TURBET 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Turbet 1000 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 life-threatening infections (see section 4).

You should 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, and throat, or in the genital or anal area.

If you have ever had agranulocytosis with metamizole or similar medicines, you should never

take this medicine again (see section 2).

Read the entire package leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Turbet and what is it used for
2. What you need to know before taking Turbet
3. How to take Turbet
4. Possible side effects
5. Storage of Turbet
6. Package contents and further information

1. What is Turbet and what is it used for

Turbet contains the active ingredient metamizole sodium monohydrate, which belongs to the group of pyrazolone medicines and has analgesic and antipyretic properties.

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

• acute and severe pain after injuries or surgical interventions;
• colic (stomach pain with spasms);
• tumor-related pain (cancer);
• other acute or chronic severe pain, when other therapeutic measures are not indicated;
• high fever that does not respond to other treatments.

2. What you need to know before taking Turbet

Do not take Turbet

• if you are allergic to metamizole or 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 cell called granulocytes, which was caused by metamizole or other similar medicines called pyrazolones or pyrazolidines;
• If you have bone marrow problems or have a disorder that affects the way
• your blood cells are produced or function.
• if you have a known intolerance to analgesics (aspirin-induced asthma or analgesic intolerance of the urticaria/angioedema type). This applies to patients who experience bronchospasm (sudden constriction of the airways) or other hypersensitivity reactions such as itching, nasal discharge, and swelling (urticaria, rhinitis, angioedema) when exposed to analgesics like 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 a genetic deficiency of glucose-6-phosphate dehydrogenase (a hereditary disease associated with the risk of red blood cell destruction);
• if you have acute intermittent porphyria (a hereditary disorder associated with alterations in hemoglobin formation);
• if you are in the last three months of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Low white blood cell count (agranulocytosis).

Turbet may cause agranulocytosis, a very low level of a type of white blood cell called granulocytes, which are important for fighting infections (see section 4). You should stop taking metamizole and contact a doctor immediately if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in the mucous membranes (wet surfaces of the body), 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 count.

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

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

You may develop agranulocytosis even if you have used metamizole without problems in the

past.

Stop taking Turbet andconsult a doctor immediately, if you experience symptoms of pancytopenia (such as general malaise, infection, persistent fever, bruising, bleeding, and pallor) or thrombocytopenia (such as increased bleeding tendency and small red spots on the skin and mucous membranes caused by bleeding) (see section 4 "Possible side effects").

Severe hypersensitivity reactions

Turbet contains metamizole, which has the following risks, although rare, of potentially life-threatening severe hypersensitivity reactions:

• If you have hypersensitivity (anaphylactic reactions) to metamizole; you are also at special risk of responding similarly to other analgesics.
• If you have allergic reactions or any other reaction (immune-mediated) to metamizole (e.g., agranulocytosis), you are also at special risk of responding similarly to other pyrazolones and pyrazolidines (chemically related substances) (analgesics like phenazone, propyphenazone, phenylbutazone, oxyphenbutazone).
• If you have allergic reactions or other immune-mediated reactions to other pyrazolones and pyrazolidines or other analgesics, you are also at high risk of responding similarly to metamizole.

If you have any of the following disorders/intolerances, the risk of severe 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 should not use metamizole (see section 2 "Do not take Turbet");
• breathing difficulties, such as those caused by bronchiolar constriction (bronchial asthma) (, especially if you also have nasal and sinus inflammation (rhinosinusitis) and nasal polyps;
• chronic urticaria,
• hypersensitivity to colorants (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 a severe rash. Such alcohol intolerance may indicate a previously undiagnosed analgesic intolerance (see section 2 "Do not take Turbet").

In patients with a 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 should be kept under close medical supervision, with emergency facilities readily available.

In particularly sensitive patients, anaphylactic shock may occur. Therefore, patients who suffer from asthma or show a predisposition to hypersensitivity reactions (atopy) should exercise extreme caution.

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 medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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

Drop in blood pressure (hypotensive reaction)

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

• if you have low blood pressure, if you are severely dehydrated or have poor blood circulation, or 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 weigh the use of the medicine and monitor you closely. If necessary, preventive measures (stabilization of blood circulation) may be taken to reduce the risk of a sudden drop in blood pressure.

If it is crucial to avoid a drop in blood pressure altogether (e.g., if you have severe coronary heart disease or any relevant narrowing [stenosis] of the blood vessels, i.e., which restricts blood supply to the brain), metamizole may only be used under close supervision of your blood circulation.

Liver problems

Inflammation of the liver has been reported in patients taking metamizole, with symptoms developing within a few days to a few months after starting treatment.

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

You should not take Turbet if you have previously taken a medicine containing metamizole and had liver problems.

Patients with renal or hepatic impairment

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

Children

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

Other medicines and Turbet

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Especially tell your doctor if you are using any of the following medicines:

• Methotrexate, a medicine used to treat cancer or certain rheumatic diseases. The concomitant administration of metamizole and methotrexate may potentiate the toxic effects on the blood of antineoplastic agents, especially in elderly patients. Therefore, this combination should be avoided.
• Chlorpromazine, a medicine used to treat mental illnesses. Taking metamizole at the same time as chlorpromazine may cause a severe drop in body temperature.
• Cyclosporine, a medicine used to suppress the immune system.
• Acetylsalicylic acid. Metamizole may reduce the effect of acetylsalicylic acid on platelet aggregation. Therefore, metamizole should be used with caution in patients taking acetylsalicylic acid in low doses to protect the heart.
• Bupropion, a medicine used in combination for the treatment of depression and/or to help stop smoking.
• Efavirenz, a medicine used to treat 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 for interactions with:

• medicines to prevent blood clotting (oral anticoagulants),
• medicines for hypertension and certain heart diseases (captopril),
• medicines for treating mental illnesses (lithium),
• medicines to increase urine production (triamterene),
• antihypertensives (medicines that lower blood pressure).

Influence 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 test methods (such as the determination of blood creatinine, triglyceride, HDL cholesterol, or uric acid levels).

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

The 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 when no other treatment options exist, single doses of metamizole during the first and second trimester may be acceptable after consulting your doctor or pharmacist and carefully evaluating the benefits and risks of using metamizole. However, in general, the use of metamizole is not recommended during the first and second trimester.

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

Breastfeeding

Metamizole degradation products are excreted in breast milk in significant amounts, and it cannot be excluded that there is a risk for the breastfed infant. Therefore, repeated use of metamizole should be avoided during breastfeeding. If a single dose of metamizole is administered, mothers are recommended to express and discard breast milk for 48 hours after administration.

Driving and using machines

Within the recommended dosage interval, no adverse effects on reaction and concentration abilities are known. However, as a precautionary measure, you should be aware of the possibility of such adverse effects - at least at higher doses - and refrain from using machines, driving vehicles, and engaging in other hazardous activities. This applies especially if you have consumed alcohol.

Turbet contains sodium

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

3. How to take Turbet

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose is established based on the intensity of the pain or fever and the sensitivity of each person to treatment with metamizol. The lowest necessary dose to control pain and fever should always be chosen. Your doctor will indicate how to take metamizol.

Adults and adolescents 15 years of age or older

Adults and adolescents over 15 years old (who weigh more than 53 kg) can take up to 1,000 mg of metamizol in a single dose (1 tablet of 1,000 mg) that can be taken up to 4 times a day at 6-8 hour intervals. The maximum daily dose is 4,000 mg (4 tablets of 1,000 mg).

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

Elderly people and patients with poor general health/renal insufficiency

The dose should be reduced in elderly people, in debilitated patients, and in those with decreased renal function, as the elimination of metamizol degradation products may be delayed.

Patients with renal or hepatic insufficiency

Since the elimination rate decreases in cases of renal or hepatic insufficiency, the administration of high repeated doses should be avoided. Only in short-term treatments is a dose reduction not necessary. There is no experience with prolonged treatments.

Use in children and adolescents

• Adolescents from 15 years old (body weight over 53 kg): see adult dose.
• Metamizol should not be used in children and adolescents under 15 years old. There are other forms and presentations of this medication for younger children; consult your doctor or pharmacist.

Method of administration

Oral use.

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

The tablet can be divided into equal doses.

Duration of treatment

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

Do not take pain relievers for more than 3 or 5 days, unless you have specifically consulted a doctor or dentist.

If you take more Turbet than you should

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

• Nausea, vomiting, stomach pain;
• Impairment of kidney function and even acute renal failure (e.g., with symptoms of interstitial nephritis);
• Dizziness, drowsiness, loss of consciousness;
• Seizures (attacks);
• Drop in blood pressure that can evolve into circulatory failure (shock);
• Heart rhythm disorders (tachycardia).

After administration of very high doses of metamizol, the excretion of a harmless metabolite (rubazonic acid) can cause a red coloration in the urine.

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

If you forget to take Turbet

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

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

• Feeling of illness (nausea or vomiting), fever, feeling of tiredness, loss of appetite, dark urine, light-colored stools, yellowish color of the skin or the white part of the eyes, itching, rash, or pain in the upper abdominal area. These symptoms can 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 itching in the eyes, coughing, nasal discharge, sneezing, chest tightness, reddening of the skin (especially around the face and head), urticaria, and swelling of the face and - less frequently - nausea and abdominal cramps.

Special warning symptoms are the sensation of burning, itching, and reddening on the tongue and underneath it, and especially on the palms of the hands and soles of the feet.

Mild reactions can turn into more severe forms with severe generalized urticaria, severe angioedema (swelling, even of the larynx), severe bronchospasm (spasmatic narrowing of the lower airways), tachycardia (increased pulse), cardiac arrhythmia, drop in blood pressure (sometimes with previous increase in blood pressure), loss of consciousness, and circulatory shock.

These reactions can continue to occur even if metamizol has been used previously without complications and can be serious to potentially fatal, even fatal in some cases.

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

• Severe skin reactions

Stop taking metamizol and seek medical attention immediately if you observe any of the following serious side effects:

• Reddish, non-elevated patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin erythemas can 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 or drug hypersensitivity syndrome) – frequency not known(frequency cannot be estimated from available data).

-Severe decrease in white blood cells (agranulocytosis) that can cause 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 probably due to immunological reasons. They can also occur when metamizol has been administered on previous occasions without complications.

Agranulocytosis manifests with high fever, chills, sore throat, difficulty swallowing, and inflammation of the mouth, nose, throat, and genital or anal area. However, in patients receiving antibiotics (medications for treating bacterial infections), these symptoms can be weak. The erythrocyte sedimentation rate is highly increased, while the lymph nodes are usually slightly or not enlarged.

Typical symptoms of thrombocytopenia are, for example, increased tendency to bleed and petechiae (round spots produced by hemorrhages in the skin and mucous membranes).

If symptoms of agranulocytosis, pancytopenia (see below), or thrombocytopenia appear, the use of metamizol should be immediately discontinued, and your doctor should monitor the complete blood count until it returns to normal (including differential blood count). Do not wait for the results of laboratory diagnostic tests to discontinue treatment.

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

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

Other possible side effects

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

• Drug-induced fixed exanthema (purple to reddish skin reactions with vesicles or blisters),
• Drop in blood pressure(arterial hypotension). This can be a direct effect of this medication and not accompanied by other symptoms of hypersensitivity reactions. Such a reaction rarely causes a severe drop in blood pressure. The risk of a hypotensive reaction may increase in case of pronounced high fever (hyperpyrexia). Typical symptoms of a rapid drop in blood pressure are tachycardia, paleness, 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(respiratory difficulty caused by narrowing of the airways),
• Severe impairment of renal function, in some cases with very little or no urine (oligo-anuria), excess of blood proteins in the urine (proteinuria), or evolving into acute renal failure; kidney inflammation (interstitial nephritis).

Frequency not known (cannot be estimated from available data)

• Anaphylactic shock,
• Myocardial infarction as a consequence of an allergic reaction(Kounis syndrome),
• Liver inflammation,yellowish color of the skin and the white part of the eyes, increased level of liver enzymes in the blood,
• Gastrointestinal bleeding.

Due to the excretion of a harmless metabolite of metamizol (rubazonic acid), it can cause a red coloration in the urine.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Turbet

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Turbet

The active ingredient is metamizol sodium monohydrate.

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

Appearance of the product and package contents

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 presented in opaque PVC-aluminum or PVC/PE/PVdC-aluminum blisters.

Packaging with 6, 10, 20, 30, 50, 60 film-coated tablets.

Not all 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

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the Member States of the European Economic Area with 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 film-coated tablets

Date of the last revision of this leaflet:August 2025

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