mental illness) are applied simultaneously. The following interactions are known for the class of substances of pyrazolones (to which also <Invented Name> belongs): - medicines to prevent the blood from clotting (oral anticoagulants), - Captopril (medicine for high blood pressure and certain heart diseases),, - Lithium (medicine to treat mental illness), - medicines to increase urine output (diuretics, e.g. triamterene) - medicines to treat high blood pressure (antihypertensive agents). It is not known to which extent also <Invented Name> may cause such interactions. Taking <Invented Name> with alcohol You should avoid drinking alcohol during treatment with <Invented Name>. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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