Metamizol Normon 500 mg/ml oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Metamizol Normon 500 mg/ml oral drops solution EFG

Sodium metamizole monohydrate

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 may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if these adverse effects are 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 taking 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 the group of medicines known as "Other analgesics and antipyretics".

This medicine is used for the treatment of moderate to severe acute postoperative or post-traumatic pain, colicky pain, or pain of tumoral origin. It is also used in cases of high fever unresponsive to other measures or other antipyretic medicines.

Metamizol Normon comes in a 20 ml bottle (supplied with a dropper dispenser) intended for children up to 10 years of age (or up to 30 kg body weight).

2. What you need to know before taking Metamizol Normon

Do not use 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 allergic reactions to any of the other components of this medicine (listed in section 6).
• If you have 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, since 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 (a genetic disorder).
• 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 (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) with prior use of Metamizol Normon or another medicine containing metamizole.

Warnings and precautions

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

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 the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in 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 can occur at any time during the use of 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 oral mucosa 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), 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 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 and progresses to blister formation or mucosal lesions, 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 medicines containing metamizole again.

• 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 Metamizol Normon 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 the whites of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You should 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 never restart treatment with Metamizol Normon (see section 4).

Taking Metamizol Normon with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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 trimester of pregnancy, you must not take Metamizol Normon 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 following 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 the use of machines, driving vehicles, or other potentially dangerous activities should be avoided.

Other medicines and Metamizol Normon

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, and 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 together with methotrexate or other antitumor medicines (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, and therefore caution is advised in patients taking it for cardioprotection.

If administered together with bupropion, it may reduce bupropion blood levels, so caution is advised. Bupropion is 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).

If administered together with efavirenz, a medicine used to treat HIV/AIDS.

If administered together with methadone, a medicine used to treat dependence on illicit drugs (opioids).

If administered together with valproate, a medicine used to treat epilepsy or bipolar disorder.

If administered together with tacrolimus, a medicine used to prevent organ transplant rejection.

If administered together with sertraline, a medicine used to treat depression.

Important information about some of the components of Metamizol Normon:

This medicine contains 35 mg of sodium (a main component of table/cooking salt) per ml. This corresponds to 1.8% of the maximum daily sodium intake recommended for an adult.

3. How to take Metamizol Normon

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

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

The following table shows the recommended single doses and maximum daily doses according to weight or age:

Single doses may be administered up to four times a day, depending on the maximum daily dose.

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

Use in children

For pain treatment, children up to 10 years of age (30 kg body weight) may take 8 to 16 mg of metamizole per kilogram of body weight as a single dose (see table above). In case of fever, a dose of 10 mg of metamizole per kilogram of body weight is generally sufficient in children:

Elderly persons and patients with poor general health/renal impairment

The dose should be reduced in elderly individuals, in debilitated patients, and in those with reduced renal function, as elimination of metamizole degradation products may be delayed.

Patients with renal or hepatic impairment

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

Method of administration

The oral solution should be dosed using the dropper cap supplied with the container, which allows dosing in drops (1 drop = 25 mg sodium metamizole monohydrate).

Instructions for correct administration of the preparation:

The drops should be administered orally with a small amount of water.

1. To remove the safety cap from the bottle, press down on its surface (A) while simultaneously unscrewing it counterclockwise (B).

2. After removing the cap, place the bottle in an upright, fully inverted position. DO NOT SHAKE. WAIT A FEW SECONDS UNTIL THE FIRST DROP APPEARS.

3. Close the bottle tightly after each administration.

Warnings for correct dosing:

• Do not withdraw the contents with a syringe.

There is a risk of permanently damaging the dropper cap, making it unusable thereafter.

• Do not use a syringe for drop dosing.

Duration of administration

The duration of treatment depends on the type and severity of the illness and will be determined by your physician.

It is recommended not to take analgesics for longer than 3 to 5 days without consulting your doctor or dentist again.

If you take more Metamizol Normon than you should

Symptoms such as nausea, vomiting, abdominal pain, impaired renal function, and very rarely dizziness, drowsiness, coma, convulsions, and decreased blood pressure may occur.

After administration of very high doses of metamizole, red discoloration of urine may occur, which disappears upon discontinuation of treatment.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20.

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 can cause adverse effects, although not everyone experiences 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), disturbances in heart rhythm, and decreased blood pressure (sometimes preceded by an increase in blood pressure).

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 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 people):

• Hypotension (decrease in 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 also several hours later,
• Skin rashes and appearance of hives (urticaria),
• Decrease in the number of white blood cells in the blood (leukopenia),
• 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,
• Increase in the 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 may occur in mucous membranes, along with sore throat and fever,
• Shock (drastic drop in blood pressure).

Frequency not known (cannot be estimated from available data):

• Sepsis (serious infection involving a systemic inflammatory response that may lead to death),

• Aplastic anemia (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 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.

• Serious 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 rashes on the chest, often with central blisters, skin peeling, mouth ulcers, and 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, 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 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 Normon

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

Do not use this medicine after the expiry date stated on the carton and on the bottle after "EXP". The expiry date refers to the last day of the stated month.

After first opening the bottle, the medicine remains valid for 12 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Metamizol Normon

The active substance is sodium metamizole monohydrate. 1 ml (20 drops) of solution contains 500 mg of sodium metamizole monohydrate (1 drop contains 25 mg of sodium metamizole monohydrate).

The other components are:

Disodium hydrogen phosphate, sodium phosphate monohydrate, raspberry flavour, sodium saccharin, purified water.

Appearance of the product and contents of the container

Clear, colourless to pale yellow solution.

It is supplied in a 20 ml amber glass bottle with a child-resistant screw cap, packaged in a cardboard box. The bottle is equipped with an integrated dropper stopper as the administration device.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

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

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

You can access detailed and updated 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/83494/P_83494.html