GELOPROFEN RAPID 400 MG ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Geloprofen Rapid 400 mg Powder for Oral Suspension

Ibuprofen (Lysine)

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

Follow the instructions for administration of the medicine contained in this leaflet or as indicated 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 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 your symptoms worsen or do not improve, if the fever persists for more than 3 days or the pain for more than 5 days.

Contents of the Package Leaflet

1. What is Geloprofen Rapid and what is it used for
2. What you need to know before you start taking Geloprofen Rapid
3. How to take Geloprofen Rapid
4. Possible side effects
5. Storage of Geloprofen Rapid
6. Contents of the pack and further information

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

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

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

You should consult a doctor if your symptoms worsen or do not improve, if the fever persists for more than 3 days or the pain for more than 5 days.

2. What you need to know before you start taking Geloprofen Rapid

Do not take Geloprofen Rapid:

• If you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may be: skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and Precautions

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

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• Inform your doctor if you are already taking this medicine, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake 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 medications can worsen these conditions.
• If you are being treated with diuretics (medicines used to increase urine elimination), 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 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.
• It is possible that allergic reactions may occur with this medicine. 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 Geloprofen Rapid 400 mg powder for oral suspension immediately and contact your doctor or the medical emergency service immediately if you observe any of these signs.
• Severe skin reactions have been reported, 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), 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 stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection: see the "Infections" section below.

It is important that you use the smallest dose that relieves/controls the 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 (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular Precautions

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

Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking this medicine 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 enlargement 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. Also, this type of medication 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 a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen may cause bronchospasm, urticaria, or angioedema in these patients.

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of ibuprofen has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible. It is believed that the risk increases with the dose and duration of treatment.

In the third trimester, the administration of this medicine is contraindicated.

For patients of childbearing age, it should be taken into account that ibuprofen medications have been associated with a decrease in fertility.

Skin Reactions

Severe skin reactions have been reported with Geloprofen. Stop taking Geloprofen Rapid and go to the doctor immediately if you present any skin rash, lesions in the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very severe skin reaction. See section 4.

Infections

Geloprofen may hide the signs of an infection, such as fever and pain. Consequently, Geloprofen may delay the appropriate treatment of the infection, which can 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 having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Other Medicines and Geloprofen Rapid

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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

• Other non-steroidal anti-inflammatory drugs, such as aspirin, as the risk of ulcer and gastrointestinal bleeding may increase.
• Antiplatelet agents (prevent the formation of thrombi or clots in blood vessels) such as ticlopidine.
• Anticoagulant medications (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 in depression).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins, such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides, such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids, such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine elimination), as they may increase the risk of kidney toxicity.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group, such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas, such as tolbutamide (for diabetes), as they may cause hypoglycemia.
• Tacrolimus or cyclosporin (used in organ transplantation to prevent rejection).
• 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 clots).
• Aminoglycoside antibiotics, such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

The intake 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

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

Taking Geloprofen Rapid with Food, Drinks, and Alcohol

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

Pregnancy, Breastfeeding, and Fertility:

Consult your doctor or pharmacist before using any medicine.

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

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

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

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

Driving and Using Machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, do not drive or use hazardous machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary 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.

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

• This medicine contains 2.050 mg of cyclodextrins in each sachet.
• This medicine may cause allergic reactions because it contains tartrazine (E-102). It can cause asthma, especially in patients allergic to acetylsalicylic acid.
• 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 contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
• This medicine contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

3. How to Take Geloprofen Rapid

Follow the administration instructions for this medication contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

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

The recommended dose is:

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

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

• Over 65 years old: the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

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

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

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

Method of administration:

This medication is administered orally.

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

Pour the contents of one sachet 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 noticed.

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 find out about the risk and ask for advice on the measures to be taken or to the Toxicology 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 bloody sputum), diarrhea, drowsiness, headache, ringing in the ears, dizziness, convulsions (mainly in children), loss of consciousness, lack of muscle coordination, 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 coagulation factors. In rare cases, there have been cases of rapid involuntary eye movements, 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 poisoning has occurred, kidney failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatics.

If You Forget to Take Geloprofen Rapid

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 for the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

4. Possible Adverse Effects

Like all medications, Geloprofen can cause adverse effects, although not all people suffer from them.

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

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

• 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 stool, vomiting blood, headache, dizziness or feeling of instability, fatigue.

• Uncommon Adverse Effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, hives, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or burning, more frequent in hands, feet, arms, or legs) and somnolence, 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 anomalies, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by proteins in the urine and swelling of the body), and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Rare Adverse Effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, irritability, nervousness, psychotic reaction, vertigo, tinnitus (ringing or sounds in the ear), hearing impairment, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx, dyspnea, tachycardia, hypotension, anaphylaxis, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been diagnosed with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other adverse effects are decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and skin pallor), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial mouth ulcers, pseudo-flu-like symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

• Very Rare Adverse Effects(may affect up to 1 in 10,000 people): Pancreatitis, prolonged bleeding time, lupus erythematosus (joint pain and fever), severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and lesions of a purplish 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, erythema multiforme. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox. Liver failure, heart failure, myocardial infarction, hypertension. Exacerbation of inflammation-related infections has been observed coinciding 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.

• 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 usually produces bloody diarrhea). 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). 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). The skin becomes sensitive to light. Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome. Stop taking Geloprofen if you experience these symptoms and seek medical attention immediately. See also section 2.

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

• Allergic reactions such as skin rashes, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Significant skin peeling or blistering.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, target-like, or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized 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 Adverse Effects

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

5. Storage of Geloprofen Rapid

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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

Do not use this medication if you notice signs of deterioration, such as if it is clumped or you notice color changes.

Medications should not be thrown away through drains or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Geloprofen Rapid

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

Appearance of the Product and Package Contents

Fine, homogeneous powder, white in color, and lemon scent. It is presented in packages of 4, 12, or 20 single-dose sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 - Barcelona (Spain)

Manufacturer:

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. - FARDI

Grassot, 16; 08025- Barcelona (Spain)

Phone: 932073751

Fax: 934570737

e-mail: lab@fardi.es

Date of the Last Revision of this Prospectus: December 2024

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