TEMPALGIN x 10 tabl Sofarma
Tempalgin for headache and toothache 500 mg/ 20 mg 10 tablets Sopharma is an over-the-counter medicine, distinguished by its formula with metamizole sodium and triacetonamine-4-toduenesulfonate. Tempalgin for headache and toothache 500 mg/ 20 mg 10 tablets Sopharma provides a strong and long-lasting analgesic effect thanks to the non-narcotic analgesic metamizole sodium, which inhibits the synthesis of prostaglandin. The product reduces motor excitement and provides a relaxing effect. The medicine is recommended for mild or moderate pain such as in cases of headache, toothache, muscle pain, neuralgia, joint pain, etc. For adults and children over 15 years of age.
Before taking Tempalgin it is good to know
Do not take Tempalgin:
if you are allergic to any of its ingredients;
if you suffer from hypersensitivity to other pyrazolone products;
if you have acute hepatic porphyria (an inherited disease with impaired red blood cell formation);
if you suffer from congenital glucose-6-phosphate dehydrogenase deficiency (an inherited disease with impaired erythrocyte formation);
with severe kidney or liver health problems;
if you suffer from impaired bone marrow function (after cytostatic treatment) or blood diseases such as: aplastic anemia (reduction in the number of blood cells, which leads to weakness, bruising or an increased likelihood of infection), agranulocytosis (severe reduction in the number of white blood cells, which increases the likelihood of infections), leukopenia (reduction in the total number of white blood cells);
with low blood pressure (below 100 mm Hg);
if you are pregnant or breastfeeding;
if you are a child under 15 years of age.
Warnings and precautions
Liver inflammation has been reported in patients taking metamizole, with symptoms developing within a few days to a few months after the start of treatment.
Stop using Tempalgin and contact a doctor if you have symptoms of liver problems such as nausea or vomiting, fever, feeling tired, loss of appetite, dark urine, light-colored stools, yellowing of the skin or whites of the eyes, itching, rash, or pain in the upper abdomen. Your doctor will check your liver function.
You should not take Tempalgin if you have previously taken a medicine containing metamizole and have had liver problems.
Serious skin reactions
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with metamizole treatment. Stop using metamizole and seek medical attention immediately if you notice any of the symptoms associated with these serious skin reactions.
If you have ever developed severe skin reactions, you should never start treatment with Tempalgin again.
Other medicines and Tempalgin
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The treatment may be affected if you simultaneously take medications that depress the central nervous system, painkillers, anti-inflammatory drugs, contraceptives, coumarin anticoagulants (reduce blood clotting), chlorpromazine (for the treatment of mental illnesses), chloramphenicol (antibiotic), cyclosporine (for tumor diseases), and sleeping pills.
Metamizole (a pain and fever reducer) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cell clumping and blood clot formation) when taken simultaneously. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection (prevention).
Metamizole should be used with caution with the following medicines as it may reduce their effect:
bupropion, a medicine used to treat depression or as an aid to stop smoking;
efavirenz, a medicine used to treat HIV/AIDS;
methadone, a medicine used to treat addiction to illicit substances (so-called opioids);
valproate, a medicine used to treat epilepsy or bipolar disorder;
tacrolimus, a medicine used to prevent organ rejection in transplant patients;
sertraline, a medicine used to treat depression.
Tempalgin with food, drink and alcohol
The tablets are taken with water, preferably after a meal.
During treatment with Tempalgin, alcohol consumption is not recommended due to the possibility of enhancing the undesirable effects of the drug.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The available data on the use of metamizole during the first 3 months of pregnancy are limited, but do not indicate harmful effects on the embryo. In certain cases, when there are no other treatment options, it is possible to accept the use of single doses of metamizole during the first and second trimesters after consultation with a doctor and after careful assessment of the benefits and risks of using metamizole. However, the use of metamizole during the first and second trimesters is not recommended. You should not take Tempalgin during the last three months of pregnancy due to an increased risk of complications for the mother and child (bleeding, premature closure of an important blood vessel, the so-called ductus Botali in the unborn child, which closes naturally only after birth).
Breastfeeding
Metamizole degradation products pass into breast milk in significant quantities and a risk to the suckling child cannot be excluded. Therefore, repeated use of metamizole during breastfeeding should be avoided. In the case of a single administration of metamizole, mothers are advised to collect and discard breast milk for 48 hours after administration of the dose.
Driving and using machines
Do not drive or use any tools or machines, as Tempalgin reduces the ability to concentrate and slows down conditioned reflexes.
Tempalgin contains wheat starch
The wheat starch in this medicine contains only very small amounts of gluten, is considered gluten-free and is unlikely to cause problems if you have coeliac disease (gluten intolerance). One tablet contains no more than 9.5 micrograms of gluten. If you have a wheat allergy (a condition other than coeliac disease), you should not take this medicine.
Tempalgin contains sodium
This medicine contains 32.7 mg sodium (main ingredient of cooking/table salt) in each tablet. This amount is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.
Possible side effects
Like all medicines, this can cause side effects, although not everybody gets them. When using Tempalgin, the possible side effects are more often due to metamizole sodium.
Stop using Tempalgin and contact a doctor immediately if you experience any of the following symptoms: nausea or vomiting, fever, feeling tired, loss of appetite, dark urine, light-colored stools, yellowing of the skin or whites of the eyes, itching, rash, or upper abdominal pain. These symptoms may be signs of liver damage.
The following side effects may have serious consequences. Do not take Tempalgin again and consult a doctor immediately.
Stop using metamizole and seek medical help immediately if you notice any of the following serious side effects: reddish, flat, target-like or circular spots on the torso, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes, widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
The following may be observed:
blood disorders such as agranulocytosis (a severe reduction in the number of white blood cells, which increases the likelihood of infections), leukopenia (a reduction in the number of white blood cells, which increases the likelihood of infections), aplastic anemia (a severe reduction in the number of blood cells, which leads to weakness, bruising or an increased likelihood of infections), thrombocytopenia (a reduction in the number of platelets, which increases the risk of bleeding or bruising), hemolytic anemia (a reduction in the number of red blood cells, which can lead to pale or yellowing of the skin, weakness or shortness of breath);
nausea, vomiting, abdominal pain and discomfort, in rare cases ulceration and bleeding;
kidney damage such as the appearance of protein in the urine, decreased or increased urine output, inflammation of the kidneys;
heart rhythm disturbances, low blood pressure;
hypersensitivity reactions (anaphylactic or anaphylactoid reactions) - itching, burning, redness of the skin, urticaria, swelling (generalized or local), difficulty breathing, asthma attack (in patients with analgesic asthma), angioedema (including laryngeal), circulatory shock;
nervous system disorders such as headache, dizziness;
liver disorders - inflammation of the liver, yellowing of the skin and whites of the eyes, increased levels of liver enzymes in the blood; cholestasis (impaired bile flow), hyperbilirubinemia (high levels of bilirubin in the blood).
If any of the side effects gets serious or you notice any other side effects not listed here, please tell your doctor or pharmacist.
