Package Insert: Information for the User

Ibuprofen Pharmex 600 mg Film-Coated Tablets

Read this package insert carefully before starting to use the 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 should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Ibuprofeno belongs to a group of medicines called nonsteroidal 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 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).

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

Do not take Ibuprofeno Pharmex

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you are allergic to other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of the medication. Allergic reactions may include skin rash with itching, facial, lip, or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered 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 (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and Precautions

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

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 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 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 fluids 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 persistent abdominal pain or black stools, or without prior warning symptoms.
• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcers, and in the elderly. In these cases, your doctor may consider associating a stomach protector medication.
• If you are taking medications that affect blood clotting, such as oral anticoagulants, antiplatelet agents (e.g., aspirin), or corticosteroids, and antidepressants (selective serotonin reuptake inhibitors).
• 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 receiving diuretic treatment, as your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition affecting the immune system and potentially affecting 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 protecting the brain and spinal cord, not caused by bacteria).
• If you have intermittent acute porphyria (a metabolic disorder affecting your blood that may cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the advisability 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 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" heading later.

Warnings and Precautions

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. Stop using Ibuprofeno Pharmex and seek medical attention immediately if you notice any of these severe skin reaction symptoms described in section 4.

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

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 using high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno 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 narrowed or blocked 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 (hypertension).

Pregnancy and Women of Childbearing Age Precautions

Due to the association of ibuprofen administration 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 strictly necessary cases. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, ibuprofen administration is contraindicated.

For women of childbearing age, it is essential to consider that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Other Medications and Ibuprofeno Pharmex

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

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

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin.
• Antiplatelet agents (e.g., ticlodipine) that prevent blood clot formation.
• Anticoagulants (e.g., for treating blood clotting problems or preventing clotting, e.g., aspirin, warfarin, ticlopidine).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for treating cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (an abortion inducer).
• Digoxin and other cardiac glycosides (used in heart disease treatment).
• Hydantoins like phenytoin (used in epilepsy treatment).
• Sulfonamides like sulfamethoxazole and trimethoprim (used in treating certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics (used to increase urine production).
• Pentoxifylline (for treating intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas like tolbutamide (for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an HIV medication).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: from the Ginkgo biloba tree.

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

Ibuprofeno 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 concentrations of urea nitrogen, creatinine, and potassium (may increase).
• Liver function tests: increased transaminase values.

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

Taking Ibuprofeno Pharmex with Food and Beverages:

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

Pregnancy, Fertility, and Breastfeeding

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

Due to the association of ibuprofen administration 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 strictly necessary cases. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, ibuprofen administration is contraindicated.

For women of childbearing age, it is essential to consider that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Consult your doctor or pharmacist before using any medication.

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

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofeno for extended periods 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, do not drive or operate hazardous machinery.

If you only take a single dose of ibuprofeno or take it for a short period, you do not need to take special precautions.

Ibuprofeno Pharmex contains lactose

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

Infections

Ibuprofeno Pharmex 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.

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

Remember to take your medication.

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

The most effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

This medication is administered orally. You must swallow the tablet whole with a little water. Patients with stomach discomfort should take the medication with milk and/or during meals.

Adults and adolescents:

In adults and adolescents from 14 to 18 years, the recommended dose is one tablet (600 mg of ibuprofen) every 6 to 8 hours, depending on the intensity of the condition and the response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents from 12 to 18 years.

Children and adolescents:

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 population:

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 checked 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.

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 Pharmex than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

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

Mild symptoms of an overdose are: abdominal pain, nausea, vomiting, indifference, sleepiness, headache, rapid involuntary eye movements, ringing in the ears, and muscle coordination problems.

It is rare for more severe symptoms to appear, such as intestinal hemorrhage, low blood pressure, low body temperature, metabolic acidosis, seizures, kidney function impairment, coma, adult respiratory distress, and transient cessation of breathing in children (after ingesting large quantities).

If you have taken more Ibuprofeno Pharmex than you should, or if a child has ingested the medication accidentally, 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 bloody sputum), headache, ringing in the ears, confusion, and involuntary eye movements. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported.

If a severe intoxication has occurred, 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 significant amounts have been ingested and within 60 minutes of ingestion.

If you forgot to take Ibuprofeno Pharmex

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 time for the next dose is close, skip the missed dose and take the next dose at your usual time.

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

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

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

Frequencies are established according to the following classification: very common (in more than 1 in 10 patients); common (between 1 and 10 in 100 patients); uncommon (between 1 and 10 in 1,000 patients); rare (between 1 and 10 in 10,000 patients); very rare (in less than 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The most frequent gastrointestinal side effects are peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, inflammation of the stomach lining (gastritis) has been observed.

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

The following side effects have been observed:

Common side effects (may affect between 1 and 10 in 100 patients):

- Skin rash.

- Fatigue or drowsiness, headache, dizziness or feeling of instability.

- Dizziness.

Uncommon side effects (may affect between 1 and 10 in 1,000 patients):

• Oral mucosa inflammation with ulcer formation.
• Redness of the skin, itching or swelling of the skin, purpura (purple spots on the skin).
• 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).
• Insomnia, anxiety, restlessness.
• Tinnitus or buzzing in the ears.
• Visual disturbances.

Rare side effects (may affect between 1 and 10 in 10,000 patients):

• Esophageal inflammation.
• Esophageal stricture.
• Exacerbation of intestinal diverticulitis.
• Unspecified hemorrhagic colitis (gastroenteritis with bloody diarrhea).
• Severe allergic reactions (anaphylactic shock).
• In case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.
• Paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms, or legs).
• Disorientation or confusion, nervousness, irritability, depression, psychotic reaction.
• Difficulty hearing.
• Abnormal or blurred vision.
• Thrombocytopenia, leukopenia (decreased white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin), granulocytopenia (a type of white blood cell deficiency that may predispose to infections), pancitopenia (deficiency of red and white blood cells and platelets in the blood), agranulocytosis (severe granulocyte deficiency), aplastic anemia (bone marrow insufficiency 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, pseudogripal symptoms, extreme fatigue, nasal and cutaneous hemorrhage.
• Medicines like ibuprofen may be associated with rare liver damage.

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

Very rare side effects (may affect less than 1 in 10,000 patients):

• Pancreatitis.
• Severe skin reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and skin detachment), hair loss, erythema multiforme (skin lesion), light-induced skin reactions, inflammation of skin blood vessels.
• Joint pain and fever (lupus erythematosus).
• Asymptomatic meningitis. In most cases where meningitis aséptica 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 meningitis aséptica observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.
• Exacerbation of inflammation during infectious processes.

Side effects of unknown frequency (cannot be estimated from available data):

• Exceptionally, severe skin infections and complications in soft tissue during chickenpox may occur.
• Medicines like ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack (myocardial infarction) or stroke.
• Edema (fluid retention), hypertension, and heart failure have also been observed in association with ibuprofen.
• Based on experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and renal insufficiency (sudden loss of kidney function) cannot be ruled out.
• Severe liver insufficiency (severe liver deterioration).
• Until now, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. The manifestations of this type of reaction may be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.
• The skin becomes sensitive to light.

If any of the following side effects occur, discontinue treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, swelling of the face, wheezing, or difficulty breathing.
• Vomiting blood or coffee ground-like material.
• Blood in stools 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 section).
• Swelling of the extremities or accumulation of fluid in the arms or legs.

• Red, non-elevated spots, 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 symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• 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 protuberances under the skin and blisters, accompanied by fever. 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 or pharmacist, 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 Vigilance of Medicinal Products for Human Use: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.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your 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 Pharmex

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

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

Appearance of Ibuprofeno Pharmex and content of the packaging

The tablets are coated, white, and oval-shaped.

Each package contains 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

PHARMEX ADVANCED LABORATORIES, S.L.

Ctra. A-431 Km.19

14720 Almodóvar del Río (Córdoba)

Last review date of this leaflet: September 2024

“Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”