Metamizole Alter 575 mg capsules EFG

Patient Information Leaflet

Introduction

Package leaflet: information for the patient

Metamizol Alter 575 mg hard capsules EFG

metamizole magnesium

Read this entire leaflet carefully before you start taking 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Metamizol Alter is and what it is used for
2. What you need to know before taking Metamizol Alter
3. How to take Metamizol Alter
4. Possible adverse effects
5. How to store Metamizol Alter
6. Contents of the pack and other information

1. What Metamizol Alter is and what it is used for

Metamizol belongs to a group of medicines known as "other analgesics and antipyretics".

This medicine is used to treat moderate to severe acute pain following surgery or trauma, colic-type pain, or pain of tumoral origin. It is also used in cases of high fever unresponsive to other measures or other antipyretic medicines.

2. What you need to know before taking Metamizol Alter

Do not take Metamizol Alter

• If you have previously experienced 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 the blood) to medicines containing metamizole or other similar compounds, or if you are allergic 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 painkillers such as acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, as you may also be sensitive to metamizole (the active substance in this medicine).
• 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 (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) after using metamizole or another medicine containing metamizole.

Warnings and precautions

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

Low white blood cell count (agranulocytosis)

Metamizol Alter 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 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 can occur at any time during the use of Metamizol Alter and even shortly after stopping metamizole.

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

Take special care:

• If you experience general malaise, infection, persistent fever, sore throat, swelling in the mouth, nose, or throat, lesions in the mucous membranes of the mouth or genitals, 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, low blood pressure, or sudden appearance of reddish skin rashes, 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-type disorders (atopy).
• If you suffer from bronchial asthma (especially in the presence of inflammation of the nasal mucosa and nasal polyps), chronic urticaria, or if you 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 stop treatment and see a doctor, as this may indicate serious skin disorders such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS), associated with metamizole treatment. Stop taking metamizole and seek immediate medical attention if you notice any of the symptoms related to these skin reactions described in section 4. If you have ever experienced severe skin reactions, you must never restart treatment with Metamizol Alter (see section 4).
• If you have impaired kidney or liver function, as you may eliminate the medicine with greater difficulty.
• If you are an elderly patient, be especially vigilant for the occurrence of any of the disorders described above, as they may occur more frequently.

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 metamizole and contact a doctor if you experience symptoms of liver problems, such as malaise (nausea or vomiting), fever, 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 metamizole if you have previously taken a medicine containing metamizole and experienced liver problems.

Taking Metamizol Alter with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine.

• bupropion, a medicine used to treat depression and/or to help quit smoking.
• efavirenz, a medicine used to treat HIV/AIDS.
• methadone, a medicine used to treat dependence on illicit drugs (called 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.

If administered together with cyclosporine (a medicine that prevents transplant rejection), it may reduce cyclosporine blood levels, and therefore these levels should be monitored regularly.

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

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

If administered together with acetylsalicylic acid, it may reduce the antiplatelet effect of acetylsalicylic acid (platelet aggregation inhibition), and therefore should be used with caution in patients taking it for cardioprotection.

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

Metamizole may alter the effect of antihypertensives (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 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 when 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 during the first and second trimesters is not recommended.

During the last three months of pregnancy, you must not take metamizole due to the increased risk of complications for mother and baby (bleeding, premature closure of an important fetal vessel called the ductus arteriosus, which normally closes after birth).

Breastfeeding

Metabolites of metamizole 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 using machines

Although adverse effects on concentration and reaction ability are not expected, at the higher end of the recommended doses, it should be considered that these abilities may be affected, and operating machinery, driving vehicles, or engaging in other hazardous activities should be avoided.

3. How to take Metamizol Alter

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

The dose is determined based on 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 metamizole.

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

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 3450 mg (equivalent to 6 capsules).

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

Metamizol Alter must not be used in children under 15 years of age. Other formulations 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 impaired renal function, as elimination of metamizole metabolites may be delayed.

Patients with renal or hepatic impairment

Since elimination rate is reduced in cases of renal or hepatic impairment, repeated administration of high doses should be avoided. Dose reduction may not be necessary only for short-term treatment. There is no experience with long-term treatment.

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

If you take more Metamizol Alter than you should

Symptoms such as nausea, vomiting, abdominal pain, impaired kidney function, and less commonly dizziness, drowsiness, coma, seizures, low blood pressure, or even shock and increased heart rate (tachycardia) may occur.

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

If you have taken more than the prescribed amount of this medicine, consult your doctor or pharmacist, and/or call the Toxicology Information Service at 91 562 04 20.

Information for the physician: There is no known specific antidote. After oral overdose, gastric lavage and induction of emesis 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 positioning 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 implementation of necessary general supportive measures.

If you forget to take Metamizol Alter

Do not take a double dose to make up for missed 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 will experience them.

Stop using metamizole 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.

Stop taking metamizole and seek immediate medical attention if you notice any of the following serious adverse effects:

• Red, non-elevated patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, or sores in the 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).

Milder 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, e.g. generalized urticaria, swelling of the feet, hands, lips, throat, and airways (angioedema), severe bronchospasm (narrowing of the bronchial walls), changes in heart rhythm, and low blood pressure (sometimes preceded by high blood pressure).

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

Common (may affect up to 1 in 10 people)

• hypotension (low 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 shortly after administration, but may also occur hours later.
• skin rashes and hives (urticaria).
• 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 involving blisters or vesicles (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 lead to death due to severe infections.
• decrease in the number of platelets in the blood (thrombocytopenia); in this case, inflammatory lesions of the mucous membranes, sore throat, and fever may occur.
• shock (a drastic drop in blood pressure).

Frequency not known (cannot be estimated from available data)

• sepsis (a serious infection causing a systemic inflammatory response that may lead to death).
• aplastic anaemia (failure in the production of blood cells by 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 bleeding.
• inflammation of the liver, yellowing of the skin and whites 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 they are possible adverse effects not listed in this leaflet. You can also report them directly via 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 Alter

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

Do not store above 30°C.

Do not use this medicine 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 containers and unused medicines at a SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metamizol Alter

The active substance is magnesium dipyrone hexahydrate. Each capsule contains 575 mg of magnesium dipyrone hexahydrate.

The other components are:

• Capsule contents: magnesium stearate (E470b).

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

Appearance of the product and contents of the pack

Metamizol Alter is presented as garnet-colored capsules containing white powder. Each pack contains 10, 20 or 500 hard capsules.

Only some pack 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 most recent review of this leaflet: November 2024.

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