ALGI-MABO 500 MG HARD CAPSULES

Patient Information Leaflet

Introduction

ALGI-MABO 500 mg hard capsules

Magnesium metamizole

Read the entire 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Algi-Mabo capsules are and what they are used for
2. What you need to know before taking Algi-Mabo capsules
3. How to take Algi-Mabo capsules
4. Possible adverse effects
5. Storage of Algi-Mabo capsules
6. Contents of the pack and other information

1. What Algi Mabo capsules are and what they are used for

Algi Mabo belongs to the group of medicines called "Other analgesics and antipyretics".

Algi-Mabo capsules are used for the treatment of moderate to severe acute postoperative or post-traumatic pain, colic-type pain, or pain of tumoral origin.

It is also used in cases of high fever that does not respond to other measures and other fever medications.

2. What you need to know before starting Algi Mabo capsules

Do not take Algi-Mabo capsules

• 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 your doctor has not prescribed this medicine for you.
• If you have previously had allergic reactions or hematological reactions (decrease in white blood cells, red blood cells, or platelets in the blood) to medicines containing metamizole or other similar compounds, or allergic reactions to any of the other components of this medicine (listed in section 6).
• If you have experienced symptoms of asthma, rhinitis, or urticaria (reddish skin rashes or hives that may cause itching) during treatment with other painkillers such as acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, as in these cases you may also be sensitive to metamizole (the active substance in Algi-Mabo).
• If you suffer from acute intermittent porphyria (a disorder in the metabolism of blood pigments that are part of hemoglobin).
• If you have glucose-6-phosphate dehydrogenase deficiency.
• If you have experienced bone marrow dysfunction (responsible for blood cell formation); for example, 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 (known, for example, as Stevens-Johnson syndrome or toxic epidermal necrolysis) while using Algi-Mabo or another medicine containing metamizole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Algi-Mabo.

Low white blood cell count (agranulocytosis)

Algi-Mabo capsules may 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 mucous membranes (wet 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 Algi-Mabo capsules 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 red 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 called anaphylactic shock. This reaction is more likely if you have asthma or allergic-type disorders (atopy).
• If you have had an allergic reaction to metamizole, you must not take any medicine containing it again.
• 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, as 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, as the risk of a sudden drop in blood pressure is higher.
• 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 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 must 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 treatment with metamizole. 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 not restart treatment with this medicine at any time (see section 4).

Taking Algi-Mabo capsules and other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

If administered concomitantly with cyclosporine (a medicine used to prevent transplant rejection), it may reduce cyclosporine blood levels; 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 anticancer medicines (antineoplastics), it may enhance the blood-related toxic effects 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 to treat depression and/or to help quit smoking), efavirenz (a medicine used to treat HIV/AIDS), methadone (a medicine used to treat addiction to illicit drugs known as opioids), 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; therefore, use with caution is advised.

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

Taking Algi-Mabo capsules with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

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 where 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 is not recommended during the first and second trimesters.

During the last three months of pregnancy, you must not take Algi-Mabo capsules 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 a risk to the nursing infant cannot be excluded. Therefore, repeated use of metamizole should be avoided during breastfeeding. If a single dose of metamizole is administered, mothers are advised to express and discard breast milk for 48 hours following administration.

Driving and use of machines

Although adverse effects on concentration and reaction ability are not expected, at the highest recommended doses, it should be considered that these abilities may be impaired. Therefore, avoid operating machinery, driving vehicles, or engaging in other hazardous activities.

3. How to take Algi-Mabo capsules

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

This medicine is 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 to the individual's sensitivity to treatment with Algi-Mabo capsules. The lowest effective dose required to control pain and fever should always be used. Your doctor will advise you on how to take Algi-Mabo capsules.

Adults and adolescents aged 15 years and older (weighing more than 53 kg) may take up to 1,000 mg of metamizole as a single dose (2 capsules), which can be administered up to 4 times daily at intervals of 6 to 8 hours. The maximum daily dose is 4,000 mg (equivalent to 8 capsules).

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

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

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

Dosage should be reduced in elderly patients, in debilitated patients, and in 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. Experience with prolonged treatment is lacking.

If you take more Algi-Mabo capsules than you should

Nausea, vomiting, abdominal pain, impaired kidney function, 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 metamizole, red discoloration of the urine may occur, which disappears upon discontinuation of treatment.

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

Information for the physician:

No specific antidote is known. In cases of oral overdose, gastric lavage and induction of emesis may be performed. Forced diuresis or dialysis may be considered, since metamizole is dialyzable.

In the event of severe hypersensitivity reactions, other standard emergency measures should also be applied, such as positioning the patient in the lateral recumbent position, maintaining airways unobstructed, or administering oxygen. Pharmacological emergency measures include administration of adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions is advised, along with implementation of all necessary general measures.

If you forget to take Algi-Mabo capsules

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

If you have any further questions about the use of this medicine, consult 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:

• Non-elevated reddish patches, or circular or target-shaped rashes on the chest, often with central blisters, skin peeling, and ulcers in the mouth, 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, feeling tired, loss of appetite, dark urine, pale stools, yellowing of the skin or the whites of the eyes, itching, rash, or pain in the upper stomach area. These symptoms may indicate 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 an increase 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, which usually occur during or immediately after administration, but may also appear hours later.
• Skin rashes and appearance of hives (urticaria) on the skin.
• Decrease in the number of white blood cells in the blood (leucopenia).
• Asthma.

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

• Skin reactions involving blisters or vesicles (toxic epidermal necrolysis, Stevens-Johnson syndrome).
• Kidney problems with reduced or suppressed urine output.
• Increased amount of proteins excreted in the 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 the blood (thrombocytopenia); in this case, inflammatory lesions in mucous membranes, sore throat, and fever may occur.
• Shock (a drastic drop in blood pressure).

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

• Sepsis (a severe infection causing a systemic inflammatory response that may result in death).

• Aplastic anemia (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 (a severe allergic reaction that may be fatal).

• Kounis syndrome (a type of cardiac disorder).

• Gastrointestinal bleeding.

• Chromaturia (abnormal discoloration of urine).

• Inflammation of the liver, 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 adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects 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 Algi-Mabo 500 mg hard capsules

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

Protect from heat and moisture.

Do not use Algi-Mabo capsules after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Algi-Mabo capsules

• The active substance is metamizole magnesium. Each hard capsule contains 500 mg of metamizole magnesium.
• The other components (excipients) are: magnesium stearate. Components of the capsule shell: gelatin, red iron oxide (E-172), erythrosine (E-127), and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Algi-Mabo capsules are presented as garnet-colored capsules containing a white powder. Each pack contains 12, 20 or 500 (hospital pack) hard capsules.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer responsible for production:

TEDEC-MEIJI FARMA, S.A.

Carretera M-300 Km 30,500

28802 Alcalá de Henares. Madrid.

Or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70. Polígono Industrial Urtinsa II.

28923 Alcorcón. Madrid

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/