Metamizole Mabo 575 mg hard capsules EFG

Patient Information Leaflet: Information for the user

Introduction

Patient Information Leaflet: information for the user

Metamizol Mabo 575 mg hard capsules EFG

Magnesium metamizole

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, 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, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Package leaflet contents

1. What Metamizol Mabo is and what it is used for
2. What you need to know before taking Metamizol Mabo
3. How to take Metamizol Mabo
4. Possible side effects
5. Storage of Metamizol Mabo
6. Contents of the pack and other information

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

This medicine belongs to the group of medicines known as "Other Analgesics and Antipyretics".

This medicine is used for the treatment of moderate to severe acute pain following surgery or trauma, of colicky type, or 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 starting to take Metamizol Mabo

Do not take Metamizol Mabo:

• 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) to medicines containing metamizole or other similar compounds, or if you are allergic to any of the other components of this medicine (listed in section 6).
• If you have previously experienced symptoms of asthma, rhinitis, or urticaria (reddish skin rashes or hives that may cause itching) while being treated with other painkillers such as acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, since in these cases you may also be sensitive to metamizole (the active substance in this medicine).
• If you suffer from acute intermittent porphyria (a disorder in the metabolism of blood pigments that are part of hemoglobin).
• If you have a genetic deficiency of glucose-6-phosphate dehydrogenase.
• If you have previously experienced disturbances in bone marrow function (responsible for blood cell formation); for example, during or after receiving antitumor (antineoplastic) chemotherapy, or if you have had diseases related to blood cell formation.
• If you are in the last three months of pregnancy.
• If you have previously experienced severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) after using this or another medicine containing metamizole.

Warnings and precautions

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

Lower than normal white blood cell count (agranulocytosis)

Metamizol Mabo 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 (moist 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 can occur at any time during the use of Metamizol Mabo 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 reddish skin rashes, stop treatment and consult your doctor. These symptoms may be due to a severe allergic reaction known as anaphylactic shock. This reaction is more likely if you suffer from asthma or allergic-type disorders (atopy).
• If you suffer from 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 alcohol, since the risk of severe allergic reactions is higher.
• If you have low blood pressure, hypovolemia (reduced circulating blood volume or any other body fluid), dehydration, or unstable circulation, since the risk of a sudden drop in blood pressure is higher.
• If you have reduced kidney or liver function, as you may eliminate the medicine with greater difficulty.
• If you are elderly, pay special attention to 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 taking this medicine 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 should not take this medicine 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 restart treatment with this medicine (see section 4).

Taking Metamizol Mabo with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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 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 metamizole 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 the 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 after 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 machines, driving vehicles, or other hazardous activities should be avoided. This is especially important if alcohol has been consumed.

Other medicines and Metamizol Mabo

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

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 decrease 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 (antiplatelet action), and therefore it should be used with caution in patients taking it for cardioprotection.

If administered together with bupropion (a medicine used to treat depression and/or to help quit smoking), efavirenz (a medicine used to treat HIV/AIDS), methadone (a medicine used to treat opioid dependence), valproate (a medicine used to treat epilepsy or bipolar disorder), tacrolimus (a medicine used to prevent organ rejection in transplant patients), or sertraline (a medicine used to treat depression), it may reduce blood levels of these medicines, so caution is advised.

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

3. How to take Metamizol Mabo

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 capsules must be swallowed whole, without chewing, with a little liquid.

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

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 metamizol) 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 3,450 mg (equivalent to 6 capsules).

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

Children and adolescents under 15 years of age

Metamizol 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 or renal impairment

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

Patients with renal or hepatic impairment

Since elimination rate is reduced in cases of renal or hepatic impairment, repeated administration of high doses should be avoided. Dose reduction is not necessary only in short-term treatments. Experience with prolonged treatment is lacking.

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

If you take more Metamizol Mabo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms may include nausea, vomiting, abdominal pain, impaired kidney function, and, less commonly, dizziness, somnolence, coma, seizures, decreased blood pressure, or even shock and increased heart rate (tachycardia).

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

Information for the physician: There is no known specific antidote. Following oral overdose, gastric lavage and induction of emesis may be possible. Forced diuresis or dialysis may be considered, as metamizol is dialyzable.

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

Careful monitoring of vital functions is recommended, along with the implementation of necessary general supportive measures.

If you forget to take Metamizol Mabo

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

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.

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

• Flat red patches, or circular or target-shaped rashes on the chest, often with central blisters, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. These severe skin rashes 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).

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

Feeling unwell (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites 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.

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 more severe forms, e.g. generalized urticaria, swelling of feet, hands, lips, throat and airways (angioedema), severe bronchospasm (narrowing of the bronchial walls), changes in heart rhythm, and decreased blood pressure (sometimes preceded by a rise in blood pressure).

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

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

• Hypotension (decrease in 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, usually occurring during or immediately after administration, but also hours later, skin rashes and hives, decreased number of white blood cells 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 reduced or suppressed urine output, increased amount of protein excreted in the urine, inflammation of the kidney (interstitial nephritis), severe decrease in white blood cells (agranulocytosis) which may lead to death due to severe infections, decreased number of platelets in the blood (thrombocytopenia); in such cases, inflammatory lesions in mucous membranes, sore throat, and fever may occur, 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 lead to death), aplastic anemia (failure in the production of bone marrow and blood cells), 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 urine coloration), liver inflammation, yellowing of the skin and whites of the eyes, increased blood levels of liver enzymes.
• Severe skin reactions.

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 may 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 Mabo

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

Do not use this medicine after the expiry date indicated on the packaging after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metamizol Mabo

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

Appearance of the product and contents of the pack

Hard gelatin capsules, size 0L, with a burgundy-colored body and cap, packed in PVC/PVdC-Aluminum blisters containing 10, 20, or 500 (clinical pack) hard capsules.

Marketing Authorization Holder:

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-68-70. Pol Ind. Urtinsa II.

28923 ALCORCÓN, Madrid

Spain

Date of the most recent revision of this leaflet: November 2024

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