Metamizole Kern Pharma 575 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metamizol Kern Pharma 575 mg hard capsules EFG

Metamizol Kern Pharma may cause lower than normal white blood cell counts (agranulocytosis), which can lead to serious and potentially fatal infections (see section 4).

You must 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 or throat, or in the genital or anal area.

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

Read the entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them. If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Metamizol Kern Pharma is 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 adverse effects
5. How to store Metamizol Kern Pharma
6. Contents of the pack and other information

1. What Metamizol Kern Pharma 575 mg hard capsules is and what it is used for

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

This medicine is used to treat moderate to severe acute pain following surgery or trauma, colicky pain, and pain of tumoral origin. It is also used in cases of high fever that does not respond to other measures or other antipyretic medicines.

2. What you need to know before starting to take 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 cells called granulocytes, caused by metamizole or other similar medicines known as pyrazolones or pyrazolidines.
• If you have bone marrow problems or a disorder affecting the production or function of your blood cells.
• If you have previously had allergic reactions or hematological reactions (decrease in white blood cells, red blood cells, or platelets in blood) to medicines containing metamizole or other similar compounds, or allergic reactions to any of the other components of this medicine (listed in section 6).
• If you have experienced symptoms of asthma, rhinitis, or urticaria (reddish skin rashes or hives that may cause itching) during treatment with other analgesics such as acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, as sensitivity to metamizole may also occur in these cases.
• If you suffer from acute intermittent porphyria (a disorder in the metabolism of blood pigments that are part of hemoglobin).
• If you have glucose-6-phosphate dehydrogenase deficiency.
• If you have experienced disturbances in bone marrow function (responsible for blood cell formation); for example, during or after receiving antitumor (antineoplastic) chemotherapy, or if you have had diseases related to blood cell formation.
• If you are in the last three months of pregnancy.
• If you have previously experienced severe skin reactions (for example, Stevens-Johnson syndrome or toxic epidermal necrolysis) with prior use of metamizole or another medicine containing metamizole.

Warnings and precautions

Consult your doctor or pharmacist before starting Metamizol Kern Pharma 575 mg.

Low white blood cell count (agranulocytosis).

Metamizol Kern Pharma can 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 must stop taking metamizole and contact a doctor immediately if you experience the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in the mucous membranes (moist body surfaces), 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 are taking metamizole for fever, some symptoms of agranulocytosis may go unnoticed. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis may occur at any time during treatment with Metamizol Kern Pharma and even shortly after stopping metamizole.

You may develop agranulocytosis even if you have previously used metamizole without problems.

Liver problems

Liver inflammation has been reported in patients taking metamizole, with symptoms developing from 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 malaise (nausea or vomiting), fever, feeling of fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or the whites of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You must not take Metamizol Kern Pharma 575 mg if you have previously taken any medicine containing metamizole and experienced liver problems.

Severe skin reactions

Serious, potentially life-threatening skin reactions have been reported in association with metamizole use, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop taking metamizole and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you have ever experienced severe skin reactions, you must not restart treatment with [brand name] at any time (see section 4).

Take special care:

• If you experience general malaise, infection, persistent fever, sore throat, swelling in the mouth, nose, or throat, mucosal lesions in the mouth or genital area, bruising, bleeding, or paleness, you must 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 failure in the production of all blood cells (aplastic anemia).

• If you experience dizziness, difficulty breathing, rhinitis, facial swelling, drop in blood pressure, or sudden appearance of reddish spots on the skin, stop treatment and consult your doctor. These symptoms may be due to a severe allergic reaction to metamizole called anaphylactic shock. This reaction is more likely if you suffer from 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 dyes and/or preservatives or to alcohol, as the risk of severe allergic reactions is higher.

• If you have low blood pressure, hypovolemia (reduced circulating volume of blood 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 and progresses to blistering or mucosal lesions, you must interrupt treatment and see a doctor, as this may indicate the onset of very serious skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In such cases, you must not receive again medicines containing metamizole.

• If you have impaired kidney or liver function, as you may eliminate the medicine with greater difficulty.

• If you are an elderly patient, pay special attention to the appearance of any of the disorders described above, as they may occur more frequently.

Use of metamizole with other medicines

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

If administered concomitantly with cyclosporine (a medicine used to prevent transplant rejection), it may reduce cyclosporine blood levels; therefore, these levels should be monitored regularly.

If administered together with chlorpromazine (a medicine used to treat psychosis), it may cause a drop in body temperature.

If administered together with methotrexate or other medicines used to treat tumors (antineoplastics), it may enhance the blood-related toxic effects of antineoplastics, especially in elderly patients.

If administered together with acetylsalicylic acid, it may reduce the antiplatelet effect of acetylsalicylic acid and therefore should be used with caution in patients taking it for cardioprotective purposes.

If administered together with bupropion, a medicine used to treat depression and/or to help quit smoking, it may reduce bupropion blood levels and therefore should be used with caution.

Metamizole may alter the effects of antihypertensives (medicines that lower blood pressure) and diuretics (medicines that increase fluid elimination).

If administered together with:

• efavirenz, a medicine used to treat HIV/AIDS
• methadone, a medicine used to treat dependence on 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

When taken with alcohol, the effects of both alcohol and the drug may be enhanced.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

During the last three months of pregnancy, you must not take METAMIZOL KERN PHARMA 575 mg due to the increased risk of complications for both mother and baby (bleeding, premature closure of a major fetal blood vessel called the ductus arteriosus, which normally closes after birth).

Breastfeeding

Metamizole metabolites are excreted in breast milk in considerable amounts, and a risk to the infant cannot be excluded. Therefore, repeated use of metamizole during breastfeeding should be avoided. If a single dose of metamizole is administered, mothers are advised to express and discard breast milk for 48 hours following administration.

Driving and use of machines

Although adverse effects on concentration and reaction ability are not expected, at the highest recommended doses, it should be considered that these abilities may be affected, and the use of machines, driving vehicles, or other hazardous activities should be avoided. This is especially applicable when alcohol has been consumed.

3. How to take Metamizol Kern Pharma 575 mg hard capsules

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, please consult your doctor or pharmacist again.

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

The dosage is determined according to the intensity of pain or fever and the individual's sensitivity to metamizole treatment. The lowest effective dose required to control pain and fever should always be selected. Your doctor will advise you on how to take Metamizol Kern Pharma.

This medicine is administered orally.

Adults and adolescents aged 15 years and older

Adults and adolescents aged 15 years or older (weighing more than 53 kg) may take 1 capsule (575 mg of metamizole) as a single dose, which can be administered up to 6 times daily at intervals of 4 to 6 hours. The maximum daily dose is 3,450 mg (equivalent to 6 capsules).

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

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

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

Elderly patients and patients with poor general health or renal impairment

Dosage should be reduced in elderly patients, debilitated patients, and those with impaired renal function, as elimination of metamizole metabolites may be delayed.

Patients with renal or hepatic impairment

Since elimination is reduced in cases of renal or hepatic impairment, repeated administration of high doses should be avoided. For short-term treatment, dose reduction may not be necessary. Experience with prolonged treatment is lacking.

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

If you take more Metamizol Kern Pharma 575 mg than you should

Symptoms may include nausea, vomiting, abdominal pain, impaired renal function, and very rarely, dizziness, drowsiness, coma, seizures, low blood pressure, or even shock and increased heart rate (tachycardia).

After administration of very high doses of metamizole, a red discoloration of urine may occur, which disappears upon discontinuation of treatment.

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

Information for the physician:

There is no known specific antidote. Following oral overdose, gastric lavage and induction of vomiting may be considered. Forced diuresis or dialysis may also be considered, as metamizole is dialyzable.

In case of severe allergic reactions, other standard emergency measures should be applied, such as placing the patient in the lateral position, ensuring airway patency, or administering oxygen. Pharmacological emergency measures include administration of adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions is recommended, along with the implementation of necessary general supportive 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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, may progress to more severe forms, for example generalized urticaria, swelling of the feet, hands, lips, throat and airways (angioedema), severe bronchospasm (narrowing of the bronchial walls), disturbances in heart rhythm, and decrease in blood pressure (sometimes preceded by an increase in blood pressure).

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

Feeling unwell (nausea or vomiting), fever, feeling tired, loss of appetite, dark urine, pale stools, yellowing of the skin or the whites 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 adverse effects that may occur with the following frequencies are

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

• hypotension (decrease in blood pressure).

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

• skin rashes and skin reactions.

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

• allergic reactions, which usually occur during or just after administration, but may also occur hours later.
• skin rashes and appearance of hives.
• decrease in the number of white blood cells in the blood (leukopenia)
• asthma.

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

• skin reactions with appearance of vesicles or blisters (toxic epidermal necrolysis, Stevens-Johnson syndrome),
• kidney problems with reduced or suppressed urine output
• increased amount of protein excreted in the urine
• inflammation of the kidney (interstitial nephritis)
• severe decrease in white blood cells (agranulocytosis), which may result in death due to severe infections
• decrease in the number of platelets in the blood (thrombocytopenia); in this case, inflammatory lesions in 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 (a severe infection causing a systemic inflammatory response that may be fatal),
• aplastic anemia (failure in the production of blood cells in the bone marrow),
• pancytopenia (low levels of red blood cells, white blood cells, and platelets simultaneously),
• anaphylactic shock (a severe allergic reaction that may be fatal),
• Kounis syndrome (a type of cardiac disorder),
• gastrointestinal hemorrhages,
• chromaturia (abnormal discoloration of urine),
• liver inflammation, yellowing of the skin and whites of the eyes (jaundice), increased blood levels of liver enzymes.

Serious skin reactions: Stop taking metamizole and seek immediate medical attention if you experience any of the following serious adverse effects:

• Non-elevated red patches, or circular or target-shaped rashes on the chest, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Generalized erythema, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Metamizol Kern Pharma 575 mg

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

Appearance of the product and contents of the container

Metamizol Kern Pharma 575 mg capsules are hard capsules with a claret color and contain white powder.

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 last reviewed in November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.