Prospect: information for the user

Difenadol rapid 400 mg granulated for oral solution

Ibuprofen (arginine)

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

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

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.
• You should consult a doctor if it worsens or does not improve, if the fever persists for more than 3 days or the pain for more than 5 days.

1.What is Difenadol rapid and for what it is used

2.What you need to know before starting to take Difenadol rapid

3.How to take Difenadol rapid

4.Possible adverse effects

5.Storage of Difenadol rapid

6. Contents of the package and additional information

The ibuprofen, active ingredient of this medication, acts by reducing pain and fever.

This medication is used in adults and adolescents 12 years of age and older (weight equal to or greater than 40 kg), for symptomatic relief of occasional mild to moderate pains, such as headaches, dental pain, menstrual cramps, muscle pain (muscle spasms) or back pain (lumbago), as well as in febrile states.

Do not take Difenadol rapid

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other ingredients in this medicine (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, bronchospasm, 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 an active cerebral hemorrhage or other active bleeding.
• If you have bleeding disorders or blood clotting problems, or are taking anticoagulants (blood thinners). If you need to take anticoagulants at the same time as this medicine, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhea, or inadequate fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may increase the risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or treatment duration. Do not take more than 3 sachets of granules (1,200 mg of ibuprofen) per day to avoid potential cardiovascular or heart problems.

Inform your doctor

• 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.
• If you have an infection, Difenadol rapid may mask the signs of an infection, such as fever and pain. Therefore, it may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms persist or worsen, consult your doctor without delay.
• 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 tell you how often these checks should be done.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case may cause kidney failure as a consequence of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent pain, or even without previous warning symptoms. This risk is higher when high doses and prolonged treatments are used, especially in patients with a history of peptic ulcer disease and in elderly patients. In these cases, your doctor may consider associating a stomach protector.
• If you take anticoagulant medications, 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).
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as this type of medication may worsen these conditions.
• If you are taking diuretics (medicines to help you urinate), as your doctor will need to 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 intermittent acute porphyria (a metabolic disorder that affects your blood and may cause symptoms such as urine discoloration, bloody urine, or liver disease), so your doctor can assess the suitability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• If you experience visual disturbances during ibuprofen treatment, discontinue treatment and consult your doctor for an eye examination.
• It is possible to experience allergic reactions with this medicine. Discontinue treatment if you notice redness, inflammation, or skin lesions.
• Severe skin reactions: Severe skin reactions associated with ibuprofen treatment (argyria) have been reported. Stop taking this medicine and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.
• Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medicine if you have chickenpox.
• Severe allergic reactions to ibuprofen, including difficulty breathing, facial swelling, and chest pain, have been reported. Discontinue treatment with ibuprofen immediately and contact your doctor or emergency medical services as soon as possible if you experience any of these symptoms.

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

Avoid taking this medicine with other NSAIDs, including COX-2 inhibitors.

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

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may increase the risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking Difenadol rapid if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, 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.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Respiratory problems

Ibuprofen should be used with caution in patients who have or have had asthma, bronchitis, or allergic diseases, as it may cause bronchospasm, urticaria, or angioedema in these patients.

Severe skin reactions

Severe skin reactions, including dermatitis exfoliativa, 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 ibuprofen treatment. Discontinue treatment with Difenadol rapid and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Children and adolescents

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

This medicine is not recommended for children and adolescents weighing less than 40 kg or under 12 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in this age group.

Precautions during pregnancy and in women of childbearing age

Due to the association of ibuprofen administration with an increased risk of congenital anomalies/abortions, its administration is not recommended during the first and second trimesters of pregnancy, except when strictly necessary and advised by your doctor.

If you need treatment during this period or while trying to become pregnant, use the lowest dose for the shortest time possible.

If you take it during the first 20 weeks of gestation, Difenadol rapid may cause kidney problems in your baby that may lead to low amniotic fluid levels or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a few more days, your doctor may recommend additional monitoring.

During the third trimester, ibuprofen administration is contraindicated.

For women of childbearing age, consider that ibuprofen-containing medications have been associated with a decrease in the ability to conceive.

Interference with laboratory tests

• Prothrombin 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)
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase)
• With liver function tests: increased values of transaminases

Inform your doctor if you are to undergo any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), as this medicine may alter the results.

Other medicines and Difenadol rapid

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

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

• Anticoagulant medications (e.g., for treating blood clotting problems or preventing coagulation, e.g., aspirin, warfarin, ticlopidine).
• Medicines that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

The following medicines may interfere and should not be taken with Difenadol rapid without consulting your doctor:

• Aspirin or other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
• Anti-hypertensive medications (beta-blockers, ACE inhibitors, and angiotensin II receptor antagonists) and diuretics: NSAIDs may reduce the effect of diuretics and other anti-hypertensive substances. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent blood clots from forming in blood vessels) like ticlopidine.
• Anticoagulant medications (blood thinners) like warfarin.
• Lithium (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 antimetabolite (slows down the growth of certain cells produced by the body).
• 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 prednisone and prednisolone.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas like tolbutamide or insulin (used to treat diabetes), may need to adjust the dose.
• Some antidepressants (SSRIs).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Thrombolytics (dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for metabolizing numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Taking Difenadol rapid with food, drinks, and alcohol

Take this medicine with meals or with milk.

Do not take ibuprofen with alcohol to avoid damaging your stomach. Drinking alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

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

Difenadol rapid should not be taken during pregnancy, especially during the third trimester (see section Precautions during pregnancy and in women of childbearing age).

It may cause kidney and heart problems in your baby. It may affect your tendency and that of your baby to bleed and make labor longer or more difficult than expected.

Small amounts of ibuprofen and its metabolites are excreted in breast milk. As no undesirable effects have been reported in the infant, it is usually not necessary to discontinue breastfeeding during short-term use at recommended doses.

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 medicine, 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.

Difenadol rapid contains aspartame, saccharose, and sodium

This medicine contains 20 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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

This medicine may cause tooth decay.

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

This medicine may cause tooth decay.

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

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

The effective dose should be the lowest dose necessary to alleviate symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose is:

• Adults and adolescents 12 years and older (weight 40 kg or more):Take one packet (400 mg of ibuprofen) every 6 or 8 hours, if necessary.

No more than 3 packets (1,200 mg of ibuprofen) should be taken in 24 hours.

• Senior patients:The dose should be established by the doctor, as it may be necessary to reduce the usual dose.
• Patients with kidney, liver, or heart diseases:Reduce the dose and consult the doctor.

The administration of this medication is subject to the appearance of pain or fever. As these symptoms disappear, the medication should be discontinued.

Consult a doctor if symptoms worsen or do not improve, if fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.

Use in children

This medication is not recommended for use in children and adolescents weighing less than 40 kg or under 12 years, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Administration form:

This medication is administered orally.

Dissolve completely the contents of a packet in a glass of water and ingest it immediately. Take this medication with meals or with milk, especially if digestive discomfort is noted.

If you take more Difenadol rapid than you should

In case of overdose or accidental ingestion, consult a doctor or pharmacist immediately or call the Toxicological Information Service (phone: 91 562 04 20), indicating the medication and the amount ingestedor go to the nearest hospital to inform about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), gastrointestinal bleeding (see also section 4 below), diarrhea, dizziness, spasms, hypotension, or depression of the nervous system (reduction of consciousness) headache, ringing in the ears, confusion, and involuntary eye movement.

Also, nervousness, drowsiness, disorientation, or coma may occur. Occasionally, patients develop seizures.

At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

In cases of significant overdose, renal insufficiency and liver damage may occur.

Furthermore, the prothrombin time/INR may be prolonged, probably due to interference with the action of circulating clotting factors. Acute renal failure and liver damage may occur. It is possible that asthma exacerbation may occur in asthmatic patients. Also, low blood pressure and reduced respiration may occur.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if significant amounts have been ingested and within 60 minutes of ingestion.

If you forget to takeDifenadol rapid

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 time for the next dose is near, skip the missed dose and take the next dose at your usual time.

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

Like all medications, Difenadol rapid may have adverse effects, although not everyone will experience them. Adverse effects of medications such as Difenadol rapid are more common in people over 65 years old.

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

Frequencies are established according to the following classification: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and infestations

Very rare: Exacerbation of infections-related inflammation (for example, the development of necrotizing fasciitis), coinciding with the use of nonsteroidal anti-inflammatory drugs.

Nota: If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to see a doctor immediately, if necessary to initiate an anti-infective/antibiotic therapy.

Blood and lymphatic system disorders

Rare: Aplastic anemia (insufficiency of the bone marrow to produce different types of cells).

Very rare: 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), decreased granulocytes (a type of white blood cell that may predispose to contracting infections), pancytopenia (deficiency of red, white, and platelet cells in the blood), agranulocytosis (very large decrease in granulocytes), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, nasal and cutaneous bleeding. Prolonged bleeding time.

Immune system disorders

Uncommon: Allergic reaction, hypersensitivity reactions with skin rash and pruritus, as well as asthma attacks (possibly accompanied by a drop in blood pressure).

Rare: Anaphylaxis (generalized allergic reaction).

Very rare: Severe hypersensitivity reactions (these may be characterized by swelling of the face, tongue, and larynx with bronchospasm, dyspnea, tachycardia, and hypotension that may include potentially fatal shock).

Nota: In the appearance of these symptoms, which may occur with the first use, immediate assistance from a doctor is required.

Mental disorders

Uncommon: Insomnia, anxiety, restlessness.

Rare: Psychotic reaction, nervousness, irritability, depression, confusion, disorientation.

Nervous system disorders

Common: Fatigue or somnolence, headache, dizziness or sensation of instability.

Uncommon: Insomnia, excitement, irritability.

Rare: Paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms, or legs).

Very rare: Aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases) which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Eye disorders

Uncommon: Vision disturbances.

Rare: Abnormal or blurred vision.

Frequency not known: Papilledema (inflammation of the optic nerve).

Ear and labyrinth disorders

Common: Dizziness.

Uncommon: Buzzing or ringing in the ears.

Rare: Hearing difficulty.

Cardiac disorders

Medications like Difenadol rapid may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Very rare: Palpitations, heart failure.

Frequency not known: Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Vascular disorders

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatments with ibuprofen (arginine) type medications.

Very rare: High blood pressure.

Frequency not known: Arterial thrombosis.

Respiratory, thoracic, and mediastinal disorders

Uncommon: Asthma, worsening of asthma, bronchospasm, dyspnea (breathing difficulty).

Frequency not known: Irritation of the throat.

Gastrointestinal disorders

The most common adverse effects that occur with medications like Difenadol rapid are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Common:Gastrointestinal discomfort such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that may cause anemia in exceptional cases.

Uncommon:Gastrointestinal ulcers, potentially with bleeding and perforation, stomatitis, exacerbation of colitis and Crohn's disease, melena (blood in stool), gastritis.

Rare: Vomiting with blood.

Very rare:Inflammation of the esophagus, pancreatitis, intestinal stenosis.

Frequency not known: Anorexia.

Hepatobiliary disorders

Rare: Liver damage, hepatitis (inflammation of the liver), abnormalities in liver function, and jaundice (yellowing of the skin and eyes).

Skin and subcutaneous tissue disorders

Common:Skin rash.

Uncommon:Redness of the skin, itching or swelling of the skin (angioedema, urticaria), purpura (purple spots on the skin).

Rare:Anaphylactic reaction

Very rare:Medications with ibuprofen (arginine) may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread skin and mucous membrane erosions and lesions with purple color, preferably on the trunk) and toxic epidermal necrolysis (skin and mucous membrane erosions with necrosis and detachment of the epidermis). Hair loss, erythema multiforme (skin lesion),. Exceptionally, severe skin infections and complications in the soft tissue may occur during chickenpox.

Frequency not known: Photosensitivity reactions, worsening of skin reactions. 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 and scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema). Stop taking Difenadol rapid if you experience these symptoms and seek medical attention immediately. See section 2.

Renal and urinary disorders

Rare: Hematuria (blood in urine).

Very rare: Edema (signs that may indicate kidney disease, which sometimes may include renal insufficiency); renal tissue damage (papillary necrosis), increased serum uric acid concentration.

Based on the experience with nonsteroidal anti-inflammatory drugs in general, cases of interstitial nephritis, nephrotic syndrome, and renal insufficiency cannot be ruled out.

General disorders and administration site conditions

Very rare: Worsening of inflammation during infectious processes.

Frequency not known: Edema.

Laboratory investigations

Rare: Alteration of liver function tests.

Frequency not known: Alteration of renal function tests.

No severe allergic reactions have been reported with Difenadol rapid to date, although they cannot be ruled out. The manifestations of this type of effect may be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, angioedema, facial swelling, tongue, and throat swelling, breathing difficulty, asthma, palpitations, hypotension, or shock.

If any of the following adverse effects occur, discontinue treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, facial swelling, chest tightness, or breathing difficulty.
• Vomiting blood or coffee ground-like material.
• Blood in stool or diarrhea with blood.
• Severe abdominal pain.
• Significant blisters or peeling of the skin.
• Severe headache or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Visual disturbances.

Discontinue treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• Red, non-elevated spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and symptoms similar to the flu [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red and scaly rash with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of adverse reactions

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

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

No special storage conditions are required. Store in the original packaging to protect from light and moisture.

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.

Medications should not be disposed of through drains or trash.Deposit empty packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Difenadol rapid

• The active ingredient is ibuprofen. Each sachet contains 400 mg of ibuprofen equivalent to 740 mg of ibuprofen (arginine).
• The other components (excipients) are L-arginine, aspartame (E-951), sucrose, sodium hydrogen carbonate, sodium saccharin, sodium lauryl sulfate, orange flavor (contains glucose in maltodextrin from corn and other excipients), and purified water.

Appearance of Difenadol rapidand contents of the packaging

White granule with a characteristic orange odor.

It is presented in packaging with 12 or 20 sachets of paper/aluminum sealed.

Trade name of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet:January2025

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