Ibuprofen Cinfa 600 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

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

Contents of the leaflet

What Ibuprofen cinfa is and what it is used for
What you need to know before taking Ibuprofen cinfa
How to take Ibuprofen cinfa
Possible adverse effects
How to store Ibuprofen cinfa
Contents of the pack and other information

1. What is Ibuprofeno 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:

The treatment of fever.
The treatment of moderate pain, including migraine.
The treatment of rheumatoid arthritis (inflammation of the joints, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), and non-rheumatic inflammation.
Primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Ibuprofeno cinfa

Do not take Ibuprofeno cinfa

If you are allergic to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6). Signs of allergy may include: skin rash with itching, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
If you have severe liver or kidney disease.
If you have or have had a stomach or duodenal ulcer or bleeding, or if you have experienced a perforation of the gastrointestinal tract.
If you are vomiting blood.
If you have black stools or bloody diarrhea.
If you have bleeding or blood coagulation disorders, or if you are taking anticoagulants (medicines used to "thin" the blood). If anticoagulants must be used simultaneously, 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 cinfa.

If you have edema (fluid retention).
If you have or have had heart problems or high blood pressure.
If you have asthma or any other respiratory disorder.
Inform your doctor if you are already taking ibuprofen, as it may mask fever, 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 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should be done.
If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
This risk is higher when high doses or long-term treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.
If you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation and usually bloody diarrhea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
If you have an infection; see the “Infections” section below.
Allergic reactions may occur with this medicine.
Your doctor will monitor you more closely if you receive ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.
With ibuprofen, signs of allergic reaction such as breathing problems, swelling of the face and neck area (angioedema), and chest pain have been reported. Stop using Ibuprofeno cinfa immediately and contact your doctor or emergency medical services immediately if you notice 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 syndrome), 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 contact your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be the first signs of a serious skin reaction. See section 4.

Infections

Ibuprofen may mask signs of infection such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine during an infection and infection symptoms persist or worsen, consult a doctor without delay.

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

Precautions in elderly patients

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

Cardiovascular precautions

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

Discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

You have heart problems, including heart failure, angina (chest pain), a previous heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

In addition, these medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

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

Precautions during pregnancy and in women of childbearing age

Do not take ibuprofen if you are in the last three 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 tendency and your baby's tendency to bleed and may delay or prolong labor. You should not take ibuprofen during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time.

From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

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

Other medicines and Ibuprofeno cinfa

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

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

Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulcer and bleeding.
Antiplatelet agents (prevent blood clot or thrombus formation), such as ticlopidine.
Anticoagulant medicines (e.g., for treating or preventing blood coagulation problems, e.g., acetylsalicylic acid, warfarin, ticlopidine).
Cholestyramine (a medicine used to treat high cholesterol).
Selective serotonin reuptake inhibitors (used in the treatment of depression).
Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
Mifepristone (an abortion-inducing agent).
Digoxin and cardiac glycosides (medicines used for heart conditions).
Hydantoins such as phenytoin (for the treatment of epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (for the treatment of certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.
Pentoxifylline (for intermittent claudication).
Probenecid (used in gout patients or together 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 cyclosporine (used to prevent organ transplant rejection).
Zidovudine (an anti-HIV medicine).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts: Ginkgo biloba.
CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also affect or be affected by ibuprofen treatment. Therefore, 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 up to 1 day after stopping treatment).
Blood glucose concentration (may decrease).
Creatinine clearance (may decrease).
Hematocrit or hemoglobin (may decrease).
Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase).
Liver function tests: increased transaminase values.

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

Taking Ibuprofeno cinfa with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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.

Pregnancy

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

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing 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 disturbances, or other symptoms while taking this medicine, you should not drive or operate machinery.

If you take only a single dose of ibuprofen, or use it for a short period, special precautions are not usually necessary.

Ibuprofen may delay your reaction time, which should be taken into account before engaging in activities requiring high alertness, such as driving and operating machinery. This is especially important when combined with alcohol.

Ibuprofeno cinfa contains lactose

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

Ibuprofeno cinfa contains sodium

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

3. How to take Ibuprofen cinfa

Follow exactly the administration instructions for this medicine provided 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 earlier, as the expected results would not be achieved. Likewise, do not use this medicine for longer than indicated by your doctor.

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

Adults and adolescents over 14 years of age

The recommended dose for adults and adolescents aged 14 years and older is one tablet (600 mg) every 6 to 8 hours, depending on the severity of symptoms and response to treatment. In some conditions, 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 14 to 18 years.

Use in children and adolescents under 14 years of age

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

Elderly patients

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

Patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower than usual dose; if so, take exactly the dose prescribed by your doctor.

Method of administration

This medicine is administered orally.

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

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

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofen cinfa than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested, or go to the nearest hospital to learn about the risks and obtain 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 blood-stained sputum), diarrhea, headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination. Agitation or disorientation may also occur. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. In addition, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors.

Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also occurred. In cases of severe poisoning, renal failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatic patients.

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

If you forget to take Ibuprofen cinfa

Do not take a double dose to make up for missed doses.

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age. The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the maximum recommended dose.

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 stools, vomiting blood, headache, dizziness or feeling of unsteadiness, and fatigue have also been observed.

Uncommon adverse effects (may affect up to 1 in 100 people):

Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), photosensitivity reactions (skin reactions due to light exposure), hypersensitivity, paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms, or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (liver inflammation), 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 urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea levels have also been observed.

Rare adverse effects (may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (ringing or noises in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, edema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema, or severe shock) may occur). Aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria) has also been reported. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which may manifest as difficulty breathing and pale skin), neutropenia (reduced neutrophils), agranulocytosis (severe reduction in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), and hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and bruising.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Pancreatitis, prolonged bleeding time, erythema nodosum (joint pain and fever), very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion), hair loss. Rarely, severe skin infections and soft tissue complications during chickenpox may occur. Hepatic failure (severe liver impairment), heart failure, myocardial infarction, hypertension. Exacerbation of inflammation associated with infections coinciding with the use of NSAIDs has been observed. If signs of infection appear or worsen during ibuprofen use, it is recommended to seek medical attention promptly.

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

Exacerbation of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea). Generalized red scaly rash, with bumps under the skin and blisters primarily 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 ibuprofen if you experience these symptoms and seek immediate medical attention. See also section 2.

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

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhea.
Severe stomach pain.
Blisters or extensive skin peeling.
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 arms or legs.
Flat, non-elevated red circular or target-like rashes on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Generalized skin rash, high body temperature, and 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 (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen cinfa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno cinfa

The active substance is ibuprofen. Each tablet contains 600 mg of ibuprofen.
The other components (excipients) are:
Core: croscarmellose sodium, 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 contents of the pack

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

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

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.

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50 Esplugues de Llobregat 08950

Barcelona – Spain

MEDREICH PLC

Warwick House, Plane Tree Crescent Feltham. United Kingdom

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

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70039/P_70039.html

QR code link: https://cima.aemps.es/cima/dochtml/p/70039/P_70039.html