IBUPROFEN CINFA 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofen Cinfa 600 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Ibuprofen Cinfa and what is it used for

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

This medicine is used for:

• Treatment of fever.
• Treatment of mild to moderate pain, including migraine.
• Treatment of rheumatoid arthritis (inflammation of the joints, including 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), and non-rheumatic inflammation.
• Primary dysmenorrhea (painful menstruation).

2. What you need to know before you take Ibuprofen Cinfa

Do not take Ibuprofen Cinfa

• If you are allergic to ibuprofen, other NSAIDs, aspirin, or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have severe liver or kidney disease.
• If you have or have had a stomach or duodenal ulcer, or if you have had 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 you need to take 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 or pharmacist before starting to take Ibuprofen Cinfa.

• If you have edema (fluid retention).
• If you have or have had heart disorders or 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 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 severe abdominal pain or persistent pain and/or black stools, or even without previous warning symptoms.
• This risk is higher when high doses are used and treatments are prolonged, in patients with a history of peptic ulcers, 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 or antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• 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, as ibuprofen-like medicines can worsen these conditions.
• If you are being treated with diuretics (medicines 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, which are the membranes 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 Ibuprofeno Cinfa immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

Special caution is recommended with ibuprofen.

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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Cinfa and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Stop taking ibuprofen and go to the 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

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen 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 you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

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

Precautions in elderly patients

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

Cardiovascular precautions

Anti-inflammatory/analgesic medicines like 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 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 if you are a smoker.

Similarly, these types of medicines 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 had 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 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 you 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 checks.

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

Other medicines and Ibuprofeno Cinfa

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 NSAIDs, such as aspirin, as the risk of stomach ulcers and 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 to treat depression).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (for the treatment of cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (an abortion inducer).
• Digoxin and cardiac glycosides (medicines used for heart diseases).
• Hydantoins, such as phenytoin (for the treatment of epilepsy).
• Sulfonamides, such as sulfamethoxazole and cotrimoxazole (for 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).
• Quinolone antibiotics, such as norfloxacin.
• Sulfinpyrazone (for the treatment of gout).
• Sulfonylureas, such as tolbutamide (for diabetes), as hypoglycemia may occur.
• Tacrolimus or cyclosporin (used to prevent organ rejection in transplants).
• 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.
• 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 ibuprofen. Therefore, you should always consult your doctor or pharmacist before using ibuprofen with other medicines.

Interference with laboratory tests

The use of 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 using or have recently used ibuprofen.

Taking Ibuprofeno Cinfa with food, drinks, and alcohol

It is recommended to take the medicine with milk or with food, or immediately after eating, to reduce the possibility of stomach upset. 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.

Pregnancy

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

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

Breastfeeding

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 changes, or other symptoms while taking this medicine, do not drive or use machinery.

If you only take one dose of ibuprofen or take it 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 Cinfa contains lactose

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

Ibuprofeno Cinfa contains sodium

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

3. How to take Ibuprofeno cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop treatment beforehand, as this will not achieve the expected results. Similarly, do not use this medication 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 your doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents over 14 years

The recommended dose in adults and adolescents from 14 years is one tablet (600 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 14 to 18 years.

Use in children and adolescents under 14 years

The use of this medication is not recommended in children or adolescents under 14 years, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these patients.

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 prescribed by your doctor.

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 ibuprofen with a sufficient amount of water. The tablets should be swallowed whole, with a glass of water, 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 cinfa than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital 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.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), diarrhea, headache, ringing in the ears, confusion, and involuntary movement of the eyes 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, there have been reports 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 (decreased blood pressure, decreased heart rate, and increased heart rate). If a severe overdose has occurred, acute renal failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

Asthma exacerbation is possible in asthmatics.

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

If you forget to take Ibuprofeno cinfa

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 the usual time.

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

4. Possible side effects

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

The side effects of medications like ibuprofen are more common in people over 65 years old. The incidence of side effects is lower in short 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 (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stool, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

Uncommon side 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). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein 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 side 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, 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 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, pseudogripal symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

Very rare side 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 can occur during chickenpox. Liver failure (severe liver damage), heart failure, myocardial infarction, hypertension. Exacerbation of inflammation-related infections has been observed with the use of NSAIDs. If signs of infection or worsening 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). Generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. The skin becomes sensitive to light. Stop taking ibuprofen 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 can 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 side effects occur, stop treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or material that looks like coffee grounds.
• 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 allergy (hypersensitivity) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, non-raised, target-like, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, 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. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's pharmacovigilance system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ibuprofeno cinfa

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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 disposed of through wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno cinfa

• The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other ingredients (excipients) are:

• Core: sodium croscarmellose, microcrystalline cellulose (E-460), anhydrous colloidal silica, and stearic acid.
• Coating: lactose monohydrate, hypromellose, titanium dioxide (E-171), and macrogol 4000.

Appearance of the product and package contents

Ibuprofeno cinfa 600 mg film-coated tablets are white, film-coated, oblong, and biconvex tablets.

They are available in PVC-PVDC/ALU blisters, in packs of 40 or 500 (clinical pack) tablets.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain.

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain.

or

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50 Esplugues de Llobregat 08950

Barcelona – Spain

or

MEDREICH PLC

Warwick House, Plane Tree Crescent Feltham.Reino Unido

Date of last revision of this leaflet:November 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Healthcare 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 leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70039/P_70039.html

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