PACKAGE LEAFLET
1 Package Leaflet: Information for the user
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
1. What
2. What you need to know before you take
Do not use
- 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
Severe hypersensitivity reactions (anaphylactoid or anaphylactic reactions) If you have any of the following disorders/intolerances, the risk of severe hypersensitivity reactions to
Before using
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
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)
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),
Patients with impaired kidney or liver dysfunction If you have kidney or liver dysfunction,
Older People In the case of elderly patients, excretion of the metabolic products of
Other medicines and Metamizole sodium
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
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
- 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
Taking
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 As no adequate experience is available for humans, you should not take
During the last three months of pregnancy, you must not take
Breast-feeding As the breakdown products of
Driving and using machines
Within the recommended dose range, there are no known adverse effects on responsiveness and the ability to concentrate. However, as a precaution, you should consider the possibility of such adverse effects - at least, at higher doses - and refrain from using machines, driving vehicles and engaging in other hazardous activities. This particularly applies if you have been consuming alcohol.
Important information about some of the ingredients of
3. How to take
Always take
If not otherwise prescribed by your doctor, the recommended dose is:
Dosage is dependent on the intensity of pain or fever and the individual’s sensitivity/response to this medicine. Your doctor will tell you how to take
- A significant effect can be expected 30 to 60 minutes after taking the tablets. - For children and adolescents up to 14 years of age a single dose of 8 to 16 mg metamizole sodium monohydrate per kg body weight may be given. - Adults and adolescents from 15 years of age on (> 53 kg) may apply single doses up to 1000 mg. - If the effect is insufficient, single doses can be given up to four times a day, depending on the maximum daily dose. The following dosage table contains the recommended single doses and maximum daily doses.
Age Single dose Maximum daily dose (body weight) 10-14 years 1 film-coated tablet
Older people The dose should be reduced for elderly patients, as excretion of the metabolites of
Patients in poor general health/with reduced creatinine clearance For patients in poor general health/with reduced creatinine clearance, the dose should be reduced, as excretion of the metabolites of this medicine may be delayed.
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.
Method of administration Oral use. It is recommended that the tablets are swallowed whole and with sufficient fluid (e.g. a glass of water).
Duration of treatment Duration of treatment will depend on the nature and severity of your illness and will be determined by your doctor. It is recommended that painkillers be taken for no more than 3 to 5 days, unless you have specifically sought further advice from a doctor or dentist.
If you take more
Taking too many
If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.
Note: After very high doses, excretion of a harmless metabolite (rubazonic acid) may cause red discolouration of the urine.
If you forget to take
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines,
The following side effects may have serious consequences; stop taking
If signs of agranulocytosis, pancytopenia or thrombocytopenia (see below) occur, the application of
Possible side effects
Uncommon (may affect up to 1 in 100 people) - Purple to deep red, partly blistering skin rash (fixed drug eruption). - A drop in blood (isolated hypotensive reaction). This may be a direct drug effect and not accompanied by other signs of hypersensitivity reactions. Such a reaction only rarely leads to a severe fall in blood pressure. The risk of a hypotensive reaction may be increased in the case of pronounced high fever (hyperpyrexia). Typical symptoms of a rapid fall in blood pressure are palpitations, paleness, trembling, dizziness, nausea and unconsciousness.
Rare side effects (may affect up to 1 in 1,000 people) - Hypersensitivity reactions (anaphylactoid or anaphylactic reactions). Milder reactions typically take the form of irritated eyes, coughing, runny nose, sneezing, chest tightness, skin reddening (especially in the face and the head), nettle rash and swelling in the face and - more rarely - nausea and stomach cramps. Special danger signals are burning sensation, itching and a sensation of heat on the tongue/below the tongue and - especially - on the palms of the hand and feet. Such mild reactions can progress to more severe reactions with pronounced nettle rash, severe angioedema (swelling, also in the area of the larynx), severe bronchospasm (crampy narrowing of the lower airways), palpitations (sometimes also slow pulse rate), heart arrhythmia, a drop in blood pressure (sometimes also with a preceding rise in blood pressure), unconsciousness and circulatory shock. These reactions may also arise after several applications without complications and may be severe up to life-threatening, sometimes even fatal. Patients with analgesic-asthma syndrome usually manifest intolerance in the form of asthma attacks (see section 2 Do not use
Very rare side effects (may affect up to 1 in 10,000 people) - Severe decrease of certain white blood cells (agranulocytosis), including cases with fatal outcome or decrease of platelets (thrombocytopenia). These reactions presumably are of immunological nature. They can also occur if metamizole was used previously without complications. There a single hints that the risk of agranulocytosis may be increased if
Not known: frequency cannot be estimated from the available data - Anaphylactic shock. - Heart attack as a symptom of allergic reaction (Kounis-syndrome). - Anaemia with concomitant disturbance of bone marrow function (aplastic anemia), reduction of white and red blood cells and platelets (pancytopenia), including cases with fatal outcome. General indisposition, infection, persisting fever, bruises, bleedings and paleness may be signs of pancytopenia and aplastic anemia.
Due to a harmless metabolite of metamizole sodium (rubazonic acid) red discoloration of the urine can occur. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What
- The active substance is metamizole sodium. - Each tablet contains 500 mg metamizole sodium. - The other ingredients are mannitol, hydroxypropylcellulose, crospovidone (Type A), croscarmellose sodium and magnesium stearate.
What
Marketing Authorisation Holder and Manufacturer
<[To be completed nationally]>
This medicinal product is authorised in the Member States of the EEA under the following names:
DE/H/2425/001/DC Germany: Metamizol AbZ 500 mg Tabletten Hungary: Optalgin
DE/H/3089/001/DC Germany: Metamizol-CT 500 mg Tabletten. Lithuania: Metamizole Teva
This leaflet was last revised in {MM/YYYY}. <[To be completed nationally]>