METAMIZOLE TEVA-RATIOPHARM 575 mg HARD CAPSULES

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 (decrease in white blood cells, red blood cells, or platelets in the blood) with medicines containing metamizol or 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.
• If you have acute intermittent porphyria (a disorder of the metabolism of blood pigments that are part of hemoglobin).
• If you have a congenital deficiency of glucose-6-phosphate dehydrogenase.
• 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 alterations in bone marrow function (the producer of blood cells); 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 third trimester of pregnancy.

• If you have had very severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) with the previous use of metamizol or another medicine that contains metamizol.

Warnings and precautions

Consult your doctor or pharmacist before taking Metamizol Teva-ratiopharm.

Low white blood cell count (agranulocytosis)

Metamizol Teva-ratiopharm 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 a 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 Teva-ratiopharm and even shortly after stopping metamizol.

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

Be especially careful:

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 resume treatment with metamizol at any time (see section 4).

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 and contact a 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.

You should not take metamizol if you have previously taken a medicine containing metamizol and had liver problems.

Taking Metamizol Teva-ratiopharm with other medicines

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

If administered together with cyclosporin (a medicine that prevents transplant rejection), it may reduce cyclosporin blood levels, and these levels should be monitored regularly.

If administered with chlorpromazine (a medicine for the treatment of psychosis), it may cause a drop in body temperature.

If administered together with methotrexate or other medicines for the treatment of tumors (antineoplastics), it may enhance the toxic effects of antineoplastics on the blood, especially in elderly patients.

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

If administered together with bupropion (a medicine used for the treatment of depression and/or to help stop smoking), efavirenz (a medicine used for the treatment of HIV/AIDS), methadone (a medicine used to treat opioid dependence), 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 the blood levels of these medicines, and caution should be exercised.

Metamizol may alter the effect 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 can be enhanced.

Pregnancy, breastfeeding, and fertility

Pregnancy

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, when there are no other treatment options, single doses of metamizol during the first and second trimesters 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 trimesters.

During the last three months of pregnancy, you should not take it due to the increased risk of complications for the mother and the baby (bleeding, premature closure of a vital vessel for the fetus, called the ductus arteriosus, which closes naturally after birth).

Breastfeeding

Metamizol degradation products are excreted in breast milk in considerable 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 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 other hazardous activities. This is especially applicable when alcohol has been consumed.

3. How to take Metamizol Teva-ratiopharm

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

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

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

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

Adults and adolescents 15 years of age or older

Adults and adolescents 15 years of age or older (weighing more than 53 kg) can take 1 capsule (575 mg of metamizol) as a single dose, which can be administered up to 6 times a day, at 4- to 6-hour intervals. The maximum daily dose is 3450 mg (corresponding 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 should not be used in children under 15 years of age. Other presentations and doses of this medicine are available for younger children; consult your doctor or pharmacist.

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.

Patient with renal or hepatic insufficiency

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

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

If you take more Metamizol Teva-ratiopharm than you should

Nausea, vomiting, abdominal pain, impaired renal function, and in very rare cases, dizziness, drowsiness, coma, convulsions, decreased blood pressure, or even shock and increased heart rate (tachycardia) 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 or call the Toxicological Information Service (Telephone 91 562 04 20), indicating the medicine and the amount taken.

Information for the doctor

No specific antidote is known. After oral overdose, gastric lavage and forced vomiting may be performed. Forced diuresis or dialysis may be considered, as metamizol is dialyzable.

In case of severe allergic reactions, other usual emergency measures should be applied, such as placing the patient on their side, keeping the airways free of obstruction, or administering oxygen. Pharmacological emergency measures include the administration of adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions and general necessary measures should be taken.

If you forget to take Metamizol Teva-ratiopharm

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.

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

• 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 rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread redness, elevated body temperature, and enlargement of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Stop using metamizol 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, yellowing of the skin or the white part of the eyes, itching, rash, or pain in the upper abdomen. These symptoms may be signs of liver damage. See also section 2 "Warnings and Precautions".

These reactions can also occur if metamizol has been used previously without complications.

Milder 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).

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

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

• hypotension (decrease in blood pressure).

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

• skin rashes and 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
• skin rashes and hives
• decrease in the number of white blood cells in the blood (leukopenia)
• asthma.

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

• skin reactions with blisters or bubbles (toxic epidermal necrolysis, Stevens-Johnson syndrome)

• kidney problems with decreased or suppressed urine output
• increase in the 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
• 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 (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, yellowing of the skin and the white part of the eyes, increased blood level 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 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 Teva-ratiopharm

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Metamizol Teva-ratiopharm

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

The components of the capsule are: red iron oxide (E172), erythrosine (E127), titanium dioxide (E171), gelatin.

Appearance of the Product and Package Contents

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

They are presented in blister packs with 10 and 20 capsules or in an HDPE bottle (contains desiccant) with 20 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108 – Madrid (Spain)

Manufacturer

Teva Pharma S.L.U.

Polígono Industrial Malpica c/ C nº 4

50016 Zaragoza. (Spain)

Date of the last revision of this prospectus:March 2025

Detailed information about 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 packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72616/P_72616.html