Package Insert: Information for the Patient

IbuprofenStada600 mg Film-Coated Tablets

Read this package insert carefully before taking 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 only for you, and you should not give it 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.

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

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (inflammation of the joints, including those in 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 Stada:

• if you are allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other ingredients in this medicine (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• if you have a severe liver or kidney disease.
• if you have had a stomach or duodenal ulcer or bleeding, or have had a perforation of the digestive tract.
• if you are vomiting blood.
• if you have black stools or bloody diarrhea.
• if you have bleeding or clotting disorders, or are taking anticoagulant medications (blood thinners). If you need to take anticoagulants, your doctor will perform blood clotting tests.
• if you have severe heart failure.
• if you are in the third trimester of pregnancy.

Inform your doctor:

• if you have swelling (fluid retention).
• if you have or have had any heart problems or high blood pressure.
• if you have asthma or any other breathing problems.
• if you are 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 this medicine for a long time (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may be indicated by severe abdominal pain and/or black stools, even without previous warning symptoms. This risk is higher with high doses and prolonged treatment, especially in patients with a history of peptic ulcers and the elderly. In these cases, your doctor may consider adding a stomach protector.
• if you are taking other medications that affect blood clotting, such as oral anticoagulants, antiplatelet agents like 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 or ulcerative colitis, as ibuprofen may worsen these conditions.
• if you are taking diuretics (medicines to increase urine production), as your doctor will need to monitor your kidney function.
• if you have systemic lupus erythematosus, as it may cause aseptic meningitis.
• if you have an infection; see the "Infections" section below.
• if you experience any of the following signs of allergic reaction: respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop taking this medicine immediately and contact your doctor or emergency medical services if you notice any of these symptoms.

Special precautions should be taken with ibuprofen:

Severe 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 (GPP), have been reported in association with ibuprofen treatment. Discontinue treatment with this medicine and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

CARDIOVASCULAR PRECAUTIONS

Nonsteroidal anti-inflammatory drugs (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 Ibuprofeno Stada if:

• you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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.

These types of medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Pregnancy and lactation

Because the administration of ibuprofen has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimesters of pregnancy, except when strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

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

For women of childbearing age, it should be noted that ibuprofen has been associated with a decrease in the ability to conceive.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that 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 varicella. If you take this medicine while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Use of Ibuprofeno Stada with other medications

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 nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin.
• Antiplatelet agents (prevent blood clots) such as ticlopidine.
• Anticoagulant medications (e.g., for blood clotting problems, e.g., aspirin, warfarin, ticlopidine).
• Lithium (a medication 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 (an abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart problems).
• Hidantoins such as phenytoin (used to treat epilepsy).
• Sulfamides such as sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids such as prednisone and prednisolone.
• Diuretics (medicines to increase urine production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas such as tolbutamide (used for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medication against HIV/AIDS).
• Antihypertensive medications (to lower high blood pressure).
• Fibrinolytic agents (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).

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

Interference with laboratory tests

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Clearance of creatinine (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Concentrations of urea nitrogen in the blood and serum concentrations of creatinine and potassium (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.

Use of Ibuprofeno Stada with food and drinks

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.

Pregnancy and lactation

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

Pregnancy

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. 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 conceive, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, 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 a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Lactation

Although only small amounts of the medicine pass into breast milk, it is recommendednot to take ibuprofen for prolonged 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 medicine, 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 Stada contains lactose and sodium

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

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

Follow exactly the administration instructions of this medication as 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 ibuprofen for a longer period than indicated by your doctor.

This medication is administered orally.

The effective dose should be used for the shortest duration necessary to alleviate symptoms. If you have an infection, consult a doctor promptly 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 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 14 to 18 years.

Use in children and adolescents

This medication is not recommended for use in children and adolescents under 14 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Geriatric patients

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

Patients with kidney and/or liver disease

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

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

If you take more Ibuprofeno Stada than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult a doctor, pharmacist, or the Toxicological Information Service immediately, telephone: 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.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged 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. Blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have also been reported.

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

If you forget to take Ibuprofeno Stada

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.

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

The 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 when the daily dose is below the maximum recommended dose.

Frequencies are established 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 unknown (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal disorders

The most common side effects that occur with medications such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. Also, nausea, vomiting, diarrhea, flatulence, constipation, stomach pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have been observed.

Less frequently, the appearance of gastritis has been observed.

Other side effects are:

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

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

Very rare:pancreatitis.

Cardiovascular disorders

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

Also, edema (fluid retention), hypertension, and heart failure have been observed in association with treatments with ibuprofen-type medications. Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome, has also been observed.

Dermatological and subcutaneous tissue disorders

Medications such as ibuprofen may be associated, in very rare cases, with 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 on mucous membranes and painful lesions with necrosis and epidermal detachment).

Other side 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 lesion), light-sensitive skin reactions, inflammation of skin blood vessels.

Unknown frequency:generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (pustular generalized acute exanthema). Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See section 2.

Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.

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

Immune system disorders

Uncommon:transient edema in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), nasal mucosa inflammation, bronchospasm (bronchi constriction that prevents air from reaching the lungs).

Rare:severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

Very rare:joint pain and fever (systemic lupus erythematosus).

Central nervous system disorders

Common:fatigue or drowsiness, headache, dizziness, or feeling unsteady.

Rare:paresthesia (numbness, tingling, burning, etc., more common 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, depression, psychotic reaction.

Vestibular disorders

Common:vertigo.

Uncommon:ringing or buzzing in the ears.

Rare:hearing difficulty.

Ocular disorders

Uncommon:vision disturbances.

Rare:abnormal or blurred vision.

Hematological and lymphatic system disorders

Rare:thrombocytopenia (low platelet count), leukopenia (low white blood cell count), anemia (low red blood cell count), granulocytopenia (low granulocyte count), pancytopenia (low count of red and white blood cells and platelets), agranulocytosis (severe decrease in granulocytes), aplastic anemia (bone marrow failure 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

Based on the experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling), and renal insufficiency (sudden loss of kidney function) cannot be ruled out.

Hepatobiliary disorders

Medications such as ibuprofen 600 mg may be associated, in rare cases, with liver damage.

Other rare side effects are: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Unknown frequency:hepatic insufficiency (severe liver deterioration).

General disorders and administration site conditions

Worsening of inflammation during infectious processes.

Until now, no severe allergic reactions have been reported with ibuprofen 600 mg, although they cannot be ruled out. Manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, facial swelling, tongue, and throat swelling, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the following side effects occur, stop treatment and seek medical attention immediately:

• Allergic reactions such as skin rash, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee ground-like material.
• Blood in stool or diarrhea with blood.
• Severe stomach pain.
• Significant blisters 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.
• Reddish spots, not elevated, in the shape of a target or circles 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 localized blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (pustular generalized acute exanthema).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, 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 medication.

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

Do not store at a temperature above 30°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 the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibuprofeno Stada

• The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components are:

Core

Croscarmelosa sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate, purified water.

Coating

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

Appearance of the product and content of the container

Ibuprofeno Stada is presented in the form of coated tablets with a film coating, oval, biconvex, and white in color.

Ibuprofeno Stada is available in blister packs containing 20, 40, or 500 (clinical pack) tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

i [email protected]

Responsible for manufacturing:

FARMALIDER, S.A,

Aragoneses, 2

28108 Alcobendas

Madrid Spain

o

FROSST IBÉRICA, S.A.,

Vía Complutense, 140,

28805 Alcalá de Henares Spain

Madrid

o

TOLL MANUFACTURING SERVICES S.L.

C/Aragoneses,2

28108 Alcobendas (Madrid) Spain

Date of the last review of this prospectus: October 2024

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/