METAMIZOLE KERN PHARMA 575 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Metamizol Kern Pharma 575 mg Hard Capsules EFG

Metamizol Kern Pharma may cause a lower than normal white blood cell count (agranulocytosis), which can lead to serious and potentially life-threatening infections (see section 4).

You should stop taking this medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful sores in your nose, mouth, and throat, or in the genital or anal area.

If you have ever had agranulocytosis with metamizol or similar medicines, you should never take this medicine again (see section 2).

Read the entire package leaflet carefully before starting to take this medicine because it contains important information for you.

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

Contents of the package leaflet:

1. What is Metamizol Kern Pharma and what is it 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. Package contents and additional information

1. What is Metamizol Kern Pharma 575 mg Hard Capsules and what is it used for

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

This medicine is used to treat acute, moderate, or severe post-operative and post-traumatic pain, colic pain, and pain of tumor origin. It is also used in cases of high fever that do not respond to other measures or medications for fever.

2. What you need to know before taking Metamizol Kern Pharma 575 mg Hard Capsules

Do not take Metamizol Kern Pharma 575 mg:

• If you have previously had a significant decrease in a type of white blood cell called granulocytes, which was caused by metamizol or other similar medicines called pyrazolones or pyrazolidines.
• If you have bone marrow problems 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 medicines containing metamizol or other similar compounds, or allergic reactions to any of the other components of this medicine (listed in section 6).
• If you have had 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 non-steroidal anti-inflammatory drugs, as you may also be sensitive to metamizol.
• If you have acute intermittent porphyria (a disorder of the metabolism of blood pigments that are part of hemoglobin).
• If you have a genetic deficiency of glucose-6-phosphate dehydrogenase.
• If you have had alterations in bone marrow function (blood cell formation); for example, during or after receiving anticancer chemotherapy (antineoplastic) or if you have had diseases related to blood cell formation.
• 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 medicine that contains 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 cell called granulocytes, which are important for fighting infections (see section 4). You should stop taking metamizol 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 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 go unnoticed. 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 shortly 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 developing within a few days to a few months after starting treatment.

Stop using Metamizol Kern Pharma 575mg 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.

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

Severe skin reactions

Potentially life-threatening 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 experience 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 Kern Pharma at any time (see section 4).

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, bruising, 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, swelling of the face, decreased blood pressure, or sudden onset of 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 in the presence of nasal mucosa inflammation and nasal polyps), chronic urticaria, or are intolerant to colorants and/or preservatives or alcohol, as the risk of severe allergic reactions is higher.
• If you have low blood pressure or hypovolemia (decreased 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 blistering or mucous membrane lesions, you should stop treatment and consult your doctor, as this may be due to very severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In these cases, you should not receive metamizol again.
• If you have impaired kidney or liver function, as you may have difficulty eliminating the medicine.
• If you are an elderly patient, be especially alert to the appearance of any of the disorders described above, as they may occur more frequently.

Using Metamizol Kern Pharma 575 mg with other medicines

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

If given together with cyclosporin (a medicine that prevents transplant rejection), it may reduce cyclosporin blood levels, and these should be measured regularly.

If given together with chlorpromazine (a medicine for the treatment of psychoses), it may cause a drop in body temperature.

If given together with methotrexate or other anticancer medicines (antineoplastics), it may increase the toxic effects of antineoplastics on the blood, especially in elderly patients.

If given together with acetylsalicylic acid, it may reduce the effect of acetylsalicylic acid on decreasing platelet aggregation (antiplatelet) and should be used with caution in patients taking it to protect the heart (cardioprotector).

If given together with bupropion, a medicine used for the treatment of depression and/or to help stop smoking, it may reduce bupropion blood levels, and should be used with caution.

Metamizol may alter the effect of antihypertensive medicines (medicines that reduce blood pressure) and diuretics (medicines that increase fluid elimination).

If given together with:

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

-methadone, a medicine used to treat addiction to illicit drugs (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

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

Together with alcohol, the effects of both can be increased.

Pregnancy, breastfeeding, and fertility

Pregnancy

Available data on the use of metamizol during the first three months of pregnancy are limited, but they do not indicate harmful effects on the embryo. In selected cases when there are no other treatment options, single doses of metamizol during the first and second trimester may be acceptable after consulting your doctor or pharmacist and carefully evaluating the benefits and risks of using metamizol. However, in general, the use of metamizol is not recommended during the first and second trimester.

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 vital 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 excluded that there is a risk for the breastfed infant. Therefore, repeated use of metamizol should be avoided during breastfeeding. If a single dose of metamizol is administered, mothers are recommended to express and discard breast milk for 48 hours after administration.

Driving and using machines

Although no adverse effects on concentration and reaction abilities are expected, at higher doses, within the recommended range, it should be taken into account that these abilities may be affected, and you should avoid using machines, driving vehicles, or engaging in other hazardous activities. This is especially applicable when alcohol has been consumed.

3. How to take Metamizol Kern Pharma 575 mg Hard Capsules

Follow the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

This medicine is for short-term use. Your doctor will indicate the duration of your treatment.

The dose is established based on the intensity of the pain or fever and the individual's sensitivity to treatment with metamizol. The lowest necessary dose should always be selected to control pain and fever. Your doctor will indicate how you should take Metamizol Kern Pharma.

This medicine should 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, at 4- to 6-hour intervals. The maximum daily dose is 3,450 mg (corresponding to 6 capsules).

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

Metamizol Kern Pharma should not be used in children under 15 years of age. Other presentations and doses of this medicine are available for younger children; consult your doctor or pharmacist.

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

Elderly patients and patients with poor general health or renal insufficiency

The dose should be reduced in elderly patients, debilitated patients, and those with decreased renal function, as the elimination of metamizol degradation products may be delayed.

Patients with renal or hepatic insufficiency

Since the elimination rate decreases in cases of renal or hepatic insufficiency, high repeated doses should be avoided. In short-term treatments, dose reduction is not necessary. There is no experience with long-term treatments.

If the pain persists or worsens, you should 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, impaired renal function, and in very rare cases, dizziness, somnolence, coma, convulsions, and decreased blood pressure or even shock and increased heart rate (tachycardia) may occur.

After administration of very high doses of metamizol, a red coloration of the urine may occur, which disappears when treatment is stopped.

If you have taken more Metamizol Kern Pharma 575 mg than you should, consult your doctor or pharmacist, or the Toxicology 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. Forcing diuresis or dialysis may be considered, as metamizol is dialyzable.

In case of severe allergic reactions, other usual emergency measures should be applied, such as placing the patient on their side, keeping the airways clear of obstruction, or administering oxygen. Pharmacological emergency measures include the administration of adrenaline, fluid therapy, and glucocorticoids.

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

If you forget to take Metamizol Kern Pharma 575 mg

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

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Mild allergic reactions (e.g., skin and mucous membrane reactions, such as itching, burning, redness, swelling), as well as difficulty breathing and gastrointestinal disorders, may progress to more severe forms, e.g., generalized urticaria, swelling of feet, hands, lips, throat, and airways (angioedema), severe bronchospasm, cardiac rhythm disturbances, decreased blood pressure (sometimes preceded by increased blood pressure).

Stop using Metamizol Kern Pharma 575mg 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 upper abdominal pain. 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

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

• Low blood pressure (hypotension).

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

• Skin rashes 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 rashes and hives.
• 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 blisters or bumps (toxic epidermal necrolysis, Stevens-Johnson syndrome),
• kidney problems with decreased or suppressed urine output
• increased amount of protein excreted in the urine
• kidney inflammation (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 the mucous membranes, sore throat, and fever may occur.
• shock (drastic drop in blood pressure).

Frequency not known (cannot be estimated from the available data):

• sepsis (severe infection that involves an inflammatory reaction of the entire body and can cause death),
• aplastic anemia (failure of the production of bone marrow and blood cells),
• pancytopenia (low number of red, white, and platelet cells simultaneously),
• anaphylactic shock (severe allergic reaction that can cause death)
• Kounis syndrome (a type of cardiac disorder),
• gastrointestinal bleeding
• chromaturia (abnormal urine coloration).
• Liver inflammation, yellowing of the skin and the white part of the eyes, increased blood level of liver enzymes.
• Severe skin reactions: Stop taking metamizol and seek immediate medical attention if you notice any of the following serious side effects:
• • Red patches that are not raised, 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 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).

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 is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

.

5. Storage of Metamizol Kern Pharma 575 mg capsules

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

No special storage conditions are required.

Store in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE point in your usual pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Metamizol Kern Pharma 575 mg

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

Appearance of the product and packaging content

The Metamizol Kern Pharma 575 mg capsules are hard capsules of a garnet color and the powder they contain is white.

The packaging contains 10 or 20 capsules.

Marketing authorization holder and manufacturer

Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturers:

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 leaflet was revised in November 2024

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