ALGI-MABO 0.4 g/ml injectable and infusion solution

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 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 not listed in this leaflet. See section 4.

Contents of the leaflet:

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

2. What you need to know before using 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

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

This medication is 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 or other fever medications.

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

Do not use Algi-Mabo:

• If you have had a significant drop in a type of white blood cells called granulocytes, 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 had previous 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 spots 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 there may also be a reaction 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 (producer of blood cells); for example, during or after receiving chemotherapy (antineoplastic) or if you have 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, do not use Algi-Mabo injectable solution by parenteral route.
• In neonates or infants under 3 months or less than 5 kg of body weight.
• In infants under 1 year by intravenous route
• In intraarterial injection.
• 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 that contained metamizol.

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 cells 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 overlooked. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis can occur at any time during the use of Algi-Mabo 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, discontinue 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, low blood pressure, sudden red spots on the skin, discontinue 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 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 to 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 myocardial infarction 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 impaired kidney or liver function, as you may eliminate the medication with greater difficulty.
• If you are an elderly patient, be especially attentive to the appearance of any of the disorders described above, as they may appear more frequently.
• There have been cases of gastrointestinal bleeding in patients treated with Algi-Mabo injectable solution.

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).

Use of Algi-Mabo with food, drinks, and alcohol

Along with alcohol, it may potentiate the effects of both this and the drug.

Use of Algi-Mabo and other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use other medications, even 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 (medication that prevents transplant rejection), it may reduce blood levels of cyclosporine and therefore these should be measured regularly.

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

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

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using 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 due to the increased risk of complications for the mother and the baby (bleeding, premature closure of a major 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, mothers are recommended to express and discard breast milk during the 48 hours following its administration.

Driving and operating machines

Although not expected to have adverse effects on concentration and reaction capacity, at higher doses within the recommended range, you should be aware that these capacities may be affected and you should avoid operating machines, driving vehicles, or other hazardous activities.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 according to the intensity of the pain or fever and the sensitivity of each person to treatment with Algi-Mabo. Always select the lowest necessary dose to control pain and fever.

Algi-Mabo will be administered by injection into a vein or muscle. Accidental intraarterial use 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 to reach the maximum daily dose indicated below.

Adults and adolescents 15 years of age or older

To adults and adolescents 15 years of age or older (who weigh more than 53 kg), 1 to 2.5 ml can be administered by intravenous or intramuscular route in a single dose; when necessary, the single dose can 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 can be increased up to 12.5 ml (corresponding to 5,000 mg of Algi-Mabo)

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

Infants and children

Use as a guide the administration schedule for single doses by intravenous or intramuscular route in the following table:

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

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

Older adults and patients with poor general health or 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.

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 can be incorporated into large volume intravenous solutions such as glucose solutions 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 veryslowlyto minimize the risk of a hypotensive reaction. Blood pressure, heart rate, and respiration should be monitored. Since the drop 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 metamizol magnesium should be carefully considered.

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

If you use more Algi-Mabo than you should

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

After administration of very high doses of metamizol, a reddish discoloration 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 Toxicological Information Service, phone 91 562 04 20, indicating 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 allergic reactions, additional emergency measures such as placing the patient on their side, maintaining airways free of obstruction, or administering oxygen should be applied. Emergency pharmacological measures include the administration of 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

Do not administer a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking metamizol and seek immediate medical attention 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 ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

-Generalized erythema, elevated body temperature, and lymph node enlargement (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, 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, e.g. 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 one in 10 people):

• hypotension (decreased blood pressure).

Infrequent (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 papules.
• decreased white blood cell count in the blood (leucopenia).
• asthma

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

• skin reactions with blisters or vesicles (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• kidney problems with decreased or suppressed urine output
• increased protein excretion in the urine
• interstitial nephritis (inflammation of the kidneys)
• severe decrease in white blood cells (agranulocytosis) that may cause death due to severe infections
• decreased platelet count in the blood (thrombocytopenia), in this case, may cause inflammatory lesions in mucous membranes, throat pain, and fever.
• shock (drastic drop in blood pressure)
• inflammation in the veins.

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)
• pancytopenia (low count 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
• local reactions at the injection site
• inflammation of the liver, yellow discoloration of the skin and white part of the eyes, increased blood levels of liver enzymes.
• 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.

This medication does not require special conditions for conservation.

Keep out of the 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.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging andthe medicines that you do not need at the SIGRE collection pointof the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and the medicines that you do not need. In this way, you will help protect the environment.

Composition of Algi-Mabo

• The active principle is metamizol magnesium. Each 5 ml ampoule contains2 gof metamizol magnesium
• The other component (excipient) is water for injectable preparations.

Appearance of the product and contents of the packaging

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

Only some sizes of containers may be commercially marketed.

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 Km30,500

28802 Alcalá de Henares. Madrid.

or

LABORATORIOS SERRA PAMIES, S.A.

Carretera de Castellvell, 24

43206, Reus (Tarragona), - Spain

Last review date of this leaflet: November 2024

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/