Tempalgin (20 tablets)

When should you not take Tempalgin?

Do not take Tempalgin if you have:

• Hypersensitivity to the active substances or to any of the excipients;
• Hypersensitivity to other pyrazolone products;
• Acute hepatic porphyria (an inherited disease with impaired red blood cell production);
• Congenital glucose-6-phosphate dehydrogenase deficiency (an inherited disease with impaired red blood cell production);
• Severe kidney or liver disease;
• Aplastic anemia, leukopenia and agranulocytosis (blood diseases leading to a decrease in the number of white blood cells);
• Low blood pressure with values ​​below 100 mm Hg;
• If you are pregnant (first and last trimester) or breast-feeding;
• Tempalgin should not be used in children under 15 years of age. Take special care with Tempalgin.

Pregnancy and breast-feeding

Do not use during the first and last trimester of pregnancy. In other cases, the product is used only under strict indications.

The product should not be used during breast-feeding, as both active ingredients are excreted in breast milk.

Side effects:

Tempalgin is generally well tolerated.

Hypersensitivity reactions are possible – skin rash, itching.

Rarely, there is swelling of the larynx, an asthma attack, or an anaphylactic reaction (severe life-threatening allergic conditions).

Rarely, headache, dizziness, low blood pressure, palpitations, nausea, vomiting, abdominal pain, bleeding, jaundice, changes in blood counts, changes in liver parameters may occur.

Renal dysfunction is possible at high doses. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contraindications:

Hypersensitivity to triacetonamine-4-toluenesulfonate, metamizole and other pyrazolone products; acute hepatic porphyria and congenital glucose-6-phosphate dehydrogenase deficiency; aplastic anemia, leukopenia and agranulocytosis; severe kidney and liver disease; pregnancy (first and last trimester); children under 12 years of age.

TEMPALGIN tablets * 20 SOPHARMA

Package leaflet: information for the user

Tempalgin® 500 mg/20 mg film-coated tablets

Metamizole sodium/triacetonamine-4-toluenesulfonate(metamizole 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 have to read it again.
• If you need further information or advice, ask your pharmacist.
• 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.
• If after 3-5 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet

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 Tempalgin is and what it is used for

Tempalgin is a combination medicinal product that contains the active substances metamizole sodium and triacetonamine-4-toluenesulfonate. It has a pronounced and prolonged pain-relieving effect due to the non-narcotic analgesic metamizole sodium, which suppresses prostaglandin synthesis. Triacetonamine-4-toluenesulfonate reduces motor agitation and has a soothing effect.

Tempalgin is used for short-term symptomatic treatment of mild to moderate pain in the following conditions: headache, toothache and dental manipulations, 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-toluenesulphonate or any of the other ingredients of this medicine (listed in section 6);
• if you have hypersensitivity to other pyrazolone products;
• if you suffer from acute hepatic porphyria (an inherited disease with impaired erythrocyte formation);
• if you have congenital glucose-6-phosphatedehydrogenase deficiency (an inherited disease with impaired erythrocyte formation);
• in severe kidney or liver diseases;
• if you have impaired bone marrow function (after cytostatic treatment) or blood diseases such as: aplastic anaemia (decrease in the number of blood cells, leading to weakness, bruising or increased likelihood of infection), agranulocytosis (a strong decrease in the number of white blood cells, which increases the likelihood of infections), leukopenia (decrease in the total number of white blood cells);
• at low blood pressure with values below 100 mm Hg;
• if you are pregnant or breast-feeding;
• 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 aware that you have a disease that occurs with a decrease in the number of white blood cells (leukocytes).
• If you are allergic to painkillers or antirheumatic drugs (intolerance to analgesics) as well as to other medications or foods.
• In allergic-conditioned bronchial asthma (shortness of breath).
• If you have low blood pressure.
• If you have kidney or liver disorders.

Liver problems

Inflammation of the liver has been reported in patients taking metamizole and symptoms develop within a few days to several months of starting 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, darkening of urine, light 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 methamisole treatment. Stop using metamizole and seek medical advice 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 restart treatment with Tempalgin (see section 4).

Other medicines and Tempalgin

Please tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
Treatment can be affected if you take simultaneously drugs that suppress the central nervous system, antipain, anti-inflammatory, contraceptive drugs, coumarin angicoagulants (reduce blood clotting), chlorpromazine (for the treatment of mental illness), chloramphenicol (antibiotic), ciclosporin (for tumor diseases), sleeping pills.
Metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and blood clot) 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 in stopping smoking;
• efavirenz, a medicine used to treat HIV/AIDS;
• methadone, a medicine used to treat dependence on prohibited substances (so-called opioids);
• valproate, a medicine used to treat epilepsy or bipolar disorder;
• tacrolimus, a medicine used to prevent organ rejection in transplanted patients;
• sertraline, a medicine used to treat depression.

Tempalgin with food, drink and alcohol

Tablets are taken with water, preferably after meals.

During treatment with Tempalgin, alcohol is not recommended due to the possibility of exacerbating the side 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 taking this medicine.

Pregnancy
Available data on the use of metamizole during the first three months of pregnancy are limited, but do not indicate harmful effects for the embryo. In certain cases, where there are no other treatment options, it is possible to accept the administration of single doses of metamizole in the first and second trimesters after consulting a doctor or pharmacist and after careful consideration of the benefits and risks of using metamizole. In general, however, the use of metamizole in the first and second trimesters is not recommended. During the last three months of pregnancy, you should not take Tempalgin because of an increased risk of complications for the mother and child (bleeding, premature closure of an important blood vessel, the so-called Bottali ductus in the unborn, which closes naturally only after birth).

Metamizole
breakdown products 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 dispose of breast milk for 48 hours after dosing.

Driving and using machines

Do not drive or use any tools or machines, as Tempalgin reduces the ability to concentrate attention 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 celiac disease (gluten intolerance). One tablet contains no more than 9.5 micrograms of gluten. If you have an allergy to wheat (a condition other than celiac disease), you should not take this medicine.

Tempalgin contains sodium

This medicine contains 32.7 mg sodium (the main ingredient of 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. Check with your doctor or pharmacist if you are not sure.

Tablets are taken orally with water, preferably after a meal. Do not apply Tempalgin for more than 3 to 5 days without consulting a doctor.

Adults
The recommended dose is 1 tablet 1 to 3 times a day, depending on the severity of symptoms. The maximum single dose should not exceed 1 tablet, and the maximum daily dose is 4 tablets.
In dental manipulations – 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 symptoms.

Elderly and patients with poor general health/renal impairment
The dose should be reduced in the elderly, in debilitated patients and in patients with reduced renal function, as 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 required only with short-term use. There is no experience available from 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 be observed: nausea, dizziness, abdominal pain, tiredness to loss of consciousness, a strong decrease in blood pressure to shock (loss of consciousness with a drop in blood pressure) and heart rhythm disturbances.
If any of these symptoms occur, discontinue taking the drug and immediately consult a doctor!

If you forget to take Tempalgin

If you miss a dose, take it as soon as possible. If it’s almost time for your next dose, take it as usual. Do not take a double dose to make up for a forgotten dose. Continue to take this medicine as described in this leaflet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

3. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. When Tempalgin is administered, 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, darkening of urine, light 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 advice immediately if you notice any of the following serious side effects:

• Reddish, flat, target-like or round patches on the torso, often with centrally located blisters, peeling of the 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 can observe:

• blood count disorders such as: agranulocytosis (a strong decrease in the number of white blood cells, which increases the likelihood of infections), leukopenia (a decrease in the number of white blood cells, which increases the likelihood of infections), aplastic anemia (a strong decrease in the number of blood cells, leading to weakness, bruising or an increased likelihood of infections), thrombocytopenia (decrease in the number of platelets, which increases the risk of bleeding or bruising), haemolytic anaemia (decrease in the number of red blood cells, which may lead to paleness or yellowing of the skin, weakness or shortness of breath);
• nausea, vomiting, abdominal pain and discomfort, in rare cases ulcerations and bleeding;
• kidney damage such as the appearance of protein in the urine, decreased or increased amount of urine, inflammation of the kidneys;
• disturbances of the heart rhythm, 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;
• disorders of the nervous system such as headache, dizziness;
• liver disorders – inflammation of the liver, yellowing of the skin and the white part of the eyes, an increase in the level of liver enzymes in the blood; cholestasis (bile drainage disorders), hyperbilirubinemia (high levels of bilirubin in the blood).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide 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 package. 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 throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other 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; povidon K25.

Film coating: opadrain 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 of green colour, diameter 13 mm. 10 film-coated tablets in a PVC/aluminium foil blister; 2 or 30 blisters per cardboard box, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria