ALGI-MABO 0.4 G/ML INJECTABLE SOLUTION AND PERFUSION SOLUTION

Contents of the leaflet:

1. What is Algi-Mabo and what is it used for

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

3. How to use Algi-Mabo

4. Possible side effects

5. Storage of Algi-Mabo

6. Contents of the package and additional information

1. What is Algi-Mabo and what is it used for

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

This medication is used for the treatment of moderate or severe acute post-operative or post-traumatic pain, colic pain, or pain of tumor origin. It is also used in cases of high fever that does not respond to other measures or medications for fever.

Algi Mabo injectable solution and for perfusion should only be administered parenterally (intravenous or intramuscular injection) in case of severe acute pain if enteral administration (oral) is not considered appropriate.

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

Do not use Algi-Mabo:

• 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 had 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 of 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 (the producer of blood cells); for example, during or after receiving antitumor chemotherapy (antineoplastic) or if you have had diseases related to the formation of blood cells.
• If you are in the last three months of pregnancy.
• If you have low blood pressure or circulation problems, you should not use Algi-Mabo injectable solution by parenteral route.
• In neonates or infants under 3 months or weighing less than 5 kg.
• In infants under 1 year by intravenous route.
• By intraarterial injection.
• 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 containing metamizole.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Algi Mabo.

Low white blood cell count (agranulocytosis).

Algi-Mabo 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 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 white 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 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 use 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 if you are intolerant to colorants 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 (for example, after a heart attack or multiple injuries). In these cases, or if the intravenous injection has been too rapid, 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.
• There have been cases of gastrointestinal bleeding in patients treated with Algi-Mabo injectable solution.

Liver problems

There have been reports of liver inflammation in patients taking metamizole with symptoms that develop within a few days to 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

There have been reports of severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), in association with treatment with metamizole. 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 resume treatment with this medication at any time (see section 4).

Using Algi-Mabo with food, drinks, and alcohol

Together with alcohol, it can enhance the effects of both alcohol and the medication.

Using Algi-Mabo and other medications

Tell your doctor or pharmacist if you are using or have recently used or may need to use other medications, including those purchased without a prescription.

Due to the possibility of incompatibilities, Algi-Mabo injectable solution and for perfusion should not be mixed with other medications in the same syringe.

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

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

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

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

If administered together 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 affect the efficacy of antihypertensives (medications that lower blood pressure) and diuretics (medications that increase fluid elimination).

Do not add the contents of the ampoule to large-volume intravenous solutions for pH correction, PAS, or parenteral nutrition (amino acids, lipids).

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 using this medication.

Pregnancy

The 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 when there are no other treatment options, single doses of metamizole during the first and second trimester may be acceptable after consulting 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 due to the increased risk of complications for the mother and the baby (bleeding, premature closure of a important 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 for the infant. Therefore, repeated use of metamizole during breastfeeding should be avoided. In case a single dose of metamizole is administered, 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 abilities 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 use Algi-Mabo

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

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

The dose is established based on the intensity of the pain or fever and the individual's sensitivity to treatment with Algi-Mabo. The lowest necessary dose to control pain and fever should always be selected.

Algi-Mabo will be administered to you by injection into a vein or muscle. Accidental intraarterial use can cause necrosis of the distal vascular area. The solution should be warmed to body temperature before injection.

If the effect of a single dose is insufficient or later, when the analgesic effect has decreased, your doctor may administer another dose until the maximum daily dose indicated below is reached.

Adults and adolescents 15 years of age or older

Adults and adolescents 15 years of age or older (weighing more than 53 kg) may be administered 1 to 2.5 ml by intravenous or intramuscular route in a single dose; when necessary, the single dose may be increased up to 6.2 ml (corresponding to 2,480 mg of Algi-Mabo). The maximum daily dose is 10.0 ml; when necessary, the daily dose may be increased up to 12.5 ml (corresponding to 5,000 mg of Algi-Mabo).

In the indication of oncologic pain, half an ampoule may be used in a single dose by oral route up to 4 times a day, at intervals of 6 to 8 hours, corresponding to a maximum daily dose of 4,000 mg (a maximum of 2 ampoules per day). The oral use of the ampoule for the treatment of oncologic pain should not exceed 7 days.

Infants and children

The following administration guideline should be used for single doses by intravenous or intramuscular route:

In case of fever, a dose of 10 mg of metamizole per kg of body weight is generally sufficient in children.

The effect of the medication usually appears 30 minutes after parenteral administration.

Elderly patients and patients with poor general health or 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, repeated high-dose administration should be avoided. Only in short-term treatments is dose reduction not necessary. There is no experience with long-term treatments.

Do not add the contents of the ampoule to large-volume intravenous solutions for pH correction or parenteral nutrition (amino acids, lipids).

The contents of the ampoules may be incorporated into large-volume intravenous solutions such as glucose or saline solutions, but should not be mixed with other medications in the same syringe.

Precautions in intravenous administration

The most common cause of a drop in blood pressure and shock is excessive injection speed. Intravenous injection should be administered very slowly to minimize the risk of a hypotension reaction. Blood pressure, heart rate, and respiration should be monitored. Since the decrease in blood pressure not due to an allergic reaction is likely to be dose-dependent, the intravenous administration of a single dose of more than 1 g of magnesium metamizole should be carefully considered.

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

If you use more Algi-Mabo than you should

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

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

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

Information for the doctor:

No specific antidote is known. After overdose by oral administration, gastric lavage and forced vomiting may be performed. Forced diuresis or dialysis may be considered, as metamizol is dialyzable.

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

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

If you forgot to take Algi-Mabo

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

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

4. Possible adverse effects

Like all medications, this medication 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:

• Red patches that are not raised, or circular patches in the shape of a target on the chest, often 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 increased size of lymph nodes (DRESS or drug hypersensitivity syndrome).

Stop using this medication and contact a doctor immediately if you experience any of the following symptoms: Feeling of illness (nausea or vomiting), fever, feeling of fatigue, loss of appetite, dark urine, light-colored stools, yellowish coloration of the skin or the white part of the eyes, itching, rash, or pain in the upper abdomen. 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 airways (angioedema), severe bronchospasm (narrowing of the bronchial walls), alterations in heart rhythm, and decrease in 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 one in 10 people):

• hypotension (decrease in blood pressure).

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

• skin eruptions and reactions
• pain at the injection site.

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

• allergic reactions that usually occur during or immediately after injection 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 one in 10,000 people):

• skin reactions with blisters or bubbles (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• kidney problems with decreased or suppressed urine output
• increase in the amount of protein excreted in the urine
• inflammation of the kidney (interstitial nephritis)
• severe decrease in white blood cells (agranulocytosis) that 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)
• inflammation in the veins.

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 bone marrow and blood cell production)
• 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
• local reactions at the injection site
• Liver inflammation, yellowish coloration 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 does not appear 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 medication.

5. Conservation of Algi-Mabo

This medication does not require special storage conditions.

Keep out of sight and reach of children.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Content of the packaging and additional information.

Composition of Algi-Mabo

• The active ingredient is magnesium metamizol. Each 5 ml ampoule contains 2 g of magnesium metamizol
• The other component (excipient) is water for injectable preparations.

Appearance of the product and content of the packaging

Algi-Mabo is an injectable and perfusion solution. It is available in packaging that contains 2, 5, 6, or 100 ampoules.

Only some packaging sizes may be commercialized.

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

LABORATORIOS SERRA PAMIES, S.A.

Castellvell Road, 24

43206, Reus (Tarragona), Spain

Date of the last revision of this prospectus: November 2024

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