Turbet 1000 mg film-coated tablets: detailed information

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Turbet 1.000 mg film-coated tablets

metamizole sodium monohydrate

Turbet may cause a lower than normal white blood cell count (agranulocytosis), which can lead to serious and potentially fatal infections (see section 4).

You must stop taking this medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful sores in your nose, mouth or throat, or in the genital or anal area.

If you have ever had agranulocytosis with metamizole or similar medicines, you must never take this medicine again (see section 2).

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

What Turbet is and what it is used for
What you need to know before taking Turbet
How to take Turbet
Possible side effects
How to store Turbet
Contents of the pack and other information

1. What Turbet is and what it is used for

Turbet contains the active substance sodium metamizole monohydrate, which belongs to the group of medicines known as pyrazolones and has analgesic and antipyretic properties.

Metamizole is indicated in adolescents from 15 years of age and adults for the treatment of:

acute and severe pain following injuries or surgical procedures;
colic (stomach pain with spasms);
pain of tumoral origin (cancer);
other severe acute or chronic pains, when no other therapeutic measures are indicated;
high fever unresponsive to other treatments.

2. What you need to know before taking Turbet

Do not take Turbet

if you are allergic to metamizole or to other pyrazolones (e.g., phenazone, propyphenazone) or pyrazolidines (e.g., phenylbutazone, oxyphenbutazone), or to any of the other ingredients of this medicine (listed in section 6);
if you have previously had a significant decrease in a type of white blood cells called granulocytes, caused by metamizole or other similar medicines known as pyrazolones or pyrazolidines;
if you have bone marrow problems or a disorder affecting the production or function of your blood cells;
if you have a known intolerance to analgesics (analgesic-induced asthma syndrome or analgesic intolerance of urticaria/angioedema type). This applies to patients who experience bronchospasm (sudden constriction of the lower airways) or other hypersensitivity reactions such as itching, runny nose, and swelling (urticaria, rhinitis, angioedema) when exposed to analgesics such as acetylsalicylic acid and paracetamol, or diclofenac, ibuprofen, indomethacin, naproxen;
if you have ever had an allergic reaction to metamizole, such as severe skin reactions (see section 4 “Possible side effects”);
if you have glucose-6-phosphate dehydrogenase deficiency (an inherited condition associated with the risk of red blood cell breakdown);
if you have acute intermittent porphyria (a hereditary disorder associated with abnormalities in hemoglobin formation);
if you are in the last three months of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Low white blood cell count (agranulocytosis)

Turbet can cause agranulocytosis, a very low level of a type of white blood cells called granulocytes, which are important for fighting infections (see section 4). You must stop taking metamizole and contact a doctor immediately if you experience the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in the mucous membranes (wet body surfaces), especially in the mouth, nose, and throat, or in the genital or anal area. Your doctor will perform laboratory tests to check your blood cell levels.

If you are taking metamizole for fever, some symptoms of agranulocytosis may go unnoticed. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis may occur at any time during the use of Turbet and even shortly after stopping metamizole.

You may develop agranulocytosis even if you have previously used metamizole without problems.

Stop taking Turbet and consult a doctor immediately if you experience symptoms of pancytopenia (such as general malaise, infection, persistent fever, bruising, bleeding, and paleness) or thrombocytopenia (such as increased tendency to bleed and small reddish spots on the skin and mucous membranes caused by hemorrhage) (see section 4 “Possible side effects”).

Severe hypersensitivity reactions

Turbet contains metamizole, which carries the following risks—rare but potentially life-threatening—of serious hypersensitivity reactions:

If you have hypersensitivity (anaphylactic reactions) to metamizole, you are also at special risk of reacting similarly to other analgesics.
If you have allergic or other immunologically mediated reactions to metamizole (e.g., agranulocytosis), you are also at special risk of reacting similarly to other pyrazolones and pyrazolidines (chemically related substances) (analgesics such as phenazone, propyphenazone, phenylbutazone, oxyphenbutazone).
If you have allergic or other immunological reactions to other pyrazolones and pyrazolidines or other analgesics, you are also at high risk of reacting similarly to metamizole.

If you have any of the following disorders/intolerances, your risk of serious hypersensitivity reactions to metamizole may increase significantly:

intolerance to non-steroidal anti-inflammatory drugs (used to treat pain and rheumatism), with symptoms such as itching and swelling (urticaria, angioedema). In this case, you must not use metamizole (see section 2 "Do not take Turbet");
episodes of dyspnea, such as those due to bronchiolar constriction (bronchial asthma), especially if you also have inflammation of the nasal mucosa and paranasal sinuses (rhinosinusitis) and nasal polyps;
chronic urticaria;
hypersensitivity to dyes (e.g., tartrazine) or preservatives (e.g., benzoates);
alcohol intolerance. Such patients react to small amounts of alcoholic beverages with symptoms such as sneezing, watery eyes, and severe rash. Alcohol intolerance may indicate previously undiagnosed analgesic intolerance (see section 2 "Do not take Turbet").

In patients at higher risk of hypersensitivity reactions, the benefits and risks of using metamizole should be carefully evaluated. If metamizole is administered in such cases, the patient must be closely monitored under medical supervision, with emergency facilities readily available.

Anaphylactic shock may occur in especially sensitive patients. Therefore, patients with asthma or predisposition to hypersensitivity reactions (atopy) must take special precautions.

Severe skin reactions

Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with metamizole treatment. Stop taking metamizole and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

If you have ever experienced severe skin reactions, you must not resume treatment with metamizole at any time (see section 4).

Drop in blood pressure (hypotensive reaction)

Metamizole may cause low blood pressure (hypotensive reactions; see section 4 "Possible side effects"). This risk increases:

if you have low blood pressure, are severely dehydrated, have poor blood circulation, or are in the early stages of circulatory failure (e.g., in cases of myocardial infarction or severe injuries);
if you have high fever.

Your doctor will carefully consider the use of the medicine and monitor you closely. Preventive measures (stabilization of blood circulation) may be taken if necessary to reduce the risk of a sudden drop in blood pressure.

If it is crucial to completely avoid a drop in blood pressure (e.g., if you have severe coronary heart disease or any significant stenosis of blood vessels, i.e., restricting blood supply to the brain), metamizole may only be used under close monitoring of your circulation.

Liver problems

Liver inflammation has been reported in patients taking metamizole, with symptoms developing from a few days to several months after starting treatment.

Stop using metamizole and contact a doctor if you experience symptoms of liver problems, such as malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes (jaundice), itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You must not take Turbet if you have previously taken any medicine containing metamizole and experienced liver problems.

Patients with renal or hepatic impairment

If you have renal or hepatic impairment, metamizole should only be used after careful consideration of benefits and risks, along with appropriate precautions (see section 3 "Impairment of renal or hepatic function").

Children

Do not use this medicine in children and adolescents under 15 years of age.

Other medicines and Turbet

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Especially inform your doctor if you are taking any of the following medicines:

Methotrexate, a medicine used to treat cancer or certain rheumatic diseases. Concomitant administration of metamizole and methotrexate may enhance the blood toxicity of antineoplastic agents, especially in elderly patients. Therefore, this combination should be avoided.
Chlorpromazine, a medicine used to treat mental illnesses. Taking metamizole together with chlorpromazine may cause a severe drop in body temperature.
Cyclosporine, a medicine used to suppress the immune system.
Acetylsalicylic acid. Metamizole may reduce the antiplatelet effect of acetylsalicylic acid. Therefore, metamizole should be used with caution in patients taking low-dose acetylsalicylic acid for heart protection.
Bupropion, a medicine used for treating depression and/or helping to quit smoking.
Efavirenz, a medicine used for the treatment of HIV/AIDS.
Methadone, a medicine used to treat dependence on illicit drugs (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.

Metamizole is a pyrazolone derivative and has a known potential to interact with:

medicines used to prevent blood clotting (oral anticoagulants);
medicines for high blood pressure and certain heart conditions (captopril);
medicines for mental illnesses (lithium);
medicines to increase urine production (triamterene);
antihypertensives (medicines that lower blood pressure).

Effect on laboratory test results

Before undergoing any laboratory tests, inform your doctor that you are taking Turbet, as metamizole may affect the results of certain tests (such as measurements of blood levels of creatinine, triglycerides, HDL cholesterol, or uric acid).

Taking Turbet with alcohol

You should avoid consuming alcohol during treatment with metamizole.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor before using 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 on the embryo. In selected cases where no other treatment options are available, single doses of metamizole during the first and second trimesters may be acceptable after consulting with your doctor or pharmacist and carefully evaluating the benefits and risks of using metamizole. However, in general, the use of metamizole during the first and second trimesters is not recommended.

During the last three months of pregnancy, you must not take Turbet due to the increased risk of complications for both mother and baby (bleeding, premature closure of an important fetal blood vessel called the ductus arteriosus, which normally closes after birth).

Breastfeeding

Metamizole metabolites are excreted in breast milk in considerable amounts, and a risk to the breastfed infant cannot be ruled out. Therefore, repeated use of metamizole during breastfeeding should be avoided. If a single dose of metamizole is administered, mothers are advised to express and discard breast milk for 48 hours after administration.

Driving and using machines

Within the recommended dose range, no adverse effects on reaction ability or concentration are known. However, as a precaution, you should consider the possibility of such adverse effects—especially at higher doses—and refrain from operating machinery, driving vehicles, or performing other potentially dangerous activities. This is particularly important if you have consumed alcohol.

Turbet contains sodium

This medicine contains 71.3 mg of sodium (main component of table/cooking salt) per tablet. This corresponds to 3.56% of the maximum daily intake of sodium recommended for an adult.

3. How to take Turbet

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose is determined according to the intensity of pain or fever and the individual's sensitivity to metamizole treatment. The lowest effective dose required to control pain and fever should always be chosen. Your doctor will advise you on how to take metamizole.

Adults and adolescents aged 15 years and older

Adults and adolescents aged 15 years or older (weighing more than 53 kg) may take up to 1,000 mg of metamizole as a single dose (1 tablet of 1,000 mg), which may be taken up to 4 times daily at intervals of 6–8 hours. The maximum daily dose is 4,000 mg (4 tablets of 1,000 mg).

The effect of the medicine usually appears between 30 and 60 minutes after taking the tablets.

Elderly patients and patients with poor general health/renal insufficiency

Dosage should be reduced in elderly patients, in debilitated patients, and in those with impaired renal function, as elimination of metamizole metabolites may be delayed.

Patients with renal or hepatic impairment

Since elimination is reduced in cases of renal or hepatic impairment, repeated administration of high doses should be avoided. For short-term treatment, dose reduction may not be necessary. Experience with long-term treatment is lacking.

Use in children and adolescents

Adolescents from 15 years of age (body weight above 53 kg): see adult dosage.
Metamizole must not be used in children and adolescents under 15 years of age. Other formulations and presentations of this medicine are available for younger children; consult your doctor or pharmacist.

Method of administration

Oral use.

Do not chew the tablets. Swallow the tablets with sufficient liquid (e.g., a glass of water).

The tablet may be divided into equal doses.

Duration of treatment

The duration of treatment will depend on the nature and severity of your condition and will be determined by your doctor.

Do not take analgesics for more than 3 to 5 days unless specifically advised by a doctor or dentist.

If you take more Turbet than you should

If you experience any of the following symptoms of overdose, call a doctor immediately or go to the nearest hospital emergency department:

nausea, vomiting, stomach pain;
impaired kidney function and even acute renal failure (e.g., with symptoms of interstitial nephritis);
dizziness, drowsiness, loss of consciousness;
seizures (fits);
drop in blood pressure which may progress to circulatory failure (shock);
cardiac rhythm disturbances (tachycardia).

After administration of very high doses of metamizole, excretion of a harmless metabolite (rubazonic acid) may cause red discoloration of urine.

If you have taken more of this medicine than you should, consult your doctor or pharmacist, or contact the Toxicology Information Service, telephone: 91 562 04 20.

If you forget to take Turbet

Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects may have serious consequences; stop taking metamizol and contact a doctor immediately:

If any of the following adverse effects appear suddenly or develop rapidly, contact your doctor immediately, as certain reactions (e.g., severe hypersensitivity reactions, serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, agranulocytosis, pancytopenia) may be life-threatening. In such cases, metamizol must not be taken without medical supervision. Timely discontinuation may be crucial for recovery.

Stop using Turbet and contact a doctor immediately if you experience any of the following symptoms:

Feeling unwell (nausea or vomiting), fever, feeling tired, loss of appetite, dark urine, pale stools, yellowing of the skin or the whites of the eyes, itching, or pain or rash in the upper stomach area. These symptoms may be signs of liver damage. See also section 2, "Warnings and precautions."
Hypersensitivity reactions (anaphylactoid or anaphylactic reactions) – rare adverse effects (may affect up to 1 in 1,000 people).

Typical signs of mild reactions include symptoms such as eye itching, cough, runny nose, sneezing, chest tightness, skin redness (especially around the face and head), urticaria (hives), and facial swelling—and less commonly, nausea and abdominal cramps.

Special warning symptoms include a burning sensation, itching, and redness of the tongue and underneath it, and particularly on the palms of the hands and soles of the feet.

Mild reactions may progress to more severe forms, including severe generalized urticaria, severe angioedema (swelling, even of the larynx), severe bronchospasm (spasmodic narrowing of the lower airways), tachycardia (increased pulse), cardiac arrhythmia, drop in blood pressure (sometimes preceded by a rise in blood pressure), loss of consciousness, and circulatory shock.

These reactions may still occur even if metamizol has previously been used without complications, and they can range from severe to potentially fatal, and in some cases may be fatal.

In patients with analgesic-induced asthma syndrome, hypersensitivity reactions typically present as asthma attacks (see section 2, "Do not take Turbet").

Serious skin reactions

Stop taking metamizol and seek immediate medical attention if you notice any of the following serious adverse effects:

Non-elevated reddish patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) – frequency not known (cannot be estimated from available data).
Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) – frequency not known (frequency cannot be estimated from available data).

Severe decrease in white blood cells (agranulocytosis), which may lead to death due to severe infections, or decrease in the number of platelets in the blood (thrombocytopenia) – very rare adverse effect (may affect up to 1 in 10,000 people).

These reactions are likely due to immunological reasons. They may also occur even if metamizol has previously been administered without complications.

Agranulocytosis manifests as high fever, chills, sore throat, difficulty swallowing, and inflammation of the mouth, nose, throat, and genital or anal area. However, in patients receiving antibiotics (medicines to treat bacterial infections), these symptoms may be mild. Erythrocyte sedimentation rate is markedly increased, while lymph nodes are usually only slightly enlarged or not enlarged at all.

Typical symptoms of thrombocytopenia include, for example, increased tendency to bleed and petechiae (round spots caused by bleeding into the skin and mucous membranes).

If symptoms of agranulocytosis, pancytopenia (see below), or thrombocytopenia occur, metamizol use must be stopped immediately, and your doctor should monitor your complete blood count until it normalizes (including differential blood count). Do not wait for laboratory diagnostic test results before discontinuing treatment.

Reduction in blood volume with concomitant impairment of bone marrow function (aplastic anemia), reduction in white and red blood cells and platelets (pancytopenia), including fatal cases – frequency not known (cannot be estimated from available data).

Symptoms of pancytopenia and aplastic anemia include general malaise, infection, persistent fever, bruising, bleeding, and pallor.

Other possible adverse effects

Uncommon (may affect up to 1 in 100 people):

Purple to reddish skin reactions with the appearance of vesicles or blisters (fixed drug eruption),
Decrease in blood pressure (hypotension). This may be a direct effect of this medicine and may not be accompanied by other symptoms of hypersensitivity reactions. Such a reaction only rarely causes a severe drop in blood pressure. The risk of a hypotensive reaction may increase in cases of marked high fever (hyperpyrexia). Typical symptoms of a rapid drop in blood pressure include tachycardia, pallor, tremors, dizziness, nausea, and loss of consciousness.

Rare (may affect up to 1 in 1,000 people):

Decrease in the number of white blood cells in the blood (leukopenia),
Skin rash (e.g., maculopapular exanthema).

Very rare (may affect up to 1 in 10,000 people):

Asthma attack (breathing difficulty caused by narrowing of the airways),
Severe deterioration of kidney function, in some cases with little or no urine output (oligo-anuria), excess of blood proteins in the urine (proteinuria), or progressing to acute renal failure; inflammation of the kidney (interstitial nephritis).

Frequency not known (cannot be estimated from available data):

Anaphylactic shock,
Myocardial infarction as a consequence of an allergic reaction (Kounis syndrome),
Inflammation of the liver, yellowing of the skin and whites of the eyes, increased blood levels of liver enzymes,
Gastrointestinal bleeding.

Due to the excretion of a harmless metabolite of metamizol (rubazonic acid), a red discoloration of the urine may occur.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Turbet Storage

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly discard medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Turbet

The active substance is metamizole sodium monohydrate.

Each tablet contains 1,000 mg of metamizole sodium monohydrate.
The other components are: croscarmellose sodium, magnesium stearate, hypromellose 2910, titanium dioxide (E 171), macrogol 8000 and talc.

Appearance of the product and contents of the pack

Film-coated tablets, white to off-white, biconvex, oblong, with a score line on one side.

The tablet can be divided into equal doses.

Turbet is available in opaque PVC-aluminum blisters or opaque PVC/PE/PVdC-aluminum blisters.

Pack sizes of 6, 10, 20, 30, 40, 50, and 60 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin, Germany

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012, Larissa Industrial Area, Larissa,

41500 Greece

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin, Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz

Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Hungary: Metamizole Aristo 1000mg filmtabletta
Germany: Metamizol Aristo 1000 mg Filmtabletten
Spain: Turbet 1.000 mg film-coated tablets
Poland: Axonalgin
Portugal: Metamizol Aristo 1000 mg comprimidos revestidos por película

Date of the most recent review of this leaflet: August 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/