Ibuprofen Pharma Combix 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Pharma Combix 600 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Ibuprofen Pharma Combix is and what it is used for
2. Before you take Ibuprofen Pharma Combix
3. How to take Ibuprofen Pharma Combix
4. Possible side effects
5. How to store Ibuprofen Pharma Combix
6. Further information

1. What Ibuprofeno Pharma Combix is and what it is 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, mild to moderate pain including migraine, arthritis (inflammation of the joints, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder causing damage to cartilage), 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, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of Ibuprofeno Pharma Combix. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, nasal discharge, breathing difficulties or asthma.

• If you have severe liver or kidney disease.

• If you have had a stomach or duodenal ulcer, gastrointestinal bleeding, or a perforation of the digestive tract.

• If you are vomiting blood.

• If you have black stools or bloody diarrhoea.

• If you have bleeding disorders or blood coagulation disorders, or if you are taking anticoagulants (medicines used to "thin" the blood). If concomitant use of anticoagulant medicines is necessary, 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

Inform your doctor:

• If you have oedema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you suffer from asthma or any other respiratory disorder.
• If you are being treated with ibuprofen, as it may mask fever, an important sign of infection, thereby making diagnosis more 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 carry out regular monitoring. Your doctor will advise you on the frequency of such checks.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• This risk is higher when high doses or prolonged treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.
• If you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urine production), because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus, as aseptic meningitis may occur.
• It is important that you use the lowest effective dose that relieves/controls your pain and that you do not take this medicine longer than necessary to control your symptoms.
• If you have an infection; see the section "Infections" below.

Infections: Ibuprofeno Pharma Combix may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine during an infection and your symptoms persist or worsen, consult a doctor immediately.

Allergic reactions to ibuprofen, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Pharma Combix immediately and contact your doctor or emergency medical services without delay if you notice any of these signs.

Serious skin reactions 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), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Pharma Combix and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions

Medicines such as ibuprofen (anti-inflammatory/analgesic) may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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), history of heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischaemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

In addition, these types of medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Precautions during pregnancy and in women of childbearing age

Because the use of medicines like ibuprofen has been associated with an increased risk of congenital abnormalities or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary and specifically advised by your doctor. In such cases, the dose and duration of treatment will be limited to the minimum possible. From week 20 of pregnancy, Ibuprofeno Pharma Combix may cause kidney problems in your unborn baby if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you require treatment for longer than a few days, your doctor may recommend additional monitoring.

During the third trimester, ibuprofen is contraindicated. It may cause kidney and heart problems in your unborn baby. It may also affect your tendency and your baby's tendency to bleed and may delay or prolong labour beyond the expected time.

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with a reduced ability to conceive.

Skin reactions

Serious skin reactions have been reported with Ibuprofeno Pharma Combix. Stop taking Ibuprofeno Pharma Combix and see a doctor immediately if you develop any skin rash, lesions of mucous membranes, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.

Use of Ibuprofeno Pharma Combix with other medicines:

Inform your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

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

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

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for up to 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Haematocrit or haemoglobin (may decrease)
• Blood urea nitrogen levels and serum creatinine and potassium levels (may increase)
• Liver function tests: increased transaminase values

Inform your doctor if you are scheduled for clinical laboratory testing and are taking or have recently taken ibuprofen.

Taking Ibuprofeno Pharma Combix with food and drinks:

You may take it alone or with food. It is generally 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 medicine.

Ibuprofen should not be taken during pregnancy, especially during the third trimester.

Although only small amounts of the medicine 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, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, no special precautions are usually necessary.

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

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

3. How to take Ibuprofen Pharma Combix

Follow exactly the dosing instructions for Ibuprofen provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will indicate how long you should take Ibuprofen. Do not stop treatment prematurely, as this may prevent the expected results. Likewise, do not use Ibuprofen for longer than prescribed by your doctor.

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

This medicine is administered orally.

Adults:

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

Higher doses may be required in some conditions; however, 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 medicine is not recommended for children and adolescents under 14 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosage in this patient group.

Elderly:

If you are over 60 years old, your doctor may prescribe a lower than usual dose. In such cases, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

Patients with kidney and/or liver disease:

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

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

If you take more Ibuprofen Pharma Combix than you should:

If you have taken more Ibuprofen Pharma Combix than prescribed, or if a child has accidentally ingested the medicine, consult a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on necessary measures.

In cases of severe poisoning, the doctor will take the necessary measures.

In case of overdose or accidental ingestion, you may also contact the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

If you forget to take Ibuprofen Pharma Combix:

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

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

4. Possible adverse effects

Like all medicines, ibuprofen may have adverse effects, although not everyone experiences them.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended maximum dose.

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

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with medicines such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Other adverse effects include: Uncommon: inflammation of the oral mucosa with ulcer formation. Rare: inflammation of the esophagus, narrowing of the esophagus (esophageal stricture), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis presenting with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatment using ibuprofen-type medicines.

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

Dermatological:

Medicines such as ibuprofen may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, predominantly on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis). Other adverse effects are: Common: skin rash. Uncommon: skin redness, itching or swelling of the skin, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesions), photosensitivity reactions, inflammation of blood vessels in the skin. Rarely, severe skin infections and complications in soft tissues may occur during chickenpox. Frequency not known: widespread red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis), skin becoming sensitive to light. Stop taking Ibuprofeno Pharma Combix if you experience these symptoms and seek immediate medical attention. See also section 2.

Immune system:

Uncommon: transient swelling in areas of skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of nasal mucosa, bronchospasm (spasm of the bronchi preventing airflow to 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, dizziness, or sensation of instability. Rare: paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms of aseptic meningitis observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

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

Auditory:

Common: dizziness. Uncommon: tinnitus (ringing or buzzing in the ears). Rare: hearing impairment.

Ocular:

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

Hematological:

Rare: decreased platelet count, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), aplastic anemia (bone marrow failure to produce various types of blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like 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 protein in urine and body swelling), and renal failure (sudden loss of kidney function) cannot be excluded.

Hepatic:

Medicines such as ibuprofen 600 mg may rarely be associated with liver injury. Other rare adverse effects include: hepatitis (liver inflammation), abnormalities in liver function, and jaundice (yellowing of the skin and eyes). Frequency not known: liver failure (severe deterioration of liver function).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen 600 mg, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

If any of the following adverse effects occur, stop treatment immediately and consult your doctor:

• Allergic reactions such as skin rashes, swelling of the face, wheezing, or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blisters or extensive peeling of the skin.
• 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 arms or legs.
• Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or 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].
• Widespread skin rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects

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

5. Storage of Ibuprofen Pharma Combix

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Ibuprofen Pharma Combix 600 mg Film-Coated Tablets EFG

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

The other components are:

Core

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

Coating

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

Appearance of the medicinal product and content of the container

Oval, biconvex, white film-coated tablets. Packaged in containers containing 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 last reviewed in March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/