Package Leaflet: Information for the User

Metamizol cinfa 575 mg Hard Capsules EFG

metamizol magnesium

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

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

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

This medicine is used for the treatment ofmoderate to severe acute pain postoperative or post-traumatic, 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 medicines.

Do not take Metamizol cinfa

• SIf 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 cinfa.

Low white blood cell count (agranulocytosis)

Metamizol cinfa 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.

Some symptoms of agranulocytosis may be masked if you are taking metamizol for fever. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis can occur at any time during the use of Metamizol cinfa 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, mucosal lesions, bruises, bleeding, or pallor, 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 patches 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 have 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 a skin rash appears that progresses to the formation of blisters or lesions in the mucous membranes, you should interrupt treatment and consult your doctor, as this may be due to the appearance of severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). 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 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 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 discomfort (nausea 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 upper abdominal pain. Your doctor will check your liver function.

You should not take metamizol if you have previously taken a medication containing metamizol and had liver problems.

Other medications andMetamizol cinfa

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

If administered together with ciclosporin (medication that prevents transplant rejection), it may reduce the levels of ciclosporin 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 who are 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 the levels of these medications in the blood, and therefore 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).

Taking Metamizol cinfa with food, drinks, and alcohol

Together with alcohol, the effects of both the alcohol 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 carefully 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 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 is a risk to the infant. Therefore, repeated use of metamizol during breastfeeding should be avoided. In the event of a single dose of metamizol, mothers are recommended to express and discard breast milk for 48 hours after administration.

Driving and operating machines

Although it is 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.This is especially applicable when alcohol has been consumed.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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. The 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 adolescents15 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 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.

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

If you take more Metamizol cinfa than you should

Nausea, vomiting, abdominal pain, kidney 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 coloration 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 should be applied, such as placing the patient on their side, maintaining airways free of obstruction, or administering oxygen. 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 cinfa

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.

Mild allergic reactions (such as skin and mucous membrane reactions like itching, burning, redness, swelling) as well as difficulty breathing and gastrointestinal discomfort can progress to more severe forms, such as 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).

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

• Flat, non-elevated red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions can 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 hypersensitivity syndrome).
• Sensation of illness (nausea or vomiting), fever, feeling of fatigue, loss of appetite, dark urine, light-colored stools, yellow discoloration of the skin or white part of the eyes, itching, rash, or pain in the upper stomach area. These symptoms may be signs of liver damage. See also section 2 Warnings and precautions.

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

Frequent (may affect up to 1 in 10 patients)

• hypotension (decreased blood pressure).

Rare (may affect up to 1 in 100 patients)

• skin eruptions and reactions.

Rare (may affect up to 1 in 1,000 patients)

• allergic reactions that usually occur during or shortly after administration but also hours later,
• skin eruptions and appearance of blisters,
• decrease in the number of white blood cells in the blood (leucopenia),
• asthma.

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

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

Frequency unknown (cannot be estimated from available data)

• sepsis (severe infection that involves a systemic inflammatory reaction and can cause death),
• aplastic anemia (failure in the production of bone marrow and blood cells),
• pancytopenia (low number of red and white blood cells and platelets simultaneously),
• anaphylactic shock (severe allergic reaction that can cause death),
• Kounis syndrome (a type of cardiac disorder),
• gastrointestinal bleeding,
• cyanuria (abnormal urine color),
• inflammation of the liver, yellow discoloration of the skin and white part of the eyes, increased serum liver enzyme levels.

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 to 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.

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.

Do not store at a temperature above 30°C.

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.

Metamizol cinfa Composition

• The active ingredient is metamizol magnesium. Each capsule contains 575 mg of metamizol (as metamizol magnesium).
• The other components are:

• Capule content: magnesium stearate (E-470b).
• Durable gelatin capsule: erythrosine (E-127), indigo carmine (E-132), titanium dioxide (E-171), and gelatin.

Product appearance and packaging contents

Metamizol cinfa is presented in the form of hard gelatin capsules with a granate-colored cap and body.

It is presented in PVC-PVDC/Aluminum blisters. Each package contains 10, 20, or 500 (clinical package) capsules.

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:November 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/68116/P_68116.html

QR code to:https://cima.aemps.es/cima/dochtml/p/68116/P_68116.html