Package Insert: Information for the User

Ibuprofen Pharma Combix 600 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication.

• Keep this package insert as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others who may have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.See section 4.

Ibuprofenbelongs 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).

Do not take this medication:

• 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 you need to take anticoagulants, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

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 taking Ibuprofen, as it may mask fever, which is 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 a prolonged period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may be indicated by severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.
• This risk is higher when taking high doses and prolonged treatment, especially in patients with a history of peptic ulcers and the elderly. In these cases, your doctor may consider adding a stomach protector medication.
• If you are taking anticoagulants (blood thinners) or other medications that affect blood clotting, such as warfarin, ticlopidine, or aspirin. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as Ibuprofen may worsen these conditions.
• If you are taking diuretics (water pills), as your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus, as it may cause meningitis.
• 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" section below.

Infections: Ibuprofeno Pharma Combix may mask the signs of an infection, such as fever and pain. Therefore, 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 your doctor without delay.

Signs of allergic reaction to Ibuprofeno Pharma Combix, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Pharma Combix 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 (PEGA), have been reported in association with Ibuprofeno Pharma Combix treatment. Discontinue treatment with Ibuprofeno Pharma Combix and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

CARDIOVASCULAR PRECAUTIONS

Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, may be associated with a small increase in the risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno Pharma Combix 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 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.

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

PREGNANCY AND BREASTFEEDING PRECAUTIONS

Due to the association of ibuprofen administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer Ibuprofeno Pharma Combix during the first and second trimesters of pregnancy, except when strictly necessary and recommended by your doctor. In these cases, the dose and duration will be limited to the minimum possible. From week 20 of pregnancy, Ibuprofeno Pharma Combix may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a longer period, your doctor may recommend additional checks.

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

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

SKIN REACTIONS

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

USE OF IBUPROFENO PHARMA COMBIX WITH OTHER MEDICATIONS:

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

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

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin.
• Anticoagulants (blood thinners) such as warfarin, ticlopidine, or aspirin.
• Lithium (a medication used to treat depression). Your doctor may adjust your lithium dose.
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust your metotrexate dose.
• Mifepristone (an abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart problems).
• Hidantoins such as phenytoin (used to treat epilepsy).
• Sulfamides such as sulfamethoxazole and cotrimoxazole (used to treat bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (water pills).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas such as tolbutamide (used for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an antiretroviral medication).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.

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

INTERFERENCES WITH LABORATORY TESTS

Ibuprofeno may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Concentration of glucose in blood (may decrease)
• Aclaramiento de creatinina (may decrease)
• Hematocrito or hemoglobina (may decrease)
• Concentrations of urea nitrogen, creatinine, and potassium in blood (may increase)
• Con pruebas de la función hepática: incremento de valores de transaminasas

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

TAKING IBUPROFENO PHARMA COMBIX WITH FOOD AND BEVERAGES:

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

PREGNANCY AND BREASTFEEDING:

Consult your doctor or pharmacist before using any medication.

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

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged 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, no special precautions are necessary.

IMPORTANT INFORMATION ABOUT SOME COMPONENTS OF IBUPROFENO PHARMA COMBIX:

This medication 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 for Ibuprofen indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The effective dose should be used for the shortest necessary period to alleviate 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.

Adults:

In adults and adolescents aged 14 to 18 years, one tablet (600 mg) will be taken every 6 to 8 hours, depending on the severity of the condition and response to treatment.

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

Children and adolescents:

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

Seniors:

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.

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

If you take more doses of Ibuprofen Pharma Combix than you should:

If you have taken more Ibuprofen Pharma Combix 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 seek advice on the measures to be taken.

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

In case of overdose or accidental ingestion, you can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

If you forgot to take Ibuprofen Pharma Combix:

Do not take a double dose to compensate for the missed doses.

If you forget to take your dose, take it as soon as you remember. However, if the next dose is due soon, skip the missed dose and take the next dose at its usual time.

Like all medicines, Ibuprofen may 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 when 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 following side effects have been observed:

Gastrointestinal::

The most common side effects that occur with medicines like Ibuprofen are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other side effects are: Uncommon: mucosal inflammation of the mouth with ulcer formation. Rare: esophageal inflammation, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulum disease, non-specific hemorrhagic colitis (gastroenteritis with diarrhea and blood). Very rare: pancreatitis.

Cardiovascular:

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), high blood pressure, and heart failure have also been observed in association with treatments with Ibuprofen-type medicines.

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

Cutaneous:

Medicines like Ibuprofen may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and epidermal detachment). Other side effects are: Common: skin rash. Uncommon: skin redness, itching, or swelling, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesion), light-induced skin reactions, inflammation of skin blood vessels. Exceptionally, severe skin infections and complications in soft tissue during chickenpox may occur. Unknown frequency: generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema), the skin becomes sensitive to light. Stop taking Ibuprofen Pharma Combix if you experience these symptoms and seek medical attention immediately. See section 2.

Immune system:

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), mucosal inflammation, bronchospasm (bronchi constriction that prevents air from reaching the lungs). Rare: 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. Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Common: fatigue or drowsiness, headache, and dizziness or feeling of instability. Rare: paresthesia (numbness, tingling, or prickling sensation, more common in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: vertigo. Uncommon: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular:

Uncommon: vision disturbances. Rare: abnormal or blurred vision.

Haematological:

Rare: decreased platelets, 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), decreased granulocytes (a type of white blood cell that may predispose to infections), pancitopenia (deficiency of red, white, and platelet cells in the blood), agranulocytosis (very large decrease in granulocytes), 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, flu-like symptoms, extreme fatigue, nasal and cutaneous bleeding. Very rare: prolonged bleeding time.

Renal:

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

Hepatic:

Medicines like ibuprofen 600 mg may be associated, in rare cases, with liver damage. Other rare side effects are: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Unknown frequency: liver insufficiency (severe liver deterioration).

General:

Worsening of inflammation during infectious processes.

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

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).

If any of the side effects listed below appear, stop treatment and seek immediate medical attention:

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Vigilance 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 reach and sight of children.

Store at a temperature below30°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 collection pointat the 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 Pharma Combix 600 mg Coated Tablets

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

The other components 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 Package

Oval, biconvex, white coated tablets. They are presented in packages with 40 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 - Pozuelo de Alarcón (Madrid)

Spain

Responsible for Manufacturing

FARMALIDER, S.A.

C/Aragoneses, nº2.

28108 - Alcobendas (Madrid)

Spain

or

FROSST IBÉRICA, S.A.

Vía Complutense, 140

28805 Alcalá de Henares (Madrid), Spain

or

PHARMALOOP, S.L.

C/ Bolivia, 15 - Polig Industrial Azque

28806 Alcalá de Henares (Madrid), Spain

or

TOLL MANUFACTURING SERVICES S.L.

C/Aragoneses,2

28108 Alcobendas (Madrid), Spain

This leaflet has been reviewed in March 2025

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/.