Prospect: information for the user

Metamizol Combix 575 mg hard capsules EFG

Magnesium metamizol

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

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and must not be given to other people even if they 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 do not appear in this prospect. See section 4.

This medication 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.

Do not take Metamizol Combix:

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Lower than normal white blood cell count (agranulocytosis).

Metamizol Combix 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 Metamizol Combix and even after stopping 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, mucosal lesions, bruises, bleeding, or paleness, you should suspend 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 spots on the skin, suspend 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 nasal mucosa inflammation and nasal polyps), chronic urticaria, or intolerance 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 (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.

• 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 restart treatment with metamizol at any time (see section 4).

• 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 occur 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 taking this medication and contact a doctor if you experience symptoms of liver problems, such as nausea, vomiting, fever, feeling tired, 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 taken a medication containing metamizol in the past and had liver problems.

Taking Metamizol Combix with food, drinks, and alcohol

Along with alcohol, the effects of both this and the medication 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, do not take metamizol due to the increased risk of complications for the mother and 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 breastfeeding should be avoided. If a single dose of metamizol is administered, mothers should 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 the recommended doses, it should be noted that these capacities may be affected at higher doses and that you should avoid using machines, driving vehicles, or other hazardous activities. This is especially applicable when alcohol has been consumed.

Taking Metamizol Combix 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 cyclosporine (medication that prevents transplant rejection), it may reduce cyclosporine levels in the blood and therefore these should be measured regularly.

• If administered together with chlorpromazine (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 (medication used for the treatment of depression and/or to help quit smoking), efavirenz (medication used for the treatment of HIV/AIDS), metadone (medication used to treat dependence on illicit drugs, called opioids), 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 the levels of these medications in the blood, so it should be used with caution.

Metamizol may modify the effect of antihypertensive medications (medications that reduce blood pressure) and diuretics (medications that increase the elimination of liquids).

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.

This medication should be taken orally. Capsules should be swallowed whole, without chewing, with a little liquid.

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 indicate how you should 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 3,450 mg (corresponding to 6 capsules).

The effect of the medication usually appears between 30 and 60 minutes after oral administration.

Children and adolescents under 15 years of age

Metamizol 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 a poor general health status 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. There is no experience with prolonged treatments.

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

If you take more Metamizol Combix than you should

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.

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 the treatment is discontinued.

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 general necessary measures, is recommended.

If you forgot to take Metamizol Combix

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 taking this medicine 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:

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

• hypotension (decreased blood pressure).

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

• Rashes and skin 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, rashes, and appearance of blisters on the skin, leukopenia (decreased white blood cell count in the blood), asthma.

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

• skin reactions with vesicles or blisters (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 granulocytopenia (decreased white blood cell count) that may cause death due to severe infections, thrombocytopenia (decreased platelet count in the blood), in this case, may cause inflammatory lesions in mucous membranes, sore throat, and fever, shock (drastic drop in blood pressure).

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), pancitopenia (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, chromaturia (abnormal urine color).

• Liver inflammation, 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, mouth ulcers, throat, nose, genital, and eye ulcers. 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 lymph node enlargement (DRESS syndrome or drug 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 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.

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

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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Metamizol Combix

• 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 content of the packaging

Hard gelatin capsules, size 0L, with a granate-colored body and cap, packaged in PVC/PVdC-Aluminum blister packs containing 10, 20, or 500 capsules.

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing:

Industria Química y Farmacéutica Vir, S.A.

C/ Laguna 66-70. Polígono industrial Urtinsa ii.

28923 Alcorcón (Madrid)

Spain

Date of the last review of this leaflet:

November 2024

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