PROSPECTO : INFORMATION FOR THE USER

Metamizol Teva-ratiopharm 575 mg hard capsules EFG

Magnesium Metamizol

Read this prospectus carefully before starting to take this medicine because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 prospectus. See section 4.

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

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

3.How to take Metamizol Teva-ratiopharm

4.Possible adverse effects

5Storage of Metamizol Teva-ratiopharm

6.Contents of the package and additional information

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

Metamizol Teva-ratiopharm is used for the treatment of acutemoderate or severepost-operative or post-traumatic pain, colic pain and pain of tumoral origin. It is also used in cases of high fever that does not respond toother measures orotherfever medications.

Do not take Metamizol Teva-ratiopharm

• If you have had previously allergic or hematologic reactions (decrease in white blood cells, red blood cells, or platelets in the blood)with medications containing metamizol or other similar compounds or allergic reactions to any of the other components of this medication (listed in section 6).
• If you have suffered symptoms of asthma, rhinitis, or urticaria (red spots or hives on the skin that may cause itching) during treatment with other analgesics such as acetylsalicylic acid, paracetamol, or nonsteroidal anti-inflammatory drugs, as in these cases there may also be sensitivity to metamizol.
• If you suffer from acute intermittent porphyria (a disorder of the metabolism of blood pigments that form part of hemoglobin).
• If you suffer from congenital glucose-6-phosphate dehydrogenase deficiency.

• If you have suffered alterations in bone marrow function (producer of blood cells); for example, during or after receiving antitumor chemotherapy or if you have diseases related to blood cell formation.
• If you are in the third trimester of pregnancy.

• If you have suffered severe skin reactions (for example, Stevens-Johnson syndrome or toxic epidermal necrolysis) with the use of Metamizol
• or another medication containing metamizol.

Warnings and precautions

Consult your doctor or pharmacist before taking this medication.

Be especially careful:

• if you experience general discomfort, infection, persistent fever, sore throat, inflammation in the mouth, nose, or throat, mucosal lesions in the mouth or genitals, bruises, bleeding, or paleness, discontinue 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 a failure in the production of all blood cells (aplastic anemia).
• if you experiencedizziness, difficulty breathing, rhinitis, facial swelling, decreased blood pressure, sudden appearance of red spots on the skin, discontinue 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 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 colorants and/or preservatives or to alcohol, as the risk of possible severe allergic reactions is higher.

• if you have low blood pressure problems or hypovolemia (decrease in 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 eruption appears that progresses to the formation of blisters or lesions in the mucosa, discontinue treatment and consult your doctor, as this may be due to the appearance of severe skin disorders (Stevens-Johnson syndrome or toxic epidermal necrolysis). In these cases, you should not receive metamizol again.
• if you have decreased liver or kidney function, as you may eliminate the medication with greater difficulty.
• if you are an elderly patient, be especially attentive to the appearance of any of the disorders described above, as they may appear more frequently.

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. Discontinue 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 suffered severe skin reactions, do not resume treatment with Metamizol ratiopharm at any time (see section 4).

Liver problems

Inflammation of the liver has been reported in patients taking metamizol with symptoms that develop within a few days to several months after starting treatment.

Discontinue 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 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 medication containing metamizol and had liver problems.

Metamizol Teva-ratiopharm with other medications

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

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

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

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

If administered together with bupropion, medication used for the treatment of depression, and/or to help quit smoking, it may reduce blood levels of bupropion, so it should be used with caution.

If administered together with efavirenz, medication used for the treatment of HIV/AIDS

If administered together with methadone, medication used to treat opioid dependence

If administered together with valproate, medication used to treat epilepsy or bipolar disorder

If administered together with tacrolimus, medication used to prevent organ rejection in transplant patients

If administered together with sertraline, medication used to treat depression

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

Metamizol Teva-ratiopharm with food, drinks, and alcohol

Together 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 then 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 three months of pregnancy, you should not take it due to the higher 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 it cannot be ruled out that there is a risk to the infant. Therefore, repeated use of metamizol during lactation should be avoided. In the event of a single dose of metamizol, mothers are recommended to express and discard breast milk during the 48 hours following its administration.

Driving and operating machines

Although no adverse effects on concentration and reaction capacity are expected at the recommended doses, you should be aware that these capacities may be affected at higher doses and you should avoid operating machines, driving vehicles, or other hazardous activities. This is especially applicable when alcohol has been consumed.

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication is for your use on a short-term basis. Your doctor will inform you of the duration of your treatment.

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

The dose is established based on the intensity of the pain or fever and the sensitivity of each person to treatment with Metamizol Teva-ratiopharm. Always select the lowest necessary dose to control pain and fever. Your doctor will inform you how to take Metamizol Teva-ratiopharm.

Adults and adolescents 15 years of age or older

Adults and adolescents 15 years of age or older (who weigh more than 53 kg) can take 1 capsule (575 mg of metamizol) in a single dose, which can be administered up to 6 times a day, at intervals of 4 to 6 hours. The maximum daily dose is 3450 mg (corresponding to 6 capsules).

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

Children and adolescents under 15 years of age

Metamizol Teva-ratiopharm should not be used in children under 15 years of age. For smaller children, other presentations and doses of this medication are available; consult your doctor or pharmacist.

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 decreased renal function, 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, repeated high doses should be avoided. Only in short-term treatments, a dose reduction is not necessary. There is no experience with prolonged treatments.

If you take more Metamizol Teva-ratiopharm than you should

Nausea, vomiting, abdominal pain, deterioration of renal function, and in very rare cases dizziness, somnolence, coma, seizures, decreased blood pressure, shock, or even tachycardia may occur.

After administration of very high doses of metamizol, a reddish 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 Toxicological Information Service (Telephone 91 562 04 20), indicating the medication 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, additional emergency measures such as placing the patient on their side, maintaining airways free of obstruction, or administering oxygen should be applied. Pharmacological emergency measures include administering adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions, as well as taking general necessary measures, is recommended.

If you forgot to take Metamizol Teva-ratiopharm

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, for example, generalized urticaria, swelling of the feet, hands, lips, throat, and respiratory passages (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 metamizol and contact a doctor immediately if you experience any of the following symptoms:

Feeling of illness (nausea or vomiting), fever, feeling tired, loss of appetite, dark urine, light-colored stools, yellow discoloration of the skin or 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).

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

- Rashes and skin 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.
• Rashes and appearance of blisters on the skin.
• 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).

• Renal 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).
• Pancytopenia (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.
• Cyanosis (abnormal coloration of the urine).
• Liver inflammation, yellow discoloration of the skin and white part of the eyes, increased serum liver enzyme levels.
• Severe skin reactions: stop taking metamizol and seek medical attention immediately 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 enlarged lymph nodes (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.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Metamizol Teva-ratiopharm

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

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

Appearance of the product and content of the packaging

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

It is presented in blister-type packaging with 10 and 20 capsules or in an HDPE bottle (contains desiccant) with 20 capsules.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas, 28108 – Madrid (Spain)

Responsible for manufacturing

Teva Pharma S.L.U.

Polígono Industrial Malpica c/ C nº 4

50016 Zaragoza. (Spain)

Last review date of this leaflet: August 2019

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

You can access detailed and updated information on this

medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.

aemps.es/cima/dochtml/p/72616/P_72616.html