Package Leaflet: Information for the User

Metamizol Basi 500mg/ml injectable solution EFG

metamizol sodium monohydrate

Read this leaflet carefully before you start using this medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Table of Contents

1. What Metamizol Basi is and what it is used for
2. What you need to know before using Metamizol Basi
3. How to use Metamizol Basi
4. Possible side effects
5. Storage of Metamizol Basi
6. Contents of the pack and additional information

Metamizol Basi is a non-addictive medication with analgesic (pain-relieving), antipyretic (fever-reducing), and spasmolytic (spasm-reducing) effects.

Due to its ability to be administered intravenously, it can achieve a very strong analgesic effect for a variety of conditions and can influence pain that would otherwise only respond to preparations containing opioids. Metamizol Basi, even in high doses (unlike opioids), does not cause addiction or respiratory depression. It does not affect intestinal movements during digestion or uterine contractions during childbirth.

The medication is used to treat intense, sudden, or persistent pain and fever that does not respond to other treatments. The active ingredient of Metamizol Basi is metamizol.

No use Metamizol Basi

• If you are allergic to metamizol or any of the other components of this medication (listed in section 6) or to related substances (e.g., phenazone, propifenazone, phenylbutazone, oxifenbutazone).
• If you have a bone marrow disorder (e.g., after cancer treatment) or a hematopoietic disorder. If you have ever had asthma or allergic reactions such as urticaria or angioedema (swelling of the face and mucous membranes of the respiratory or digestive tract) related to the use of analgesics (salicylates, paracetamol, or other analgesics such as diclofenac, ibuprofen, indomethacin, naproxen).
• If you have a severe liver disease called porphyria (risk of developing a porphyria attack).
• If you have a congenital deficiency of the enzyme glucose-6-phosphate dehydrogenase (risk of hemolysis of red blood cells).
• Within the last three months of pregnancy.
• If you have low blood pressure or a circulatory disorder.
• If you have previously had a significant decrease 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 production or function of your blood cells.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Metamizol Basi.

Low white blood cell count (agranulocytosis).

Metamizol Basi 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 on 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 may occur at any time during the use of Metamizol Basi and even after you have stopped taking metamizol.

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

You need to be especially careful when using Metamizol Basi:

• If you develop fever, chills, sore throat, or ulcers in the mouth. If you develop any of these symptoms, stop treatment immediately and consult your doctor. These symptoms may be related to neutropenia (a lack of a type of white blood cells called neutrophils)

In the case of neutropenia (neutrophil count <1500 cells/mm3), treatment must be interrupted immediately. Your doctor will monitor your blood cell count until it returns to normal.

• If you notice signs and symptoms that suggest blood disorders (e.g., general weakness, infection, persistent fever, petechiae, bleeding, pallor), consult a doctor immediately. This may be pancitopenia (a reduction in the number of all types of blood cells).
• If you have bronchial asthma or atopy (a type of allergy). With these conditions, there is a higher risk of anaphylactic shock (a potentially fatal allergic reaction) after administration of metamizol, especially when the product is injected.
• If a severe skin reaction occurs, for example, worsening of the rash with blistering and damage to mucous membranes. This may be a symptom of potentially fatal skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis). Treatment with metamizol must be interrupted immediately in this case and should never be restarted.
• If you have any of the following diseases, as you have a higher risk of developing severe anaphylactoid reactions to metamizol:
• • bronchial asthma and concomitant inflammation of the nasal mucosa,
  • long-term or permanent urticaria,
  • hypersensitivity to alcohol, i.e., if you react even to small amounts of alcoholic beverages with sneezing, watery eyes, and significant facial redness,
  • hypersensitivity to colorants (e.g., tartrazine) or preservatives (e.g., benzoates).
• If you have low blood pressure, are losing fluids, have unstable fluid volume, or have incipient circulatory failure, or have high fever. In these cases, there is a higher risk of severe hypotensive reactions (associated with a drop in blood pressure). Administration of metamizol should be considered with special care, and if, even in these circumstances, metamizol needs to be administered, strict medical supervision is required. Preventive measures are necessary to reduce the risk of a severe hypotensive reaction. Metamizol administration may cause hypotensive reactions even unrelated to previous diseases. These reactions are likely dose-dependent and are more likely to occur after injection.
• If you have severe coronary heart disease or have significantly narrowed blood vessels supplying the brain. In these cases, it is absolutely necessary to avoid a drop in blood pressure, so metamizol should only be administered under strict monitoring of circulatory function.
• If you have kidney or liver disease. In this case, you should not receive high doses of metamizol because your excretion is reduced.

Liver Problems

Hepatitis has been reported in patients taking metamizol, with symptoms appearing between a few days and several months after starting treatment.

Stop using Metamizol Basi and contact your doctor if you have symptoms of liver problems such as nausea (sensation of discomfort or vomiting), fever, fatigue, loss of appetite, dark urine, light-colored stools, yellowing of the skin or white part of the eyes, itching, rash, or pain in the upper abdomen. Your doctor will check your liver function.

Do not use Metamizol Basi if you have previously taken a medication containing metamizol and have had liver problems.

Other Medications and Metamizol Basi

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Metamizol may reduce the effects of certain medications:

• Bupropion, a medication used to treat depression or to help quit smoking.
• Efavirenz, a medication used to treat HIV/AIDS.
• Metadone, a medication used to treat addiction to illegal drugs (called opioids).
• Valproate, a medication used to treat epilepsy or bipolar disorder.
• Tacrolimus, a medication used to prevent organ rejection in patients after a transplant.
• Sertraline, a medication used to treat depression.
• Ciclosporin, an immunosuppressant.

Your doctor will closely monitor you if you are given metamizol along with any of the above medications.

The addition of metamizol to methotrexate (an immunosuppressant) may increase the adverse effects of methotrexate on blood cell formation (hematotoxicity), especially in elderly patients. Avoid administering this combination of medications.

Care should be taken when coadministering this medication and taking aspirin for the prevention of cardiovascular events.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

The available data on the use of metamizol during the first three months of pregnancy are limited but do not suggest any harm to the fetus. In selected cases where there are no other treatment options, single doses of metamizol administered during the first and second trimesters may be acceptable after consulting with your doctor or pharmacist and carefully evaluating the benefits and risks of using metamizol. However, in general, the use of metamizol is not recommended during the first and second trimesters.

During the last three months of pregnancy, do not use Metamizol Basi due to the higher risk of complications for the mother and the baby (bleeding, fetal heart defect).

Breastfeeding

Metamizol metabolites pass into breast milk in significant amounts and cannot be ruled out as a risk to the infant. It is especially necessary to avoid repeated use of metamizol during breastfeeding. In the case of a single administration of metamizol, mothers should express and discard breast milk for 48 hours after the dose.

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.

Driving and Operating Machines

When used at recommended doses, the medication does not affect the ability to drive and operate machines. When using doses higher than recommended of Metamizol Basi and when taken concomitantly with alcohol, reaction time and concentration are affected. In these cases, do not drive vehicles or operate machines.

Metamizol Basi contains sodium

This medication contains 32.7mg of sodium (main component of table salt/for cooking) per 1ml of injectable solution. This is equivalent to 1.63% of the maximum daily sodium intake recommended for an adult.

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

The dosage depends on the intensity of the pain or fever and the individual response to Metamizol Basi.

Metamizol Basi will be administered through an injection into a vein or muscle. The onset of action can be expected 30 minutes after administration, and the duration of the effect is usually around 4 hours.

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 in the following table.

Adults and adolescents over 15 years old

Adults and adolescents 15 years of age or older (who weigh more than 53 kg) may receive a single dose of 1-2 ml by intravenous or intramuscular route; when necessary, the individual dose may be increased up to 5 ml (equivalent to 2,500 mg of Metamizol Basi). The maximum daily dose is 8 ml; when necessary, the daily dose may be increased up to 10 ml (equivalent to 5,000 mg of Metamizol Basi).

Use in children

The administration guide for single doses by intravenous or intramuscular route is as follows:

Older adults and patients with a poor general health condition with renal insufficiency

The dose should be reduced in older adults, in debilitated patients, and in those with impaired renal function, as the elimination of metamizol degradation products may be prolonged.

Patients with renal or hepatic insufficiency

In patients with renal or hepatic deterioration, it is recommended to avoid repeated high doses of metamizol, as the elimination rate decreases in these patients. No dose reduction is necessary for short-term use. There is no experience with long-term use.

When administered by injection, it is essential to remain lying down after administration under the supervision of a doctor who will closely monitor your condition.

If you use more Metamizol Basi than you should

Notified reactions after an acute overdose included nausea, vomiting, abdominal pain, worsening of renal function/acute renal failure, nervous system disturbances (dizziness, drowsiness, coma, seizures), decreased blood pressure, and cardiac rhythm alterations. After very high doses, a harmless reddish discoloration of the urine may occur.

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.

If you forgot to use Metamizol Basi

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 can cause side effects, although not everyone will experience them.

Side effects are classified according to the frequency of their occurrence as follows: very common (≥1/10); common (≥1/100 to <1/1000); rare (<1/1000); frequency unknown (cannot be estimated from available data).

Stop using Metamizol Basi and contact your doctor immediately if you experience any of the following symptoms:

Nausea (feeling of discomfort or vomiting), fever, fatigue, loss of appetite, dark urine, light-colored stools, yellowish discoloration of the skin or the white part of the eyes, itching, rash, or pain in the epigastrium (upper abdomen). These symptoms may be signs of liver damage. See also section 2 “Warnings and precautions”.

Blood and lymphatic system disorders

Rarely, blood disorders may occur: aplastic anemia (depletion of the bone marrow leading to a decrease in red blood cells), agranulocytosis (decrease or disappearance of a type of white blood cell), pancytopenia (decrease in all types of blood cells, including fatal cases), leukopenia (decrease in white blood cells), and thrombocytopenia (decrease in platelets).

Very rarely:The typical symptoms of thrombocytopenia (decrease in platelets) are an increased tendency to bleed and the appearance of small reddish-brown spots (petechiae) on the skin and mucous membranes, while the signs of agranulocytosis (decrease or disappearance of a certain type of white blood cell) include inflammatory changes in the mucous membranes, especially in the oral cavity, nose, and throat, as well as inflammatory changes in the rectal and genital areas, sore throat, and fever (which persists or recurs unexpectedly). These symptoms may be mild in patients treated with antibiotics. Red blood cell sedimentation increases significantly, while lymph node enlargement is mild or non-existent.

Immune system disorders

Rare:Metamizol may cause allergic reactions (anaphylactic shock, anaphylactoid reactions) that can be severe or potentially fatal or, in some cases, even fatal. These reactions may occur even if metamizol has been taken many times before without complications. Such reactions usually develop within the first hour after using Metamizol Basi, but may occur immediately or several hours later.

Mild forms of allergic reactions are characterized by manifestations on the skin or mucous membranes (e.g., itching, burning, redness, urticaria, swelling), difficulty breathing, and - less frequently - digestive problems. However, these symptoms may become severe with widespread urticaria, a severe condition characterized by swelling of the face, tongue, throat, or larynx (angioedema), severe shortness of breath, irregular heart rhythm (cardiac arrhythmia), sudden drop in blood pressure (sometimes preceded by a rise in blood pressure), and shock. In patients with bronchial asthma, these reactions take the form of a bronchial attack.

Unknown frequency:Kounis syndrome (allergic cardiac disease).

Vascular disorders

Unknown frequency:Transient and isolated decrease in blood pressure without other symptoms of hypersensitivity reaction.

Hepatobiliary disorders

Unknown frequency:Liver inflammation, yellowish discoloration of the skin and the white part of the eyes, increased liver enzymes in the blood.

Skin and subcutaneous tissue disorders

Rare:Rash.

Unknown frequency:A skin reaction characterized by the formation of round, purple to dark red blisters the size of a coin to the size of a palm; rarely, a rash and, in isolated cases, severe skin reactions with blisters that usually affect the mucous membranes (Stevens-Johnson syndrome or Lyell syndrome).

Renal and urinary disorders

Very rare:Transient alteration of renal function with reduced urine production (oliguria) or urine retention (anuria) or acute renal failure accompanied by urinary excretion of proteins (proteinuria).

Unknown frequency:Interstitial nephritis (inflammation of the kidneys).

General disorders and administration site conditions

Unknown frequency:Pain at the injection site, inflammation of the veins.

The medicine may affect the results of some laboratory blood tests (e.g., creatinine levels, triglycerides, HDL cholesterol, and uric acid).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction 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 adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store below 25°C.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the label after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Metamizol Base Composition

• The active ingredient is metamizol sodium monohydrate. 1 ml of injectable solution contains 500 mg of metamizol sodium monohydrate.
• The other component (excipient) is water for injectable preparations.

Product Appearance and Packaging Contents

Clear solution, practically free of particles. Glass type I ampoules of 2 ml with colored rings and a color point.

Packaging sizes: 5 x 2 ml, 50 × 2ml (clinical packaging).

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua - Portugal

Tel.: +351 231 920 250

Fax.: +351 231 921 055

E-mail: [email protected]

Responsible Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

3450-232 Mortágua – Portugal

Local Representative

Laphysan SAU

C/ Anabel Segura nº11,

Edificio B, Ground Floor, Door 3, Office 3,

28108 Alcobendas, Madrid, Spain

Last Review Date of this Leaflet:November 2024

Other Information Sources

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/.

This information is intended solely for healthcare professionals:

Parenteral administration is associated with a high risk of anaphylactic/anaphylactoid reactions.

If the injectable administration is considered in children between 3 and 11 months of age, it should be emphasized that metamizol should only be administered intramuscularly in these children.

It is essential to ensure that the injection is suspended and the risk of isolated hypotensive reaction is minimized at the first sign of an anaphylactic/anaphylactoid reaction. In the case of parenteral administration, it is essential to ensure that the patient remains lying down and under close medical supervision. Additionally, to prevent hypotensive reactions, intravenous injection should be administered very slowly, i.e., not more than 1 ml (500 mg of metamizol) per minute.

The injectable solution can be diluted in 5% glucose solution, 0.9% NaCl solution, 0.9% NaCl and 5% glucose solution, or lactate Ringer solution. These solutions should be administered immediately because their stability is limited.

Due to possible incompatibility, the metamizol solution should not be administered with other injectable solutions.