Package Leaflet: Information for the User

Metalgial 500 mg/mlOral Solution Drops

(metamizol sodium)

Read this 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 for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Metalgial and what it is used for

2. What you need to know before starting to take Metalgial

3. How to take Metalgial

4. Possible side effects

5. Storage of Metalgial

6. Contents of the pack and additional information

Metalgial belongs to the group of medications known as “Other Analgesics and Antipyretics”.

This medication is used for the treatment of moderate to severe acute postoperative or post-traumatic pain, of colic type or of tumor origin.It is also used in cases of high fever that does not respond to other measures or other fever medications.

Metalgial is presented in a 20 ml bottle (provided with a dosing dropper) intended for children up to 7 years of age (or up to 23 kg of weight), and 30 ml containers (which include a graduated syringe) for exclusive use in children 7 years of age and older (or from 23 kg of weight) and adults.

Do not take Metalgial:

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Metalgial.

Low white blood cell count (agranulocytosis).

Metalgial may 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 should stop taking metamizol and contact a doctor immediately if you experience the following symptoms: chills, fever, sore throat, and painful sores in the mucous membranes (moist surfaces of the body) especially in the mouth, nose, and throat or in the genital or anal area.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).Your doctor will perform laboratory tests to check your blood cell levels.

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 Metalgial and even after stopping metamizol.

You may develop agranulocytosis even if you have used metamizol without problems in the past.

Be careful:

Stop using Metalgial and contact a doctor if you experience symptoms of liver problems, such as nausea, vomiting, fever, fatigue, loss of appetite, dark urine, light-colored stools, yellowing of the skin or whites of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

Do not take Metalgial if you have previously taken a medication containing metamizol and had liver problems.

Metalgial with food and beverages:

Along with alcohol, the effects of both may be potentiated.

Pregnancy and lactation

Pregnancy

The available data on the use of metamizol during the first three months of pregnancy are limited, but do not indicate harmful effects on the embryo. In selected cases where there are no other treatment options, single doses of metamizol 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 metamizol. However, in general, it is not recommended to use metamizol during the first and second trimesters.

During the last trimester of pregnancy, do not take Metalgial due to the increased risk of complications for the mother and baby (bleeding, premature closure of a major vessel for the fetus, called the ductus arteriosus, which closes naturally after birth).

Lactation

Metamizol degradation products are excreted in breast milk in significant amounts and cannot be ruled out as a risk to the infant. Therefore, repeated use of metamizol during lactation should be avoided. If a single dose of metamizol is administered, mothers should express and discard breast milk for 48 hours after administration.

Driving and using machines:

Although no adverse effects on concentration and reaction capacity are expected, at higher doses within the recommended range, you should be aware that these capacities may be affected and you should avoid using machines, driving vehicles, or other hazardous activities.

Metalgial and other medications:

Inform your doctor or pharmacist if you are using or have used or may need to use any other medication.

If administered together with ciclosporin (a medication that prevents transplant rejection), it may reduce ciclosporin levels in the blood and therefore these should be measured regularly.

If administered together with clorpromazina (a medication for the treatment of psychoses), it may cause a decrease in body temperature.

If administered together with metotrexato or other medications for the treatment of tumors (antineoplastic), it may potentiate the toxic effects in the blood of antineoplastic medications, especially in elderly patients.

If administered together with acetylsalicylic acid, it may reduce the effect of acetylsalicylic acid to decrease platelet aggregation (antiplaquetary) and therefore it should be used with caution in patients taking it to protect the heart (cardioprotector).

If administered together with the following medications, it may reduce blood levels of these medications with a possible decrease in clinical efficacy, and therefore they should be used with caution:

Metamizol may modify the effect of antihypertensive medications (medications that reduce blood pressure) and diuretics (medications that increase the elimination of liquids).

Important information about some components of Metalgial:

This medication contains 35 mg (1.5 mmol) of sodium per ml (20 drops). This is equivalent to 1.8% of the maximum daily recommended dose of sodium for an adult.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medication is for short-term use. Your doctor will indicate the duration of your treatment.

If you estimate that the effect of Metalgial is too strong or too weak, inform your doctor or pharmacist.

This medication must be taken orally.

The dose is established according to the intensity of the pain or fever and the sensitivity of each person to treatment with metamizol. Always select the lowest necessary dose to control pain and fever. Your doctor will indicate how to take this medication.

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

The single doses (dose per intake) can 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 and adolescents

For the treatment ofpain, children and adolescents up to 14 years of age can take 8 to 16 mg of metamizol per kilogram of body weight in a single dose (see table above).

Forfever, a dose of 10 mg of metamizol per kilogram of body weight is usually sufficient in children:

There are two formats, 20 and 30 ml, containing a dropper and a syringe for oral use, respectively:

20 ml format

In childrenunder 7 years or up to 23 kg of weight, the oral solution must be dosed with the dropper included in the 20 ml container, which allows dosing in drops (1 drop = 25 mg metamizol sodium).

30 ml format

In childrenover 7 years or over 23 kg of weight, the oral solution must be dosed using the oral syringe included in the 30 ml container, which allows dosing up to 2 ml (1 ml = 500 mg metamizol sodium).

Older adults and patients with poor general health/renal insufficiency

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

Patients with renal or hepatic insufficiency

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

Instructions for correct administration of the preparation:

The drops will be administered orally with a little water.

20 ml container with dropper:

1. To extract thesafety stopperfrom the container, press on the surface of the container (A) and at the same time unscrew in the opposite direction to the clock (B).
2. Once the stopper is extracted, place the container in a vertical position and upside down.DO NOT SHAKE.WAIT FOR A FEW SECONDS UNTIL THE FIRST DROP APPEARS.

1. Close the container well after each administration.

Warnings for correct dosing:

Do not extract the content with a syringe.

Do not use a syringe for dosing.

30 ml container with oral syringe:

1. To extract thesafety stopperfrom the container, press on the surface of the container (A) and at the same time unscrew in the opposite direction to the clock (B). The same as in the drawing 1 of the 20 ml format.
2. Insert the syringe, pressing on the perforated stopper.
3. Invert the container and remove the necessary dose.
4. Administer directly or dilute with water.
5. The syringe must be washed with water after each intake.
6. Close the container well after each administration.

Warnings for correct dosing:

Use the syringe contained in this format for correct dosing.

The oral syringe should not be used for dosing in drops.

The container should not be used for dosing in drops.

If you take more Metalgialthan you should:

You may experience nausea, vomiting, abdominal pain, renal function deterioration, and in very rare cases, dizziness, somnolence, coma, convulsions, and decreased blood pressure.

After administration of very high doses of metamizol, it may cause a reddish discoloration of the urine, which disappears when treatment is suspended.

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

If you forgot to take Metalgial:

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Mild allergic reactions (such as skin and mucous membrane reactions like itching, burning, redness, swelling) as well as difficulty breathing and gastrointestinal discomfort may progress to more severe forms, such as generalized urticaria, swelling of the 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 Metalgial 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, light-colored stools, yellow discoloration of the skin or the white part 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 side effects that may occur with the following frequencies are:

Frequent (may affect up to 1 in 10 people):

- Hypotension (decreased blood pressure).

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

- Skin eruptions and reactions.

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

- Allergic reactions that usually occur during or shortly after administration but also hours later,

- Skin eruptions and appearance of blisters,

- Decreased white blood cell count in the blood (leucopenia),

- Asthma.

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

- Skin reactions with the appearance of vesicles or blisters (toxic epidermal necrolysis, Stevens-Johnson syndrome),

- Kidney problems with decreased or suppressed urine output,

- Increased protein excretion in the urine,

- Interstitial nephritis (inflammation of the kidneys),

- Severe decrease in white blood cells (agranulocytosis) that may cause death due to severe infections,

- Decreased platelet count in the blood (thrombocytopenia), in this case, may cause inflammatory lesions in mucous membranes, throat pain, and fever,

- Shock (drastic drop in blood pressure).

Unknown frequency (cannot be estimated from available data):

- Sepsis (severe infection that involves a systemic inflammatory reaction and may cause death),

- Aplastic anemia (failure in the production of bone marrow and blood cells),

- Pancitopenia (low count of red and white blood cells and platelets simultaneously),

- Anaphylactic shock (severe allergic reaction that may cause death),

- Kounis syndrome (a type of cardiac disorder),

- Gastrointestinal bleeding,

- Chromaturia (abnormal urine color).

- Liver inflammation, yellow discoloration of the skin and the white part of the eyes, increased serum levels of liver enzymes.

- Severe skin reactions: stop taking metamizol and seek immediate medical attention if you observe any of the following severe side effects:

• Flat, red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, elevated body temperature, and increased lymph node size (DRESS syndrome or drug hypersensitivity syndrome).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use Metalgial after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Metalgial

The active principle is metamizol sodium. Each ml (20 drops) of solution contains 500 mg of metamizol sodium, which is equivalent to 467 mg of metamizol.

The other components are: Dodecahydrate dibasic sodium phosphate, dihydrate sodium phosphate, purified water, raspberry aroma, and sodium saccharin.

Appearance of the product and content of the container

Metalgial500 mg/ml is presented in the form of an oral solution.

There are two types of containers:

20 ml format with dropper

Brown glass bottle, with incorporated dropper and white polypropylene cap with child-resistant safety feature.

30 ml format with oral syringe

Brown glass bottle, with dropper and white polypropylene cap with child-resistant safety feature, plus oral syringe (2 ml) with 0.2 ml divisions and 0.1 ml subdivisions.

Holder of the authorization and manufacturer responsible

Holder of the authorization:

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturer responsible:

ABC Farmaceutici S.p.A.

Canton Moretti 29 – Loc. S. Bernardo

10090 Ivrea (TO) – Italy

or

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain

Last review date of this leaflet: November 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.