Metamizole Tecnigen 575 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User

Metamizol Tecnigen 575 mg Hard Capsules EFG

Magnesium Metamizole

Read the entire leaflet carefully before starting to take this medicine, as 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; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

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

This medicine 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, 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 starting to take Metamizol Tecnigen

Do not take Metamizol Tecnigen:

• 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 experienced allergic reactions or hematological reactions (reduction in white blood cells, red blood cells, or platelets in the 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 (red spots or hives on the skin that may cause itching) during treatment with other painkillers such as acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, since in these cases you may also be sensitive to metamizole (the active substance in this medicine).
• If you have 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 had severe skin reactions (for example, Stevens-Johnson syndrome or toxic epidermal necrolysis) with prior use of this or another medicine containing metamizole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Lower than normal white blood cell count (agranulocytosis).

Metamizole Tecnigen 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 can occur at any time during the use of Metamizole Tecnigen 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), a decrease in 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 known as anaphylactic shock. This reaction is more likely if you suffer from asthma or allergic-type 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 to alcohol, as the risk of severe allergic reactions is higher.
• If you have low blood pressure, hypovolemia (reduced 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 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 onset of any of the disorders described above, as they may occur more frequently.

Liver problems:

Hepatic inflammation has been reported in patients taking metamizole, with symptoms developing from a few days to several months after starting treatment.

Stop using Metamizole Tecnigen 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.

Do not take Metamizole Tecnigen if you have previously taken a medicine containing metamizole and experienced 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 metamizole treatment. Stop taking metamizole and seek immediate medical attention if you notice any 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 Metamizole Tecnigen at any time (see section 4).

Use of Metamizol Tecnigen with food, beverages, and alcohol

When taken together with alcohol, the effects of both alcohol and the medication 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 following a careful assessment of 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 metamizole due to the increased risk of complications for both mother and baby (bleeding, premature closure of an important blood vessel for the fetus 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 nursing infant cannot be excluded. Therefore, repeated use of metamizole should be avoided during breastfeeding. If a single dose of metamizole is administered, mothers are advised to express and discard breast milk for 48 hours following administration.

Driving and operating machinery

Although adverse effects on concentration and reaction ability are not expected, at the highest doses within the recommended range, it should be borne in mind that these abilities may be impaired. Therefore, operating machinery, driving vehicles, or engaging in other hazardous activities should be avoided. This is especially applicable when alcohol has been consumed.

Other medicines and Metamizol Tecnigen

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

• When administered concomitantly with cyclosporine (a medicine used to prevent transplant rejection), it may reduce blood levels of cyclosporine; therefore, cyclosporine levels should be monitored regularly.
• When administered together with chlorpromazine (a medicine used to treat psychosis), it may cause a decrease in body temperature.
• When administered together with methotrexate or other anticancer medicines (cytostatic or antineoplastic agents), it may enhance the blood-related toxic effects of these antineoplastic drugs, especially in elderly patients.
• When administered together with acetylsalicylic acid, it may reduce the antiplatelet effect of acetylsalicylic acid (antiplatelet effect), and therefore should be used with caution in patients taking acetylsalicylic acid for cardioprotection.

When administered together with bupropion (a medicine used to treat depression and/or to help stop smoking), efavirenz (a medicine used to treat HIV/AIDS), methadone (a medicine used to treat dependence on illicit drugs known as opioids), valproate (a medicine used to treat epilepsy or bipolar disorder), tacrolimus (a medicine used to prevent organ rejection in transplant patients), or sertraline (a medicine used to treat depression), it may reduce blood levels of these medicines; therefore, caution is advised when using them concomitantly.

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

3. How to take Metamizol Tecnigen

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

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

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

The dose is determined according to the intensity of pain or fever and to the individual's sensitivity to metamizol 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.

Adults and adolescents aged 15 years and older

Adults and adolescents aged 15 years and 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.

Children and adolescents under 15 years of age

Metamizole must not be used in children under 15 years of age. For younger children, other formulations and dosages of this medicine are available; consult your doctor or pharmacist.

Elderly individuals and patients with poor general health or renal insufficiency

The dose should be reduced in elderly individuals, in debilitated patients, and in those with impaired renal function, as elimination of metamizole degradation products may be delayed.

Patients with renal or hepatic impairment

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

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

If you take more Metamizol Tecnigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, specifying the medication and the amount ingested.

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

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

Information for the physician: There is no known specific antidote. Following oral overdose, gastric lavage and induction of vomiting may be possible. Forced diuresis or dialysis may be considered, as metamizole is dialyzable.

In case of severe allergic reactions, other standard emergency measures should also be applied, such as placing the patient in the recovery position, ensuring airways are free from obstruction, or administering oxygen. Emergency pharmacological measures include administration of adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions is advised, along with implementation of necessary general supportive measures.

If you forget to take Metamizol Tecnigen

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 may cause adverse effects, although not everyone experiences them.

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

• Flat red patches, or circular or target-like patches 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, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Stop using Metamizol Tecnigen 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.

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, e.g. generalized urticaria, swelling of feet, hands, lips, throat, and airways (angioedema), severe bronchospasm (narrowing of the bronchial walls), changes in heart rhythm, and decreased blood pressure (sometimes preceded by an increase in 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 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 also sometimes several hours later,
• skin rashes and appearance of wheals on the skin,
• 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 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 such cases, inflammatory lesions in 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 severe infection causing a systemic inflammatory response that may lead to death),
• aplastic anemia (failure in the production of bone marrow and blood cells),
• 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,
• chromaturia (abnormal urine coloration),
• inflammation of the liver, yellowing of the skin and whites of the eyes, increased blood levels of liver enzymes,
• severe skin reactions.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Metamizol Tecnigen

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

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.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Metamizole Tecnigen

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

Appearance of the product and contents of the pack

Hard gelatin capsules of size 24 x 7.7 mm, with burgundy-colored body and cap, packed in PVC/PVdC-Aluminum blister packs containing 10, 20 or 500 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13. 3ºD.

28108 Alcobendas (Madrid)

Spain

Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70. Polígono Industrial Urtinsa II.

28923 Alcorcón (Madrid)

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/.