Leaflet: information for the user

Turbet 1.000 mg film-coated tablets

metamizol sodium monohydrate

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

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

1. What is Turbet and for what it is used

2. What you need to know before starting to take Turbet

3. How to take Turbet

4. Possible side effects

5. Storage of Turbet

6. Contents of the pack and additional information

Turbet contains the active ingredient metamizol sodium monohydrate, which belongs to the group of medications known as pyrazolones and has analgesic and antipyretic properties.

Metamizol is indicated in adolescents from 15 years old and adults for the treatment of:

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

Do not take Turbet

• If you are allergic to metamizol or other pyrazolones (such as phenazone, propifenazone) or pyrazolidines (such as phenylbutazone, oxifenbutazone) - this also includes patients who have experienced, for example, a marked decrease in certain white blood cells (agranulocytosis) after using these agents;
• If you are allergic to any of the other components of this medication (included in section 6);
• If you have a known intolerance to analgesics (anaphylactic syndrome or analgesic intolerance of the urticaria/angioedema type). This applies to patients who experience bronchospasm (sudden constriction of the lower respiratory tract) or other hypersensitivity reactions such as itching, nasal secretion, 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 metamizol, such as severe skin reactions (see section 4 "Possible side effects");
• If you have suffered from bone marrow function disorders (for example, during or after receiving chemotherapy to treat cancer);
• If you have diseases related to blood cell formation (hematopoietic system);
• If you have a genetic deficiency of glucose-6-phosphate dehydrogenase (a hereditary disease associated with a 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 medication.

Turbet contains metamizol, which presents the following risks, rare but potentially fatal:

• Sudden circulatory collapse,
• Agranulocytosis (acute disorder due to a severe decrease in the number of white blood cells in the blood).

Stop taking Turbet and consult a doctor immediatelyif any of the following symptoms occur, which may indicate agranulocytosis:

• If you experience general discomfort (for example, fever, chills, sore throat, difficulty swallowing),
• Fever that does not subside or recurs,
• Mouth mucosa lesions, inflammation in the mouth, nose, throat, or genital and anal regions (see section 4 "Possible side effects").

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

Severe hypersensitivity reactions

• If you are hypersensitive (anaphylactic reactions) to metamizol; you also have a special risk of responding in the same way to other analgesics.
• If you have allergic reactions or any other reaction (mediated immunologically) to metamizol (for example, agranulocytosis), you also have a special risk of responding in the same way to other pyrazolones and pyrazolidines (chemically related substances) (analgesics such as phenazone, propifenazone, phenylbutazone, oxifenbutazone).
• If you have allergic reactions or otherimmunologically mediated reactions to other pyrazolones and pyrazolidines orother analgesics,you also have a high risk of reacting in the same way to metamizol.

If you have any of the following disorders/intolerances, the risk of severe hypersensitivity reactions to metamizol 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 metamizol (see section 2 "Do not take Turbet");
• Attacks of dyspnea, such as those due to bronchiolar constriction (asthma bronchial) (, especially if you also have inflammation of the nasal mucosa and paranasal sinuses (rhinosinusitis) and nasal polyps;
• Chronic urticaria,
• Hypersensitivity to colorants (for example, tartrazine) or preservatives (for example, benzoates);
• Intolerance to alcohol. Such patients react to small amounts of alcoholic beverages with symptoms such as sneezing, watery eyes, and a severe rash. Such intolerance to alcohol may indicate 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 metamizol should be carefully evaluated. If metamizol is administered in such cases, the patient should be closely monitored by a doctor, with emergency facilities readily available.

In patients who are especially sensitive, anaphylactic shock may occur. Therefore, patients with asthma or 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 metamizol treatment. Stop taking metamizol and seek medical attention immediately if you observe 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 metamizol at any time (see section 4).

Decrease in blood pressure (hypotensive reaction)

Metamizol 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 (for example, in cases of myocardial infarction or severe injuries),
• If you have high fever.

Your doctor will weigh the use of the medication and closely monitor you. 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 (for example, if you have severe coronary heart disease or any significant narrowing (stenosis) of blood vessels, that is, that restricts blood supply to the brain), metamizol can only be used under close supervision of your blood circulation.

Liver problems

Inflammation of the liver has been reported in patients taking metamizol with symptoms that develop within a few days to several months after starting treatment.

Stop using metamizol 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, light-colored stools, yellowing of the skin or 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 medication containing metamizol and had liver problems.

Patients with renal or hepatic insufficiency

If you have renal or hepatic insufficiency, metamizol should only be used after careful consideration of the benefits and risks, along with the necessary precautions (see section 3 "Renal or hepatic dysfunction").

Children

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

Other medications and Turbet

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor especially if you are using any of the following medications:

• Metotrexate, a medication used to treat cancer or certain rheumatic diseases. The concurrent administration of metamizol and metotrexate may potentiate the toxic effects of antineoplastic agents, especially in elderly patients. Therefore, this combination should be avoided.
• Clorpromazina, a medication for the treatment of mental illnesses. Taking metamizol at the same time as clorpromazina may cause a severe drop in body temperature.
• Ciclosporina, a medication used to suppress the immune system.
• Acetylsalicylic acid. Metamizol may reduce the effect of acetylsalicylic acid to decrease platelet aggregation. Therefore, metamizol should be used with caution in patients taking acetylsalicylic acid in low doses to protect the heart
• Bupropión, a medication used in combination to treat depression and/or to help quit smoking.
• Efavirenz, a medication used to treat HIV/AIDS.
• Metadona, a medication used to treat opioid dependence.
• Valproato, a medication used to treat epilepsy or bipolar disorder.
• Tacrólimus, a medication used to prevent organ rejection in transplant patients.
• Sertralina, a medication used to treat depression.

Metamizol is a derivative of pyrazolone and has a known potential for interactions with:

• Blood clotting medications (oral anticoagulants),
• Blood pressure medications and certain heart diseases (captopril),
• Medications for mental illnesses (litio),
• Medications to increase urine production (triamtereno),
• Anti-hypertensive medications (medications that reduce blood pressure).

Influence on laboratory test results

Inform your doctor before any laboratory test that you are taking Turbet, as metamizol may affect the results of certain methods of testing (such as determination of blood creatinine, triglycerides, HDL cholesterol, or uric acid levels).

Taking Turbet with alcohol

You should avoid consuming alcohol during metamizol treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Pregnancy

The available data on the use of metamizol during the first three months of pregnancy are limited, but do not indicate harmful effects on the embryo. In selected cases where there are no other treatment options, single doses of metamizol during the first and second trimesters may be acceptable after consulting with your doctor or pharmacist and then evaluating the benefits and risks of using metamizol. However, in general, the use of metamizol is not recommended during the first and second trimesters.

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

Lactation

Metamizol degradation products are excreted in breast milk in significant amounts and cannot be ruled out as a risk to the infant. Therefore, repeated use of metamizol during lactation should be avoided. In the event of a single dose of metamizol, mothers are recommended to express and discard breast milk for 48 hours after administration.

Driving and operating machinery

Within the recommended dose range, no adverse effects on reaction time and concentration are known. However, as a precaution, you should be aware of the possibility of such adverse effects - at least at higher doses - and refrain from using machines, driving vehicles, and performing other hazardous activities. This applies especially if you have consumed alcohol.

Turbet contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of 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. Always choose the lowest necessary dose to control pain and fever. Your doctor will indicate how to take metamizol.

Adults and adolescents 15 years of age or older

Adults and adolescents 15 years of age or older (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 in intervals of 6-8 hours. 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.

Older adults and patients with poor general health/renal insufficiency

The dose should be reduced in older adults, 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 in cases of renal or hepatic insufficiency the elimination rate decreases, high repeated doses should be avoided. Only in short-term treatments, a dose reduction is not necessary. No experience is available with prolonged treatments.

Use in children and adolescents

• Adolescents 15 years of age or older (body weight above 53 kg): see adult doses.
• Metamizol should not be used in children and adolescents under 15 years of age. Other forms and presentations of this medication are available for younger children; consult your doctor or pharmacist.

Administration form

Oral use.

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

The tablet can be divided into equal doses.

Treatment duration

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

Do not take analgesics 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 symptoms of overdose, call your doctor immediately or go to the nearest hospital emergency department:

• nausea, vomiting, stomach pain;
• kidney function deterioration and even acute renal failure (e.g., with symptoms of interstitial nephritis);
• dizziness, drowsiness, loss of consciousness;
• seizures (convulsions);
• decrease in blood pressure that can evolve into circulatory failure (shock);
• cardiac rhythm disorders (tachycardia).

After administration of very high doses of metamizol, the excretion of an innocuous metabolite (rubazonic acid) may cause a reddish 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 forgot to take Turbet

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine 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 (for example, severe hypersensitivity reactions, severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis, agranulocytosis, pancitopenia) can be life-threatening. In such cases, metamizol should not be taken without medical supervision. Timely withdrawal may be crucial for recovery.

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

- Nausea or vomiting, fever, feeling of fatigue, loss of appetite, dark urine, light-colored stools, yellow discoloration of the skin or the white part of the eyes, itching, rash, or pain in the upper stomach. These symptoms may be signs of liver damage. See also section 2 "Warnings and precautions".

- Hypersensitivity reactions(anaphylactoid or anaphylactic reactions) -very rare(may affect up to 1 in 1,000 people).

The 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, and facial swelling and -less frequently- nausea and abdominal cramps.

Warning signs are burning sensation, itching, and redness on the tongue and underneath it and, above all, on the palms of the hands and the soles of the feet.

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

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

In patients with asthma-like reactions to analgesics, 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 severe side effects:

Flat red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).(Stevens-Johnson syndrome, toxic epidermal necrolysis).-unknown frequency(cannot be estimated from available data).

Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome) –unknown frequency(frequency cannot be estimated from available data).

-Severe reduction in white blood cells (agranulocytosis) that can cause death due to severe infections or reduction in blood platelets (thrombocytopenia) -very rare(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 used previously without complications. There are isolated cases where the risk of agranulocytosis may increase if metamizol is taken for more than a week.

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

The typical symptoms of thrombocytopenia include, for example, increased bleeding tendency and petechiae (round spots produced by hemorrhages in the skin and mucous membranes).

If symptoms of agranulocytosis, pancitopenia (see below), or thrombocytopenia appear, stop using metamizol immediately and have your doctor check your complete blood count until it normalizes (including differential blood count). Do not wait for laboratory test results to discontinue treatment.

-Severe reduction in blood volume with concomitant alteration of bone marrow function (aplastic anemia), reduction of white and red blood cells, and platelets (pancitopenia), including fatal cases -unknown frequency(frequency cannot be estimated from available data).

The symptoms of pancitopenia and aplastic anemia include general malaise, infection, persistent fever, hematomas, hemorrhages, and pallor.

Other possible side effects

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

• Fixed drug eruption with purple to reddish skin lesions and vesicles or blisters (fixed drug eruption),
• decreased blood pressure(hypotension). This can be a direct effect of this medication and not accompanied by other symptoms of hypersensitivity reactions. A reaction of this type only rarely causes severe hypotension. The risk of a hypotensive reaction may increase in cases of high fever (hyperpyrexia). The typical symptoms of a rapid decrease in blood pressure are tachycardia, pallor, tremors, dizziness, nausea, and loss of consciousness.

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

• Decreased white blood cell count in the blood (leucopenia),
• skin rash(for example, maculopapular exanthema).

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

• Asthma attack(difficulty breathing caused by narrowing of the airways),
• severe deterioration of kidney function, in some cases with very little or no urine (oligo-anuria), excess protein in the urine (proteinuria), or evolving to acute kidney failure; interstitial nephritis.

Unknown frequency (cannot be estimated from available data)

• Anaphylactic shock,
• myocardial infarction as a result of an allergic reaction(Kounis syndrome),
• inflammation of the liver,yellow discoloration of the skin and the white part of the eyes, elevated blood levels of liver enzymes,
• gastrointestinal hemorrhage.

Due to the excretion of an innocuous metabolite of metamizol (rubazonic acid), it may cause a reddish color 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not requirespecial conditions for conservation.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE pointat the pharmacy. Ask your pharmacist how to dispose of the medicines you no longer need. This way, you will help protect the environment.

Composition of Turbet

The active principle is metamizol sodium monohydrate.

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

Appearance of the product and contents of the package

Coated tablets, white to off-white in color, biconvex, oblong, with a notch on one face.

The tablet can be divided into equal doses.

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

Packages with 6, 10, 20, 30, 50, 60 coated tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin, Germany

Responsible for manufacturing

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

Further information about this medicinal product can be obtained by contacting the local representative of the holder of the marketing authorization:

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 with the following names:

HungaryMetamizole Aristo 1000mg filmtabletta

GermanyMetamizol Aristo 1000 mg Filmtabletten

SpainTurbet 1.000 mg coated tablets

PolandAxonalgin

PortugalMetamizol Aristo 1000 mg coated tablets

Last review date of this leaflet:September 2023

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/