Package Leaflet: Information for the User

Metamizol Kern Pharma 575 mg Hard Capsules EFG

Read this leaflet carefully before starting to take 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 or pharmacist.
• This medicine has been prescribed for you only and must not be given 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).

1. What is Metamizol Kern Pharma and what it is used for

2. What you need to know before taking Metamizol Kern Pharma

3. How to take Metamizol Kern Pharma

4. Possible side effects

5. Storage of Metamizol Kern Pharma

6. Contents of the pack and additional information

Metamizol belongs to the group of medicinesdenominated“Otheranalgesics and antipyretics.“

This medicineis used for the treatment of acute, moderate or intensepost-operative and post-traumatic pain, of colic type and of tumoral origin. It is also used in cases of high fever that does not respond to other measures or other fever medicines.

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Do not take Metamizol Kern Pharma 575 mg:

• If you have previously 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 previously had 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.
• 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 bone marrow function (producer of blood cells); for example, during or after receiving chemotherapy 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 Metamizol Kern Pharma 575 mg.

Low white blood cell count (agranulocytosis).

Metamizol Kern Pharma 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 levels.

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 Kern Pharma and even after stopping metamizol.

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

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 Kern Pharma 575 mg and contact a doctor if you experience symptoms of liver problems, such as 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 upper abdominal pain. Your doctor will check your liver function.

You should not take Metamizol Kern Pharma 575 mg if you have previously taken a medication containing metamizol and had liver problems.

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 the use of metamizol. 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).

Be 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 paleness, 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 to metamizol 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 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 havehypovolemia (decrease in circulating blood volume or any other body fluid), dehydration, orunstable circulation, as the risk of a sudden drop in blood pressure is higher.
• If a rash appears on the skin that progresses to the formation of blisters or lesions in the mucous membranes, you should interrupt 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-containing medications againIf you have decreased liver or kidney functionas you may eliminate the medicationwithgreater difficulty.
• If you are an elderly patient, be especially aware of the appearance of any of the disorders described above, as they may appear more frequently.

Use of metamizol with other medications

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

If administered together with ciclosporin (a 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 (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 the levels of bupropion 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).

If administered together with:

-efavirenz, a medication used for the treatment of HIV/AIDS

-metadona, a medication used to treat dependence on illicit drugs (designated opioids)

-valproato, a medication used to treat epilepsy or bipolar disorder

-tacrolimus, a medication used to prevent transplant rejection

-sertralina, a medication used to treat depression

Taking Metamizol Kern Pharma 575 mg with food, drinks, and alcohol

Together with alcohol, the effects of both 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, the use of metamizol during the first and second trimesters is not recommended.

During the last three months of pregnancy, you should not take METAMIZOL KERN PHARMA 575 mg 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 normally 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. In the event of a single dose of metamizol, mothers are recommended to express and discard breast milk during the 48 hours following its 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. This is especially applicable when alcohol has been consumed.

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 Kern Pharma.

This medication must be administered orally.

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.

Metamizol Kern Pharma 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.

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

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. 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 Kern Pharma 575 mg than you should

Nausea, vomiting, abdominal pain, renal function deterioration, and in very rare cases, dizziness, somnolence, coma, seizures, and 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 suspended.

If you have taken more Metamizol Kern Pharma 575 mg than you should, consult your doctor or pharmacist, or the Toxicological Information Service, phone: (91) 562 04 20

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 Kern Pharma 575 mg

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 medicinecanproduceside effects, although not everyone will experience them.

Mild allergic reactions (e.g. skin and mucous membrane reactions such as itching, burning, redness, swelling), as well as difficulty breathing and gastrointestinal discomfort can 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), alterations in heart rhythm, and decreased blood pressure (sometimes preceded by an increase in blood pressure.

Stop using Metamizol Kern Pharma 575mg and contact a doctor immediately if you experience any of the following symptoms:

Sensation of illness (nausea or vomiting), fever, feeling of fatigue, loss of appetite, dark urine, light-colored stools, yellow discoloration of the skin or the white part of the eyes, itching, rash, or pain in the upper stomach area. Thesesymptoms 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 people):

• hypotension (decreased blood pressure).

Rare (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 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 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 protein excretion in the urine
• inflammation of the kidneys (interstitial nephritis)
• severe decrease in white blood cells (agranulocytosis) that may 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 may 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 may cause death)
• Kounis syndrome (a type of cardiac disorder),
• gastrointestinal bleeding
• cyanuria (abnormal coloring of the urine).
• Inflammation of the liver, yellow discoloration of the skin and the white part of the eyes, increase in 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 increased size of lymph nodes (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 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 side effects, you can contribute to providing more information on the safety of this medicine.

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Keep Metamizol Kern Pharma 575 mg out of the sight and reach of children.

No special storage conditions are required.

Store in the original packaging.

Do not use Metamizol Kern Pharma 575 mg after the expiration date shown on the packaging.after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at your local SIGRE collection pointat your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Metamizol Kern Pharma 575 mg

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

Appearance of the product and contents of the packaging

Metamizol Kern Pharma 575 mg capsules are hard, purple capsules, and the powder they contain is white.

The packaging contains 10 or 20 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturing responsible parties:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid).

or

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

This prospectus was reviewed in November 2024

The 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/.