Package Leaflet: Information for the User

Ibuprofen Teva 600 mg Film-Coated Tablets

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

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

Do not take Ibuprofeno Teva

• if you are allergic to the active ingredient, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• if you have a severe liver or kidney disease,
• if you have had a stomach or duodenal ulcer, bleeding, or perforation,
• if you vomit blood.
• if you have black stools or bloody diarrhea.

• if you have bleeding or clotting disorders, or are taking anticoagulants (blood thinners). If necessary, your doctor will perform blood clotting 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 Ibuprofeno Teva:

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• Inform your doctor if you are already receiving ibuprofen treatment, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you present symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case could cause kidney insufficiency as a consequence of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor may consider associating a stomach protector medication.
• If you are taking anticoagulants (blood thinners) or other medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like aspirin, corticosteroids, and selective serotonin reuptake inhibitors (SSRIs). Also, inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and SSRIs.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications to urinate), as your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).

• If you have porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease), so your doctor can assess the suitability or not of ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Teva immediately and contact your doctor or emergency medical services if you observe any of these signs.
• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery.
• It is not recommended to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" heading later.

It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular Precautions

NSAIDs, like ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking this medication if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, 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 are a smoker.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin Reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (GAP), have been reported in association with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Respiratory Problems

Ibuprofen should be used with caution in patients who have or have had asthma, bronchial asthma, or allergic diseases, as it may cause bronchospasm, urticaria, or angioedema in these patients.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medication may delay or prolong the treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the symptoms persist or worsen, consult a doctor without delay.

Children and Adolescents

There is a risk of kidney insufficiency in dehydrated children and adolescents.

This medication is not recommended for use in children or adolescents under 14 years old, as the dose of ibuprofen contained is not suitable for the recommended dosage in these patients.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of ibuprofen is contraindicated.

For fertile women, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Other medications and Ibuprofeno Teva

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

Ibuprofen may affect or be affected by other medications. For example:

• Other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
• Anticoagulants (e.g. for treating blood clotting problems or preventing coagulation, e.g. aspirin, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Antiplatelet agents (prevent blood clots in blood vessels) like ticlopidine).
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.

• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems),
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids like prednisone and prednisolone.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas like tolbutamide (used for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• Inhibitors of CYP2C9 (responsible for metabolizing many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medications may also affect or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using this medication with other medications.

Taking Ibuprofeno Teva with food, drinks, and alcohol

You can take it alone or with food. Generally, it is recommended to take it before meals or with milk to reduce the possibility of stomach discomfort.

Consuming alcohol 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery.Ibuprofen may cause kidney and heart problems in your fetus. It may affect your and your baby's predisposition to bleeding and delay or prolong delivery.Do not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessaryand as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible.From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may result in low amniotic fluid levels (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Small amounts of ibuprofen and its metabolites are excreted in breast milk. As no undesirable effects have been reported in the infant, it is usually not necessary to discontinue breastfeeding during short-term use at recommended doses.

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

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, you do not need to take special precautions.

Ibuprofeno Teva contains lactose and sodium

If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with ibuprofen. Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use this medication for a longer period than indicated by your doctor.

The effective dose should be used for the shortest time necessary to alleviate 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 14 to 18 years, one tablet (600 mg) will be taken every 6 to 8 hours, depending on the severity of the condition and the response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg in adults and 1,600 mg in adolescents aged 12 to 18 years.

Senior patients

In elderly patients, the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

Patients with kidney and/or liver diseases

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

Use in children and adolescents

This medication is not recommended for use in children or adolescents under 14 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in these patients.

Adolescents over 14 years old will follow adult dosage recommendations, but the maximum daily recommended dose in these patients is 1,600 mg.

This medication is administered orally.

If gastrointestinal discomfort is detected after taking the medication, it will be administered with milk or during meals.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofeno Teva than you should

If you have taken more ibuprofen than you should, or if a child has ingested the medication accidentally, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to inform them of the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. In cases of severe overdose, renal insufficiency and liver damage may occur.

It is rare for more severe symptoms to appear, such as intestinal hemorrhage, hypotension, hypothermia, metabolic acidosis, seizures, renal function impairment, coma, dyspnea/acute respiratory distress syndrome in adults, and transient respiratory arrest in children (after ingesting large quantities).

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

In cases of significant ingestion, activated charcoal should be administered. Gastric emptying will be considered if large quantities have been ingested and within 60 minutes of ingestion.

If you forgot to take Ibuprofeno Teva

Do not take a double dose to compensate for the missed doses.

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects of medicines like ibuprofen are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

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

The following side effects have been observed:

Infections and infestations

Very rare:Exacerbation of infections-related inflammation (for example, the development of necrotizing fasciitis), coinciding withthe use of nonsteroidal anti-inflammatory drugs*

Nota: If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to see a doctor immediately, if necessary to initiate an anti-infective/antibiotic therapy.

Gastrointestinal disorders

The most common side effects that occur with medicines like ibuprofen are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Also, gastrointestinal discomfort such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that can cause anemia in exceptional cases have been observed. Uncommon peptic ulcers, potentially with bleeding and perforation, oral ulcers, exacerbation of colitis and Crohn's disease, gastritis.

Other side effects are:

Uncommon: inflammation of the oral mucosa with the formation of ulcers.

Rare: esophagitis, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulitis disease, non-specific hemorrhagic colitis (gastroenteritis that occurs with bloody diarrhea).

Very rare: esophagitis, pancreatitis, intestinal stenosis.

Cardiovascular and vascular disorders

Medicines like ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack (“myocardial infarction”) or cerebral.

Also, edema (fluid retention), high blood pressure, and heart failure have been observed in association with treatments with ibuprofen-like medicines.

Dermatological and subcutaneous tissue disorders

Medicines likeibuprofenomay be associated, in very rare cases, to severe blistering reactions such as Stevens-Johnson Syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and epidermal detachment).

Other side effects are:

Common: skin rash.

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

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

Frequency not known: skin sensitivity to light. Generalized red scaly rash, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (pustular psoriasis). Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See also section 2.

Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Immune system disorders

Uncommon: hypersensitivity reactions with skin rash and pruritus, as well as asthma attacks (possibly accompanied by 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 that may include a potentially fatal shock).

Nota: In the appearance of these symptoms, which may occur with the first use, immediate assistance from a doctor is required.

Nervous system disorders

Common: fatigue or drowsiness, headache, and dizziness or feeling of instability.

Uncommon: headache, dizziness

Rare: paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms, or legs),

Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases) which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric disorders

Uncommon: insomnia, anxiety, restlessness.

Rare: disorientation or confusion, nervousness, irritability,

Very rare: psychotic reactions, depression

Vestibular and labyrinthine disorders

Common: vertigo.

Uncommon: ringing or buzzing in the ears.

Rare: hearing difficulty.

Ocular disorders

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Haematological and lymphatic system disorders

Rare: thrombocytopenia, leukopenia (decrease in white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin), granulocytopenia (a decrease in a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red and white blood cells and platelets in the blood), agranulocytosis (a very large decrease in granulocytes), aplastic anemia (insufficiency of the bone marrow to produce different types of cells) or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, nasal and cutaneous bleeding.

Very rare: prolonged bleeding time.

Renal and urinary disorders

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

Hepatobiliary disorders

Medicines like ibuprofen may be associated, in rare cases, to liver damage.

Other rare side effects are: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Very rare: liver dysfunction, liver damage (particularly in long-term treatment), liver insufficiency, acute hepatitis

Frequency unknown: liver insufficiency (severe deterioration of the liver).

General

Exacerbation of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure) or shock.

A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Stop taking ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• Flat, red, circular, or target-like spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (pustular psoriasis).
• Allergic reactions such as skin rash, swelling of the face, chest tightness, or difficulty breathing,
• Vomiting blood or coffee-ground-like material.
• Blood in the stool or diarrhea with blood.
• Severe abdominal pain.
• Significant blistering or peeling of the skin.
• Severe headache or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above30°C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Ibuprofeno Teva 600 mg film-coated tablets EFG

The active ingredient is ibuprofen. Each film-coated tablet contains 600 mg of ibuprofen.

The other components are:

• Core: sodium croscarmellose, hypromellose, lactose, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate.
• Tablet coating: hypromellose, titanium dioxide (E-171), talc, and propylene glycol.

Appearance of the product and content of the packaging

Ibuprofeno Teva 600 mg is presented in packaging with 40 tablets conditioned in aluminum-PVC/PVDC blisters or in HDPE bottles. The tablets are oval, biconvex, and white.

Other available presentations

Ibuprofeno Teva 400 mg film-coated tablets EFG. Packaging of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

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 de Malpica c/C nº 4

50016-Zaragoza

Spain

or

FROSST IBÉRICA, S.A.

Vía Complutense, 140,

Alcalá de Henares,

28805 Madrid

Spain

or

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36

28750 San Agustín de Guadalix,

Madrid- Spain

Spain

Last review date of this leaflet: November 2023

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