Ibuprofen Pharma Combix 400 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofen Pharma Combix 400 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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 only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

What Ibuprofen Pharma Combix is and what it is used for
What you need to know before taking Ibuprofen Pharma Combix
How to take Ibuprofen Pharma Combix
Possible side effects
How to store Ibuprofen Pharma Combix
Contents of the pack and other 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 used to treat fever and 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 condition causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before starting to take Ibuprofeno Pharma Combix

Do not take Ibuprofeno Pharma Combix

if you are allergic 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 this medicine (listed in section 6). Signs indicating allergy may include skin rash with itching, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma,
if you have severe liver or kidney disease,
if you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract,
if you are vomiting blood,
if you have black stools or bloody diarrhea,
if you have bleeding or blood coagulation disorders, or 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 dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
if you have severe heart failure,
if you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen

if you have edema (fluid retention),
if you have or have had heart problems or high blood pressure,
if you have asthma or any other respiratory disorder,
if you are already taking ibuprofen, inform your doctor, 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 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should be done,
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 clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such 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 usually results in bloody diarrhea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions,
if you are taking diuretics (medicines to increase urine production), as your doctor needs to monitor your kidney function,
if you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur,
if you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate,
if you suffer from headaches after prolonged treatment, do not take higher doses of the medicine,
if you have an infection: see the “Infections” section below.

Signs of allergic reaction to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop taking ibuprofen immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Your doctor will perform stricter monitoring if you receive ibuprofen after major surgery.

It is advisable not to take this medicine if you have chickenpox.

It is important to use the lowest dose that relieves/controls pain and not to take this medicine longer than necessary to control your symptoms.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Skin reactions

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

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen 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 this medicine if:

you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in 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 if you smoke. Also, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution in patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Precautions during pregnancy and in women of childbearing potential

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital malformations or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration of treatment should be kept to a minimum. The risk is believed to increase with dose and duration of treatment.

Administration of ibuprofen is contraindicated during the third trimester.

For women of childbearing potential, it should be noted that medicines like ibuprofen have been associated with reduced fertility.

Infections

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

Other medicines and Ibuprofeno Pharma Combix

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

Ibuprofen may affect or be affected by other medicines. For example:

Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulceration and bleeding.
Antiplatelet agents (to prevent blood clots or thrombi in blood vessels) such as ticlopidine.
Anticoagulant medicines (e.g., to treat coagulation disorders or prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
Cholestyramine (a medicine used to treat high cholesterol).
Selective serotonin reuptake inhibitors (used in depression).
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 (an abortion-inducing agent).
Digoxin and cardiac glycosides (used in the treatment of heart disorders).
Hydantoins such as phenytoin (used in the treatment of epilepsy).
Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine output), as they may increase the risk of renal toxicity.
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in patients with gout or together with penicillin in infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes), which could cause hypoglycemia.
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-containing medicines, and angiotensin-II receptor antagonists such as losartan).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts: Ginkgo biloba.
CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

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).
Hematocrit or hemoglobin (may decrease).
Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase).
Liver function tests: increased transaminase values.

Inform your doctor if you are scheduled for a clinical test and are currently taking or have recently taken ibuprofen.

Taking Ibuprofeno Pharma Combix with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of this medicine is not recommended in women trying to become pregnant.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing potential), 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 or your baby's tendency to bleed and delay or prolong labor beyond expected. You should not take ibuprofen during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose should be used 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 lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

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, special precautions are generally not required.

Ibuprofen may slow your reaction time, which should be considered before performing activities requiring high alertness, such as driving or operating machinery.

This is especially relevant when combined with alcohol.

Ibuprofeno Pharma Combix contains lactose

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

Ibuprofeno Pharma Combix contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, it is essentially "sodium-free".

3. How to take Ibuprofen Pharma Combix

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop the treatment earlier, as otherwise the expected results would not be achieved. Likewise, do not use ibuprofen for longer than indicated by your doctor.

The lowest effective dose should be used for the shortest duration necessary to relieve 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 12 years (≥ 40 kg)

The recommended dose for adults and adolescents aged 12 years and older is one tablet (400 mg) 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 2,400 mg in adults and 1,600 mg in adolescents aged 12 to 18 years.

Use in children

This medicine is not recommended for use in children weighing less than 40 kg or under 12 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosing in these children.

Elderly patients

If you are over 60 years old, your doctor may prescribe a lower than usual dose. If so, 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.

Method of administration

This medicine is administered orally.

The score line should not be used to divide the tablet.

To achieve a faster onset of action, the dose may be taken on an empty stomach. Patients with a sensitive stomach are advised to take ibuprofen with food.

Take ibuprofen with a sufficient amount of water. The tablets should be swallowed whole, without chewing, breaking, crushing, or sucking, to avoid discomfort in the mouth and throat irritation.

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 than you should, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to obtain information about the risk and advice on the measures to be taken.

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

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination. 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. Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, temporary cessation of breathing (apnea), central nervous system depression, and respiratory depression have occurred. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been reported.

In cases of severe poisoning, kidney failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

In case of ingestion of large amounts, activated charcoal should be administered.

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 your 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 dose at your usual time.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 maximum recommended dose.

Common adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood or material resembling coffee grounds, headache, dizziness or feeling unsteady, fatigue.
Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), photosensitivity reactions (skin reactions due to light exposure), hypersensitivity, paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (liver inflammation), abnormalities in liver function and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), renal failure (sudden loss of kidney function), acute kidney failure and papillary necrosis (especially with prolonged use) associated with increased urea levels.
Rare adverse effects (may affect up to 1 in 1,000 people): Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (ringing or noises in the ear), hearing impairment, reversible toxic amblyopia, liver injury, edema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, swelling of face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), neutropenia (reduction in neutrophils), agranulocytosis (severe reduction in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, bleeding and unexplained bruising.
Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, prolonged bleeding time, lupus erythematosus (joint pain and fever), very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and shedding of the epidermis), erythema multiforme (skin lesion), hair loss. Rarely, serious skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver deterioration), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation associated with infections has been observed during use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to consult a doctor promptly.

Frequency not known (cannot be estimated from available data):

Exacerbation of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhea).

A serious skin reaction known as DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cell). Generalized 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). Stop taking ibuprofen if you experience these symptoms and seek immediate medical attention. See also section 2.

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

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

Flat, non-elevated red spots, target-shaped or circular rashes 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).
Generalized skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
Generalized 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).
Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhea.
Severe stomach pain.
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.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 sight and reach of children.

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

Do not store above 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofen Pharma Combix

The active substance is ibuprofen. Each tablet contains 400 mg of ibuprofen.
The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica, and hypromellose.

Coating: hypromellose, propylene glycol (E1520), talc, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Ibuprofen Pharma Combix 400 mg are white, film-coated, oblong, biconvex tablets, scored on both sides. The tablet length is approximately 17 mm and the width is approximately 8 mm.

It is presented in PVC/PVDC-Aluminum blisters containing 30 film-coated tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Rovi Pharma Industrial Services, S.A.

Vía Complutense 140,

E-28805 Alcalá de Henares (Madrid)

Spain

Toll Manufacturing Services S.L.

C/ Aragoneses, 2

28108 (Alcobendas-Madrid)

Spain

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the most recent review of this leaflet: December 2024

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