Metamizole Teva-Ratiopharm 575 mg hard capsules EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metamizol Teva-ratiopharm 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 you should not give it to other people, even if they have the same symptoms as you, because 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.

Leaflet contents:

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

1. What Metamizol Teva-ratiopharm is and what it is used for

Metamizol belongs to a group of medicines known as "Other Analgesics and Antipyretics".

This medicine is used for the treatment of moderate to severe acute pain following surgery or trauma, colic-type pain, and pain of tumoral origin. It is also used in cases of high fever unresponsive to other measures or other antipyretic medicines.

2. What you need to know before taking Metamizol Teva-ratiopharm

Do not take Metamizol Teva-ratiopharm

• If you have previously had allergic or hematological reactions (decreased white blood cells, red blood cells, or platelets in the blood) to medications 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 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), since sensitivity to metamizole may also occur in these cases.

• If you suffer from acute intermittent porphyria (a disorder in the metabolism of blood pigments that form part of hemoglobin).

• If you have congenital glucose-6-phosphate dehydrogenase deficiency.

• 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 experienced impaired 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 third trimester of pregnancy.

• If you have previously experienced severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) after using metamizole or another medicine containing metamizole.

Warnings and precautions

Talk to your doctor or pharmacist before taking Metamizol Teva-ratiopharm.

Low white blood cell count (agranulocytosis)

Metamizol Teva-ratiopharm 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 (wet 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 Teva-ratiopharm 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 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, drop in 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 have intolerance to dyes and/or preservatives or to alcohol, since 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, since 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 be due to the development of very severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In such cases, you must not receive again medicines containing metamizole.

• 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.

Severe skin reactions

• Serious 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 serious skin reactions described in section 4.

If you have ever experienced serious skin reactions, you must not restart treatment with metamizole at any time (see section 4).

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

You must not take metamizole if you have previously taken a medicine containing metamizole and experienced liver problems.

Taking Metamizol Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

If administered together 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 drop 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 (platelet aggregation inhibition), and therefore caution should be used in patients taking it for cardioprotection.

If administered together with 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 addiction to illicit drugs known as opioids), valproate (a medicine used to treat epilepsy or bipolar disorder), tacrolimus (a medicine used to prevent organ rejection in transplant patients), or sertraline (a medicine used to treat depression), it may reduce blood levels of these medicines, so caution should be exercised.

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

Taking Metamizol Teva-ratiopharm with food, drinks, and alcohol

Together with alcohol, the effects of both alcohol and the medicine may be enhanced.

Pregnancy, breastfeeding, and fertility

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 where 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 metamizole due to the increased risk of complications for both mother and baby (bleeding, premature closure of an important fetal 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 breastfed 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 use of machines

Although adverse effects on concentration and reaction ability are not expected, at the highest recommended doses, you should be aware that these abilities may be affected, and you should avoid operating machinery, driving vehicles, or engaging in other hazardous activities. This is especially important if alcohol has been consumed.

3. How to take Metamizol Teva-ratiopharm

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

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

This medicine should be taken orally. The capsules must be swallowed whole, without chewing, with a little liquid.

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 required to control pain and fever should always be used. Your doctor will advise you on how to take metamizole.

Adults and adolescents aged 15 years and older

Adults and adolescents aged 15 years and older (weighing more than 53 kg) may take 1 capsule (575 mg 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

Metamizole must not be used in children under 15 years of age. Other formulations and doses of this medicine are available for younger children; consult your doctor or pharmacist.

Elderly patients and patients with poor general health/renal impairment

The dose should be reduced in elderly patients, 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. Dose reduction is not necessary only in short-term treatments. Experience with prolonged treatment is lacking.

If pain persists or worsens, consult a doctor to investigate the cause of symptoms.

If you take more Metamizol Teva-ratiopharm than you should

Symptoms such as nausea, vomiting, abdominal pain, impaired renal function, and very rarely dizziness, drowsiness, coma, convulsions, decreased blood pressure, or even shock and increased heart rate (tachycardia) may occur.

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, consult 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 be considered, as metamizole is dialyzable.

In case of severe allergic reactions, other standard emergency measures should also be applied, such as placing the patient in the recovery position, maintaining airways free of obstruction, or administering oxygen. Pharmacological emergency measures include administration of adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions is advised, along with the implementation of necessary general measures.

If you forget to take Metamizol Teva-ratiopharm

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 will experience them.

The following adverse effects may be serious or life-threatening. Stop taking metamizole and contact your doctor immediately if you are affected. You may require urgent medical attention.

• Reddish, flat patches or circular or target-like rashes on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes 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).

Stop using metamizole 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”.

These reactions may also occur even if metamizole has previously been used without complications.

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).

Other adverse effects that may occur with the following frequencies are:

Common (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 immediately after administration, but also hours later
• Skin rashes and appearance of hives (urticaria)
• Decreased number of white blood cells in blood (leukopenia)
• Asthma.

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

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

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

• Sepsis (serious infection causing a systemic inflammatory response that may lead to death)
• Aplastic anemia (failure in the production of blood cells in the bone marrow)
• 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 urine coloration)
• Inflammation of the liver, yellowing of the skin and whites of the eyes, increased blood levels of liver enzymes
• Severe skin reactions

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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metamizole Teva-ratiopharm

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point located 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. Contents of the pack and other information

Composition of Metamizol Teva-ratiopharm

• The active substance is metamizole. Each capsule contains 575 mg of metamizole.
• 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 contents of the pack

Metamizol Teva-ratiopharm 575 mg are gelatin capsules with a red body and cap, marked with a white ink "M" on the cap and "575" on the body.

It is available in blister packs containing 10 and 20 capsules, or in HDPE bottles (containing a desiccant) with 20 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 – Madrid (Spain)

Manufacturer

Teva Pharma S.L.U.

Polígono Industrial Malpica c/ C nº 4

50016 Zaragoza (Spain)

Date of the most recent review of this leaflet: March 2025

Detailed 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 up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72616/P_72616.html