PROSPECTO: INFORMATION FOR THE USER

Ibuprofeno Qualigen 600 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

- Keep this prospect as you may need to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine 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 or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Ibuprofeno Qualigen and what is it used for

2. What you need to know before starting to take Ibuprofeno Qualigen

3. How to take Ibuprofeno Qualigen

4. Possible adverse effects

5. Storage of Ibuprofeno Qualigen

6. Contents of the package and additional information

Ibuprofeno Qualigen belongs 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 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 Qualigen:

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of this medication (listed in section 6). Allergic reactions may include skin rash with itching, facial swelling, 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 (blood thinners). If necessary, your doctor will perform blood clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

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

• 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 Ibuprofeno Qualigen treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Warnings and precautions

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

• 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.
• Inform your doctor if you are already taking ibuprofen, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is higher with high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and the elderly. In these cases, your doctor may consider associating a stomach protector medication.
• If you are taking medications that alter 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 (a chronic condition in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications to increase urine production), as your doctor 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 aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in 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 not recommended to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" heading later.
• 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.
• If you have an infection; see the "Infections" heading later.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Severe skin reactions

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

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

Inform your doctor or pharmacist before taking Ibuprofeno Qualigen 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.

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

Respiratory problems

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

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen 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 fertility.

Infections

Ibuprofeno Qualigen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno Qualigen may delay or complicate the treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult your doctor without delay.

Other medications and Ibuprofeno Qualigen

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

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

• Other NSAIDs, such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots) like ticlopidine.
• Anticoagulants (prevent blood clotting) like aspirin, warfarin, ticlopidine.
• Cholestyramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs) used in depression.
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics (used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonylureas like tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Thrombolytics (dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for metabolizing many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Ibuprofeno Qualigen may alter the following laboratory tests:

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

Taking Ibuprofeno Qualigen 600 mg with food and beverages

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

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

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

Do not take ibuprofen during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in fertile women), 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 and your baby's predisposition to bleeding and delay or prolong delivery.

Do not take ibuprofen during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises it. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest time necessary. From week 20 of pregnancy onwards, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in your baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for extended periods during 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 ibuprofen or for a short period, you do not need to take special precautions.

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

This applies to a greater extent when combined with alcohol.

Ibuprofeno Qualigen contains lactose and sodium

If your doctor has indicated that you have a intolerance to certain sugars, consult with them before taking this medication.

This medication 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. In case of doubt, consult your doctor or pharmacist again.

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

The effective dose should be used for the shortest period 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 old:

The recommended dose for adults and adolescents over 14 years old is one tablet (600 mg) every 6 to 8 hours, depending on the severity 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 aged 14 to 18 years.

There are also available presentations with 400 mg of ibuprofen.

Use in children and adolescents under 14 years old:

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

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 doses of Ibuprofeno Qualigen than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately, call the Toxicological Information System (phone: 91 562 04 20), indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

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

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

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, involuntary eye movement. Agitation and muscle coordination failure may also occur. Somnolence, disorientation, or coma may also occur. In rare cases, patients may 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, probably due to interference with the actions of coagulation factors. Acute renal failure and liver damage may occur. Asthma exacerbation is possible in asthmatics. In rare cases, cases of metabolic acidosis, hypothermia, renal function impairment, gastrointestinal bleeding, coma, transient loss of breathing (apnea), central nervous system and respiratory 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 failure 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.

If you forgot to take Ibuprofeno Qualigen

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 near, skip the missed dose and take the next dose at your 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.

• Frequent side effects(may occur in up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients.

Other side effects that have been observed include nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach burning, abdominal pain, blood in stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

• Rare side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple spots on the skin), skin reactions caused by light, hypersensitivity, paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms or legs) and drowsiness, insomnia, anxiety, auditory disorders, 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), acute renal failure, acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

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

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (golpes or sounds in the ear), auditory disturbances, toxic amblyopia (reversible), 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 include decreased white blood cells (may manifest as frequent infections with fever, chills or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), neutropenia (decreased 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, bleeding and bruises of unknown cause.

• Extremely rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, prolonged 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 skin detachment), erythema multiforme (skin lesion), hair loss, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections coinciding with the use of NSAIDs has been observed. If signs of infection or these worsen during the use of ibuprofen, it is recommended to see a doctor as soon as possible.

-Unknown frequency(cannot be estimated from available data):

Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood). Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

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

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

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 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.

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 packaging and unused medications at the SIGRE collection point at 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.

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Composition of Ibuprofeno Qualigen 600 mg tablets

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

The other components (excipients) are:

Core: Sodium croscarmellose, hypromellose (E-464), lactose, microcrystalline cellulose (E-460i), pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate (E-572).

Coating: Titanium dioxide (E-171), purified talc, hypromellose (E-464), and propylene glycol (E-1520).

Appearance of the product and contents of the packaging

Ibuprofeno Qualigen 600 mg is presented in the form of coated tablets.

Each package contains 40 oval, biconvex, and white tablets, conditioned in a blister pack.

Holder of the marketing authorization and responsible manufacturer

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible manufacturer

Frosst Iberica, S.A.

Vía Complutense, 140

Alcalá de Henares - 28805 Madrid- Spain

Farmalider, S.A.

Aragoneses, 2

Alcobendas – 28108 Madrid – Spain

Toll Manufacturing Services S.L.

C/ Aragoneses,2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet: March 2025

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/