Prospect: Information for the User

Metamizol Stada 575 mg Hard Capsules EFG

Magnesium Metamizol

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

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

2.What you need to know before starting to take Metamizol Stada

3.How to take Metamizol Stada

4.Possible adverse effects

5.Storage of Metamizol Stada

6. Contents of the package and additional information

Metamizol Stada belongs to the group of medicines called “Other Analgesics and antipyretics”.

This medicine is used for the treatment of moderate to severe acute postoperative 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-reducing medications.

Do not take Metamizol Stada:

-If you have had a significant decrease in a type of white blood cells called granulocytes, which was 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 you have had previous allergic reactions or hematologic 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 patches 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 sensitivity to metamizol (active substance of Metamizol Stada).

-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 had severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) with the use of metamizol or another medication containing metamizol.

Warnings and precautions

Consult your doctor or pharmacist before starting to take metamizol.

Low white blood cell count (agranulocytosis).

Metamizol Stada 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 masked. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis can occur at any time during the use of Metamizol Stada 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 pallor, 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 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 bronchial asthma (especially with inflammation of the nasal mucosa and nasal polyps), chronic urticaria, or if you are intolerant to dyes and/or preservatives or to alcohol, as the risk of possible 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, as the risk of a sudden drop in blood pressure is higher.
• If you develop a skin rash that progresses to the formation of blisters or lesions in the mucous membranes, you should stop treatment and see a doctor, as this may be due to the appearance of severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In these cases, you should not receive metamizol again (see section 4).
• If you have decreased liver or kidney 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.

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 metamizol 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.

You should not take metamizol if you have had previous liver problems with medications containing metamizol.

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, you should not restart treatment with [brand name] at any time (see section 4).

Taking Metamizol Stada with food, drinks, and alcohol

With alcohol, the effects of both the medication and the alcohol may be potentiated.

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 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, you should not take metamizol due to the increased risk of complications for the mother and the baby (bleeding, premature closure of a major blood vessel for the fetus, called the ductus arteriosus, which closes naturally after birth).

Breastfeeding

Metamizol degradation products are excreted in breast milk in significant amounts, and it cannot be ruled out that there may be a risk to the infant. Therefore, repeated use of metamizol during breastfeeding should be avoided. If a single dose of metamizol is administered, it is recommended that mothers express and discard breast milk for 48 hours after administration.

Driving and operating machines

Although no adverse effects on concentration and reaction capacity are expected, 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.

Taking Metamizol Stada with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

• If administered together with ciclosporin (a medication that prevents transplant rejection), it may reduce ciclosporin levels in the blood and therefore these should be measured regularly.
• If administered together with chlorpromazine (a medication for the treatment of psychoses), it may cause a decrease 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 it 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, it may reduce bupropion levels in the blood, and therefore it should be used with caution.
• Metamizol may modify the effect of anti-hypertensive medications (medications that reduce blood pressure) and diuretics (medications that increase the elimination of liquids).
• 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
• Sertraline, a medication used to treat depression

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 inform you of the duration of your treatment.

The dose is established based on the intensity of the pain or fever and the sensitivity of each person to treatment with metamizol. Always select the lowest necessary dose to control pain and fever. Your doctor will inform you how to take metamizol.

Adults and adolescents 15 years of age or older

Adults and adolescents 15 years of age or older (who weigh more than 53 kg) can take 1 capsule (575 mg of metamizol) in a single dose, which can be administered up to 6 times a day, in intervals of 4 to 6 hours. The maximum daily dose is 3450 mg (corresponding to 6 capsules).

The effect of the medication usually appears between 30 and 60 minutes after oral administration. Metamizol Stada should not be used in children under 15 years of age. For smaller children, other presentations and doses of this medication are available; consult your doctor or pharmacist.

Older adults and patients with poor general health/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. There is no experience with prolonged treatments.

The capsules should be swallowed whole, without chewing, with a little liquid.

If you take more Metamizol Stada than you should

Nausea, vomiting, abdominal pain, renal function deterioration, and in some cases, dizziness, somnolence, coma, seizures, decreased 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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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. Pharmacological emergency measures include administering adrenaline, fluid therapy, and glucocorticoids.

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

If you forgot to take Metamizol Stada

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.

Stop using metamizol and contact a doctor immediately if you experience any of the following symptoms:

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 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 respiratory tract (angioedema), severe bronchospasm (narrowing of the bronchial walls), heart rhythm disturbances, and decreased blood pressure (sometimes preceded by an increase in blood pressure).

Other side effects that may occur with the following frequencies are:

-hypotension (decreased blood pressure)

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

-decreased blood pressure

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

-skin eruptions and reactions

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

-allergic reactions that usually occur during or shortly after administration but also hours later

-skin eruptions and the appearance of blisters

-decreased white blood cell count in the blood (leucopenia)

-asthma.

Very rare (may affect up to 1 in 10,000 people):

-skin reactions with the appearance of vesicles or blisters (toxic epidermal necrolysis, Stevens-Johnson syndrome)

-kidney problems with decreased or suppressed urine elimination

-increased excretion of proteins in the urine

-inflammation of the kidneys (interstitial nephritis)

-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, inflammatory lesions in mucous membranes, throat pain, and fever may occur

-shock (drastic decrease in blood pressure)

Unknown frequency (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 hemorrhages

-chromaturia (abnormal coloring of the urine)

• inflammation of the liver, yellowing of the skin and the white part of the eyes, increased blood levels of liver enzymes.

Severe skin reactions

Stop taking metamizol and seek medical attention immediately 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, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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-induced hypersensitivity syndrome).

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children. No special storage conditions are required.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Metamizol Stada

• The active ingredient is metamizol magnesium. Each capsule contains 575 mg of metamizol magnesium.
• The other components are magnesium stearate, indigotin (E 132), erythrosine (E 127), titanium dioxide (E 171) and gelatin.

Appearance of the product and contents of the packaging

Metamizol Stada capsules are hard gelatin capsules, with a granate-colored body and cap, and white powder inside.

Metamizol Stada is presented in boxes containing blisters with 10, 20 or 500 (clinical packaging) hard capsules.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

International Medicines Laboratories, S.A.

C/Solana 26, Torrejón de Ardoz

28850 Madrid

Spain

Last review date of this leaflet:November 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.