Tempalgin x20 tablets Sopharma

TEMPALGIN tablets * 20 SOPHARMA Leaflet: information for the userTempalgin® 500 mg/20 mg film-coated tabletsTempalgin® 500 mg/20 mg film-coated tabletsmetamizole sodium/triacetonamine-4-toluensulfonate
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. If you do not feel better after 3-5 days or your condition worsens, you should seek medical advice. What this leaflet contains 1. What Tempalgin is and what it is used for 2. What you need to know before you take Tempalgin 3. How to take Tempalgin 4. Possible side effects 5. How to store Tempalgin 6. Contents of the pack and other information
1. What is Tempalgin and what is it used forTempalgin is a combined medicinal product containing the active substances metamizole sodium and triacetonamine-4-toluenesulfonate. It has a pronounced and prolonged analgesic effect due to the non-narcotic analgesic metamizole sodium, which inhibits prostaglandin synthesis. Triacetonamine-4-toluenesulfonate reduces motor agitation and has a calming effect.
Tempalgin is used for short-term symptomatic treatment of mild to moderate pain in the following conditions: headache, toothache and dental procedures, myalgia (muscle pain), neuralgia, arthralgia (joint pain).
2. What you need to know before you take Tempalgin Do not take Tempalgin if you are allergic to the active substances metamizole sodium, triacetonamine-4-toluenesulfonate or any of the other ingredients of this medicine (listed in section 6); if you are hypersensitive to other pyrazolone products; if you suffer from acute hepatic porphyria (an inherited disease with impaired red blood cell formation); if you have congenital glucose-6-phosphate dehydrogenase deficiency (an inherited disease with impaired red blood cell formation); in severe kidney or liver disease; if you have impaired bone marrow function (after cytostatic treatment) or blood diseases such as: aplastic anemia (a decrease in the number of blood cells, which leads to weakness, bruising or an increased likelihood of infection), agranulocytosis (a severe decrease in the number of white blood cells, which increases the likelihood of infection), leukopenia (a decrease in the total number of white blood cells cells); with low blood pressure with values below 100 mm Hg; if you are pregnant or breastfeeding; if the patient is a child under 15 years of age. Warnings and precautions Talk to your doctor or pharmacist before taking Tempalgin:
If you are known to have a disease that causes a decrease in the number of white blood cells (leukocytes). If you are allergic to painkillers or antirheumatic drugs (analgesic intolerance), as well as to other medications or foods. If you have allergic-induced bronchial asthma (shortness of breath attack). If you have low blood pressure. If you have kidney or liver disorders. Liver problems
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 described in section 4.
If you have ever developed severe skin reactions, you should never start treatment with Tempalgin again (see section 4).
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 are taking central nervous system depressants, painkillers, anti-inflammatory drugs, contraceptives, coumarin anticoagulants (reduce blood clotting), chlorpromazine (for the treatment of mental illnesses), chloramphenicol (antibiotic), cyclosporine (for tumour diseases), sleeping pills. Metamizole (a substance for reducing pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cell clumping and blood clot formation) when taken at the same time. 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 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 using this medicine.
PregnancyThe available data on the use of metamizole during the first three 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 administration of single doses of metamizole during the first and second trimesters after consultation with a doctor or pharmacist and after a careful assessment of the benefits and risks of using metamizole. However, the use of metamizole is generally not recommended during the first and second trimesters. 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, which closes naturally only after birth).
Breastfeeding Metamizole metabolites pass into breast milk in significant quantities and a risk to the infant cannot be excluded. Therefore, repeated use of metamizole during breast-feeding 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 sodiumThis 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.
3. How to take Tempalgin Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The tablets are taken orally with water, preferably after a meal. Do not use Tempalgin for more than 3 to 5 days without consulting a doctor.
AdultsThe recommended dose is 1 tablet 1 to 3 times a day, depending on the severity of the symptoms. The maximum single dose should not exceed 1 tablet, and the maximum daily dose is 4 tablets. For dental procedures - 1 tablet 1/2 hour before the intervention.
Children over 15 years of age: 1 tablet daily. The maximum daily dose is 2 tablets and depends on the severity of the symptoms.
Elderly and patients with impaired general health/with renal impairment The dose should be reduced in elderly patients, in debilitated patients and in patients with reduced renal function, since the excretion of metamizole degradation products may be delayed.
Patients with impaired renal or hepatic function: Since the rate of excretion is reduced in patients with impaired renal or hepatic function, repeated high doses should be avoided. No dose reduction is necessary for short-term use only. There is no experience with long-term use.
If you take more Tempalgin than you should: In cases of taking a large dose of the medicinal product, the following may occur: nausea, dizziness, abdominal pain, weakness up to loss of consciousness, severe drop in blood pressure up to shock (loss of consciousness with a drop in blood pressure) and heart rhythm disturbances. If any of these symptoms occur, stop taking the medicine and consult a doctor immediately!
If you forget to take Tempalgin If you miss a dose, take it as soon as possible. If it is almost time for your next dose, take it as usual. Do not take a double dose to make up for a forgotten dose. Continue taking the medicine as described in this leaflet.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
3. Possible side effects Like all medicines, this medicine 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-coloured stools, yellowing of the skin or whites of the eyes, itching, rash or pain in the upper abdomen. These symptoms may be signs of liver damage. See also section 2 „Warnings and precautions“.
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. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis). widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). You may experience:
blood disorders such as: agranulocytosis (severe reduction in the number of white blood cells, which increases the likelihood of infections), leukopenia (reduction in the number of white blood cells, which increases the likelihood of infections), aplastic anemia (severe reduction in the number of blood cells, which leads to weakness, bruising or an increased likelihood of infections), thrombocytopenia (reduction in the number of platelets, which increases the risk of bleeding or bruising), hemolytic anemia (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, reduced or increased urine output, inflammation of the kidneys; heart rhythm disturbances, lowering blood pressure; hypersensitivity reactions (anaphylactic or anaphylactoid reactions) - itching, burning, redness of the skin, urticaria, edema (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 become serious or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects If you get any side effects, please tell 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 at the Bulgarian Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, tel.: +35928903417, website: www.bda.bg. By reporting side effects, you can help to obtain more information on the safety of this medicine.
5. How to store Tempalgin Store in the original package in order to protect from moisture. Store below 25°C. Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and additional information What Tempalgin contains The active substances are: metamizole sodium 500 mg and triacetonamine-4-toluenesulfonate 20 mg in one tablet. The other ingredients are: wheat starch; microcrystalline cellulose (type 101); magnesium stearate; talc; povidone K25. Film coating: opadry II85 F21526 green (polyvinyl alcohol - partially hydrolyzed, macrogol, talc, E171, E104, E133).
What Tempalgin looks like and contents of the pack: Round, biconvex film-coated tablets, green in colour, 13 mm in diameter. 10 film-coated tablets in a PVC/aluminium foil blister; 2 or 30 blisters in a cardboard box, together with a leaflet.
Marketing Authorization Holder and Manufacturer SOPHARMA AD, Bulgaria
This leaflet was last revised in: January 2022