Metalgial 500 mg/ml oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metalgial 500 mg/ml oral drops solution

(metamizole sodium)

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 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.

Contents of the leaflet

1. What Metalgial is and what it is used for
2. What you need to know before taking Metalgial
3. How to take Metalgial
4. Possible adverse effects
5. Storage of Metalgial
6. Package contents and additional information

1. What Metalgial is and what it is used for

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

This medicine is used to treat 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.

Metalgial is available in a 20 ml bottle (supplied with a dropper dispenser) intended for children up to 7 years of age (or up to 23 kg body weight), and in 30 ml containers (including a graduated syringe) for exclusive use in children 7 years of age and older (or weighing 23 kg and above) and adults.

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

Do not take Metalgial:

• 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 previously 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 (NSAIDs), as you may also be sensitive to metamizole (the active substance in Metalgial).
• If you suffer from acute intermittent porphyria (a disorder in the metabolism of blood pigments that form part of hemoglobin).
• If you have a genetic deficiency of glucose-6-phosphate dehydrogenase.
• 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 (known, for example, as Stevens-Johnson syndrome or toxic epidermal necrolysis) with prior use of Metalgial or another medicine containing metamizole.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Metalgial.

Lower than normal white blood cell count (agranulocytosis).

Metalgial 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: 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. 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). Your doctor will perform laboratory tests to check your blood cell levels.

If you take 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 Metalgial 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, mucosal lesions in the mouth 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 red spots 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 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 blister formation or mucosal lesions, interrupt treatment and see a doctor, as 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 Metalgial (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 Metalgial 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 white part of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You should not take Metalgial if you have previously taken any medicine containing metamizole and experienced liver problems.

Taking Metalgial with food and drinks:

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

Pregnancy and breastfeeding

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 Metalgial 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 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 the use of machinery, driving vehicles, or other hazardous activities should be avoided.

Use of Metalgial with other medicines:

Inform your doctor or pharmacist if you are 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 decrease 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 and should therefore be used with caution in patients taking it for cardioprotection.

If administered together with the following medicines, it may reduce blood levels of these drugs, potentially decreasing their clinical efficacy; therefore, they should be used with caution:

• 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 (opioids).
• Valproate, a medicine used to treat epilepsy or bipolar disorder.
• Tacrolimus, a medicine used to prevent organ rejection in transplant patients.
• Sertraline, a medicine used to treat depression.

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

Important information about some of the components of Metalgial:

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

3. How to take Metalgial

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

This medicine is for short-term use. Your doctor will advise you on the duration of your treatment.

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

This medicine is to be taken orally.

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

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

Single doses (dose per administration) may be given up to four times daily, depending on the maximum daily dose.

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

Use in children and adolescents

For the treatment of pain, children and adolescents up to 14 years of age may take 8 to 16 mg of metamizole per kilogram of body weight as a single dose (see table above).

In the case of fever, a dose of 10 mg of metamizole per kilogram of body weight is generally sufficient in children:

There are two available formats, 20 ml and 30 ml, containing a dropper cap and an oral dosing syringe, respectively:

20 ml format

In children under 7 years of age or weighing up to 23 kg, the oral solution should be dosed using the dropper included with the 20 ml container, which allows dosing in drops (1 drop = 25 mg sodium metamizole).

30 ml format

In children 7 years and older or weighing 23 kg and above, the oral solution should be dosed using the graduated oral syringe included with the 30 ml container, which allows dosing up to 2 ml (1 ml = 500 mg sodium metamizole).

Elderly patients and patients with poor general health/concomitant renal insufficiency

Dosage 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. Dose reduction is not required only in short-term treatments. Experience with prolonged treatment is lacking.

Instructions for correct administration of the preparation:

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

20 ml bottle with dropper cap:

1. To remove the child-resistant cap, press down on its surface (A) while simultaneously unscrewing it counterclockwise (B).
2. After removing the cap, place the bottle in an upright position and then completely invert it. DO NOT SHAKE. WAIT A FEW SECONDS UNTIL THE FIRST DROP APPEARS.

1. Close the bottle tightly after each administration.

Warnings for correct dosing:

Do not withdraw the contents using a syringe.

Do not use a syringe for dosing.

30 ml bottle with oral dosing syringe:

1. To remove the child-resistant cap, press down on its surface (A) while simultaneously unscrewing it counterclockwise (B). Same as shown in figure 1 of the 20 ml format.
2. Insert the syringe by pressing it into the pierced opening of the cap.
3. Invert the bottle and withdraw the required dose.
4. Administer directly or dilute with water.
5. The oral syringe should be washed with water after each use.
6. Close the bottle tightly after each administration.

Warnings for correct dosing:

Use only the syringe provided in this package for accurate dosing.

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

Do not use the bottle for drop dosing.

If you take more Metalgialdel than you should:

Symptoms such as nausea, vomiting, abdominal pain, impaired renal function, and very rarely dizziness, somnolence, 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 physician or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20.

If you forget to take Metalgial:

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may 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 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 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, 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 (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, usually occurring during or shortly after administration, but also 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 characterized by 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 lead to 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 serious infection causing a systemic inflammatory response that may lead to death),
• aplastic anaemia (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 (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.
• 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, and ulcers in the mouth, 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 it is a possible adverse effect 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 Metalgial

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use Metalgial after the expiry date stated on the container following EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Metalgial

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

The other components are: Disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, purified water, raspberry flavour, and sodium saccharin.

Appearance of the medicine and contents of the pack

Metalgial 500 mg/ml is presented as an oral solution.

There are two types of packaging:

20 ml format with dropper cap

Brown glass bottle with integrated dropper and white polypropylene child-resistant cap.

30 ml format with oral syringe

Brown glass bottle with closure and white polypropylene child-resistant cap, plus an oral syringe (2 ml) with 0.2 ml graduations and 0.1 ml subdivisions.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios ERN, S.A.

C/Perú, 228 - 08020 Barcelona, Spain

Manufacturer:

ICE S.P.A.

Cantone Moretti 29 – Loc. S. Bernardo

10015 Ivrea (TO) – Italy

or

Laboratorios ERN, S.A.

C/Gorchs Lladó, 188

08210 Barberà del Vallès (Barcelona), Spain

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

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