Package leaflet: Information for the user <invented name> 500 mg/ml oral drops, solution metamizole sodium monohydrate 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 that contains metamizole sodium monohydrate. It belongs to a group of medicines called pyrazolones and is used for pain and fever. <invented name> is used for: acute severe pain from trauma or surgical operations colic (spasmodic stomach pain) tumour pain (cancer pain) other acute or chronic severe pain if other treatments cannot be used high fever that does not respond to other measures 2. What you need to know before you take <invented name> DO NOT take <invented name>: if you are allergic to metamizole sodium, propyphenazone, phenazone, phenylbutazone or any of the other ingredients of this medicine (listed in section 6) if you suffer from a known analgesic asthma syndrome or known analgesic intolerance of the urticaria/angiooedema type, i.e. patients who react with bronchospasm or other anaphylactoid types of reaction to salicylates, paracetamol or other non-narcotic analgesics, such as diclofenac, ibuprofen, indomethacin or naproxen if you have a bone marrow function disorder, e.g. after treatment with cytostatic medicines (medicines that treat cancer) if you have diseases of blood formation (diseases of the haematopoietic system) if you suffer from a genetic glucose-6-phosphate dehydrogenase deficiency (a hereditary defect with the risk of red blood cells breaking down) if you suffer from acute hepatic porphyria (hereditary disorder with disturbances in haemoglobin synthesis) if you are in the last three months of pregnancy Warnings and precautions Talk to your doctor or pharmacist before taking <invented name>: if you have a known intolerance to pain relievers (analgesic intolerance) if you suffer from allergy-induced bronchial asthma (attacks of shortness of breath due to an allergy) if you suffer from diseases associated with a reduced white blood cell count if your kidney function is impaired if you have known allergies, since you then have an increased tendency to a shock reaction (sudden circulatory collapse) if you suffer from any disease that is possibly caused by allergies (including events in your medical history), since you then have an increased tendency to a shock reaction This particularly affects patients with: bronchial asthma (shortness of breath caused by constriction of the smallest airways) and chronic (long- term) inflammation of the respiratory tract chronic urticaria (hives) allergy to painkillers and rheumatoid arthritis relievers (analgesic intolerance) or other medicines allergies to food, preservatives, alcoholic beverages allergy to fur or hair dye If you belong to any of these patient groups, you should take <invented name> only under a doctor’s supervision. The risk of a shock reaction is lower with metamizole sodium tablets or drops than if a medicine that contains metamizole sodium is applied with a syringe. <invented name> should be used only after careful consideration has been given to the benefit versus risk ratio and only if appropriate precautions are taken in patients with impaired renal or hepatic function. Warning <invented name> contains the pyrazolone derivative metamizole sodium, which has the rare, but life-threatening, risk of shock (sudden circulatory collapse) and of agranulocytosis (acute disorder caused by a severe reduction in the count of specific white blood cells; see section 4.). Other medicines and <invented name> Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Which other medicines influence the action of <invented name>? The pyrazolone class of active substances (to which also belongs metamizole sodium) has a known potential to cause interactions with - chlorpromazine (used to treat certain symptoms of mental illness). Combination of metamizole and chlorpromazine can cause severe hypothermia (excessively low body temperature). - medicines to prevent the blood from clotting (oral anticoagulants) - medicines for high blood pressure and certain heart diseases (captopril) - medicines to treat mental illness (lithium) - medicines to treat cancer or certain rheumatic disorders (methotrexate) - medicines to increase urine output (triamterene) - antihypertensive agents (used to treat high blood pressure) and diuretics (water tablets) as it can alter the effectiveness of these medicines Metamizole sodium may decrease the effect of acetylsalicylic acid (ASA) on the blood platelets. If you use low-dose acetylsalicylic acid for heart protection, use <invented name> with caution. On what other medicines does <invented name> have an effect? Metamizole sodium can reduce blood levels of ciclosporin (a medicine for suppressing the immune system). If taken at the same time, your dosage of ciclosporin may need to be increased. 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. Pregnancy Available data on the use of metamizole during the first three months of pregnancy is limited but do not indicate harmful effects to the embryo. In selected cases when no other treatment options exist, single doses of metamizole during the first and second trimester might be acceptable after consultation with your doctor or pharmacist and after the benefits and risks of metamizole use have been carefully weighed up. However, in general, the use of metamizole during the first and second trimester is not recommended. During the last three months of pregnancy you must not take <invented name> because of an increased risk of complications for the mother and child (haemorrhaging, premature closure of an important vessel, the so-called Ductus Botalli, of the unborn, which naturally closes only after birth). Breast-feeding The breakdown products of metamizole pass into breast-milk in considerable amounts and a risk to the breast-fed infant cannot be excluded. Especially the repeated use of metamizole during breast-feeding must therefore be avoided. In case of a single administration of metamizole, mothers are advised to collect and discard the breastmilk for 48 hours after the dose. Driving and using machines Taking higher amounts of <invented name> can affect the brain. In this situation you would no longer be able to react quickly and effectively to unexpected and sudden events. Do not drive a car or any other vehicle. Do not operate electrical tools or machines. Do not work unsecured. Please note that alcohol further impairs your ability to drive! However, in the recommended dosage range (see dosage table in section 3.) no special precautionary measures are necessary. <invented name> contains sodium This medicine contains 33.4 mg sodium (main component of cooking/table salt) in each ml (20 drops). This is equivalent to 1.7 % of the recommended maximum daily dietary intake of sodium for an adult. 3. How to take <invented name> Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dosage is depended on the intensity of the pain or fever and the individual’s sensitivity of response to <invented name>. The lowest dose needed to control pain and fever should always be selected. Your doctor will tell you how to take <invented name>. The following table shows recommended single doses and maximum daily doses depending on weight or age: Body weight Single dose Daily maximum dose kg age drops mg drops mg < 9 < 12 months 1-5 25-125 4-20 100-500 9-15 1-3 years 3-10 75-250 12-40 300-1,000 16-23 4-6 years 5-15 125-375 20-60 500-1500 24-30 7-9 years 8-20 200-500 32-80 800-2,000 31-45 10-12 years 10-30 250-750 40-120 1,000-3,000 46-53 13-14 years 15-35 375-875 60-140 1,500-3,500 > 53 ≥ 15 years 20-40 500-1,000 80-160 2,000-4,000 Single doses can be given up to four times a day, depending on the maximum daily dose. A clear effect can be expected 30 to 60 minutes after oral administration. Elderly and patients in poor general health/with renal impairment The dose should be reduced in elderly people, in debilitated patients and in those with reduced renal function, as excretion of the breakdown products of metamizole may be delayed. Patients with impaired kidney or liver function As the rate of elimination is reduced in patients with impaired kidney or liver function, repeated high doses should be avoided. No dose reduction is required with short-term use only. There is no experience available with long-term use. Use in children and adolescents For the treatment of pain children and adolescents up to 14 years old can take from 8 to 16 mg of <invented name> per kilogram body weight as an individual dose (see table above). In the case of fever, a dose of 10 mg of <invented name> per kilogram body weight is generally sufficient for children: Body weight Single dose kg age drops mg < 9 < 12 months 1-3 25-75 9-15 1-3 years 4-6 100-150 16-23 4-6 years 6-9 150-225 24-30 7-9 years 10-12 250-300 31-45 10-12 years 13-18 325-450 46-53 13-14 years 18-21 450-525 Route /method of administration This medicine is for oral use.