METAMIZOLE NORMON 500 mg/ml ORAL SOLUTION DROPS

2. What you need to know before taking Metamizol Normon

Do not use Metamizol Normon

• If you have previously had a significant decrease in a type of white blood cell called granulocytes, which was caused by metamizol or other similar medicines called pyrazolones or pyrazolidines.
• If you have bone marrow problems or a disorder that affects the way your blood cells are produced or function.
• If you have had allergic reactions or hematological reactions (decrease in white blood cells, red blood cells, or platelets in the blood) with medicines containing metamizol or other similar compounds, or allergic reactions to any of the other components of this medicine (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 non-steroidal anti-inflammatory drugs, as you may also be sensitive to metamizol (the active substance of Metamizol Normon).
• If you have 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 had alterations in bone marrow function (blood cell formation); for example, during or after receiving antitumor chemotherapy (antineoplastic) or if you have had diseases related to blood cell formation.
• 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 Normon or another medicine that contains metamizol.

Warnings and precautions:

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

Low white blood cell count (agranulocytosis).

Metamizol Normon may cause agranulocytosis, a very low level of a type of white blood cell called granulocytes, which are important for fighting infections (see section 4). You should stop taking metamizol and contact your doctor immediately if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in the mucous membranes (wet 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 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 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 mouth or genital area, bruising, bleeding, or paleness, you should 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 a failure in the production of all blood cells (aplastic anemia).

• If you experience dizziness, difficulty breathing, rhinitis, swelling of the face, decreased blood pressure, sudden onset of red patches on the skin, 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 have asthma or allergic 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 colorants and/or preservatives or alcohol, as the risk of severe allergic reactions is higher.

• If you have low blood pressure or 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 blistering or lesions in the mucous membranes, you should interrupt treatment and consult your doctor, as this may be due to the appearance of very severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In these cases, you should not receive medicines that contain metamizol again.
• If you have impaired kidney or liver function, as you may have difficulty eliminating the medicine.
• If you are an elderly patient, be especially alert to the appearance of any of the disorders described above, as they may occur more frequently.

• Liver problems: inflammation of the liver has been reported in patients taking metamizol, with symptoms developing within a few days to a few months after starting treatment.

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

Do not take Metamizol Normon if you have previously taken a medicine that contains 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 restart treatment with Metamizol Normon at any time (see section 4).

Taking Metamizol Normon with food and drinks

Together with alcohol, the effects of both can 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 metamizol during the first three months of pregnancy are limited, but they do not indicate harmful effects on the embryo. In selected cases when there are no other treatment options, single doses of metamizol during the first and second trimester may be acceptable after consulting your doctor or pharmacist and carefully evaluating the benefits and risks of using metamizol. However, in general, the use of metamizol is not recommended during the first and second trimester.

During the last trimester of pregnancy, you should not take Metamizol Normon due to the increased risk of complications for the mother and the baby (bleeding, premature closure of an important 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 excluded that there is a risk for the breastfed infant. Therefore, repeated use of metamizol should be avoided during breastfeeding. If a single dose of metamizol is administered, mothers are recommended to express and discard breast milk for 48 hours after administration.

Driving and using machines

Although no adverse effects on concentration and reaction ability are expected, at the highest recommended doses, it should be taken into account that these abilities may be affected, and you should avoid using machines, driving vehicles, or engaging in other hazardous activities.

Other medicines and Metamizol Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

If you are taking cyclosporin (a medicine that prevents transplant rejection), metamizol may reduce cyclosporin blood levels, and these should be regularly monitored.

If you are taking chlorpromazine (a medicine for the treatment of psychoses), metamizol may cause a drop in body temperature.

If you are taking methotrexate or other anticancer medicines (antineoplastics), metamizol may enhance the toxic effects of these medicines on the blood, especially in elderly patients.

If you are taking acetylsalicylic acid, metamizol may reduce the effect of acetylsalicylic acid on platelet aggregation (antiplatelet effect) and should be used with caution in patients taking it to protect the heart (cardioprotective).

If you are taking bupropion, a medicine used to treat depression and/or help quit smoking, metamizol may reduce bupropion blood levels, and it should be used with caution.

Metamizol may modify the effect of antihypertensive medicines (medicines that lower blood pressure) and diuretics (medicines that increase fluid elimination).

If you are taking efavirenz, a medicine used to treat HIV/AIDS.

If you are taking methadone, a medicine used to treat drug addiction (opioids).

If you are taking valproate, a medicine used to treat epilepsy or bipolar disorder.

If you are taking tacrolimus, a medicine used to prevent organ rejection in transplant patients.

If you are taking sertraline, a medicine used to treat depression.

Important information about some of the components of Metamizol Normon:

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

3. How to take Metamizol Normon

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

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

The following table shows the recommended single doses and maximum daily doses based on weight or age:

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

The effect of the medicine 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 of weight) can take 8 to 16 mg of metamizol per kilogram of body weight in a single dose (see table above). In case of fever, a dose of 10 mg of metamizol per kilogram of body weight is generally sufficient in children:

Elderly patients and patients with poor general health/renal insufficiency

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

Patients with renal or hepatic insufficiency

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

Method of administration

The oral solution should be dosed with the drop counter included in the package, which allows dosing in drops (1 drop = 25 mg metamizol sodium monohydrate).

Instructions for correct administration of the preparation:

The drops should be administered orally with a little water.

1. To remove the safety cap from the bottle, press on the surface (A) and unscrew in the opposite direction of the clock hands (B).

1. Once the cap is removed, place the bottle in a vertical position and completely inverted. DO NOT SHAKE.WAIT A FEW SECONDS UNTIL THE FIRST DROP COMES OUT.

1. Close the bottle well after each administration.

Warnings for correct dosing:

• Do not extract the contents with a syringe.

There is a risk of permanently damaging the drop counter and it may not be usable later.

• Do not use a syringe for dosing in drops.

Duration of administration

The duration of treatment is determined based on the type and severity of the disease and will be decided by your doctor.

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

If you take more Metamizol Normon than you should

Nausea, vomiting, abdominal pain, deterioration of renal function, and in very rare cases, dizziness, drowsiness, coma, convulsions, and decreased blood pressure may occur.

After administration of very high doses of metamizol, a red coloration of the urine may occur, which disappears when treatment is stopped.

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

If you forget to take Metamizol Normon

Do not take a double dose to make up for forgotten doses.

If you have any other 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 all people suffer from 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 can progress to more severe forms, e.g., generalized urticaria, swelling of 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 Normon and contact a doctor immediately if you experience any of the following symptoms:

Feeling of illness (nausea or vomiting), fever, feeling of tiredness, loss of appetite, dark urine, light-colored stools, yellowish discoloration of the skin or the white part of the eyes, itching, rash, or pain in the upper abdominal 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 (decreased blood pressure).

Uncommon (may affect up to 1 in 100 people):

• Rashes and skin reactions.

Rare (may affect up to 1 in 1,000 people):

• Allergic reactions that usually occur during or immediately after administration but also hours later,

• Rashes and appearance of hives on the skin,

• Decreased number of white blood cells in the blood (leukopenia),
• Asthma.

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

• Skin reactions in which blisters or bubbles appear (toxic epidermal necrolysis, Stevens-Johnson syndrome),
• Kidney problems with decreased or suppressed urine output,
• Increased amount of protein excreted in the urine,
• Kidney inflammation (interstitial nephritis),
• Severe decrease in white blood cells (agranulocytosis) that can cause death due to severe infections,
• Decreased number of platelets in the blood (thrombocytopenia), in this case, inflammatory lesions in the mucous membranes, sore throat, and fever may occur,
• Shock (drastic drop in blood pressure).

Frequency Not Known (cannot be estimated from available data):

• Sepsis (severe infection that involves an inflammatory reaction of the entire body and can cause death),
• Aplastic anemia (failure of the production of bone marrow and blood cells),
• Pancytopenia (low number of red, white, and platelet cells simultaneously),
• Anaphylactic shock (severe allergic reaction that can cause death),
• Kounis syndrome (a type of cardiac disorder),
• Gastrointestinal bleeding,
• Chromaturia (abnormal urine coloration),
• Liver inflammation, yellowish discoloration of the skin and the white part of the eyes, increased blood level of liver enzymes.
• Severe skin reactions: stop taking metamizol and seek immediate medical attention if you observe any of the following serious adverse effects:

• Red patches that are not raised, 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 erythemas can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the box and on the bottle after "CAD". The expiration date is the last day of the month indicated.

After the first opening of the bottle, the validity period of the medicine is 12 months.

Medicines should not be thrown away through the sewers or in the trash. Deposit the containers and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Metamizol Normon

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

The other components are:

Sodium phosphate dibasic, sodium phosphate monohydrate, raspberry essence, sodium saccharin, purified water.

Appearance of the Product and Package Contents

Clear, colorless to light yellow solution.

It is presented in a 20 ml amber glass bottle with a child-resistant screw cap, packaged in a cardboard box. The bottle has an incorporated drop counter as an administration device.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus:November 2024

Detailed and updated information on this medicine 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 the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83494/P_83494.html