Algi-Mabo 0.4 g/ml solution for injection and for infusion

Patient Information Leaflet

Introduction

ALGI-MABO 0.4 g/ml injection solution and infusion solution

Magnesium metamizole

Read the entire leaflet carefully before starting to take 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 and should not be given 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

Algi-Mabo is a medicine that contains two active substances: Acidum ascorbicum (vitamin C) and Natrium metamizolum (also known as dipyrone). This combination is used for the short-term treatment of mild to moderate pain and fever.

The active substance Natrium metamizolum belongs to a group of medicines called non-opioid analgesics and antipyretics. It works by blocking the production of certain natural substances in the body that cause pain and fever.

The active substance Acidum ascorbicum is vitamin C, which supports the normal function of the immune system and increases iron absorption from the gut.

Algi-Mabo is used for the short-term relief of:

• Headache
• Toothache
• Pain during menstruation
• Feverish colds
• Other mild to moderate pain conditions

This medicine is intended for short-term use only. If symptoms persist or worsen, a doctor should be consulted.

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

3. How to use Algi-Mabo

4. Possible adverse effects

5. Storage of Algi-Mabo

6. Contents of the container and additional information

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

Algi-Mabo 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.

Algi-Mabo solution for injection and infusion should only be administered by the parenteral route (intravenous or intramuscular injection) in cases of severe acute pain when enteral (oral) administration is not considered appropriate.

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

Do not use Algi-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 this medicine has not been prescribed to you by your doctor.
• 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 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 rash or hives on the skin that may cause itching) during treatment with other painkillers such as acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, as you may also react to metamizole (the active substance in Algi-Mabo).
• If you suffer from acute intermittent porphyria (a disorder in the metabolism of blood pigments that form part of hemoglobin).
• If you have glucose-6-phosphate dehydrogenase deficiency.
• If you have suffered bone marrow dysfunction (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 low blood pressure or circulatory problems, do not use Algi-Mabo injectable solution by parenteral route.
• In neonates or infants under 3 months of age or weighing less than 5 kg body weight.
• In infants under one year of age by intravenous route.
• By intra-arterial injection.
• If you have previously experienced severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) with prior use of Algi-Mabo or another medicine containing metamizole.

Warnings and precautions

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

Low white blood cell count (agranulocytosis).

Algi-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 any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in 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 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 treatment with Algi-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, inflammation in the mouth, nose, or throat, lesions in the mucosa 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 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 suffer from asthma or allergic-type disorders (atopy).
• If you have had an allergic reaction to metamizole, you should not use any medicine containing it again.
• 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 to alcohol, as the risk of severe allergic reactions is higher.
• If you have low blood pressure or hypovolemia (reduced circulating volume of blood or any other body fluid), dehydration, or unstable circulation (e.g., after acute myocardial infarction or multiple injuries). In these cases, or if intravenous injection has been administered too rapidly, the risk of a sudden drop in blood pressure is greater.
• If you have reduced kidney or liver function, as you may eliminate the medicine with greater difficulty.
• If you are elderly, be especially vigilant for the appearance of any of the disorders described above, as they may occur more frequently.
• Cases of gastrointestinal bleeding have been reported in patients treated with Algi-Mabo injectable solution.

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 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 a 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 resume treatment with this medicine (see section 4).

Using Algi-Mabo with food, drinks, and alcohol

Alcohol may enhance the effects of both alcohol and the medicine.

Use of Algi-Mabo and other medicines

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

Due to the possibility of incompatibilities, Algi-Mabo injectable and infusion solution must not be mixed with other drugs in the same syringe.

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 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 dependence on illicit opioid drugs), 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, it should be used with caution.

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

The contents of the ampoule must not be added to large-volume intravenous solutions used 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 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. However, in general, the use of metamizole during the first and second trimesters is not recommended.

During the last three months of pregnancy, Algi-Mabo must not be taken 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 nursing 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 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 taken into account that these abilities may be affected. Therefore, driving, operating machinery, or engaging in other potentially hazardous activities should be avoided.

3. How to use Algi-Mabo

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The dose is determined according to the intensity of pain or fever and to the individual's sensitivity to treatment with Algi-Mabo. The lowest dose required to control pain and fever should always be selected.

Algi-Mabo will be administered to you by injection into a vein or into a muscle. Accidental intra-arterial administration may cause necrosis of the distal vascular area. The solution must 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, up to the maximum daily dose indicated below.

Adults and adolescents aged 15 years and older

For adults and adolescents aged 15 years and older (weighing more than 53 kg), 1 to 2.5 ml may be administered intravenously or intramuscularly as 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 oncological pain, half an ampoule may be used orally as a single dose up to 4 times daily, at intervals of 6 to 8 hours, corresponding to a maximum daily dose of 4,000 mg (a maximum of 2 ampoules per day). Oral use of the ampoule for the treatment of oncological pain should not exceed 7 days.

Infants and children

The following table should be used as a guide for single-dose administration by intravenous or intramuscular route:

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

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

Elderly patients and patients with poor general health or renal insufficiency

Dosage should be reduced in elderly individuals, debilitated patients, and those with impaired renal function, as elimination of metamizole degradation products may be delayed.

Patients with renal or hepatic insufficiency

Since elimination rate decreases in cases of renal or hepatic insufficiency, repeated administration of high doses should be avoided. In short-term treatments, dose reduction is not necessary. Experience with prolonged treatments is lacking.

The contents of the ampoule must not be added to large-volume intravenous solutions used for pH correction or for parenteral nutrition (amino acids, lipids).

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

Precautionary measures for intravenous administration

The most frequent cause of a drop in blood pressure and shock is excessively rapid injection. Intravenous injection must be administered very slowly to minimize the risk of hypotensive reactions. Blood pressure, heart rate, and respiration must be monitored. Since a drop in blood pressure not due to an allergic reaction is likely to be dose-dependent, intravenous administration of a single dose exceeding 1 g of metamizole sodium should be carefully considered.

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

If you use more Algi-Mabo than you should

Nausea, vomiting, abdominal pain, impaired kidney function, and more rarely dizziness, drowsiness, coma, convulsions, low 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 ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

Information for the physician:

There is no known specific antidote. After oral overdose, gastric lavage and induction of vomiting may be performed. Forced diuresis or dialysis may be considered, as metamizole is dialyzable.

In case of severe allergic reactions, other standard emergency measures should also be applied, such as placing the patient in the lateral position, maintaining airways free of obstruction, 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 necessary general supportive measures.

If you forget to take Algi-Mabo

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

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

4. Possible adverse effects

Like all medicines, this medicine may 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, frequently 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, fatigue, 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, for example generalized urticaria, swelling of the 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:

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

• Hypotension (low blood pressure).

Uncommon (may affect up to 1 in 100 people):

• Skin rashes and skin reactions.
• Pain at the injection site.

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

• Allergic reactions, which usually occur during or shortly after injection, but may also appear hours later.
• Skin rashes and hives (urticaria).
• Decreased number of white blood cells in the blood (leukopenia).
• 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 protein excreted in the urine.
• Inflammation of the kidneys (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 this case, inflammatory lesions in mucous membranes, sore throat, and fever may occur.
• Shock (severe drop in blood pressure).
• Inflammation of the veins.

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

• Sepsis (a severe infection causing a systemic inflammatory response that may be fatal).
• 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 (a severe allergic reaction that may be fatal).
• Kounis syndrome (a type of cardiac disorder).
• Gastrointestinal bleeding.
• Chromaturia.
• Local reactions at the injection site.
• 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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

This medicine does not require any special storage conditions.

Keep out of the sight and reach of children.

Do not use Algi-Mabo 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 containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information.

Composition of Algi-Mabo

• The active substance is magnesium metamizole. Each 5 ml ampoule contains 2 g of magnesium metamizole.
• The other component (excipient) is water for injections.

Appearance of the product and contents of the container

Algi-Mabo is an injectable and infusion solution. It is available in packages containing 2, 5, 6, or 100 ampoules.

Only certain package sizes may be marketed.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3,

Edificio 6, 28033 Madrid,

Spain.

Manufacturer

TEDEC-MEIJI FARMA, S.A.

Carretera M-300 Km 30,500

28802 Alcalá de Henares. Madrid.

or

LABORATORIOS SERRA PAMIES, S.A.

Carretera de Castellvell, 24

43206, Reus (Tarragona), - Spain

Date of the most recent review of this summary: 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/