Package Insert: Information for the User

Metamizol Aristo 575 mg Capsules EFG

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

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.- What is Metamizol Aristo and what is it used for

2.- What you need to know before starting to take Metamizol Aristo

3.- How to take Metamizol Aristo

4.- Possible adverse effects

5.- Storage of Metamizol Aristo

6.- Contents of the package and additional information

Metamizol Aristo belongs to the group of medications known as “Other analgesics and antipyretics”.

This medication is used for the treatment of moderate to severe acute post-operative or post-traumatic pain, of colic type or of tumoral origin. It is also used in cases of high fever that does not respond to other measures or other fever medications.

Do not take Metamizol Aristo

-If you are allergic to metamizol or any of the other components of this medication (listed in section 6).

-If you have previously had allergic reactions or hematological reactions (decrease in white blood cells, red blood cells, or platelets in the blood) with medications containing metamizol or other similar compounds.

-If you have experienced symptoms of asthma, rhinitis, or urticaria (red patches or hives on the skin that may cause itching) during treatment with other analgesics such as acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, as in these cases there may also be sensitivity to metamizol.

-If you have acute intermittent porphyria (a disorder of the metabolism of blood pigments that form part of hemoglobin).

-If you have a genetic deficiency of glucose-6-phosphate dehydrogenase.

-If you have had alterations in bone marrow function (responsible for producing blood cells); for example, during or after receiving chemotherapy (antineoplastic) or if you have had diseases related to blood cell formation.

-If you are in the last three months of pregnancy.

-If you have had severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) with the use of Metamizol Aristo or another medication containing metamizol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Metamizol Aristo.

Be especially careful:

• If you experience general discomfort, infection, persistent fever, sore throat, inflammation in the mouth, nose, or throat, mouth or genital mucosa lesions, bruises, bleeding, or paleness, discontinue treatment and consult your doctor immediately. These disorders may be due to a decrease in white blood cells in the blood (agranulocytosis), platelets (thrombocytopenia), or a failure in the production of all blood cells (aplastic anemia).
• If you experience dizziness, difficulty breathing, rhinitis, facial swelling, decreased blood pressure, sudden appearance of red patches on the skin, discontinue treatment and consult your doctor. These symptoms may be due to a severe allergic reaction called anaphylactic shock. This reaction is more likely if you have asthma or allergic disorders (atopy).
• If you have bronchial asthma (especially with nasal mucosa inflammation and nasal polyps), chronic urticaria, or if you are intolerant to dyes and/or preservatives or to alcohol, as the risk of severe allergic reactions is higher.
• If you have low blood pressure or hypovolemia (decrease in circulating blood volume or any other body fluid), dehydration, or unstable circulation, as the risk of a sudden drop in blood pressure is higher.
• If a skin eruption appears that progresses to the formation of blisters or lesions in the mucosa, discontinue treatment and seek medical attention, as this may be due to the appearance of severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In these cases, you should not receive metamizol-containing medications again (see section 4).
• If you have decreased liver or kidney function, as you may eliminate the medication with greater difficulty.
• If you are an elderly patient, be especially attentive to the appearance of any of the disorders described above, as they may appear more frequently.

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 Aristo and contact a doctor if you experience symptoms of liver problems, such as nausea, vomiting, fever, fatigue, 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 Metamizol Aristo if you have previously taken a medication containing metamizol and had liver problems.

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 restart treatment with Metamizol Aristo at any time (see section 4).

Other medications and Metamizol Aristo

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

• If administered together with cyclosporine (a medication that prevents transplant rejection), it may reduce cyclosporine levels in the blood and therefore these should be measured regularly.
• If administered with chlorpromazine (a medication for the treatment of psychosis), it may cause a decrease in body temperature.
• If administered together with methotrexate or other medications for the treatment of tumors (antineoplastic), it may potentiate the toxic effects on the blood of antineoplastic medications, especially in elderly patients.
• If administered together with acetylsalicylic acid, it may reduce the effect of acetylsalicylic acid to decrease platelet aggregation (antiplaquetary) and therefore should be used with caution in patients taking it for heart protection (cardioprotector).
• If administered together with bupropion, a medication used together for the treatment of depression and/or to help quit smoking, it may reduce bupropion levels in the blood, and therefore should be used with caution.
• Efavirenz, a medication used for the treatment of HIV/AIDS.
• Metadona, a medication used to treat dependence on illicit drugs (designated opioids).
• Valproate, a medication used to prevent organ rejection in transplant patients.
• Sertralina, a medication used to treat depression.

Metamizol may modify the effect of antihypertensive medications (medications that reduce blood pressure) and diuretics (medications that increase the elimination of liquids).

Taking Metamizol Aristo with food, drinks, and alcohol

Together with alcohol, the effects of both may be potentiated.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using this medication.

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 carefully evaluating the benefits and risks of using metamizol. However, in general, it is not recommended to use metamizol during the first and second trimesters.

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

Breastfeeding

Consult your doctor or pharmacist before using this medication.

Metamizol degradation products are excreted in breast milk in significant amounts and it cannot be ruled out that there is a risk to the infant. Therefore, repeated use of metamizol should be avoided during breastfeeding. 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

Although no adverse effects on concentration and reaction capacity are expected at the recommended doses, you should be aware that these capacities may be affected at higher doses and you should avoid operating machinery, driving vehicles, or other hazardous activities.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication is for short-term use. Your doctor will inform you of the duration of your treatment.

This medication must be administered orally.

The dose is established according to the intensity of the pain or fever and the sensitivity of each person to Metamizol Aristo treatment. Always select the lowest necessary dose to control pain and fever. Your doctor will inform you how to take Metamizol Aristo.

Adults and adolescents 15 years of age or older

Adults and adolescents 15 years of age or older (weighing more than 53 kg) can take 1 capsule (575 mg of metamizol) in a single dose, which can be administered up to 6 times a day, in intervals of 4 to 6 hours. The maximum daily dose is 3450 mg (corresponding to 6 capsules).

The effect of the medication usually appears between 30 and 60 minutes after oral administration.

Metamizol Aristo should not be used in children under 15 years of age. For smaller children, other presentations and doses of this medication are available; consult your doctor or pharmacist.

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. There is no experience with prolonged treatments.

If the pain persists or worsens, consult a doctor to investigate the cause of the symptoms.

If you take more Metamizol Aristo than you should

Nausea, vomiting, abdominal pain, kidney function deterioration, and in rare cases, dizziness, drowsiness, coma, seizures, decreased blood pressure, or even shock and increased heart rate (tachycardia) may occur.

After administration of very high doses of metamizol, a reddish discoloration of the urine may occur, which disappears when treatment is discontinued.

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

Information for the doctor:

No specific antidote is known. After oral overdose, gastric lavage and forced vomiting may be performed. Forced diuresis or dialysis may be considered, as metamizol is dialyzable.

In case of severe allergic reactions, additional emergency measures such as placing the patient on their side, maintaining airways free of obstruction, or administering oxygen should be applied. Pharmacological emergency measures include administering adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions, as well as taking general necessary measures, is recommended.

If you forgot to take Metamizol Aristo

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Mild allergic reactions (e.g. skin and mucous membrane reactions such as itching, burning, redness, swelling, difficulty breathing, and gastrointestinal discomfort) may progress to more severe forms, such as generalized urticaria, swelling of the feet, hands, lips, throat, and respiratory tract (angioedema), severe bronchospasm (narrowing of the bronchial walls), heart rhythm disturbances, and decreased blood pressure (sometimes preceded by an increase in blood pressure).

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

Feeling of illness (nausea or vomiting), fever, feeling tired, 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 area. These symptoms may be signs of liver damage. See also section 2 Warnings and precautions.

Other side effects that may occur with the following frequencies are:

Frequent (may affect up to 1 in 10 people):

• hypotension (decreased blood pressure).

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

• skin eruptions and reactions.

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

• allergic reactions that usually occur during or shortly after administration, but also hours later.
• skin eruptions and appearance of blisters.
• decreased white blood cell count in the blood (leucopenia)
• asthma

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

• skin reactions with the appearance of vesicles or blisters (toxic epidermal necrolysis, Stevens-Johnson syndrome),
• kidney problems with decreased or suppressed urine elimination
• increased protein excretion in the urine
• interstitial nephritis (inflammation of the kidneys)
• severe decrease in white blood cells (agranulocytosis) that may cause death due to severe infections
• decreased platelet count in the blood (thrombocytopenia), in this case, may cause inflammatory lesions in mucous membranes, throat pain, and fever.
• shock (drastic drop in blood pressure).

Unknown frequency (cannot be estimated from available data):

• sepsis (severe infection that involves a systemic inflammatory reaction and may cause death),
• aplastic anemia (failure in the production of bone marrow and blood cells),
• pancytopenia (low count of red and white blood cells and platelets simultaneously),
• anaphylactic shock (severe allergic reaction that may cause death)
• Kounis syndrome (a type of cardiac disorder),
• gastrointestinal bleeding
• cyanuria (abnormal urine color).
• Liver inflammation, yellow discoloration of the skin and the white part of the eyes, increased blood levels of liver enzymes.
• 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, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

- Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, including possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for 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 medicine.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE pointat the pharmacy. Ask your pharmacist how to dispose of medications you no longer need. In this way, you will help protect the environment.

Composition of Metamizol Aristo

-The active ingredient is metamizol magnesium. Each capsule contains 575 mg of metamizol magnesium.

-The other components (excipients) are: magnesium stearate. The capsule components are: indigotin (E 132), erythrosine (E 127), titanium dioxide (E 171) and gelatin

Appearance of the product and contents of the packaging

Metamizol Aristo capsules are hard, granate-colored capsules, and the powder they contain is white.

The packaging contains 10 or 20 capsules.

Holder of the marketing authorization and responsible for manufacturing

Marketing authorization holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Responsible for manufacturing

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana, 26

28850 – Torrejón de Ardoz (Madrid)

Spain

Last review date of this leaflet:February 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/.