Metamizol Cinfa 575 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metamizol cinfa 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 only for you; do not give it to others, even if they have the same symptoms as you, as 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 cinfa is and what it is used for
2. What you need to know before taking Metamizol cinfa
3. How to take Metamizol cinfa
4. Possible adverse effects
5. How to store Metamizol cinfa
6. Contents of the pack and other information

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

Metamizole 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, colicky pain, or pain of tumoral origin.

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 taking Metamizol cinfa

Do not take Metamizol cinfa

• 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 are allergic to metamizole or to any of the other ingredients of this medicine (listed in section 6).

• If you have previously had allergic reactions or hematological reactions (decrease in white blood cells, red blood cells, or platelets in the blood) with medicines containing metamizole.

• 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 metamizole).

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

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

• 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 (known, for example, as Stevens-Johnson syndrome or toxic epidermal necrolysis) after using metamizole or another medicine containing metamizole.

Warnings and precautions

Talk to your doctor or pharmacist before taking Metamizol cinfa.

Low white blood cell count (agranulocytosis).

Metamizol cinfa 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 may occur at any time during the use of Metamizol cinfa 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 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 volume of blood or any other body fluid), dehydration, or unstable circulation, as the risk of a sudden drop in blood pressure is greater.
• If a skin rash appears and progresses to blistering or mucosal lesions, you must stop treatment and see a doctor, as this may be due to the onset of very serious skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). 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 severe skin reactions, you must never restart treatment with metamizole (see section 4).

• If you have impaired kidney or liver function, as you may eliminate the medicine with greater difficulty.
• If you are elderly, pay special attention to 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 metamizole 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 metamizole if you have previously taken a medicine containing metamizole and experienced liver problems.

Other medicines and Metamizol cinfa

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

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 psychoses), it may cause a drop in body temperature.

If administered together with methotrexate or other medicines for the treatment of 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 it should be used with caution in patients taking it for cardioprotection.

If administered together 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 called 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, 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 cinfa with food, drinks, and alcohol

Together with alcohol, the effects of both alcohol and the medicine 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 both mother and baby (bleeding, premature closure of an important fetal vessel called the ductus arteriosus, which normally closes after birth).

Breastfeeding

Metamizole metabolites 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 after administration.

Driving and using machines

Although adverse effects on concentration and reaction ability are not expected, at the highest recommended doses, it should be considered that these abilities may be affected, and you should avoid operating machinery, driving vehicles, or engaging in other hazardous activities. This is especially important if alcohol has been consumed.

3. How to take Metamizol cinfa

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 is 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 the individual sensitivity to metamizol treatment. The lowest effective dose required to control pain and fever should always be used. Your doctor will advise you on how to take metamizol.

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 metamizol) 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

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

Elderly patients and patients with poor general health or renal impairment

The dose should be reduced in elderly patients, debilitated patients, and in those with impaired renal function, as elimination of metamizol metabolites may be delayed.

Patients with renal or hepatic impairment

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

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

If you take more Metamizol cinfa than you should

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

After administration of very high doses of metamizol, the urine may turn red; this discoloration resolves upon discontinuation of treatment.

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

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 metamizol is dialyzable.

In case of severe allergic reactions, other standard emergency measures should be applied, such as placing 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 cinfa

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 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).

Stop using metamizole and contact a doctor immediately if you experience any of the following serious adverse effects:

• Reddish flat patches, or circular or target-shaped rashes on the chest, often with central blisters, skin peeling, 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, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Feeling unwell (nausea or vomiting), fever, feeling tired, loss of appetite, dark urine, pale-coloured 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.

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

Frequent (may affect up to 1 in 10 patients)

• hypotension (decreased blood pressure).

Uncommon (may affect up to 1 in 100 patients)

• skin rashes and skin reactions.

Rare (may affect up to 1 in 1,000 patients)

• allergic reactions, which usually occur during or immediately after administration but may also appear 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 patients)

• 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 result in death due to serious infections,
• decrease in the number of platelets in the blood (thrombocytopenia); in this 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 causing a systemic inflammatory response that may be fatal),
• aplastic anaemia (failure in the production of blood cells and bone marrow 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.

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 may 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 cinfa

Keep this medicine out of 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.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metamizol cinfa

• The active substance is magnesium dipyrone. Each capsule contains 575 mg of dipyrone (as magnesium dipyrone).

• The other components are:

• Capsule contents: magnesium stearate (E-470b).

• Hard gelatin capsule: erythrosine (E-127), indigo carmine (E-132), titanium dioxide (E-171) and gelatin.

Appearance of the product and contents of the pack

Metamizol cinfa is available as hard gelatin capsules with burgundy-colored cap and body.

It is presented in PVC-PVDC/Aluminum blisters. Each pack contains 10, 20 or 500 capsules (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: November 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68116/P_68116.html

QR code a: https://cima.aemps.es/cima/dochtml/p/68116/P_68116.html