Metamizol Pensa 575 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metamizol Pensa 575 mg hard capsules EFG

Magnesium metamizole

Read the entire leaflet carefully before you start taking 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Metamizol Pensa belongs to a 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, 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 taking Metamizol Pensa

Do not take Metamizol Pensa:

• 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 (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 previously experienced symptoms of asthma, rhinitis, or urticaria (reddish 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, as you may also be sensitive to metamizole.
• 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 previously experienced disturbances in bone marrow function (which produces blood cells); 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 Metamizol Pensa or another medicine containing metamizole.

Warnings and precautions

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

Low white blood cell count (agranulocytosis)

Metamizol Pensa 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 (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 can occur at any time during the use of Metamizol Pensa 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 suffer from asthma or allergic-type disorders (atopy).
• If you suffer from 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 (decreased 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 interrupt treatment and see a doctor, as this may indicate very severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In such cases, you must not receive again medicines containing metamizole.
• 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 appearance 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 Metamizol Pensa 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 whites of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You must not take Metamizol Pensa if you have previously taken any 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 of the symptoms related to these severe skin reactions described in section 4.

If you have ever experienced severe skin reactions, you must never restart treatment with Metamizol Pensa (see section 4).

Taking Metamizol Pensa with food, drinks, and alcohol

When taken 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 Metamizol Pensa 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).

Breastfeeding

Metamizole metabolites are excreted in breast milk in considerable amounts, and 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 after 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.

Other medicines and Metamizol Pensa

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

• If administered concomitantly with cyclosporine (a medicine used to prevent transplant rejection), it may reduce cyclosporine blood levels, and therefore these levels should be monitored regularly. If administered with chlorpromazine (a medicine used to treat psychosis), it may cause a drop in body temperature.
• If administered concomitantly with methotrexate or other medicines used to treat tumors (antineoplastics), it may enhance the blood toxicity of antineoplastics, especially in elderly patients.
• If administered concomitantly with acetylsalicylic acid, it may reduce the antiplatelet effect of acetylsalicylic acid (platelet aggregation inhibition), and therefore it 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.
• Metamizole may alter the effect of antihypertensives (medicines that lower blood pressure) and diuretics (medicines that increase fluid elimination).
• Efavirenz, a medicine used to treat HIV/AIDS.
• Methadone, a medicine used to treat dependence on illegal 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.

3. How to take Metamizol Pensa

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

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

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

The dose is determined according to the intensity of pain or fever and to the individual's sensitivity to treatment with Metamizol Pensa. The lowest effective dose required to control pain and fever should always be selected. Your doctor will advise you on how to take Metamizol Pensa.

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

Elderly patients and patients with poor general health/renal impairment

The dose should be reduced in elderly patients, 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 elimination rates are reduced in cases of renal or hepatic impairment, repeated administration of high doses should be avoided. Dose reduction is not necessary only in short-term treatments. Experience with prolonged treatment is lacking.

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

If you take more Metamizol Pensa than you should

Symptoms such as nausea, vomiting, abdominal pain, impaired kidney function, and, more rarely, dizziness, somnolence, coma, convulsions, decreased 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 medicine than you should, consult your doctor or pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

Information for the physician: There is no known specific antidote. After 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 hypersensitivity 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. Pharmacological emergency 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 Pensa

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.

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), 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:

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, skin rash, or upper stomach pain or discomfort. These symptoms may be signs of liver damage. See also section 2 Warnings and precautions.

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 may also occur hours later.
• skin rashes and appearance of 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 decreased 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 result in 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 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 (a severe allergic reaction that may be fatal)
• Kounis syndrome (a type of cardiac disorder)
• gastrointestinal bleeding
• chromaturia (abnormal discoloration 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 adverse effects:
  • Non-elevated red patches, or circular or target-shaped rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. 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-induced hypersensitivity syndrome).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Pensa

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Metamizol Pensa

• The active substance is magnesium metamizole. Each capsule contains 575 mg of magnesium metamizole.
• The other components are magnesium stearate (E 470b). The components of the capsule shell are: indigo carmine (E 132), erythrosine (E 127), titanium dioxide (E 171), and gelatin.

Appearance of the product and contents of the container

Metamizol Pensa 575 mg hard capsules are dark red gelatin capsules containing a white powder.

Metamizol Pensa is available in packs containing 10 or 20 capsules in aluminum/PVC blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer

Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)
Spain

Date of latest review of this leaflet: November 2024

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