Metamizole Aristo 575 mg capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Metamizol Aristo 575 mg capsules EFG

Metamizol Aristo 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 this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

2.- What you need to know before taking Metamizol Aristo

3.- How to take Metamizol Aristo

4.- Possible adverse effects

5.- How to store Metamizol Aristo

6.- Contents of the pack and other information

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

Metamizol Aristo belongs to a group of medicines called "Other analgesics and antipyretics".

This medicine is used to treat moderate to severe acute pain following surgery or trauma, colicky pain, or pain of tumoral origin. It is also used in cases of high fever unresponsive to other measures or other antipyretic medicines.

2. What you need to know before taking Metamizol Aristo

Do not take Metamizol Aristo

• If you are allergic to metamizole or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously experienced 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 previously had allergic reactions or hematological reactions (reduction in white blood cells, red blood cells, or platelets in the blood) with medicines containing metamizole or other similar compounds.
• If you have previously experienced symptoms of asthma, rhinitis, or urticaria (reddish spots or hives on the skin that may cause itching) during treatment with other painkillers such as acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, since sensitivity to metamizole may also occur in these cases.
• If you suffer from acute intermittent porphyria (a disorder in the metabolism of blood pigments that form part of hemoglobin).
• If you have glucose-6-phosphate dehydrogenase deficiency.
• If you are in the last three months of pregnancy.
• If you have previously experienced severe skin reactions (for example, Stevens-Johnson syndrome or toxic epidermal necrolysis) after using Metamizol Aristo or another medicine containing metamizole.

Warnings and precautions

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

Low white blood cell count (agranulocytosis).

Metamizol Aristo 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, 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 Metamizol Aristo and even shortly after stopping metamizole.

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

Take special care:

• If you experience general malaise, infection, persistent fever, sore throat, swelling in the mouth, nose, or throat, lesions in the mucous membranes of the mouth or genitals, bruising, bleeding, or paleness, you must stop treatment and consult your doctor immediately. These disorders may be due to a decrease in the number of white blood cells in the blood (agranulocytosis), platelets (thrombocytopenia), or failure in the production of all blood cells (aplastic anemia).
• If you experience dizziness, difficulty breathing, rhinitis, facial swelling, low blood pressure, or sudden appearance of red spots on the skin, stop 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 suffer from asthma or allergic-type disorders (atopy).
• If you have bronchial asthma (especially in the presence of nasal mucosa inflammation and nasal polyps), chronic urticaria, or if you are intolerant to dyes and/or preservatives or to alcohol, since the risk of severe allergic reactions is higher.
• If you have low blood pressure, hypovolemia (reduced circulating volume of blood or any other body fluid), dehydration, or unstable circulation, since the risk of a sudden drop in blood pressure is higher.
• If a skin rash appears and progresses to blistering or mucosal lesions, you must stop treatment and see a doctor, as this may indicate very severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In such cases, you must not receive medicines containing metamizole again.
• If you have impaired kidney or liver function, as you may eliminate the medicine with greater difficulty.
• If you are an elderly patient, be especially vigilant for the appearance of any of the disorders described above, as they may occur more frequently.

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

You must not take Metamizol Aristo if you have previously taken any medicine containing metamizole and experienced 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 metamizole treatment. Stop taking metamizole and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you have ever experienced severe skin reactions, you must never resume treatment with Metamizol Aristo (see section 4).

Other medicines and Metamizol Aristo

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

• If administered concomitantly with cyclosporine (a medicine used to prevent transplant rejection), it may reduce cyclosporine blood levels, and therefore these levels should be monitored regularly.
• If administered together with chlorpromazine (a medicine used to treat psychosis), it may cause a drop in body temperature.
• If administered together with methotrexate or other medicines used to treat tumors (antineoplastics), it may enhance the blood toxicity of antineoplastics, especially in elderly patients.
• If administered together with acetylsalicylic acid, it may reduce the antiplatelet effect of acetylsalicylic acid (platelet aggregation inhibition), and therefore should be used with caution in patients taking it for cardioprotection.
• If administered together with bupropion, a medicine used for treating depression and/or to help quit smoking, it may reduce bupropion blood levels, and therefore should be used with caution.
• Efavirenz, a medicine used to treat HIV/AIDS.
• Methadone, a medicine used to treat dependence on illicit drugs (opioids).
• Valproate, a medicine used to prevent organ transplant rejection.
• Sertraline, a medicine used to treat depression.

Metamizole may alter the effects of antihypertensives (medicines that lower blood pressure) and diuretics (medicines that increase fluid elimination).

Taking Metamizol Aristo with food, drinks, and alcohol

When taken with alcohol, the effects of both alcohol and the drug may be enhanced.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using this medicine.

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 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 Metamizol Aristo due to the increased risk of complications for mother and baby (bleeding, premature closure of an important fetal vessel called the ductus arteriosus, which normally closes after birth).

Breastfeeding

Consult your doctor or pharmacist before using this medicine.

Metamizole metabolites are excreted in breast milk in considerable amounts, and a risk to the infant cannot be excluded. 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 following administration.

Driving and using machines

Although adverse effects on concentration and reaction ability are not expected, at the higher end of the recommended doses, it should be considered that these abilities may be affected, and the use of machinery, driving vehicles, or other hazardous activities should be avoided.

3. How to take Metamizol Aristo

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

This medicine is intended for short-term use. Your doctor will determine the duration of your treatment.

This medicine is to be taken orally.

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

Adults and adolescents aged 15 years and older

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

The effect of the medicine usually occurs between 30 and 60 minutes after oral administration.

Metamizol Aristo must not be used in children under 15 years of age. For younger children, other formulations and doses of this medicine are available; please consult your doctor or pharmacist.

Elderly patients and patients with poor general health/concomitant renal impairment

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

Patients with renal or hepatic impairment:

Since elimination rates are 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. There is no clinical experience with prolonged treatment.

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

If you take more Metamizol Aristo than you should

Symptoms may include nausea, vomiting, abdominal pain, impaired kidney function, and, more rarely, dizziness, drowsiness, coma, convulsions, low blood pressure, or even shock and increased heart rate (tachycardia).

After administration of very high doses of metamizole, red discoloration of the urine may occur, which disappears upon discontinuation of treatment.

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

Information for the physician:

There is no known specific antidote. After oral overdose, gastric lavage and induction of emesis may be considered. Forced diuresis or dialysis may also be considered, as metamizole is dialyzable.

In case of severe allergic reactions, other standard emergency measures should also be applied, such as positioning the patient in the lateral position, maintaining airway patency, or administering oxygen. Pharmacological emergency measures include administration of adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions is advised, together with the implementation of necessary general supportive measures.

If you forget to take Metamizol Aristo

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 everybody gets them.

Mild allergic reactions (e.g. skin and mucous membrane reactions such as itching, burning, redness, swelling, as well as difficulty breathing and gastrointestinal discomfort) may progress to severe forms, e.g. generalized urticaria, swelling of feet, hands, lips, throat and airways (angioedema), severe bronchospasm (narrowing of the bronchial walls), heart 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 unwell (nausea or vomiting), fever, feeling of fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or the whites of the eyes, itching, skin rash or pain in the upper stomach area. These symptoms may be signs of liver damage. See also section 2, Warnings and precautions.

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

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

• hypotension (decreased blood pressure).

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

• skin rashes and skin reactions.

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

• allergic reactions, which usually occur during or shortly after administration, but may also occur hours later.
• skin rashes and appearance of hives.
• decrease in the number of white blood cells in blood (leucopenia)
• asthma

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

• skin reactions with the appearance of blisters or bullae (toxic epidermal necrolysis, Stevens-Johnson syndrome),
• kidney problems with decreased or suppressed urine output
• increased amount of protein excreted in urine
• inflammation of the kidney (interstitial nephritis)
• severe decrease in white blood cells (agranulocytosis), which may result in death due to severe infections
• decrease in the number of platelets in blood (thrombocytopenia); in this case, inflammatory lesions may occur in mucous membranes, accompanied by sore throat and fever.
• shock (drastic drop in blood pressure).

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

• sepsis (serious infection causing a systemic inflammatory response that may result in death),
• aplastic anaemia (failure in the production of blood cells in the bone marrow),
• pancytopenia (low levels of red blood cells, white blood cells and platelets simultaneously),
• anaphylactic shock (severe allergic reaction that may be fatal)
• Kounis syndrome (a type of cardiac disorder),
• gastrointestinal bleeding
• chromaturia (abnormal discoloration of urine).
• Liver inflammation, yellowing of the skin and whites of the eyes, increased blood levels of liver enzymes.
• Severe skin reactions

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

• Non-elevated reddish patches, or circular or target-like patches on the chest, frequently with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin erythemas 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 adverse effects

If you experience any type of adverse effect, consult 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. Storage of Metamizol Aristo

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Metamizol Aristo

• The active substance is magnesium metamizole. Each capsule contains 575 mg of magnesium metamizole.
• The other components (excipients) are: magnesium stearate. Components of the capsule shell: indigotine (E 132), erythrosine (E 127), titanium dioxide (E 171) and gelatin.

Appearance of the product and contents of the pack

Metamizol Aristo capsules are hard capsules of dark red color containing white powder.

Pack sizes contain 10 or 20 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 Torrejón de Ardoz (Madrid)

Spain

Manufacturer

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana, 26

28850 – Torrejón de Ardoz (Madrid)

Spain

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

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