Metamizole Tarbis 575 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metamizol Tarbis 575 mg hard capsules EFG

Magnesium metamizole

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

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

Metamizol belongs to a group of medicines known as: Other Analgesics and antipyretics.

Metamizol Tarbis is used for the treatment of acute post-operative or post-traumatic pain, colic-type pain, and pain of tumoral origin. It is also used in cases of high fever unresponsive to other antipyretics.

2. What you need to know before taking Metamizol Tarbis

Do not take Metamizol Tarbis

• 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 Metamizol Tarbis).
  • 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 experienced bone marrow dysfunction (responsible for blood cell formation); for example, during or after receiving antitumor chemotherapy (antineoplastic therapy), 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 suffered severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) after using Metamizol Tarbis or another medicine containing metamizole.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Metamizol Tarbis.

Lower than normal white blood cell count (agranulocytosis)

Metamizol Tarbis 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 Tarbis 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 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 blistering or mucosal lesions, you must stop treatment and see a doctor, as this may indicate very severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In such cases, you should not take metamizole-containing medicines again.
• If you have impaired kidney or liver function, as you may eliminate the medicine with greater difficulty.
• If you are elderly, be especially vigilant for 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 Tarbis 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 the whites of the eyes, itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You should not take Metamizol Tarbis 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 Tarbis (see section 4).

Taking Metamizol Tarbis with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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 three months of pregnancy, you must not take Metamizol Tarbis 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 recommended doses, at the higher end of the recommended dose range, these abilities may be affected. Therefore, avoid operating machinery, driving vehicles, or engaging in other potentially dangerous activities.

Taking Metamizol Tarbis 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 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 therefore caution is advised in patients taking it for cardioprotection.

If administered together with bupropion, a medicine used to treat depression and/or to help quit smoking, it may reduce bupropion blood levels, so caution is advised.

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

• 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 effects of antihypertensives (medicines that lower blood pressure) and diuretics (medicines that increase fluid elimination).

3. How to take Metamizol Tarbis

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 only. Your doctor will determine the duration of treatment.

This medicine should be taken orally. The capsules must be swallowed whole, without chewing, with the help of a small amount of liquid.

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

Adults and adolescents over 15 years of age:

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 may be administered up to 6 times daily at intervals of 4 to 6 hours. The maximum daily dose is 3450 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 Tarbis 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 or renal impairment:

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 is 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 Tarbis 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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist, or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medicine and the amount taken.

Information for the physician: There is no known specific antidote. After 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 placing the patient in the recovery 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 the implementation of necessary general supportive measures.

If you forget to take Metamizol Tarbis:

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 severe forms, for example 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).

In patients with analgesic-induced asthma syndrome, these intolerance reactions usually manifest as asthma attacks.

Drug eruptions have been reported infrequently (may affect up to 1 in 100 patients), rare cases (may affect up to 1 in 1,000 patients) of skin reactions presenting as slightly raised spots (maculopapular rashes), and very rare cases (may affect up to 1 in 10,000 patients) of skin reactions involving blisters or vesicles (Stevens-Johnson syndrome or Lyell's syndrome). Infrequent occurrences (may affect up to 1 in 100 patients) of reactions involving decreased blood pressure may also occur.

Stop using Metamizol Tarbis 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, which usually occur during or immediately after administration, but may also occur hours later.
• Skin rashes and appearance of wheals (urticaria) on the skin.
• Decreased number of white blood cells in the blood (leucopenia).
• Asthma.

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

• Skin reactions involving 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.
• Decreased number of platelets in the blood (thrombocytopenia); in such cases, 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 that may result in death).
• Aplastic anemia (failure in the production of blood cells and bone marrow 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).
• Liver inflammation, 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 experience 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, elevated 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 Tarbis

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Metamizol Tarbis after the expiry date stated on the packaging after 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 medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and additional information

Composition of Metamizol Tarbis

• The active substance is metamizol. Each capsule contains 575 mg of metamizol.
• The other components are: magnesium stearate.

Components of the capsule shell: red iron oxide (E172), erythrosine (E127), titanium dioxide (E171), gelatin.

Appearance of the product and package contents

Metamizol Tarbis 575 mg are red capsules with a red body and cap, marked with a white "M" on the cap and "575" on the body.

The medicine is available in packs containing 10 and 20 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran Via Carlos III, 94

08028- Barcelona. (Spain)

Manufacturer

TEVA PHARMA, S.L.U.

Polígono Malpica c/ C 4,

50016 Zaragoza. (Spain)

Date of the most recent revision 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 Medical Devices (AEMPS) http://www.aemps.gob.es