Patient Information

Ibuprofen Alter Generics 600 mg Film-Coated Tablets

Read this 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. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ibuprofenobelongs 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 Alter Generics

• if you are allergic to ibuprofen or any of the other ingredients in this medication (listed in section 6)or to other nonsteroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• if you have had a previous stomach or duodenal ulcer or have experienced a perforation of the digestive tract
• if you vomit blood
• if you have black stools or bloody diarrhea
• if you have severe heart failure
• if you have a severe liver or kidney disease
• if you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• if you are in the third trimester of pregnancy
• if you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake)

Warnings and Precautions

Consult your doctor or pharmacist before starting this medication.

Inform your doctor:

• 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
• if you are receiving treatment with this medication, as it may mask fever, an important sign of infection, making its 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 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• if you experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case may cause kidney failure due to dehydration.
• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using 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 associating a stomach protector medication.
• if you are taking anticoagulants (medications used to "thin" the blood) or other medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like aspirin, corticosteroids, and selective serotonin reuptake inhibitors (SSRIs). Your doctor will perform blood clotting tests if necessary.
• 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 used to increase urine production), as your doctor will need to 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 meningitis.
• if you have porphyria (a metabolic disorder that affects your blood and can cause symptoms such as urine discoloration, bloody urine, or liver disease), as your doctor will need to evaluate the suitability of 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 more stringent monitoring 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" section below.

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.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay the appropriate treatment of the infection, which may increase 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 a doctor without delay.

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

NSAIDs may also 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 may cause bronchospasm, urticaria, or angioedema in these patients.

Ibuprofen has been associated with signs of allergic reactions to this medication, such as 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.

Skin Reactions

Severe skin reactions have been associated with ibuprofen treatment. Stop taking ibuprofen and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

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 (GAPP), have been associated with ibuprofen treatment. Discontinue ibuprofen treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

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. It is believed that the risk increases with the dose and duration of treatment.

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.

Adolescents

There is a risk of kidney damage in dehydrated adolescents.

Taking Ibuprofeno Alter Generics with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

The following medications may interact and should not be taken with ibuprofen without consulting your doctor:

• Do not take this medication if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots) like ticlopidine.
• Anticoagulants (medications used to "thin" the blood) like warfarin.
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Baclofen (used to treat involuntary muscle contractions).
• Lithium (used to treat depression). Your doctor may need to adjust the dose of this medication.
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin (cardiotonic glucosides) (used to treat heart conditions).
• Hidantoins like phenytoin (used to treat epilepsy).
• Sulfamides like sulfamethoxazole and cotrimoxazole (used to treat bacterial infections).
• Diuretics (medications used to increase urine production).
• Corticosteroids like cortisone and prednisolone, used in inflammatory processes.
• Selective serotonin reuptake inhibitors (SSRIs), used to treat depression.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Ion exchange resins like cholestyramine (used to lower cholesterol levels in the blood).
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas like tolbutamide (used to treat diabetes).
• Tacrine (used to treat Alzheimer's disease).
• 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.
• CYP2C9 inhibitors (responsible for metabolizing numerous medications in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: Ginkgo biloba.

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 diagnostic tests

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

Taking Ibuprofeno Alter Generics with food, drinks, and alcohol

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

If you consume alcohol while taking this medication, you may be more prone to adverse effects.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Pregnancy

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

Do not take ibuprofen during pregnancy, especially during the third trimester.

Do not take Ibuprofeno Alter if you are in the last 3 months of pregnancy, as it may harm your 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 Ibuprofeno Alter 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, Ibuprofeno Alter may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios). If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Fertility

The use of this medication is not recommended in women trying to become pregnant.

Breastfeeding

Although only small amounts of the medication pass into breast milk, it is recommended to consult your doctor in cases of prolonged treatment or high doses during breastfeeding.

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, you should not drive or operate machinery. If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary.

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 Alter Generics contains lactose.If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

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.

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

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 and adolescents over 14 years:

The recommended dose for adults and adolescents 14 to 18 years old is one tablet (600 mg) 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 12 to 18 years old.

Use in children and adolescents under 14 years:

This medication is not recommended for use in children weighing less than 40 kg or under 12 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Senior 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 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 should 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 Alter Genéricos than you should

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

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

Overdose symptoms 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. It may also cause agitation, drowsiness, disorientation, or coma. Occasionally, patients develop seizures. At high doses, somnolence, 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, likely due to interference with the actions of circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma exacerbation may occur in asthmatics. Hypotension and decreased respiration may also occur.

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

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

Consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

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

If you forgot to take Ibuprofeno Alter Genéricos

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 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.

The following side effects have been observed:

• Frequent side effects(can affect up to 1 in 10 people):Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, dizziness or feeling of instability, fatigue.

• Rare side effects(can affect up to 1in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), skin reactions caused by light, hypersensitivity, paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms, or legs), and somnolence, 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 renal insufficiency (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Very rare side effects(can 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, 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,decrease in white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decrease in red blood cells (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, flu-like symptoms, extreme fatigue, unexplained bleeding, and hematomas.

• Extremely rare side effects(can affect up to 1 in 10,000 people): Pancreatitis,prolongation of bleeding time, systemic 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.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection or these worsen during ibuprofen use, 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 can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

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

Generalized red, scaly rash, with bumps under the skin and blisters, located mainly on skin folds, trunk, and upper limbs, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema). Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See section 2. The skin becomes sensitive to light.

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

• Allergic reactions such as skin rash, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood, or of a coffee ground-like appearance.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Intense or persistent headache.
• Yellow discoloration 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.
• Flat, red, non-elevated patches, 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 can be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized red, scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 30 °C.

Do not usethis medicationafter 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 pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ibuprofeno Alter Generics

• The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components (excipients) are: sodium croscarmellose, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, and magnesium stearate.

Coating: hypromellose, titanium dioxide (E-171), talc, and propylene glycol.

Appearance of the product and contents of the packaging

Oval, biconvex tablets, white in color.

Presented in packs of 40 tablets in PVC/PVdC-Al blisters.

Holder of the marketing authorization:

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Farmalider, S.A.

C/Aragoneses 2

28108 Alcobendas (Madrid)

Spain

Toll Manufacturing Services, S.L.

C/Aragoneses 2

28108-Alcobendas

Madrid

Spain

Last review date of this leaflet: November 2024

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/