Metamizol Basi 500 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metamizol Basi 500mg/ml solution for injection EFG

metamizole sodium monohydrate

Read the entire leaflet carefully before you start using 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Package leaflet 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 other information

1. What Metamizol Basi is and what it is used for

Metamizol Basi is a non-addictive medicine with analgesic (to relieve pain), antipyretic (to reduce fever), and spasmolytic (to relieve spasms) effects.

Because it can be administered intravenously, a strong analgesic effect can be achieved for a variety of conditions, and it can influence pain that would otherwise only respond to opioid-containing preparations. Metamizol Basi, even at 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 medicine is used to treat sudden or persistent severe pain and fever unresponsive to other treatments. The active substance in Metamizol Basi is metamizol.

2. What you need to know before using Metamizol Basi

Do not use Metamizol Basi

• If you are allergic to metamizole or to any of the other ingredients of this medicine (listed in section 6), or to related substances (e.g., phenazone, propyphenazone, phenylbutazone, oxyphenbutazone).
• If you have bone marrow impairment (e.g., following 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 tracts) related to the use of analgesics (salicylates, paracetamol or other analgesics such as diclofenac, ibuprofen, indomethacin, naproxen).
• If you have the serious liver disease called porphyria (risk of developing a porphyria attack).
• If you have congenital deficiency of the enzyme glucose-6-phosphate dehydrogenase (risk of red blood cell breakdown).
• During the last three months of pregnancy.
• If you have low blood pressure or a circulatory disorder.
• 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 problems with your bone marrow or a disorder affecting the production or function of your blood cells.

Warnings and precautions

Talk to your doctor or pharmacist before using Metamizol Basi.

Low white blood cell count (agranulocytosis).

Metamizol Basi 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 the mucous membranes (wet 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 are taking metamizole for fever, some symptoms of agranulocytosis may go unnoticed. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis may occur at any time during treatment with Metamizol Basi and even shortly after stopping metamizole.

You may develop agranulocytosis even if you have previously used metamizole without problems.

Special caution is required when using Metamizol Basi:

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

In case of neutropenia (neutrophil count < 1,500 cells/mm³), treatment must be stopped immediately. Your doctor will monitor your blood cell count until it returns to normal.

• If you notice signs and symptoms suggesting blood disorders (e.g., general weakness, infection, persistent fever, bruising, bleeding, paleness), consult a doctor immediately. This could indicate pancytopenia (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 an increased risk of anaphylactic shock (a potentially life-threatening allergic reaction) after administration of metamizole, especially when the product is injected.
• If a severe skin reaction occurs, for example, worsening of rash with blister formation and mucosal damage. This may be a sign of potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis). Treatment with metamizole must be stopped immediately in such cases and must never be restarted.
• If you have any of the following conditions, as you are then at increased risk of developing severe anaphylactoid reactions to metamizole:
  • bronchial asthma and concomitant inflammation of the nasal mucosa,
  • long-term/permanent urticaria,
  • alcohol hypersensitivity, i.e., if you react even to small amounts of alcoholic beverages with sneezing, watery eyes, and significant facial flushing,
  • hypersensitivity to dyes (e.g., tartrazine) or preservatives (e.g., benzoates).
• If you have low blood pressure, fluid loss, unstable body fluid volume, or incipient circulatory failure, or if you have high fever. In these cases, there is an increased risk of severe hypotensive reactions (associated with a drop in blood pressure). Administration of metamizole should be considered with special caution, and if metamizole must be administered under these circumstances, strict medical supervision is required. Preventive measures are necessary to reduce the risk of a severe hypotensive reaction. Administration of metamizole may cause hypotensive reactions even unrelated to the above conditions. These reactions are likely dose-dependent and are more likely to occur after injection.
• If you have severe coronary heart disease or significantly narrowed blood vessels supplying the brain. In these cases, a drop in blood pressure must be strictly avoided, so metamizole should only be administered with strict monitoring of circulatory function.
• If you have kidney or liver disease. In this case, high doses of metamizole should not be given because its excretion is reduced.

Liver problems

Hepatitis has been reported in patients taking metamizole, with symptoms appearing from a few days to several months after starting treatment.

Stop using Metamizol Basi and contact your doctor if you experience symptoms of liver problems such as nausea (feeling unwell or vomiting), fever, fatigue, loss of appetite, dark-colored urine, pale stools, yellowing of the skin or whites of the eyes, itching, rash, or epigastric pain (upper abdominal pain). Your doctor will check your liver function.

Do not use Metamizol Basi if you have previously taken any medicine containing metamizole and experienced liver problems.

Other medicines and Metamizol Basi

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Metamizole may reduce the effects of certain medicines:

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

Your doctor will closely monitor you if you are given metamizole together with any of the medicines listed above.

Adding metamizole to methotrexate (an immunosuppressive drug) may increase the adverse effects of methotrexate on blood cell formation (hematotoxicity), especially in elderly patients. Administration of this combination of drugs should be avoided.

Caution should be exercised when co-administering this medicine with aspirin used for prevention of cardiac events.

Pregnancy, breastfeeding, and fertility

Pregnancy

Available data on the use of metamizole during the first three months of pregnancy are limited but do not suggest harmful effects on the fetus. In selected cases where no other treatment options are available, single doses of metamizole administered during the first and second trimesters may be acceptable after consultation with your doctor or pharmacist and careful evaluation of the benefits and risks of using metamizole. However, in general, the use of metamizole during the first and second trimesters is not recommended.

During the last three months of pregnancy, you must not use Metamizol Basi due to the increased risk of complications for mother and baby (bleeding, fetal ductus arteriosus (premature closure of an important fetal blood vessel called the ductus arteriosus, which normally closes after birth)).

Breastfeeding

Metabolized products of metamizole pass into breast milk in significant amounts, and a risk to the breastfed infant cannot be excluded. Repeated use of metamizole during breastfeeding should especially be avoided. In the case of a single dose of metamizole, mothers are advised to express and discard breast milk for 48 hours after administration.

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.

Driving and using machines

When used at the recommended doses, this medicine does not affect the ability to drive or operate machinery. When higher than recommended doses of Metamizol Basi are used, or when taken concomitantly with alcohol, reaction ability and concentration may be impaired. In these cases, do not drive or operate machinery.

Metamizol Basi contains sodium

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

3. How to use Metamizol Basi

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

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

Metamizol Basi will be administered by injection into a vein or into a muscle. Onset of action can be expected within 30 minutes after administration; the duration of effect is usually about 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 up to the maximum daily dose indicated in the table below.

Adults and adolescents over 15 years of age

Adults and adolescents aged 15 years or older (weighing more than 53 kg) may receive a single dose of 1–2 ml intravenously or intramuscularly; if 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; if necessary, the daily dose may be increased up to 10 ml (equivalent to 5,000 mg of Metamizol Basi).

Use in children

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

Elderly people and patients with poor general health and renal impairment

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

Patients with renal or hepatic impairment

In patients with impaired renal or hepatic function, repeated high doses of metamizole should be avoided, as elimination rate is reduced in these patients. Dose reduction is not necessary for short-term use. Experience with long-term use is lacking.

In case of injection administration, it is essential to remain lying down after administration under the supervision of a physician who will carefully monitor your condition.

If you use more Metamizol Basi than you should

Reactions reported after acute overdose include nausea, vomiting, abdominal pain, worsening of renal function/acute renal failure, neurological disturbances (dizziness, drowsiness, coma, convulsions), decreased blood pressure, and cardiac rhythm disturbances. After very high doses, a harmless red discoloration of urine may occur.

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.

If you forget to use Metamizol Basi

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

If you have any further 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 everybody experiences them.

Adverse effects are classified according to their frequency of occurrence as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).

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

Feeling nauseous (feeling unwell or vomiting), fever, fatigue, loss of appetite, dark-coloured urine, pale stools, yellowing of the skin or the whites of the eyes, itching, rash, or upper abdominal pain. 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: decreased number of red blood cells due to bone marrow depletion (aplastic anemia), decreased number or absence of a type of white blood cells in the blood (agranulocytosis), and decreased number of all blood cell lines (pancytopenia), including fatal cases, decreased number of white blood cells (leukopenia), and thrombocytopenia (decreased number of platelets).

Very rarely: typical symptoms of thrombocytopenia (decreased number of platelets) include increased tendency to bleeding and appearance of small reddish-brown spots (petechiae) on the skin and mucous membranes, whereas signs of agranulocytosis (decreased number or absence of a certain type of white blood cells in the blood) include inflammatory changes in 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 unexpectedly reappears). These symptoms may be minimal in patients treated with antibiotics. Erythrocyte sedimentation rate increases considerably, while lymph node enlargement is slight or absent.

Immune system disorders

Rare: metamizole may cause allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reactions) which can be severe or potentially fatal, and occasionally even fatal. These reactions may occur even if metamizole has been taken many times previously without complications. Such reactions usually develop within the first hour after using Metamizol Basi, but may occur immediately or several hours later.

Milder forms of allergic reactions are characterized by skin or mucous membrane manifestations (e.g., itching, burning, redness, urticaria, swelling), difficulty breathing, and—less frequently—gastrointestinal disturbances. However, these symptoms may progress to severe forms with generalized urticaria, a serious condition characterized by swelling of the face, tongue, throat, or larynx (angioedema), severe shortness of breath, irregular heartbeat (cardiac arrhythmia), drop in blood pressure (sometimes preceded by a rise in blood pressure), and shock. In patients with bronchial asthma, these reactions may manifest as a bronchial attack.

Frequency not known: Kounis syndrome (allergy-induced heart disease).

Vascular disorders

Frequency not known: isolated and transient - only exceptionally critical - decrease in blood pressure without other symptoms of hypersensitivity reaction.

Hepatobiliary disorders

Frequency not known: liver inflammation, yellowing of the skin and the white part of the eyes, increased liver enzymes in the blood.

Skin and subcutaneous tissue disorders

Rare: rash.

Frequency not known: a skin reaction characterized by the formation of round blisters ranging in color from purple to dark red, from the size of a coin to the size of the palm; rarely, a rash, and in isolated cases, severe skin reactions with blisters usually affecting mucous membranes (Stevens-Johnson syndrome or Lyell syndrome).

Renal and urinary disorders

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

Frequency not known: inflammation of the kidneys (interstitial nephritis).

General disorders and administration site reactions

Frequency not known: pain at the injection site, inflammation of the veins.

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

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 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 reactions, you can help provide more information on the safety of this medicine.

5. Storage of Metamizole Basi

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

Store below 25 °C.

Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Metamizol Basi

• The active substance is metamizole sodium monohydrate. 1 ml of injectable solution contains 500 mg of metamizole sodium monohydrate.
• The other component (excipient) is water for injections.

Appearance of the product and contents of the pack

Clear solution, practically free from particles. Type I glass ampoules of 2 ml with coloured rings and a coloured dot.

Pack sizes: 5 x 2 ml, 50 × 2 ml (hospital pack).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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]

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, Planta 0, Puerta 3, Oficina 3,

28108 Alcobendas, Madrid, Spain

Date of the most recent review of this summary: November 2024

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

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

If injectable administration is considered in children between 3 and 11 months of age, it must be emphasized that metamizole should only be administered by intramuscular route in these children.

It is essential to ensure that the injection is discontinued at the first sign of an anaphylactic/anaphylactoid reaction, and the risk of an isolated hypotensive reaction is minimized. 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 must be administered very slowly, i.e., no more than 1 ml (500 mg of metamizole) per minute.

The injectable solution may be diluted in 5% glucose solution, 0.9% sodium chloride solution, 0.9% sodium chloride and 5% glucose solution, or Ringer's lactate solution. These solutions should be administered immediately, as their stability is limited.

Due to possible incompatibility, metamizole solution must not be administered simultaneously with other injectable solutions.