ALGI-MABO 500 mg Hard Capsules

Magnesium Metamizol

Read this leaflet carefully before starting to take 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 must not be given to others, 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 they are not listed in this leaflet (see section 4).

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

2. What you need to know before starting to take 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 additional information

Algi Mabo belongs to the group of medications known as “Other analgesics and antipyretics”.

Algi-Mabo capsules are 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 and other fever medications.

Do not take Algi-Mabo capsules

• If you have previously had a significant decrease in a type of white blood cell called granulocytes, which was caused by metamizol or other similar medications called pyrazolones or pyrazolidines.
• If you have problems with your bone marrow or have a disorder that affects the way your blood cells are produced or function.
• If your doctor has not prescribed this medication 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) with medications containing metamizol or other similar compounds or allergic reactions to any of the other components of this medication (listed in section 6).
• If you have experienced symptoms of asthma, rhinitis, or urticaria (red patches or hives on the skin that can cause itching) during treatment with other analgesics such as acetylsalicylic acid, paracetamol, or nonsteroidal anti-inflammatory drugs, as in these cases you may also be sensitive to metamizol (active substance of Algi Mabo).
• 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 the function of your bone marrow (blood cell-forming organ); for example, after receiving chemotherapy or if you have 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 Algi-Mabo and another medication containing metamizol.

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 cell called granulocytes, which are important for fighting infections (see section 4). You should stop taking metamizol and contact a doctor immediately if you experience the following symptoms, as they may indicate a possible agranulocytosis: chills, fever, sore throat, and painful sores in the mucous membranes (moist surfaces of the body) 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 count.

If you take metamizol for fever, some symptoms of agranulocytosis may be masked. 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 after you have stopped taking metamizol.

You may develop agranulocytosis even if you have used metamizol without problems in the past.

Be especially careful:

• If you experience general discomfort, infection, persistent fever, sore throat, inflammation in the mouth, nose, or throat, lesions in the mucous membranes of the mouth or genitals, bruises, bleeding, or paleness, 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 a failure in the production of all blood cells (aplastic anemia).
• If you experience dizziness, difficulty breathing, rhinitis, facial swelling, decreased blood pressure, sudden red patches 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 have asthma or allergic disorders (atopy).
• If you have had an allergic reaction to metamizol, do not take another medication that contains it.
• If you have asthma, chronic urticaria, or are intolerant to dyes and/or preservatives or alcohol, as the risk of severe allergic reactions is higher.
• If you have low blood pressure or hypovolemia (decreased 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 you have impaired kidney or liver function, as you may have difficulty eliminating the medication.
• If you are an elderly patient, be especially attentive to the appearance of any of the disorders described above, as they may occur 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 this medication 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.

Do not take this medication 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, do not resume treatment with this medication at any time (see section 4).

Algi-Mabo capsule use and other medications

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

If administered together with ciclosporin (a medication that prevents transplant rejection), it may reduce the levels of ciclosporin in the blood and therefore these should be measured regularly.

If administered together with clorpromazina (a medication for the treatment of psychoses), it may cause a decrease in body temperature.

If administered together with metotrexato or other medications for the treatment of tumors (antineoplastic), it may potentiate the toxic effects in 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 to protect the heart (cardioprotector).

If administered together with bupropión (a medication used for the treatment of depression and/or to help quit smoking), efavirenz (a medication used for the treatment of HIV/AIDS), metadona (a medication used to treat addiction to illicit drugs, called opioids), valproato (a medication used to treat epilepsy or bipolar disorder), tacrolimus (a medication used to prevent organ rejection in transplant patients) or sertralina (a medication used to treat depression), it may reduce the levels of these medications in the blood, and therefore should be used with caution.

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

Algi-Mabo capsule use with food, drinks, and alcohol

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking 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, it is not recommended to use metamizol during the first and second trimesters.

During the last three months of pregnancy, do not take Algi-Mabo capsules 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 closes naturally after birth).

Lactation

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 during lactation should be avoided. In the event of a single dose of metamizol, it is recommended that mothers express and discard breast milk for 48 hours after administration.

Driving and using machines

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

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

Remember to take your medication.

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

This medication should be taken orally. Capsules should be swallowed whole, without chewing, with a little liquid.

The dose is established based on the intensity of the pain or fever and the sensitivity of each person to treatment with Algi-Mabo capsules.Always select the lowest necessary dose to control pain and fever.Your doctor will indicate how to take Algi-Mabo capsules.

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 (2 tablets) that can be administered up to 4 times a day, in intervals of 6 to 8 hours. The maximum daily dose is 4,000 mg (corresponding to 8 capsules).

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

Algi-Mabo capsules 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. No experience is available with prolonged treatments.

If you take more Algi-Mabo capsules than you should

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

After administration of very high doses of metamizol, urine may turn red, which disappears when treatment is stopped.

In case of overdose or accidental massive ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the name of the medication and the amount ingested.

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 hypersensitivity reactions, additional emergency measures should be applied, such as putting the patient on their side, maintaining airways free of obstruction, or administering oxygen. 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 Algi-Mabo capsules

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.

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, throat, nose, genital, and eye ulcers. 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, light-colored stools, yellow discoloration of the skin or white part of the eyes, itching, rash, or stomach pain. 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, such as generalized urticaria, swelling of the feet, hands, lips, throat, and airways (angioedema), severe bronchospasm (narrowing of the bronchial walls), heart rhythm disturbances, and decreased blood pressure (sometimes preceded by increased blood pressure).

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 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 with the appearance of vesicles or blisters (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• kidney problems with decreased or suppressed urine elimination
• increase in the amount of proteins excreted in the urine
• inflammation of the kidney (interstitial nephritis)
• severe decrease in white blood cells (agranulocytosis), which may cause death due to severe infections
• decrease in the number of platelets in the blood (thrombocytopenia), in this case, may cause inflammatory lesions in mucous membranes, throat pain, and fever.
• shock (drastic drop in blood pressure).

Frequency not known (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),
• Pancitopenia (low number 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,
• Cromaturia (abnormal urine color).

• Liver inflammation, yellow discoloration of the skin and white part of the eyes, increased levels of liver enzymes in the blood.
• Severe skin reactions

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 medicine.

Keep this medication out of the sight and reach of children

Protect from heat and moisture.

Do not use Algi-Mabo capsules after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Algi-Mabo capsules

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

Appearance of the product and contents of the packaging

Algi Mabo capsules are presented in the form of granate-colored capsules containing a white powder. Each package contains 12, 20, or 500 (clinical package) hard capsules.

Holder of the marketing authorization

MABO-FARMA, S.A.

Calle Rejas 2, 1st floor

28821 Coslada, Madrid.

Responsible for manufacturing:

TEDEC-MEIJI FARMA, S.A.

Carretera M-300 Km 30,500

28802 Alcalá de Henares. Madrid.

O

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón. Madrid

Last review date of this leaflet: November 2024

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