Patient Information

Ibuprofen Farmalid 600 mg Film-Coated Tablets

Read this entire 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 the same symptoms as you, 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.

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 to severe 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 condition 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 Farmalid:

• if you are allergic to ibuprofen or any of the other components of 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, lip, or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• if you have had a previous stomach or duodenal ulcer or have suffered 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 to take this medication.

Inform your doctor:

• if you have edema (fluid retention)
• if you have or have had any heart problems or have 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 a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• if you present symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluid and contact your doctor immediately, as ibuprofen in this case could cause kidney failure as a result of dehydration.
• if you have had or develop a stomach 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 adding a stomach protector medication.
• if you are taking anticoagulants (medications used to "thin" the blood) 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 (a chronic condition in which the immune system attacks the intestine, causing inflammation that often results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• if you are receiving diuretics (medications used 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.
• if you have intermittent acute porphyria (a metabolic disorder that affects the blood and can cause symptoms such as red urine, bloody urine, or liver disease), as your doctor should evaluate the advisability of treatment with ibuprofen.
• 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 undergoing major surgery.
• It is not recommended to take this medication if you have chickenpox.
• Signs of allergic reactions to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Farmalider immediately and contact your doctor or emergency medical services if you observe any of these signs.

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

Ibuprofeno Farmalid may mask the signs of an infection, such as fever and pain. Consequently, it 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 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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like 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. 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 (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 medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Respiratory problems

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

Severe skin reactions

Severe skin reactions associated with Ibuprofeno Farmalid treatment have been reported. Stop taking Ibuprofeno Farmalider immediately and seek medical attention 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 (PEGA), have been reported in association with ibuprofen treatment. Discontinue Ibuprofeno Farmalider treatment and seek medical attention immediately if you notice any of the 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 should 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 fertility.

Adolescents

There is a risk of kidney damage in dehydrated adolescents.

Other medications and Ibuprofeno Farmalid

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 in blood vessels) like ticlopidine.

- Anticoagulants (medications used to "thin" the blood) such as aspirin, 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 adjust your dose of this medication.

- Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust your dose of this medication.

- Mifepristone (induces abortion).

- Digoxin (cardiotonic glycosides) (used to treat heart problems).

- Hydantoins like phenytoin (used to treat epilepsy).

- Sulfonamides 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).

- Sulfonureas 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 the metabolism of many medications in the liver), such as voriconazole or fluconazole, used to treat fungal infections.

- Herbal extracts: from the Ginkgo biloba tree.

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

Interference with diagnostic tests

If you are to undergo any diagnostic test (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 Farmalid with food, drinks, and alcohol

You can take it alone or with food. In general, 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.

Do not take Ibuprofeno Farmalid 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 Ibuprofeno Farmalid 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 Farmalid may cause kidney problems in your fetus if taken for more than a few days, which may result in low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Pregnancy

Do not take ibuprofen during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in fertile women).

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

This is particularly true when combined with alcohol.

Ibuprofeno Farmalid contains lactose.If your doctor has told you that you have a certain sugar 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 most effective dose should be used for the shortest duration 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 12 years:

The recommended dose for adults and adolescents aged 12 to 18 years is one tablet (400 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 aged 12 to 18 years.

Use in children:

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 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 Farmalid than you should

If you have taken more ibuprofen than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet to the healthcare professional.

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

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

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. In rare cases, symptoms of rapid involuntary eye movements, metabolic acidosis, decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central and respiratory nervous system depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe intoxication has occurred, renal insufficiency and liver damage may occur. In these cases, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if more than 400 mg/kg has been ingested and within 60 minutes of ingestion.

If you forgot to take Ibuprofeno Farmalid

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 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.

The following side effects have been observed:

• Frequent side effects(may 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(may 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 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, toxic amblyopia (reversible visual disturbance), 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 of aseptic meningitis 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 thrombocytopenia,leukopenia (decrease in white blood cells, may manifest as frequent infections with fever, chills, or sore throat), anemia (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.

• Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis,prolongation of bleeding time, systemic lupus erythematosus (joint pain and fever),severe skin 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 may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

A 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 (generalized acute pustular exanthema). Stop taking Ibuprofeno Farmalid 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 immediate medical attention:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood, or of a coffee grounds-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.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• 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 may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (generalized acute 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 leaflet. 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 Farmalid

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

Core

Sodium croscarmellose, 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 contents of the packaging

Oval, biconvex tablets, white in color.

They are presented in packs of 40 tablets and clinical pack of 500 tablets in aluminum-PVC/PVdC blister.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Farmalider, S.A.

C/ La Granja 1,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

Farmalider, S.A,

C/Aragoneses 2,

28108 Alcobendas (Madrid)

Spain

FROSST IBÉRICA, S.A.,

Vía Complutense, 140,

28805 Alcalá de Henares, Madrid

Spain

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

This leaflet has been revised in: 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/