• Brand:SOPHARMA
• Code:
  999412

PRODUCT INFORMATION Tempalgin contains the active substances Metamizole sodium and triacetone-4-toluensulfonate. The non-narcotic analgesic Metamizole sodium inhibits prostaglandin synthesis, and triacetone-4-toluensulfonate reduces motor arousal and has a calming effect.

Contraindications: Do not take Tempalgin if you have an allergy to the active substances or any of the other ingredients of the medicine. Do not take Tempalgin if you are allergic to other pyrazole products or suffer from acute hepatic porphyria and congenital glucose-6-phosphate dehydrogenase (an inherited disease with impaired red cell formation). Do not take Tempalgin if you have severe liver and kidney disease or impaired bone marrow function (after cytostatic treatment). Do not take for blood diseases (aplastic anaemia, agranulocytosis) and blood pressure with values below 100 mm Hg (low blood pressure). It is not recommended to take Tempalgin during pregnancy and lactation. Do not use in children under 15 years of age. Stop using Tempalgin if you have symptoms of liver problems such as nausea, vomiting, fever, feeling tired, loss of appetite, dark urine, light stools, yellowing of the skin, yellowing of the white part of the eyes, itching and rash, pain in the upper abdomen. Stop using Tempalgin if you have symptoms of serious skin reactions, including Stevens –Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia, and systemic symptoms (DRESS). If you develop such severe skin reactions, you should never use Tempalgin.

Taking other medicines: Treatment with Tempalgin may be affected if you take concomitant medicines that depress the central nervous system, painkillers, anti-inflammatory drugs, contraceptives, coumarin anticoagulants, chlorpromazine, chloramphenicol, ciclosporin and sleeping medicines. Metamizole may reduce the effect of Aspirin (acetylsalicylic acid), bupropion, Efavirenz, methadone, valproate, tacrolimus and sertraline, therefore caution should be used.

Food, drink and alcohol intake: The tablets should be taken with water, preferably after meal. Alcohol should not be used during treatment with Tempalgin, due to the possibility of increasing the possibility of adverse effects of the drug.

Pregnancy and lactation: If you are pregnant, think you are pregnant or breast-feeding you should consult a doctor before treatment with Tempalgin. Available data on the use of Metamizole in the first 3 months of pregnancy are insufficient but do not indicate harmful effects to the embryo. In general, it is not recommended to take the drug in the first and second trimester of pregnancy. During the third trimester, Tempalgin should not be taken because of an increased risk of complications in the mother and child. When breast-feeding, Metamizole should be avoided because its breakdown products pass into breast milk. If it is still used once, it is recommended that the mother discard breast milk within 48 hours of taking Tempalgin.

Driving and using machines: Do not drive or use machines while taking Tempalgin because it reduces the ability to concentrate and slows down conditioned reflexes.

Tempalgin contains wheat starch and sodium: The wheat starch in the medicine contains very small amounts of gluten (it is considered gluten-free), therefore it is unlikely to cause problems if you have a gluten intolerance. One tablet contains no more than 9.5 μg gluten. If you have an allergy to wheat, do not take Tempalgin.

Each Tempalgin tablet contains 32.7 mg sodium (the main ingredient of table salt). This is equivalent to 1.6% of the recommended maximum daily intake of sodium for an adult.

Method of use: For oral use. The tablets are taken with water, preferably after a meal. Do not take Tempalgin for more than 3 to 5 days without consulting a doctor.

Adults: 1 tablet, 1 to 3 times a day depending on the severity of symptoms. For dental manipulations: 1 tablet 30 minutes before the intervention.

Children over 15 years: 1 tablet per day.

Overdose and dose omission: If you take more than the recommended dose, contact a doctor immediately. Nausea, dizziness, abdominal pain, tiredness, loss of consciousness, severely decreased blood pressure and heart rhythm disturbances may occur. If you forget to take a dose, take it when you have identified the deficiency. If the next dose is approaching, skip the forgotten dose and continue as recommended. Do not take a double dose to make up for a forgotten dose.

Possible side effects: If side effects occur, discontinue treatment with Tempalgin immediately and consult a doctor. Adverse reactions are more often due to Metamizole sodium. These are nausea, vomiting, fever, feeling tired, loss of appetite, dark urine, light burns, yellowing of the skin, yellowing of the white part of the eyes, itching and rash, upper abdominal pain, heart rhythm disturbances, hypersensitivity reactions, headache.

Ingredients in 1 tablet: Active substances: Metamizole sodium-500 mg, triacetonamine - 4 – toluenesulfonate – 20 mg.

Other ingredients: Wheat starch, microcrystalline cellulose (type 101), magnesium stearate, talc, povidone K25. Film coating: FALLRAI. 85 .21526 Green (polyvinyl alcohol – partially hydrolyzed, macrogol, talc, E171, E104, E133).

What Tempalgin looks like: Round, double-recessed film-coated tablets of green color, 13 mm in diameter. Blister contains 10 film-coated tablets (2 blisters in each carton).

Storage: Store at room temperature without direct sunlight. Keep out of the reach of children.