IBUPROFEN CINFAMED 400 mg FILM-COATED TABLETS

2. What you need to know before you take Ibuprofeno Cinfamed

Do not take Ibuprofeno Cinfamed

• If you are allergic to ibuprofen, to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6).

Allergic reactions may 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 have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe 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 Ibuprofeno Cinfamed.

• 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.
• Tell your doctor if you are already taking ibuprofen, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

• This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, since ibuprofen-type medications can worsen these conditions.

• If you are being treated with diuretics (medicines to increase urine production), because 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 suffer from headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.

• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery. It is advisable not to take this medication if you have chickenpox.
• It is important that you use the smallest dose that relieves/controls the pain and do not take this medication for longer than necessary to control your symptoms.
• If you have an infection; see the "Infections" section below.
• With ibuprofeno, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofeno Cinfamed immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

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

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 Ibuprofeno Cinfamed treatment. Discontinue Ibuprofeno Cinfamed treatment and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Stop taking Ibuprofeno Cinfamed and go to the doctor immediately if you present any skin rash, lesions in the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very severe skin reaction. See section 4.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses.

Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen 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 are a smoker.
• Similarly, these types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution when administered to 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.

Infections

Ibuprofeno Cinfamed may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofeno Cinfamed may delay the 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 medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Precautions during pregnancy and in women of childbearing age

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 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 cause low levels of the fluid that surrounds 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 checks.

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

Taking Ibuprofeno Cinfamed with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 the risk of stomach ulcers and bleeding may increase.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestyramine (a medication used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (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 they may increase the risk of kidney toxicity.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), as they may cause hypoglycemia.
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs 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.

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping 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.

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

Taking Ibuprofeno Cinfamed with food, drinks, and alcohol

It is recommended to take ibuprofen 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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

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

If you only take one dose of ibuprofen or for a short period, you do not need to take special precautions.

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

Ibuprofeno Cinfamed contains lactose.

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

Ibuprofeno Cinfamed contains sodium.

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

3. How to take Ibuprofeno Cinfamed

Follow the administration instructions of this medication exactly as 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 suspend treatment beforehand, as the expected results will not be obtained. Similarly, do not use ibuprofen for longer than indicated by your doctor.

The lowest effective dose should be used for the shortest time 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 adolescentsover 12 years old (≥ 40 kg)

The recommended dose in adults and adolescents from 12 years old is one tablet (400 mg) every 6 to 8 hours, depending on the intensity of the condition and response to treatment.

In some cases, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg in adults and 1,600 mg in adolescents from 12 to 18 years old.

Use in children

The use of this medication is not recommended in children with less than 40 kg of weight or under 12 years old, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these children.

Elderly 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 checked 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 that your doctor has prescribed.

Method of administration

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. It is recommended that patients with sensitive stomachs take ibuprofen with food.

Take ibuprofeno 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 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 or go to the nearest hospital immediately to find out 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

It is recommended to take the package and the prospectus of the medication to the healthcare professional.

Normally, the symptoms of overdose occur 4 to 6 hours after taking ibuprofen. The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), 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, 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, there have been cases of increased blood plasma acidity (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. There have also been cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate).

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.

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

If you forgot to take Ibuprofeno Cinfamed

Do not take a double dose to make up for missed 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 missed dose and take the next dose at its usual time.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

The adverse effects of medications like ibuprofen are more common in people over 65 years old.

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

• 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 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, hives, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, burning, etc., 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). Interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by proteins in the urine and body swelling), 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, irritability, nervousness, psychotic reaction, 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), 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 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 pale skin), 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, pseudo-flu symptoms, extreme fatigue, bleeding, and bruising of unknown cause.

• Very rare adverse effects(may affect up to 1 in 10,000 people): Pancreatitis, prolonged bleeding time, lupus erythematosus (joint pain and fever), 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 shedding of the epidermis), 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 infections has been observed 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.

• Frequency not known(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).

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 (acute generalized exanthematous pustulosis). 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 can be a sign of a potentially severe allergic reaction called Kounis syndrome.

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

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

Reporting 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 Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno Cinfamed

Keep this medication out of sight and reach of children.

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

Do not store above 30°C.

Medications should not be thrown down the drain or into the trash. Deposit the packages 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 packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno 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 corn starch, 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 package contents

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

They are available in packages of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

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

Date of the last revision of this prospectus:November 2024

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus 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

QR code to: https://cima.aemps.es/cima/dochtml/p/67278/P_67278.html