Ibuprofen Teva 400 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibuprofen Teva 400 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you. - Keep this leaflet as you may need to read it again. - If you have any questions, ask 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 may 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.

Package leaflet:

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

1. What Ibuprofeno Teva is and what it is used for

Ibuprofeno Teva belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of fever, mild to moderate pain including migraine, arthritis (inflammation of the joints, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before starting to take Ibuprofen Teva

Do not take Ibuprofen Teva

• If you are allergic to the active substance, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines at the same time, your doctor will carry out blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor before starting to take Ibuprofen Teva:

• If you have edema (fluid retention).
• If you have or have had heart disorders or high blood pressure.
• If you suffer from asthma or any other respiratory disorder.
• If you are receiving treatment with ibuprofen, as it may mask fever—a key sign of infection—making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise how often these checks should occur.
• If you have symptoms of dehydration, e.g., severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure due to dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms. This risk is higher with high doses and prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.
• If you are taking medications that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about using other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation and usually bloody diarrhea) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions.
• If you are taking diuretics (medicines to increase urine production), because your doctor needs to monitor kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions to ibuprofen, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop taking ibuprofen immediately and contact your doctor or emergency medical services if you notice any of these signs.
• Your doctor will perform stricter monitoring if you are receiving ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection; see the “Infections” section below.

It is important to use the lowest effective dose that relieves/controls your pain and not to take this medicine longer than necessary to control your symptoms.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking this medicine if:

• you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a “mini-stroke” or transient ischemic attack “TIA”),
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Furthermore, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Serious skin reactions have been reported with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Stop taking ibuprofen and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Respiratory disorders

Ibuprofen should be used with caution in patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Infections

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Children and adolescents

There is a risk of renal failure in dehydrated children and adolescents.

Precautions during pregnancy and in women of childbearing age

Because administration of ibuprofen-type medicines has been associated with an increased risk of congenital malformations and miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be kept to a minimum.

Administration of ibuprofen is contraindicated during the third trimester.

For women of childbearing age, it should be noted that ibuprofen-type medicines have been associated with reduced fertility.

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Other medicines and Ibuprofen Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Ibuprofen may interact with or be affected by other medicines. For example:

• anticoagulant medicines (e.g., to treat or prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
• antiplatelet agents (prevent blood clots in blood vessels), such as ticlopidine
• lithium (used to treat depression). Your doctor may adjust the dose of this medicine.
• methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• mifepristone (used to induce abortion).
• digoxin and cardiac glycosides (used to treat heart disorders)
• hydantoins such as phenytoin (used to treat epilepsy)
• sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections)
• corticosteroids such as cortisone and prednisolone
• pentoxifylline (used to treat intermittent claudication)
• probenecid (used in gout patients or with penicillin in infections)
• quinolone antibiotics such as norfloxacin
• sulfinpyrazone (for gout)
• sulfonylureas such as tolbutamide (for diabetes)
• tacrolimus or cyclosporine (used in organ transplants to prevent rejection)
• zidovudine (an anti-HIV medication)
• antihypertensives: to reduce high blood pressure
• thrombolytics (medicines that dissolve blood clots)
• aminoglycoside antibiotics such as neomycin
• herbal extracts: Ginkgo biloba
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections)

Other medicines may also interact with or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using this medicine with other medicines.

Taking Ibuprofen Teva with food, drinks, and alcohol

You may take it alone or with food. It is generally recommended to take it with meals or milk to reduce the possibility of stomach discomfort.

Alcohol consumption during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take ibuprofen during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may also affect the likelihood of bleeding in both you and your baby, and may delay or prolong labour beyond the expected duration. You should not take ibuprofen during the first six months of pregnancy unless clearly necessary and specifically advised by your doctor. If treatment is required during this period or while trying to become pregnant, the lowest effective dose should be used for the shortest possible time. Starting from week 20 of pregnancy, taking ibuprofen for more than a few days may cause kidney problems in the fetus, which could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Minimal amounts of ibuprofen and its metabolites are excreted in breast milk. As no adverse effects in infants have been reported, it is generally not necessary to interrupt breastfeeding during short-term use at recommended doses.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and use of machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you must not drive or operate heavy machinery.

If you take only a single dose of ibuprofen or use it for a short period, no special precautions are necessary.

Ibuprofen Teva contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".

3. How to take Ibuprofen Teva

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

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop treatment earlier, as otherwise the expected results will not be achieved. Likewise, do not use this medicine for longer than indicated by your doctor.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults

In adults and adolescents aged 12 to 18 years, one tablet (400 mg) should be taken every 6 to 8 hours, depending on the severity of symptoms and response to treatment.

The maximum daily dose in adults is 2,400 mg, whereas in adolescents aged 12 to 18 years it is 1,600 mg.

In case of chronic dosing, the dose should be adjusted to the minimum maintenance dose that provides adequate control of symptoms.

Elderly patients

In elderly patients, dosage must be determined by the physician, as a reduction from the usual dose may be necessary.

Patients with kidney and/or liver disease

If you suffer from kidney and/or liver disease, your doctor may prescribe a lower than usual dose. If so, take exactly the dose prescribed by your doctor.

Use in children and adolescents

This medicine is not recommended for use in children under 12 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosing in these children.

Adolescents over 12 years of age should follow adult dosing recommendations, but the maximum recommended daily dose in these patients is 1,600 mg.

This medicine is administered orally.

If gastrointestinal discomfort occurs after taking the medicine, it should be taken together with milk or during meals.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofen Teva than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to obtain information about the risk and advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. In cases of significant overdose, renal failure and liver damage may occur.

Serious symptoms such as gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, dyspnea/acute respiratory distress syndrome in adults, and transient respiratory arrest in children (after ingestion of large quantities) are rare.

If a severe poisoning has occurred, the doctor will take the necessary measures.

In case of ingestion of large amounts, activated charcoal should be administered. Gastric emptying should be considered if large amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Ibuprofen Teva

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

If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.

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.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended maximum dose.

Frequencies are defined according to the following classification: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and infestations

Very rare: Exacerbation of inflammation associated with infection (e.g., development of necrotizing fasciitis), coinciding with the use of non-steroidal anti-inflammatory drugs*

Note: If signs of infection appear or worsen during treatment with ibuprofen, it is recommended to seek medical advice immediately in case anti-infective/antibiotic therapy is required.

Gastrointestinal disorders

The most common adverse effects associated with medicines such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Gastrointestinal discomfort such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor gastrointestinal bleeding, which may exceptionally lead to anemia, have also been observed. Uncommon: gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis.

Other adverse effects include: Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: inflammation of the esophagus, esophageal narrowing (esophageal stricture), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: esophagitis, pancreatitis, intestinal stricture.

Cardiac and vascular disorders

Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments using ibuprofen-type medicines.

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Skin and subcutaneous tissue disorders

Medicines such as ibuprofen may, in very rare cases, be associated with severe blistering reactions such as Stevens-Johnson Syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis). Other adverse effects are:

Common: skin rash. Uncommon: redness of the skin, itching or swelling of the skin, purpura (purple spots on the skin).

Very rare: hair loss, erythema multiforme (skin lesions), photosensitivity reactions, inflammation of blood vessels in the skin. Severe skin infections and soft tissue complications during chickenpox may exceptionally occur.

Frequency not known: skin becomes sensitive to light. Drug eruption with fixed lesions, generalized red scaly rash with bumps under the skin and blisters, primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen Teva if you experience these symptoms and seek medical attention immediately. See also section 2.

Immune system disorders

Uncommon: hypersensitivity reactions with skin rash and pruritus, as well as asthma attacks (possibly together with a drop in blood pressure).

Very rare: severe hypersensitivity reactions (these may be characterized by swelling of the face, tongue, and larynx with bronchospasm, dyspnea, tachycardia, and hypotension, which may include potentially fatal shock).

Note: if these symptoms occur, even with first use, immediate medical assistance is required.

Nervous system disorders

Common: fatigue or drowsiness, headache, dizziness, or feeling of instability. Uncommon: headache, dizziness. Rare: paresthesia (numbness, tingling, "pins and needles," etc., more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or confusion.

Psychiatric disorders

Uncommon: insomnia, anxiety, restlessness.

Rare: disorientation or confusion, nervousness, irritability.

Very rare: psychotic reactions, depression.

Ear and labyrinth disorders

Common: dizziness.

Uncommon: tinnitus (ringing or buzzing in the ears).

Rare: hearing impairment.

Eye disorders

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Blood and lymphatic system disorders

Rare: decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), aplastic anemia (bone marrow failure to produce various types of blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.

Very rare: prolonged bleeding time.

Renal and urinary disorders

Very rare: edema (signs that may indicate kidney disease, which sometimes may include renal failure); kidney tissue damage (papillary necrosis), increased serum uric acid concentration.

Hepatobiliary disorders

Medicines such as ibuprofen may, in rare cases, be associated with liver injury.

Other rare adverse effects: hepatitis (liver inflammation), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Very rare: hepatic dysfunction, liver damage (particularly with long-term treatment), liver failure, acute hepatitis.

Frequency not known: liver failure (severe liver impairment).

General

Worsening of inflammation during infectious processes.

To date, severe allergic reactions with ibuprofen have not been reported, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Stop treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• Flat, non-elevated reddish spots, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or diarrhea with blood.
• Severe stomach pain.
• Blisters or significant skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting of adverse effects

If you experience any 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 Ibuprofen Teva

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Do not use this medicine 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. Instead, return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen Teva

The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.

The other components are:

• Core: croscarmellose sodium, hypromellose, lactose, microcrystalline cellulose, maize starch, anhydrous colloidal silica, magnesium stearate.

• Tablet film coating: hypromellose, titanium dioxide (E-171), talc, propylene glycol.

Appearance of Ibuprofen Teva and contents of the pack

The tablets are white, oval-shaped, biconvex, and scored on both sides.

The score line is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.

Pack size: 30 tablets.

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta, Alcobendas

28108 Madrid

Spain

Manufacturer

SAG Manufacturing S.L.U.

Crta N-I, Km 36

28750 San Agustin de Guadalix, Madrid (Spain)

Date of the most recent revision of this leaflet: June 2025

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