Metamizole Pensa Pharma 575 mg hard capsules EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User

Metamizol pensa pharma 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, and you should not give it to others, 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Metamizol pensa pharma is and what it is used for
2. What you need to know before taking Metamizol pensa pharma
3. How to take Metamizol pensa pharma
4. Possible adverse effects
5. Storage of Metamizol pensa pharma
6. Package contents and additional information

1. What Metamizol pensa ph arma 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 for the treatment of moderate to severe acute pain following surgery or trauma, of colicky origin or due to tumors. 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 pensa phama

Do not take Metamizol pensa pharma:

• 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 (reduction 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 ingredients 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 in these cases you may also be sensitive to metamizole (the active substance in this medicine).

• If you suffer from acute intermittent porphyria (a metabolic disorder affecting blood pigments that are part of hemoglobin).

• If you have a genetic deficiency of glucose-6-phosphate dehydrogenase.

• If you have suffered bone marrow dysfunction (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) with prior use of this or another medicine containing metamizole.

Warnings and precautions

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

Low white blood cell count (agranulocytosis):

Metamizol pensa pharma may cause agranulocytosis, a severely 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 (wet 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 pensa pharma 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 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), 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 mucosal 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 increased.

• Serious 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 of the symptoms related to these serious skin reactions described in section 4.

If you have ever experienced serious skin reactions, you must not restart treatment with metamizole at any time (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 appear 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 taking this medicine 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.

Do not take this medicine if you have previously taken any medicine containing metamizole and experienced liver problems.

Metamizolepensa pharmacon and food, drinks, and alcohol

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

Pregnancy, lactation 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 fetal blood vessel called the ductus arteriosus, which normally closes after birth).

Lactation

Metamizole metabolites are excreted in breast milk in considerable amounts, and a risk to the breastfed 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 their 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 noted that these abilities may be impaired. Therefore, driving, operating machinery, or engaging in other potentially hazardous activities should be avoided. This is especially applicable when alcohol has been consumed.

Other medicines and Metamizolpensa pharma

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

• 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 decrease in body temperature.

• If administered concomitantly with methotrexate or other antineoplastic medicines (used to treat tumors), 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 cardioprotection.

If administered concomitantly with 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 illegal 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, use with caution is recommended.

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

3. How to take Metamizol pensa pharma

Follow exactly the administration instructions for this medicine as given 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.

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 each individual's sensitivity to metamizole treatment. The lowest effective dose required to control pain and fever should always be used. Your doctor will advise you on how to take metamizole.

Adults and adolescents 15 years of age or older

Adults and adolescents 15 years of age 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.

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 dosage forms of this medicine are available; please consult your doctor or pharmacist.

Elderly individuals and patients with poor general health or renal insufficiency

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

Patients with renal or hepatic impairment

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

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

If you take more Metamizolpensa pharmadel 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, indicating the medication and the amount ingested.

Symptoms may include 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).

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 emesis 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 lateral position, maintaining airways free of 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 all necessary general supportive measures.

If you forget to take Metamizolpensa pharma

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 will experience them.

Stop taking this medicine 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 the feet, hands, lips, throat and airways (angioedema), severe bronchospasm (narrowing of the bronchial walls), disturbances 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:

Common (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 immediately after administration but may also occur hours later, skin rashes and appearance of wheals on the skin, decreased number of white blood cells in blood (leucopenia), asthma.

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

• skin reactions with the appearance of blisters or vesicles (toxic epidermal necrolysis, Stevens-Johnson syndrome), kidney problems with reduced or suppressed urine output, increased amount of protein excreted in urine, inflammation of the kidney (interstitial nephritis), severe decrease in white blood cells (agranulocytosis) which may result in death due to severe infections, decreased number of platelets in blood (thrombocytopenia), in which 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 available data):

• sepsis (a severe infection involving an inflammatory response throughout the body which may result in death), aplastic anaemia (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 (severe allergic reaction which may result in death), Kounis syndrome (a type of cardiac disorder), gastrointestinal haemorrhages, chromaturia (abnormal colouration of urine).

• Inflammation of the liver, yellowing of the skin and whites of the eyes, increased blood levels of liver enzymes.

• Severe skin reactions.

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

• Flat, red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, sores in the throat, nose, genitals and eyes. These severe skin erythemas 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).

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 pensa pharma

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.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 Metamizol pensa pharma

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

Appearance of the medicinal product and contents of the pack

Hard gelatin capsules of size 0L (24 x 7.7 mm ± 1 mm), with a 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

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer

Industria Química y Farmacéutica Vir, S.A.
C/ Laguna 66-68-70. Polígono Industrial Urtinsa II.
28923 Alcorcón (Madrid)
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Metamizol pensa pharma 575 mg hard capsules EFG
Portugal: Metamizol magnésico toLife

Date of the most recent revision of this package leaflet: November 2024

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