Package Leaflet: Information for the User

Metamizol Pensa 575 mg Hard Capsules EFG

Magnesium Metamizol

Read this leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to use Metamizol Pensa

3. How to take Metamizol Pensa

4. Possible side effects

5. Storage of Metamizol Pensa

6. Contents of the pack and additional information

Metamizol Pensa 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 post-operative or post-traumatic, of colic type or of tumoral origin. It is also used in cases of high fever that does not respond to other measures or other fever medications.

Do not take Metamizol Pensa:

- If you have had a significant decrease in a type of white blood cells called granulocytes, which was caused by metamizol or other similar medications called pyrazolones or pyrazolidines.

- If you have problems with your bone marrow or have a disorder that affects the way your blood cells are produced or function.

- If you have had previous allergic reactions or hematologic reactions (decrease in white blood cells, red blood cells, or platelets in the blood) with medications containing metamizol or other similar compounds or allergic reactions to any of the other components of this medication (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 nonsteroidal anti-inflammatory drugs, as in these cases there may also be sensitivity to metamizol.

- If you have acute intermittent porphyria (a disorder of the metabolism of the pigments that form part of hemoglobin).

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

- If you have had alterations in the function of your bone marrow (producer of blood cells); for example, during or after receiving chemotherapy (antineoplastic) or if you have diseases related to the formation of blood cells.

- 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 use of Metamizol Pensa or another medication that contained metamizol.

Warnings and precautions

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

Low white blood cell count (agranulocytosis).

Metamizol Pensa may 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 should stop taking metamizol 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 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 be masked. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis can occur at any time during the use of Metamizol Pensa and even after you have stopped taking 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, bruises, bleeding, or paleness, you should suspend 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, facial swelling, decreased blood pressure, sudden red patches on the skin, suspend 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 with 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, or have 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 the formation of blisters or lesions in the mucous membranes, you should interrupt treatment and seek medical attention, as this may be due to the appearance of severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In these cases, you should not receive metamizol again (see section 4).
• If you have decreased liver or kidney function, as you may eliminate the medication with greater difficulty.
• If you are an elderly patient, be especially attentive to the appearance of any of the disorders described above, as they may appear more frequently.

Liver problems:

Inflammation of the liver has been reported in patients taking metamizol with symptoms that develop in a few days to several months after starting treatment.

Stop using Metamizol Pensa and contact a doctor if you experience symptoms of liver problems, such as nausea, vomiting, fever, fatigue, loss of appetite, dark urine, light-colored stools, yellowing of the skin or white part of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You should not take Metamizol Pensa if you have previously taken a medication containing metamizol and had 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 metamizol treatment. Stop taking metamizol and seek medical attention immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

If you have ever had severe skin reactions, you should not resume treatment with Metamizol Pensa at any time (see section 4).

Taking Metamizol Pensa with food, drinks, and alcohol

With alcohol, the effects of both the medication and the alcohol may be potentiated.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

During the last three months of pregnancy, you should not take Metamizol Pensa due to the increased risk of complications for the mother and the baby (bleeding, premature closure of a major 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 ruled out that there is a risk to the infant. Therefore, repeated use of metamizol during breastfeeding should be avoided. If a single dose of metamizol is administered, mothers should express and discard breast milk for 48 hours after administration.

Driving and operating machines

Although no adverse effects on concentration and reaction ability are expected, at higher doses within the recommended range, you should be aware that these abilities may be affected, and you should avoid operating machines, driving vehicles, or other hazardous activities.

Other medications and Metamizol Pensa

Inform your doctor or pharmacist if you are using or have used recently or may need to use another medication.

• If administered together with cyclosporine (medication that prevents transplant rejection), it may reduce cyclosporine levels in the blood and therefore these levels should be measured regularly.If administered together with chlorpromazine (medication for the treatment of psychoses), it may cause a decrease in body temperature.
• If administered together with methotrexate or other medications for the treatment of tumors (antineoplastic), it may potentiate the toxic effects in the blood of antineoplastic medications, especially in elderly patients.
• If administered together with acetylsalicylic acid, it may reduce the effect of acetylsalicylic acid to decrease platelet aggregation (antiplaquetary) and therefore it should be used with caution in patients taking it to protect the heart (cardioprotector).
• If administered together with bupropion, medication used for the treatment of depression and/or to help quit smoking.
• Metamizol may modify the effect of antihypertensive medications (medications that reduce blood pressure) and diuretics (medications that increase the elimination of liquids).
• Efavirenz, medication used for the treatment of HIV/AIDS.
• Metadona, medication used to treat dependence on illicit drugs (opioids).
• Valproate, medication used to treat epilepsy or bipolar disorder.
• Tacrolimus, medication used to prevent organ rejection in transplant patients.
• Sertralina, medication used to treat depression.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication is for short-term use. Your doctor will inform you of the duration of your treatment.

This medication should be taken orally. Capsules should be swallowed whole, without chewing, with a little liquid.

The dose is established based on the intensity of the pain or fever and the sensitivity of each person to treatment with Metamizol Pensa. Always select the lowest necessary dose to control pain and fever. Your doctor will inform you how to take Metamizol Pensa.

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) in a single dose, which can be administered up to 6 times a day, in intervals of 4 to 6 hours. The maximum daily dose is 3450 mg (corresponding to 6 capsules).

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

Metamizol Pensa should not be used in children under 15 years of age. For smaller children, other presentations and doses of this medication are available; consult your doctor or pharmacist.

Older adults and patients with poor general health/renal insufficiency

The dose should be reduced in older adults, in debilitated patients, and in those with decreased renal function, as the elimination of metamizol degradation products may be delayed.

Patients with renal or hepatic insufficiency

Since in cases of renal or hepatic insufficiency the elimination rate decreases, repeated high doses should be avoided. Only in short-term treatments, a dose reduction is not necessary. There is no experience with prolonged treatments.

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

If you take more Metamizol Pensa than you should

Nausea, vomiting, abdominal pain, kidney function deterioration, and, in rare cases, dizziness, drowsiness, coma, seizures, decreased blood pressure, or even shock, and increased heart rate (tachycardia) may appear.

After administration of very high doses of metamizol, a reddish discoloration of the urine may occur, which disappears upon discontinuation of treatment.

If you have taken more of the medication than you should, consult your doctor or pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Information for the doctor:No specific antidote is known. 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 hypersensitivity reactions, additional emergency measures should be applied, such as placing the patient on their side, maintaining airways free of obstruction, or administering oxygen. Pharmacological emergency measures include administering adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions, as well as taking general necessary measures, is recommended.

If you forgot to take metamizol Pensa

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Mild allergic reactions (such as skin and mucous membrane reactions like itching, burning, redness, swelling) as well as difficulty breathing and gastrointestinal discomfort can progress to more severe forms, such as generalized urticaria, swelling of the 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 an increase in blood pressure).

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

Sensation of illness (nausea or vomiting), fever, feeling of fatigue, loss of appetite, dark urine, light-colored stools, yellow discoloration 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.

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

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

• hypotension (decreased blood pressure).

Infrequent (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 shortly after administration but also hours later.
• Skin eruptions and appearance of blisters.
• Decreased white blood cell count in the blood (leucopenia)
• Asthma

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

• Skin reactions with the appearance of vesicles or blisters (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• Renal problems with decreased or suppressed urine elimination
• Increased protein excretion in the urine
• Interstitial nephritis (inflammation of the kidneys)
• Severe decrease in white blood cells (agranulocytosis) that may cause death due to severe infections
• Decreased platelet count in the blood (thrombocytopenia), in this case, may cause

inflammatory lesions in mucous membranes, sore throat, and fever

• shock (drastic drop in blood pressure)

Frequency unknown (cannot be estimated from available data):

• Sepsis (severe infection that involves a systemic inflammatory reaction and may cause death)
• Aplastic anemia (failure in the production of bone marrow and blood cells)
• Pancytopenia (low count of red and white blood cells and platelets simultaneously)
• Anaphylactic shock (severe allergic reaction that may cause death)
• Kounis syndrome (a type of cardiac disorder)
• Gastrointestinal bleeding
• Cyanuria (abnormal urine coloration)
• Hepatitis, yellow discoloration of the skin and the white part of the eyes, increased blood levels of liver enzymes
• Severe skin reactions. Stop taking metamizol and seek medical attention immediately if you observe any of the following side effects:
• • Flat, red 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 reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Generalized erythema, elevated body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directlythrough theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Store in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Metamizol Pensa

• The active ingredient is metamizol magnesium. Each capsule contains 575 mg of metamizol magnesium.
• The other components are e stearate of magnesium (E 470b). The capsule components are: indigotina (E 132), eritrosina (E 127), dióxido titanio (E 171) and gelatina

Appearance of the product and contents of the packaging

Metamizol Pensa 575 mg hard capsules are gelatin capsules of a deep pink color that contain a white powder.

Metamizol Pensa is available in packaging containing 10 or 20 capsules in Aluminio/PVC blisters

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet: November 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/