METAMIZOLE ALTER 575 mg CAPSULES

2. What you need to know before taking Metamizol Alter

Do not take Metamizol Alter

• 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 hematological 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 (the active substance of this medicine).
• 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 previous use of metamizol or another medicine that contained metamizol.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Metamizol Alter.

Low White Blood Cell Count (Agranulocytosis).

Metamizol Alter 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 your 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 count.

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 Alter and even shortly 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, 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, sudden onset of red patches on the skin, stop 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 in the presence of nasal mucosa inflammation and nasal polyps), chronic urticaria, or if you are intolerant to dyes and/or preservatives or alcohol, as the risk of severe allergic reactions is higher.
• If you have low blood pressure, 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 blistering or mucous membrane lesions, you should stop treatment and consult your doctor, as this may be due to severe skin disorders, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), associated with metamizol treatment. Stop taking metamizol and seek medical attention immediately if you observe any of the symptoms related to these skin reactions described in section 4. If you have ever had severe skin reactions, you should not restart treatment with Metamizol Alter at any time (see section 4).
• 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.

Liver Problems

Inflammation of the liver has been reported in patients taking metamizol, with symptoms developing within a few days to months after starting treatment.

Stop using metamizol and contact your doctor if you experience symptoms of liver problems, such as discomfort (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 if you have previously taken a medicine containing metamizol and had liver problems.

Taking Metamizol Alter with Other Medicines

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

• bupropion, a medicine used to treat depression and/or help quit smoking.
• efavirenz, a medicine used to treat HIV/AIDS.
• methadone, a medicine used to treat opioid dependence.
• 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.

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

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

If administered with methotrexate or other anticancer medicines (antineoplastic), it may enhance the toxic effects on the blood of the anticancer medicines, especially in elderly patients.

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

If administered with bupropion, it may reduce bupropion blood levels, and should be used with caution.

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

Taking Metamizol Alter with Food, Drinks, and Alcohol

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

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 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 the highest recommended doses, 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.

3. How to Take Metamizol Alter

Follow your doctor's or pharmacist's instructions for taking this medicine exactly. 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 determined based on the intensity of the pain or fever and the individual's sensitivity to metamizol treatment. The lowest necessary dose should always be selected to control pain and fever. Your doctor will indicate how to take metamizol.

This medicine should be taken orally. The capsules should be swallowed whole, without chewing, with a little liquid.

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) as a single dose, which can be administered up to 6 times a day, at 4- to 6-hour intervals. The maximum daily dose is 3450 mg (corresponding to 6 capsules).

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

Metamizol Alter 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.

Elderly Patients and Patients with Poor General Health/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.

Patient with Renal or Hepatic Insufficiency

Since the elimination rate decreases in cases of renal or hepatic insufficiency, administration of high repeated doses should be avoided. Only in short-term treatments is a dose reduction 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 Alter Than You Should

Nausea, vomiting, abdominal pain, deterioration of kidney function, and, in rarer cases, dizziness, drowsiness, coma, convulsions, 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 of the medicine than you should, consult your doctor or pharmacist, and/or call the Toxicology Information Service, telephone 91 562 04 20.

Information for the Doctor:There is no known specific antidote. 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, 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.

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

If You Forget to Take Metamizol Alter

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

If you have any further questions on 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 all people suffer from them.

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

Feeling of illness (nausea or vomiting), fever, feeling of tiredness, loss of appetite, dark urine, light-colored stools, yellowish coloration of the skin or the 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.

Stop taking metamizol and seek medical attention immediately if you observe any of the following serious adverse effects:

• Reddish 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 erythemas 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 or drug hypersensitivity syndrome).

Milder 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 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 increased blood pressure).

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

Frequent (may affect up to 1 in 10 people)

• hypotension (decreased blood pressure).

Uncommon (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 immediately after administration but also hours later.
• skin eruptions 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 blisters or bubbles (toxic epidermal necrolysis, Stevens-Johnson syndrome).
• kidney problems with decreased or suppressed urine output.
• increase in the 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), which can 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 an inflammatory reaction of the entire body and can cause death).
• aplastic anemia (failure of bone marrow and blood cell production).
• 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.
• liver inflammation, yellowish coloration of the skin and the white part of the eyes, increased blood levels of liver enzymes.
• chromaturia (abnormal urine coloration).
• severe skin reactions.

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

5. Storage of Metamizol Alter

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

Do not store at a temperature above 30°C.

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Metamizol Alter

The active ingredient is magnesium metamizole hexahydrate. Each capsule contains 575 mg of magnesium metamizole hexahydrate.

The other components are:

• Capsule content: magnesium stearate (E470b).

• Hard gelatin capsule: erythrosine (E127), indigo carmine (E132), titanium dioxide (E171), and gelatin.

Appearance of the Product and Package Contents

Metamizol Alter is presented in the form of maroon-colored capsules containing white powder. Each package contains 10, 20, or 500 hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10

Polígono Industrial Areta

31620 Huarte, Navarra

Spain

Date of the Last Revision of this Prospectus: November 2024.

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