Leaflet: information for the user

Geloprofen Rapid 400 mg powder for oral suspension

Ibuprofen (lysine)

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve, if the fever persists for more than 3 days or the pain for more than 5 days.

1. What is Geloprofen Rapid and what it is used for

2. What you need to know before starting to take Geloprofen Rapid

3. How to take Geloprofen Rapid

4. Possible side effects

5. Storage of Geloprofen Rapid

6. Contents of the pack and additional informationadditional information

Ibuprofen, the active ingredient of this medication, acts by reducing pain and fever.

Geloprofen is used for the symptomatic relief of occasional mild or moderate pains, such as headaches, dental pain, menstrual cramps, muscle pain (spasms) or back pain (lumbago), as well as in febrile states, in adults and adolescents over 12 years old (weight above 40 kg).

Consult a doctor if it worsens or does not improve, if fever persists for more than 3 days or pain for more than 5 days.

Do not take Geloprofen Rapid:

• If you are allergic (hypersensitive) to ibuprofen or any of the other components of this medication (listed in section 6) or to other medications in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding or clotting disorders or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• Inform your doctor if you are already taking this medication, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in elderly patients. In these cases, your doctor may consider associating a stomach-protecting medication.
• If you are taking medications that alter blood clotting, 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.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen-containing medications may exacerbate these conditions.
• If you are being treated with diuretics (medications 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 intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the advisability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication. With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Geloprofen Rapid 400 mg powder for oral suspension immediately and contact your doctor or emergency medical services if you observe any of these signs.
• Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with Geloprofen Rapid 400 mg powder for oral suspension and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in 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 medication if you have chickenpox.
• If you have an infection: see the heading "Infections" later.

It is essential to use the smallest dose that relieves or controls pain and not to take this medication 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

NSAIDs, such as ibuprofen, may be associated with a small increase in the risk of heart attack or stroke, especially when used at high doses.

Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking this medication 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 when administered to patients who have or have had asthma, bronchial asthma, or allergic diseases, as ibuprofen may cause bronchospasm, urticaria, or angioedema in these patients.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen-containing medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible. It is believed that the risk increases with the dose and duration of treatment.

Administration of this medication is contraindicated in the third trimester.

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

Severe skin reactions

Severe skin reactions have been reported in association with Geloprofen treatment. Stop taking Geloprofen Rapid 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.

Infections

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

Other medications and Geloprofen Rapid

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

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

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

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

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (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 a clinical analysis and are taking or have taken ibuprofen recently.

Taking Geloprofen Rapid with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility:

Consult your doctor or pharmacist before using any medication.

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

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

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

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

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, no special precautions are necessary.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require increased vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

Geloprofen Rapid contains cyclodextrins (betadex E-459), tartrazine (E-102), glucose, sucrose, and sodium.

• This medication contains 2,050 mg of cyclodextrins in each packet.
• This medication may cause allergic reactions because it contains tartrazine (E-102). It may cause asthma, especially in patients allergic to aspirin.
• This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
• This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
• This medication contains less than 1 mmol of sodium (23 mg) per packet; it is essentially "sodium-free".

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

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

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

The recommended dose is:

• Adults and adolescents over 12 years (over 40 kg of weight): 1 tablet (equivalent to 400 mg of ibuprofen) every 6-8 hours.

No more than 3 tablets (equivalent to 1200 mg of ibuprofen) should be taken within 24 hours.

• Over 65 years: the dosage should be established by the doctor, as there is a possibility that a reduction in the usual dose may be needed.

• Patients with kidney, liver, or heart disease: reduce the dose and consult the doctor.

If symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days, you should consult the doctor.

Use in children and adolescentsThis medication is not recommended for use in children (under 12 years) or adolescents with a weight of less than 40 kg.

Administration form:

This medication is administered orally.

Once the packet is opened, the suspension should be prepared and administered immediately.

Empty the contents of one packet into a half glass of water, shake it, and take it afterwards.

Take the medication with meals or with milk, especially if digestive discomfort is noted.

If you take more Geloprofen Rapid than you should

If you have taken more Geloprofen Rapid than you should or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken or to the Toxicological Information Service, phone: 91.562 04 20, indicating the medication and the amount ingested.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

The most frequent symptoms are: abdominal pain, nausea, vomiting (which may contain blood-tinged mucus), diarrhea, drowsiness, headache, tinnitus, dizziness, convulsions (mainly in children), loss of consciousness, muscle coordination loss, and low potassium levels in the blood. Agitation or disorientation may also occur.Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors.In rare cases, rapid involuntary eye movements, metabolic acidosis, decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system and respiratory system depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

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

Exacerbation of asthma is possible in asthmatics.

If you forget to take Geloprofen 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 its usual time.

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

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

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

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

• Infrequent side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching, or tingling, urticaria, purpura (purple skin patches), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, or prickling sensations, more common in hands, feet, arms, or legs) and drowsiness, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (nasal mucosa inflammation), oral mucosa inflammation with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities, and jaundice (yellow skin and eye discoloration), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (proteinuria and body edema), and acute 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 (ear ringing), auditory disturbances, reversible toxic amblyopia, liver damage, edema (fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in severe cases of generalized hypersensitivity, may include facial swelling, tongue swelling, laryngeal swelling, dyspnea, tachycardia, hypotension, anaphylaxis, angioedema, or shock). In most cases of ibuprofen-associated meningitis, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. Symptoms of meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects include thrombocytopenia, leukopenia (decreased white blood cell count, may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin), neutropenia, and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency), and hemolytic anemia (premature destruction of red blood cells). Initial symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding, and bruising.

• Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, prolonged bleeding time, systemic lupus erythematosus (joint pain and fever), severe allergic reactions, including Stevens-Johnson syndrome (widespread skin and mucous membrane erosions) and toxic epidermal necrolysis (skin erosions and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesions), hair loss, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure, heart failure, myocardial infarction, hypertension. Inflammations related to infections have been observed coinciding with the use of NSAIDs. If signs of infection or worsening of symptoms occur during ibuprofen use, seek medical attention as soon as possible.

• Unknown frequency(cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea). A severe skin reaction known as DRESS syndrome may occur. 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 localized blisters, primarily on skin folds, trunk, and upper limbs, accompanied by fever at the onset of treatment (acute generalized pustular exanthema). The skin becomes sensitive to light.Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.Stop taking Geloprofen if you experience these symptoms and seek medical attention immediately. See section 2.

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

• Allergic reactions such as skin rash, facial swelling, hives, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blistering or peeling of the skin.
• Intense or persistent headache.
• Yellow skin discoloration (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the extremities or fluid accumulation in arms or legs.
• Flat, red, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. 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 side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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

Do not use this medication if you observe signs of deterioration; for example, if it isclumped or observes color alterations.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Geloprofen Rapid

• The active ingredient is ibuprofen. Each blister pack contains 400 mg of ibuprofen (provided by 683.34 mg of ibuprofen lysine).
• The other components (excipients) are beta-cyclodextrin (E-459), lemon flavor (contains tartrazine (E-102), cornstarch, and glucose derived from corn maltodextrin), sodium saccharin, sodium cyclamate, sodium citrate (E-331), and sucrose.

Appearance of the product and content of the packaging

Fine, homogeneous powder, white in color, and lemon-scented. It is presented in blister packs of 4, 12, or 20 single-dose units.

T itle of the marketing authorization and responsible manufacturer

Title of the marketing authorization:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 - Barcelona (Spain)

Responsible manufacturer:

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. - FARDI

Grassot, 16; 08025- Barcelona (Spain)

Phone: 932073751

Fax: 934570737

Email: [email protected]

Date of the last review of this leaflet: December 2024

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/