IBUFEN 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ibufén 400 mg film-coated tablets

ibuprofen

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your fever worsens or does not improve after 3 days or if your pain persists after 5 days (3 days in children and adolescents).

Contents of the Package Leaflet

1. What is ibufén and what is it used for
2. What you need to know before taking ibufén
3. How to take ibufén
4. Possible side effects
5. Storage of ibufén
6. Contents of the pack and further information

1. What is ibufén and what is it used for

Ibufén contains ibuprofen as the active substance and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the symptomatic relief of mild or moderate occasional pain, such as headache, dental, menstrual, muscular (cramps), or back (lumbago) pain, as well as febrile conditions.

2. What you need to know before taking ibufén

Do not take ibufén

• If you are allergic to ibuprofen or any of the other components of this medicine (listed in section 6) or to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs) or to aspirin. 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 if you are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines at the same time, 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, pharmacist, or nurse before starting to take ibufén

• 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 this medicine, 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 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 elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medicine.
• If you are taking medicines that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the aspirin type. You should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces diarrhea with blood) or ulcerative colitis, as medicines of the ibufén type may worsen these conditions.
• If you are being treated with diuretics (medicines used to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• If you have an infection; see the "Infections" section below.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• 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 Ibufén immediately and contact your doctor or the medical emergency service immediately if you observe any of these signs.

It is important that you use the smallest dose that relieves-controls the pain and do not take this medicine for longer than necessary to control your symptoms.

Skin Reactions

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

Stop taking ibufén and consult your doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Infections

Ibufén may mask the signs of an infection, such as fever and pain. Consequently, ibufén may delay appropriate treatment of the infection, which may 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.

Cardiovascular Precautions

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

You should discuss your treatment with your doctor or pharmacist before taking ibufén 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.

Children and Adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Precautions during Pregnancy and in Women of Childbearing Age

Do not take ibufén if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is strictly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, 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 a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medicines of the ibufén type have been associated with a decrease in fertility.

Taking ibufén with other Medicines

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

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

• Other non-steroidal anti-inflammatory drugs like aspirin, as the risk of stomach ulcers and gastrointestinal bleeding may increase.
• Antiplatelet agents (which prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (an abortion inducer).
• 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 production), as the risk of kidney toxicity may increase.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), as hypoglycemia may occur.
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medicine against the AIDS virus).
• 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 tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medicines in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

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 urea nitrogen and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values

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

Taking ibufén with Food, Drinks, and Alcohol

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

Pregnancy, Breastfeeding, and Fertility

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

You should not take ibufén during pregnancy, especially during the third trimester (see section precautions during pregnancy and in women of childbearing age).

Although only small amounts of the medicine pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and Using Machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should 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.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require increased vigilance, such as driving and using machinery. This applies to a greater extent to the combination with alcohol.

ibufén contains lactose and sodium

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

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

3. How to take ibufén.

Follow the administration instructions of the medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor, pharmacist, or nurse.

This medication is administered orally.

The tablet can be divided into equal doses.

Take the medication with meals or with milk, especially if digestive discomfort is noticed. The tablet should be swallowed whole with a sufficient amount of liquid.

Only for occasional use and during limited periods.

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

The recommended dose is:

Adults and adolescents over 12 years old (over 40 kg of weight):

half a tablet (200 mg of ibuprofen) every 4-6 hours, if necessary. If pain or fever does not respond to the half-tablet dose, 1 tablet can be taken every 6-8 hours.

No more than 3 tablets (1200 mg of ibuprofen) should be taken per day (24 hours).

Use in children:

Children from8 to12 years old:half a tablet (200 mg of ibuprofen) every 6-8 hours, not exceeding the total daily amount of 2 tablets (800 mg of ibuprofen).

Elderly population:the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

Patients with kidney, liver, or heart disease:reduce the dose and consult a doctor.

If symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days (3 days in children and adolescents), consult a doctor.

The administration of this medication is subject to the appearance of pain or fever. As they disappear, the medication should be suspended.

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

If you take more ibufén than you should

If you have taken more medication than you should, or if a child has accidentally ingested the medication, 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.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring this prospectus with you if possible.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), diarrhea, headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. Agitation or disorientation may also occur. At high doses, symptoms of 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. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. In rare cases, metabolic acidosis, decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system depression have occurred. Cardiovascular toxicity (decreased blood pressure, decreased heart rate, and increased heart rate) has also been reported.

If a severe poisoning has occurred, kidney failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatics.

If you forgot to takeibufén

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 very close, skip the forgotten dose and take the next dose at its usual time.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them. The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1200 mg of oral ibuprofen:

• Frequent 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 stool, vomiting with blood, headache, dizziness or feeling of instability, 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), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or burning, more frequent in hands, feet, arms, or legs) and drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth sores), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing).

Tubulointerstitial nephritis (kidney disorder) nephrotic syndrome (disorder characterized by proteins in the urine and swelling of the body) and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare adverse effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or sounds in the ear), hearing impairment, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx, dyspnea, tachycardia, hypotension, anaphylaxis, or severe shock may occur), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other adverse effects are 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 skin pallor), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow failure to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

• Very rare adverse effects(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two 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 desquamation of the epidermis), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure, heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation-related infections has been observed coinciding with the use of NSAIDs. If signs of infection or worsening of symptoms occur during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

• Unknown frequency(cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea). Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis). The skin becomes sensitive to light. Stop taking ibufén if you experience these symptoms and seek medical attention immediately. See also section 2. Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

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, interrupt treatment and goimmediately to your doctor:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-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 (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, non-elevated, target-like, or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. 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. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. 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 medication.

5. Conservation of ibufén

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of ibufén

The active ingredient of ibufén is ibuprofen. Each tablet contains 400 mg of ibuprofen.

The other components are:

Core excipients: sodium croscarmellose (E-468), anhydrous colloidal silica, microcrystalline cellulose (E-460), stearic acid, talc (E-553b).

Coating excipients: Opadry OYL 28900 (Lactose monohydrate + HPMC 2910/Hypromellose 15 cp + Titanium dioxide + Macrogol/PEG 4000), Opadry OYS 29019 (HPMC 2910/Hypromellose 50 cp + Macrogol/PEG 6000).

Appearance of Ibufén and package contents

White, oblong, biconvex, film-coated tablets, scored on one side and with the code "i" on the other. Each package contains 10 or 20 film-coated tablets packaged in a PVC/PVDC-Aluminum blister pack.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this prospectus:November 2024

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