Package Insert: Information for the User

Ibuprofen Cinfamed 400 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

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

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not take Ibuprofeno Cinfamed

• If you are allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other ingredients in this medication (listed in section 6).

The signs of an allergic reaction could be: 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 bleeding, or have suffered a perforation of the digestive tract.

-If you vomit blood.

• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate 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 Ibuprofeno Cinfamed.

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• Inform your doctor if you are already taking ibuprofen, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 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 develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms.

• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor may consider associating a stomach protector medication.
• If you are taking anticoagulants (medications used to "thin" the blood) such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may increase the risk of bleeding such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs). You should also inform your doctor about the use of other medications that may increase the risk of bleeding.
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.

• If you are taking diuretics (medications used to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition 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, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the need for ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.

• Your doctor will perform a more stringent check if you receive ibuprofen after major surgery. It is recommended not to take this medication if you have chickenpox.
• Use the smallest dose that relieves or controls pain, and do not take this medication for longer than necessary to control your symptoms.
• If you have an infection; see the "Infections" section later.
• Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Cinfamed immediately and contact your doctor or emergency medical services if you observe any of these signs.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

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), generalized acute pustular psoriasis (PEGA), have been reported in association with Ibuprofeno Cinfamed treatment.Stop treatment with Ibuprofeno Cinfamed and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Stop taking Ibuprofeno Cinfamed and see a 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.

Cardiovascular precautions

NSAIDs 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 inform your doctor or pharmacist before taking ibuprofen if

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation in the legs or feet due to 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, a family history of heart disease or stroke, or are a smoker.
• These types of medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory problems

Ibuprofen should be used with caution in patients who have or have had asthma, bronchial asthma, or allergic diseases, as it has been reported to cause bronchospasm, urticaria, or angioedema in these patients.

Infections

Ibuprofeno Cinfamed may mask the signs of an infection, such as fever and pain. Therefore, it is possible that ibuprofeno Cinfamed may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Precautions during pregnancy and in fertile women

Do not take ibuprofen 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 bleeding tendency and that of your baby, and may delay or prolong delivery more than expected. Do 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 time possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels 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 monitoring.

For fertile women, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Taking Ibuprofeno Cinfamed with other medications

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

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

• Other NSAIDs like aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots) like ticlopidine.
• Anticoagulants (medications used to "thin" the blood) such as aspirin, warfarin, ticlopidine.
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs) used in depression.
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics (medications used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used to treat gout).
• Sulfonureas like tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba.
• Inhibitors of CYP2C9 (responsible for the metabolism of many medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Clearance of creatinine (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Concentrations of urea nitrogen in the blood and serum concentrations of creatinine and potassium (may increase).
• With liver function tests: increase in transaminase values.

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

Taking Ibuprofeno Cinfamed with food, drinks, and alcohol

Se recommend taking ibuprofen with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not take alcohol, as it may increase the risk of gastrointestinal side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The use of this medication is not recommended for women trying to become pregnant. Do not take ibuprofen during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in fertile women). Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and operating machinery:

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery.

If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary.

Ibuprofen may delay your reaction time, which should be taken into account before engaging in activities that require increased vigilance, such as driving and operating machinery. This applies to a greater extent when combined with alcohol.

Ibuprofeno Cinfamed contains lactose.

If your doctor has indicated that you have a intolerance to certain sugars, consult with them before taking this medication.

Ibuprofeno Cinfamed contains sodium.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The effective dose should be used for the shortest 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).

Adults and adolescentsover 12 years (≥ 40 kg)

The recommended dose for adults and adolescents over 12 years is one tablet (400 mg) every 6 to 8 hours, depending on the severity of the condition and the 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 2,400 mg in adults and 1,600 mg in adolescents aged 12 to 18 years.

Use in children

This medication is not recommended for use in children weighing less than 40 kg or under 12 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in these children.

Older patients

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

Patients with kidney and/or liver 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.

Administration form

This medication is administered orally.

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

Take ibuprofen with sufficient amounts of water. Tablets should be swallowed whole, without chewing, breaking, crushing, or sucking to avoid mouth discomfort and throat irritation.

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

If you take more Ibuprofeno Cinfamed than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

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

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Agitation or disorientation may also occur. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties may occur. Furthermore, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors.In rare cases, cases of metabolic acidosis, decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), depression of the central nervous system and respiratory system have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe intoxication has occurred, renal insufficiency and liver damage may occur. In these cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatics.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if more than 400 mg/kg has been ingested and within 60 minutes of ingestion.

If you forgot to take Ibuprofeno Cinfamed

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

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

Like all medications, this medication may cause side effects,although not everyone will experience them.

The side effects of medications such as ibuprofen are more common in people over 65 years old.

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

• Common side effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

• Rare side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple spots on the skin), skin reactions caused by light, hypersensitivity, paresthesia (numbness, tingling, burning, etc. more common in hands, feet, arms, or legs) and drowsiness, insomnia, anxiety, auditory disorders, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities and jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and acute renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

• Very rare side effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (golpes or sounds in the ear), auditory disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, may appear facial swelling, tongue, and larynx, dyspnea, tachycardia, hypotension, anaphylaxis, angioedema, or severe shock), 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 had 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 side effects are thrombocytopenia, leukopenia (decrease in white blood cells, may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin), neutropenia, and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), and hemolytic anemia (premature destruction of red blood cells). The first symptoms are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, bleeding, and unexplained bruises.

• Extremely rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, prolonged bleeding time, systemic lupus erythematosus (joint pain and fever), severe skin reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and skin detachment), erythema multiforme (skin lesion), hair loss. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure, heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection or they worsen during ibuprofen use, it is recommended to see 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 produces diarrhea with blood).

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). 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 (generalized acute pustular exanthema). The skin becomes sensitive to light.Stop taking Ibuprofeno Cinfamed if you experience these symptoms and seek medical attention immediately. See also section 2. Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

If any of the following side effects appear, discontinue treatment and seek medical attention immediately:

• Allergic reactions such as skin rash, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee ground-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Severe headache or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin 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 beginning of treatment (generalized acute pustular exanthema).

Reporting of side effects

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

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

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

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

CompositionofIbuprofen Cinfamed

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

Core:Sodium croscarmellose, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate, and purified water.

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

Appearance of the product and contents of the package

Ibuprofen Cinfamed are film-coated tablets, oblong, biconvex, white in color, and scored on both sides.

They are presented in packages of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

FROSST IBÉRICA, S.A.

Vía Complutense 140

Alcalá de Henares

28805 Madrid

Spain

or

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas

(Madrid)

Spain

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Pharmaloop, S.L.

C/Bolivia, 15 Polígono Industrial Azque

Alcalá de Henares 28806

Madrid Spain

or

TOLL Manufacturing Services, S.L

C/Aragoneses, 2, Madrid,

28108 Madrid Spain

Last review date of this leaflet:November 2024

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/67278/P_67278.html

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