Package leaflet: Information for the user
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 take
Warnings and precautions
Please consult your doctor or pharmacist before taking
Severe hypersensitivity reactions (Anaphylactic/anaphylactoid reactions) You should not take
If you have any of the following disorders/intolerances, the risk of severe hypersensitivity reactions to
In patients at increased risk of hypersensitivity reactions,
Especially hypersensitive patients may experience an anaphylactic reaction. Therefore patients suffering from asthma or showing disposition of hypersensitivity reactions (atopia) should exercise extreme caution. Severe skin reactions The life-threatening skin reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported during the use of metamizol sodium. If signs or symptoms (progressive rash, often combined with blisters or lesions of mucosa) of SJS or TEN develop, treatment with
Hypotensive reactions
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 severe hepatic and renal impairment If you have kidney or liver dysfunction,
Elderly people In elderly people the elimination rate of the metabolites of metamizole sodium may be reduced.
Children Children who are younger than 10 years old or weigh less than 32 kg should not be given medicines that contain metamizole sodium because there are no scientific experiences available on the safety of its use.
Other medicines and
Which other medicines influence the action of
On what other medicines does
Pregnancy Because no adequate experience is available, you should not use
Breast-feeding The breakdown products of metamizole pass into breast-milk. No adequate data about the effects on breast-fed infants are available. You must not nurse while taking
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.
3. How to take
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage is determined by the intensity of the pain or fever and individual sensitivity of response to
Adolescents of 15 years of age or older (> 53 kg) and adults can take up to 1,000 mg metamizole sodium monohydrate as a single dose. In dependence on the daily maximum dose a single dose can be taken up to 4 times daily at intervals of 6–8 hours. A clear effect can be expected 30 to 60 minutes after oral administration.
The following table shows recommended single doses and maximum daily doses depending on weight or age:
Body weight / Age Single dose Daily maximum dose kg age tablets mg tablets mg 32-53 10-14 years 1 500 4 2,000 more than 53 more than 15 years 1-2 500-1,000 8 4,000 Paediatric population In the case of fever, a dose of 10 mg metamizole per kilogram body weight is generally sufficient for children. In the case of children and adolescents up to 14 years old, 8 to 16 mg metamizole sodium monohydrate per kilogram body weight is to be administered as an individual dose.
Older people, debilitated patients, and patients with reduced creatinine clearance The dose should be reduced in older people, in debilitated patients and in those with reduced creatinine clearance, as elimination of the metabolic products of metamizole sodium may be prolonged.
Patients with severe hepatic and renal impairment As the elimination rate is reduced when renal or hepatic function is impaired, multiple high doses should be avoided. No dose reduction is needed when used for only a short time. To date, there has been insufficient experience with long-term use of metamizole sodium in patients with severe hepatic and renal impairment.
Method of administration
This medicine is for oral use. The tablets should be taken in whole and with sufficient fluid (e.g. a glass of water).
Duration of use
The duration of treatment depends upon the nature and severity of your disease and will be determined by your doctor. It is recommended to use painkillers for not more than 3 to 5 days, unless you have specifically sought further advice from a doctor or dentist.
If you take more
In case an overdose has occurred contact your doctor immediately so that appropriate countermeasures can be initiated.
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 medicine, ask your doctor or pharmacist. 4. Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them. If you are affected by any of the following side effects, stop taking
The most common side effects of
Uncommon side effects (may affect up to 1 in 100 people)
Skin and mucous membrane reactions Violet to dark- red skin rash (fixed drug eruptions), sometimes with vesicles
Reactions with a drop in blood pressure Drop in blood pressure (isolated hypotensive reaction), which possibly is caused by a direct effect of the medicinal product and is not accompanied by other signs of hypersensitivity reactions. Only in rare cases such a reaction results in a severe drop in blood pressure. The risk of a drop in blood pressure may be increased in patients with very high fever (hyperpyrexie). Typical signs of a severe drop in blood pressure are: increased heart rate, paleness, tremble, dizziness, nausea and unconsciousness.
Rare side effects (may affect up to 1 in 1,000 people)
Allergic (hypersensitivity) reactions Hypersensitivity reactions are rare and they very rarely (may affect up to 1 in 10,000 people) take a severe and life-threatening course. These can develop immediately after taking the medicine or hours later. They occur predominantly in the initial hour after the medicine has been taken.
Symptoms of mild allergic (hypersensitivity) reactions are: - skin and mucous membrane reactions (such as itching, burning, redness, hives, swelling) - shortness of breath - gastrointestinal complaints (such as nausea, digestive problems, vomiting)
Such mild reactions can progress into more severe forms: - hives that cover the entire body - severe swelling of the skin and mucous membranes (angio-oedemas; including around the larynx) - severe cramping of the bronchial muscles - cardiac arrhythmias - drop in blood pressure (sometimes preceded by a rise in blood pressure) - circulatory shock
Patients who have asthma that is caused by pain relievers (analgesic-asthma syndrome) usually manifest intolerance in the form of attacks of shortness of breath.
Skin and mucous membrane reactions Skin rush (maculopapulous exanthema) Reaction of organs and tissues that make blood (haematopoietic system) Rarely leukopenia (reduced white blood cell count in the blood) develop.
These reactions can also occur even if metamizole sodium was used previously without complications. Immediate discontinuation of the medicine is crucial for recovery.
Very rare side effects (may affect up to 1 in 10,000 people)
Reaction of organs and tissues that make blood (haematopoietic system) Very rarely (may affect up to 1 in 10,000 people) agranulocytosis (reduced count of certain white blood cells) or thrombocytopenia (reduced platelet count in the blood) develop. These reactions can also occur even if metamizole sodium was used previously without complications. The risk of agranulocytosis increases if metamizole sodium is used for longer than a week.
Typical signs of agranulocytosis include - inflammatory changes to the mucous membranes (e.g. in the mouth, nose and throat area and the genital or anal area) - sore throat - difficulty in swallowing - high fever - chills - lymph node swelling may be mild or absent In patients who are taking antibiotics (medicines that combat infection), these signs could, however, be minimal. An unexpected worsening of your general health can be an indication of agranulocytosis.
Immediate discontinuation of the medicine is crucial for recovery. If there are signs of agranulocytosis, it is therefore strongly recommended that
Skin and mucous membrane reactions Very rarely skin reactions like Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) may develop.
If signs or symptoms (progressive rash, often combined with blisters or lesions of mucosa) of SJS or TEN develop, treatment with
Other reactions Very rarely, particularly in the case of reduced blood volume in the circulatory system, a history of kidney disease, or an overdose the following reactions may occur: - impaired kidney function with too little or no urine - excretion of blood protein in the urine - kidney inflammation
Unknown side effects (frequency cannot be estimated from the available data)
Allergic (hypersensitivity) reactions Anaphylactic shock Seek immediate medical attention at the first signs of shock, such as: - cold sweat - dizziness - light-headedness - skin discoloration - chest tightness
Reaction of organs and tissues that make blood (haematopoietic system) Aplastic anemia (anemia with concomitant bone marrow dysfunction) and panzytopenia (concomitant anemia, reduced blood cell count and reduced platelet count in the blood), including cases with lethal outcome may occur.
Signs of an aplastic anemia and of a panzytopenia are: - general dyscomfort - infection - persistent fever - hematomas - bleeding - paleness
A red discoloration of the urine can be caused by an harmless degradation product of metamizole sodium (rubazonic acid).
Countermeasures
Shock The following are warning signs of shock: cold sweat, dizziness, light-headedness, nausea, skin discoloration and shortness of breath. Other symptoms include swelling of the face, itching, chest tightness, rapid pulse rate, and the sensation of cold in the arms and legs (critical drop in blood pressure). These symptoms can occur even an hour after taking
At the first sign of shock, immediately call a doctor for help. Until a doctor arrives, keep the upper part of the body flat and the legs raised. To prevent a chill, the patient should be kept warm with a blanket.
Agranulocytosis You should no longer take
Call a doctor for help!
Fixed drug eruption A fixed drug eruption is a violet to dark-red skin rash, sometimes with vesicles.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 this medicine 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.
Store in the original package in order to protect from light.
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 other ingredients are pregelatinized maize starch, macrogol 6000, crospovidone (Type A), magnesium stearate and silica, colloidal anhydrous.
What
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last revised in May 2018. [To be completed nationally]