Package Insert: Information for the User

Ibuprofen Viatris 600 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others who may 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 package insert. See section 4.

Ibuprofenbelongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the treatment of fever, the treatment of 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 Viatris

• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• 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 dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno Viatris:

• If you have edema (fluid retention).
• If you have heart disease or high blood pressure.
• If you have asthma or any other respiratory disorder.
• Inform your doctor if you are already taking ibuprofen, 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 an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.

This risk is higher with high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor may consider adding a stomach protector medication.

• If you are taking anticoagulants (blood thinners) or antiplatelet agents (such as aspirin), or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (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 increase urine production), as your doctor should 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 intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the need for ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery.
• It is recommended not to take this medication if you have chickenpox.
• If you have an infection: see the "Infections" section below.

With ibuprofen, signs of allergic reaction to this medication have been reported, including respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or emergency medical services if you observe any of these signs.

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.

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 (PEGA), 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.

Cardiovascular precautions

NSAIDs, such as 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 discuss your treatment with 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 (circulation problems in the legs or feet due to narrowing or blockage of the 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 are a smoker.

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

Respiratory disorders

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

Precautions during pregnancy and in women of childbearing age

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 should be limited to the minimum possible. It is believed that the risk increases with dose and treatment duration.The administration of ibuprofen is contraindicated in the third trimester.

For women of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in fertility.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay the appropriate 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 infection symptoms persist or worsen, consult your doctor without delay.

Other medications and Ibuprofeno Viatris

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 NSAIDs, such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (such as ticlopidine), which prevent the formation of blood clots or thrombi in blood vessels.
• Anticoagulants (such as warfarin, ticlopidine), which prevent blood clotting or coagulation.
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs), used in depression.
• 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 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.
• Diuretics (used to increase urine production), which may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics, such as norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonureas, such as tolbutamide (used to treat diabetes), which may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin II receptor antagonists, such as losartan).
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics, such as neomycin.
• Herbal extracts: Ginkgo biloba.
• Inhibitors of CYP2C9 (responsible for the metabolism of numerous medications 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 ibuprofen with other medications.

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Serum urea nitrogen concentrations and serum creatinine and potassium concentrations (may increase).
• With liver function tests: increased values of transaminases.

Inform your doctor if you are to undergo a clinical analysis and are taking or have taken ibuprofen recently.

Taking Ibuprofeno Viatris with food and beverages:

It is recommended to take the medication with milk or with food, or immediately after eating, to reduce the possibility of gastrointestinal discomfort. Do not take alcohol, as it may increase the risk of gastrointestinal adverse reactions.

Pregnancy, lactation, and fertility:

Consult your doctor or pharmacist before using any medication.

This medication is not recommended for women trying to become pregnant.

Do not take ibuprofen during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age), as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and 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 possible time. From week 20 of pregnancy onwards, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for extended periods during lactation.

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.

Ibuprofen may delay your reaction time, which should be taken into account before engaging in activities that require increased vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol

Ibuprofeno Viatris contains lactose and sodium

This medication contains lactose. 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, which is essentially "sodium-free."

This medication contains 0.97 mg of propylene glycol in each tablet.

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 necessary period 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 and adolescents over 14 years:

The recommended dose for adults and adolescents over 14 years is one tablet (600 mg of ibuprofen) every 6 to 8 hours, depending on the intensity of symptoms and 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 2400 mg in adults and 1600 mg in adolescents aged 14 to 18 years.

Use in children and adolescents under 14 years:

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

Older patients:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

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.

Administration form:

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. Patients with sensitive stomachs are recommended to take ibuprofen with food.

Take ibuprofen with sufficient water. Tablets should be swallowed whole, with a glass of water, without chewing, breaking, crushing, or sucking to avoid mouth discomfort and throat irritation.

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 Viatris than you should:

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, 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 yourself about the risk and ask for advice on the measures to be taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Normally, the symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), gastrointestinal bleeding (see section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties may occur. Furthermore, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may worsen in asthmatics. Hypotension and decreased respiration may also occur.

In rare cases, cases of increased plasma acidity (metabolic acidosis), decreased body temperature, transient loss of breathing (apnea), depression of the central nervous system and respiratory system, and cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have been reported.

In these cases, the doctor will take the necessary measures.

In cases of ingestion of significant amounts, activated charcoal should be administered.

If you forgot to take Ibuprofeno Viatris:

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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Side effects of medications such as 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.

Frequent side effects (may affect up to 1 in 10 people):

• Gastrointestinal bleeding, especially in elderly patients.Also, nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

Rare side effects(may affect up to 1 in 100 people):

There has been an observation of gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (numbness, tingling, aching, etc. more frequent in hands, feet, arms or legs) and drowsiness, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities and jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and acute renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

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

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (golpes or sounds in the ear), auditory disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction may appear facial swelling, tongue and larynx swelling, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases) which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever or disorientation.

Other side effects are platelet decrease, white blood cell decrease (may manifest as frequent infections with fever, chills or sore throat), red blood cell decrease (may manifest as difficulty breathing and pale skin), neutropenia (decrease in neutrophils) and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, bleeding and bruises of unknown cause.

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

• Pancreatitis, prolongation of bleeding time, lupus erythematosus (joint pain and fever), very severe bullous reactions including 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), erythema multiforme (skin lesion), hair loss, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension.

There has been an observation of increased inflammation related to infections coinciding with the use of NSAIDs. If there are signs of infection or these worsen during the use of ibuprofen, it is recommended to see a doctor as soon as possible.

Unknown frequency(cannot be estimated from available data):

• Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood).
• A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).
• Generalized red scaly rash, with bumps under the skin and blisters, located mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking ibuprofen if you present these symptoms and seek medical attention immediately. See section 2.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

If any of the following side effects appear, interrupt treatment and seek medical attention immediately:

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store at a temperature below 30°C.

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

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

Composition of Ibuprofeno Viatris

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

The other components are:

Core

Sodium croscarmellose, hypromellose, lactose monohydrate, microcrystalline cellulose, cornstarch, anhydrous colloidal silica, magnesium stearate.

Coating

Hypromellose, titanium dioxide (E-171), talc, and propylene glycol.

Appearance of Ibuprofeno Viatrisand content of the container

Coated tablets with a film coating, oval, biconvex, and white in color.

They are presented in containers with 40 tablets.

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

Farmalider, S.A.

C/ Aragoneses, 2

28108 – Alcobendas, Madrid

Spain

OR

ROVI PHARMA INDUSTRIAL SERVICES, S.A.

Vía Complutense, 140

28805 - Alcalá de Henares

Madrid

Spain

OR

TOLL MANUFACTURING SERVICES, S.L.

C/Aragoneses, 2

28108 - Alcobendas

Madrid

Spain

Last review date of this leaflet:February 2025

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