Metamizole Normon 575 mg capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Metamizol Normon 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 other people, 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.

Contents of the leaflet

1. What Metamizol Normon is and what it is used for
2. What you need to know before starting to take Metamizol Normon
3. How to take Metamizol Normon
4. Possible adverse effects
5. Storage of Metamizol Normon
6. Contents of the pack and other information

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

Metamizol Normon belongs to a group of medicines called "Other Analgesics and Antipyretics".

This medicine is used to treat moderate to severe acute pain following surgery or trauma, colic-type 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 Normon

Do not take Metamizol Normon:

• 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 components 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 sensitivity to metamizole (the active substance in Metamizol Normon) may also occur in these cases.
• 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 (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) after using metamizole or another medicine containing metamizole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take metamizole.

Low white blood cell count (agranulocytosis)

Metamizol Normon 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 any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in 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 treatment with Metamizol Normon 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 to alcohol, as the risk of severe allergic reactions is higher.

• If you have low blood pressure or 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 higher.

• If a skin rash appears and progresses to blistering or mucosal lesions, interrupt treatment and see a doctor immediately, as this may indicate the onset of 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 elderly, pay special attention to the appearance 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 Metamizol Normon 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 whites of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You must not take Metamizol Normon 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 not restart treatment with Metamizol Normon at any time (see section 4).

Taking Metamizol Normon with food, drinks, and alcohol

Alcohol may enhance the effects of both alcohol and the drug.

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 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 following administration.

Driving and using machines

Although adverse effects on concentration and reaction ability are not expected, at higher doses within the recommended range, it should be considered that these abilities may be affected, and you should avoid operating machinery, driving vehicles, or engaging in other hazardous activities.

Taking Metamizol Normon with other medicines

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

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 together with chlorpromazine (a medicine used to treat psychosis), it may cause a drop in body temperature.

If administered together with methotrexate or other medicines used to treat 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 (antiplatelet action), 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 illicit opioids), valproate (a medicine used to treat epilepsy or bipolar disorder), tacrolimus (a medicine used to prevent organ transplant rejection), or sertraline (a medicine used to treat depression), it may reduce blood levels of these drugs, so caution is advised.

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

3. How to take Metamizol Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, please 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 for oral administration. 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's sensitivity to treatment with Metamizol Normon. The lowest effective dose required to control pain and fever should always be used. Your doctor will advise you on how to take Metamizol Normon.

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 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 Normon 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 and renal insufficiency

The dose 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 elimination rates are 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 Normon than you should

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.

If you have taken more medicine than you should, consult your doctor or pharmacist, or contact the Toxicology Information Service at telephone number 91 562 04 20.

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

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

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 using Metamizol Normon 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-coloured stools, yellowing of the skin or of 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 walls of the bronchi), 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 immediately after administration, but may also occur hours later.
• skin rashes and hives.
• 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 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 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 this case, 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 which may result in death).
• aplastic anaemia (failure in the production of blood cells in the bone marrow).
• pancytopenia (low number of red blood cells, white blood cells and platelets simultaneously).
• anaphylactic shock (a severe allergic reaction which may result in death).
• Kounis syndrome (a type of cardiac disorder).
• gastrointestinal bleeding.
• chromaturia (abnormal colouration of urine).
• liver inflammation, yellowing of the skin and of the 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:
  • non-elevated reddish patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, and ulcers in the 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).

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metamizol Normon

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

No special storage conditions are required.

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.

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

6. Contents of the pack and other information

Composition of Metamizol Normon

• The active substance is metamizole magnesium. Each capsule contains 575 mg of metamizole magnesium.

• The other components are: colloidal silica and magnesium stearate; capsule: gelatin, erythrosine (E-127), red iron oxide (E-172), and titanium dioxide (E-171).

Nature of the product and pack contents

Metamizol Normon 575 mg is presented as opaque red hard gelatin capsules (80 BVR), size OL, available in packs of 10 and 20 capsules.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision 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 the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63431/P_63431.html