IBUPROFENO PHARMA COMBIX 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofeno Pharma Combix 600 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Ibuprofeno Pharma Combix and what is it used for
2. Before taking Ibuprofeno Pharma Combix
3. How to take Ibuprofeno Pharma Combix
4. Possible side effects
5. Storage of Ibuprofeno Pharma Combix
6. Additional information

1. What is Ibuprofeno Pharma Combix and what is it used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of fever, treatment of mild or moderate pain, including migraine, treatment of arthritis (inflammation of the joints, including 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).

2. Before taking Ibuprofeno Pharma Combix

Do not take this medicine:

• If you are allergic (hypersensitive) to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other ingredients of Ibuprofeno Pharma Combix. Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, 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 have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Tell your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with Ibuprofeno, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged 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 have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications can worsen these conditions.
• If you are being treated with diuretics (medicines to urinate), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus, as it can cause aseptic meningitis.
• It is essential to use the smallest dose that relieves/control the pain and not take this medicine for longer than necessary to control your symptoms.
• if you have an infection; see the "Infections" section below.

Infections: Ibuprofeno Pharma Combix may hide the signs of an infection, such as fever and pain. Consequently, this medicine may delay the appropriate treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofeno Pharma Combix immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

Severe skin reactions have been reported, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), in association with ibuprofen 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

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno Pharma Combix if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems 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, have a family history of heart disease or stroke, or if you are a smoker.

Similarly, this type of medication can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Precautions during pregnancy and in women of childbearing age

Since the administration of ibuprofen-type medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is considered strictly necessary and your doctor recommends it. In these cases, the dose and duration will be limited to the minimum possible. From the 20th week of pregnancy, Ibuprofeno Pharma Combix may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of amniotic fluid 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 checks.

In the third trimester, the administration of ibuprofen is contraindicated. It may cause kidney and heart problems in your fetus. It may affect you and your baby's tendency to bleed and delay or prolong labor more than expected.

For patients of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in fertility.

Skin reactions

Severe skin reactions have been reported in association with Ibuprofeno Pharma Combix treatment. Stop taking Ibuprofeno Pharma Combix and go to the doctor immediately if you present any skin rash, lesions in the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very severe skin reaction. See section 4.

Use of Ibuprofeno Pharma Combix with other medications:

Tell your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

• Other non-steroidal anti-inflammatory drugs, such as aspirin.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (an abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart disorders).
• Hydantoins, such as phenytoin (used to treat epilepsy).
• Sulfonamides, such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids, such as cortisone and prednisolone.
• Diuretics (medications used to increase urine elimination).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics, such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas, such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin-II receptor antagonists, such as losartan)
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics, such as neomycin.
• Herbal extracts: Ginkgo biloba tree.

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after discontinuing treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood levels of urea nitrogen and serum creatinine and potassium (may increase)
• Liver function tests: increased transaminase values

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

Taking Ibuprofeno Pharma Combix with food and drinks:

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 upset.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

Ibuprofen should not be taken 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 using machines:

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medicine, do not drive or use hazardous machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Important information about some of the ingredients of Ibuprofeno Pharma Combix:

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Ibuprofeno Pharma Combix

Follow the administration instructions of Ibuprofeno indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Your doctor will indicate the duration of treatment with Ibuprofeno. Do not stop treatment before, as the expected results will not be obtained. Similarly, do not use Ibuprofeno for longer than indicated by your doctor.

The effective lowest dose should be used during the shortest necessary time to relieve symptoms. If you have an infection, consult a doctor without delay if the symptoms (such as fever and pain) persist or worsen (see section 2).

This medicine is administered orally.

Adults:

In adults and adolescents from 14 to 18 years, take one tablet (600 mg) every 6 to 8 hours, depending on the intensity 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 from 12 to 18 years.

Children and adolescents:

The use of this medicine is not recommended in children and adolescents under 14 years, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Elderly:

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 medicine well.

Patient with kidney and/or liver disease:

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ibuprofeno Pharma Combix than you should:

If you have taken more Ibuprofeno Pharma Combix than you should, or if a child has accidentally ingested the medicine, consult a doctor or go to the nearest hospital immediately to find out about the risk and ask for 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the medicine package and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

If you forget to take Ibuprofeno Pharma Combix:

Do not take a double dose to make up for forgotten doses.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is near, skip the forgotten dose and take the next dose at the usual time.

4. Possible Adverse Effects

Like all medicines, Ibuprofen can have adverse effects, although not all people suffer from them.

The adverse effects of medicines like Ibuprofeno are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very frequent (in more than 1 in 10 patients); frequent (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 adverse effects have been observed:

Gastrointestinal:

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

Other adverse effects are: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticulitis, hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

Medicines like Ibuprofeno may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medicines of the Ibuprofeno type.

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

Dermatological:

Medicines like Ibuprofeno 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 purple-colored lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis). Other adverse effects are: Frequent: skin rash. Uncommon: skin redness, itching or swelling of the skin, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of the skin blood vessels. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Unknown frequency: 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 start of treatment (acute generalized exanthematous pustulosis), the skin becomes sensitive to light. Stop taking Ibuprofeno Pharma Combix if you experience these symptoms and seek medical attention immediately. See also section 2.

Immune System:

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in viscera (angioedema), nasal mucosa inflammation, bronchospasm (bronchial spasm that prevents air from passing into the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur. Very rare: joint pain and fever (lupus erythematosus).

Central Nervous System:

Frequent: fatigue or somnolence, headache, and dizziness or feeling of instability. Rare: paresthesia (sensation of numbness, tingling, acalculia, etc., more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from 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:

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

Ocular:

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

Blood:

Rare: decreased platelets, decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which may manifest as difficulty breathing and paleness of the skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red, white blood cells, and platelets in the blood), agranulocytosis (very significant decrease in granulocytes), aplastic anemia (bone marrow failure 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, pseudo-influenza symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Renal:

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

Hepatic:

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

General:

Worsening of inflammation during infectious processes.

To date, no serious allergic reactions have been reported with ibuprofeno 600 mg, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), 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 following adverse effects occur, discontinue treatment and seek medical attention immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, target-like, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Adverse Effect Reporting

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

5. Conservation of Ibuprofeno Pharma Combix

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

Store at a temperature below 30°C.

Do not use this medicine after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Ibuprofeno Pharma Combix 600 mg film-coated tablets EFG

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

The other components are:

Core

Croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, magnesium stearate, purified water.

Coating

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

Appearance of the Product and Packaging Content

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 - Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

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 was revised in March 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/