ALGI-MABO 500 mg HARD CAPSULES

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

They are also used in cases of high fever that does not respond to other measures and other medications for fever.

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

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 metamizole or other similar medications called pyrazolones or pyrazolidines.
• If you have bone marrow problems 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 had previous allergic reactions or hematological reactions (decrease in white blood cells, red blood cells, or platelets in the blood) with medications containing metamizole 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 non-steroidal anti-inflammatory drugs, as you may also be sensitive to metamizole (the active substance in Algi Mabo).
• If you have acute intermittent porphyria (a disorder of the metabolism of blood pigments that are part of hemoglobin).
• If you have a genetic deficiency of glucose-6-phosphate dehydrogenase.
• If you have had alterations in bone marrow function (blood cell formation); for example, after receiving antitumor 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 Algi-Mabo or another medication that contains 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 cell called granulocytes, which are important for fighting infections (see section 4). You should stop taking metamizole and contact a doctor immediately if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in the mucous membranes (wet 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 levels.

If you take 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 used metamizole 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, bruising, bleeding, or paleness, you should 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, swelling of the face, decreased blood pressure, sudden onset of 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 metamizole, you should not take a medication that contains it again.
• If you have bronchial asthma (especially in the presence of nasal mucosa inflammation and nasal polyps), 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 (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 you have decreased kidney or liver function, as you may have difficulty eliminating the medication.
• If you are an elderly patient, be especially alert 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 metamizole, with symptoms developing within a few days to a few months after starting treatment. Stop using this medication and contact a doctor if you experience symptoms of liver problems, such as discomfort (nausea or vomiting), fever, feeling tired, loss of appetite, dark urine, light-colored stools, yellowing of the skin or the 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 metamizole 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 metamizole treatment. Stop taking metamizole 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 this medication at any time (see section 4).

Taking Algi-Mabo capsules with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, including those obtained without a prescription.

If administered concomitantly with cyclosporine (a medication that prevents transplant rejection), it may reduce cyclosporine blood levels and therefore they should be measured regularly.

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

If administered concomitantly with methotrexate or other medications for the treatment of tumors (antineoplastics), it may enhance the toxic effects of antineoplastics on the blood, especially in elderly patients.

If administered concomitantly with acetylsalicylic acid, it may reduce the effect of acetylsalicylic acid on platelet aggregation (antiplatelet) and therefore should be used with caution in patients taking it to protect the heart (cardioprotector).

If administered concomitantly with bupropion (a medication used for the treatment of depression and/or to help quit smoking), efavirenz (a medication used for the treatment of HIV/AIDS), methadone (a medication used to treat opioid dependence), valproate (a medication used to treat epilepsy or bipolar disorder), tacrolimus (a medication used to prevent organ rejection in transplant patients), or sertraline (a medication used to treat depression), it may reduce the blood levels of these medications, so it should be used with caution.

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

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

Together with alcohol, the effects of both can be enhanced.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

Available data on the use of metamizole during the first three months of pregnancy are limited, but they do not indicate harmful effects on the embryo. In selected cases where there are no other treatment options, single doses of metamizole during the first and second trimester 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 trimester.

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

Breastfeeding

Metamizole degradation products are excreted in breast milk in significant amounts, and it cannot be excluded that there is a risk to the breastfed infant. Therefore, repeated use of metamizole should be avoided during breastfeeding. If a single dose of metamizole is administered, mothers are recommended to express and discard breast milk for 48 hours after administration.

Driving and using machines

Although no adverse effects on concentration and reaction are expected, at the highest recommended doses, it should be taken into account that these abilities may be affected, and you should avoid using machines, driving vehicles, or engaging in other hazardous activities.

3. How to take Algi-Mabo capsules

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in 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. The 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 individual's sensitivity to treatment with Algi-Mabo capsules. The lowest necessary dose should always be selected to control the 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 metamizole in a single dose (2 capsules) that can be administered up to 4 times a day, at 6- to 8-hour intervals. 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. Other presentations and doses of this medication are available for younger children; consult your doctor or pharmacist.

Elderly patients and patients with poor general health/renal insufficiency

The dose should be reduced in elderly patients, debilitated patients, and those with decreased renal function, as the elimination of metamizole degradation products may be delayed.

Patients with renal or hepatic insufficiency

Since the elimination rate decreases in cases of renal or hepatic insufficiency, the administration of high repeated doses should be avoided. Only in short-term treatments is a dose reduction not necessary. There is no experience with prolonged treatments.

If you take more Algi-Mabo capsules than you should

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

After administration of very high doses of metamizole, a red coloration of the urine may occur, which disappears when treatment is stopped.

In case of overdose or accidental massive ingestion, consult your doctor or pharmacist immediately or call the Toxicology 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 metamizole is dialyzable.

In case of severe hypersensitivity reactions, other usual emergency measures should be applied, such as placing the patient on their side, keeping the airways clear of obstruction, or administering oxygen. Pharmacological emergency measures include the administration of adrenaline, fluid therapy, and glucocorticoids.

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

If you forget to take Algi-Mabo capsules

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking metamizol and seek medical attention immediately if you observe any of the following serious adverse effects:

• Reddish 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 erythemas can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, elevated body temperature, and enlargement of 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 of illness (nausea or vomiting), fever, feeling of tiredness, loss of appetite, dark urine, light-colored stools, yellowing of the skin or the white part of the eyes, itching, rash, or pain in the upper abdomen area. These symptoms may be signs of liver damage. See also section 2 Warnings and Precautions.

Milder allergic reactions (e.g., skin and mucous membrane reactions such as itching, burning, redness, swelling) as well as difficulty breathing and gastrointestinal discomfort can progress to more severe forms, e.g., generalized urticaria, swelling of 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).

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 eruptions and reactions.

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

• Allergic reactions that usually occur during or immediately after administration but also hours later.
• Skin eruptions and appearance of hives
• Decrease in the number of white blood cells in the blood (leukopenia)
• Asthma

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

• Skin reactions with blisters or bubbles (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• Kidney problems with decreased or suppressed urine output
• Increased amount of protein excreted in the urine
• Kidney inflammation (interstitial nephritis)
• Severe decrease in white blood cells (agranulocytosis), which can cause 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 (drastic drop in blood pressure).

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

• Sepsis (severe infection that involves an inflammatory reaction of the entire body and can cause death)
• Aplastic anemia (failure of the production of bone marrow and blood cells)
• Pancytopenia (low number of red, white, and platelet cells simultaneously)
• Anaphylactic shock (severe allergic reaction that can cause death)
• Kounis syndrome (a type of cardiac disorder)
• Gastrointestinal bleeding
• Chromaturia (abnormal urine coloration)

• Liver inflammation, yellowing of the skin and the white part of the eyes, increased blood level 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 that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Algi-Mabo Capsules

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder

MABO-FARMA, S.A.

Vía de los Poblados Street, 3,

Building 6, 28033 Madrid,

Spain.

Manufacturer:

TEDEC-MEIJI FARMA, S.A.

M-300 Highway, Km 30.500

28802 Alcalá de Henares, Madrid.

Or

Industria Química y Farmacéutica VIR, S.A.

Laguna Street, 66-70, Urtinsa II Industrial Park.

28923 Alcorcón, Madrid

Date of the Last Revision of this Prospectus: November 2024

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