GELOPROFEN PEDIATRIC 40 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Geloprofen Pediatric 40 mg/ml Oral Suspension

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package 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 side effects not listed in this package leaflet. 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 3 days in children and adolescents or 5 days in adults.

Package Leaflet Contents

1. What Geloprofen Pediatric is and what it is used for
2. What you need to know before taking Geloprofen Pediatric
3. How to take Geloprofen Pediatric
4. Possible side effects
5. Storage of Geloprofen Pediatric
6. Package Contents and Additional Information

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

Geloprofen Pediatric contains ibuprofen as the active ingredient and belongs to a group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

This medication is used in children from 3 months, adolescents, and adults for the symptomatic relief of occasional mild or moderate pain, as well as in febrile states.

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

Do not take Geloprofen pediatric

• if you are allergic (hypersensitive) to ibuprofen or to any of the other components of this medicine (included in section 6) or to other medicines of the non-steroidal anti-inflammatory group (NSAIDs) or to aspirin. Reactions that indicate allergy could 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 an active inflammatory bowel disease,
• if you have had an ulcer or bleeding (two or more episodes of ulcer or confirmed bleeding) of the stomach or duodenum (peptic ulcers) or have suffered a perforation of the digestive tract,
• if you vomit blood,
• if you have black stools or bloody diarrhea,
• if you have cerebral hemorrhage (cerebrovascular hemorrhage) or other active bleeding 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, the doctor will perform blood coagulation tests,
• if you have severe heart failure,
• if you have significant dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
• if you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor, pharmacist, or nurse 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,
• if you are receiving treatment with this medicine as it may mask fever, which is an important sign of infection, making its diagnosis difficult,
• you are taking another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib), as they should not be taken together (see section "Use of other medicines"),
• 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), it is possible that your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks,
• if you experience symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could cause kidney failure as a consequence of dehydration,
• 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 higher when using high doses and prolonged treatments, 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 medicine,
• if you take medications that alter blood coagulation, such as oral anticoagulants (e.g. warfarin) and antiplatelet agents (e.g. acetylsalicylic acid). You should also discuss the use of other medications that could increase the risk of such bleeding, such as corticosteroids (e.g. prednisolone) and selective serotonin reuptake inhibitors (medicines for depression),
• if you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-like medications can worsen these conditions (see section 4 "Possible side effects"),
• if you are being treated with diuretics (medicines to increase urine production) because 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 can produce 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. If this situation is experienced or suspected, medical advice should be obtained and treatment should be interrupted. The diagnosis of medication overuse headache should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache medications,
• it is possible that allergic reactions may occur with this medicine,
• the doctor will perform stricter control 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" heading later.
• Ibuprofen has been reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Geloprofen pediatric immediately and contact your doctor or medical emergency service immediately if you observe any of these signs.

Infections

Geloprofen pediatric may hide the signs of an infection, such as fever and pain. Consequently, Geloprofen pediatric 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.

Skin reactions

Severe skin reactions have been reported in association with ibuprofen treatment. Stop taking ibuprofen and go to the doctor immediately if you present any skin rash, lesions on 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.

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. Interrupt treatment with Geloprofen pediatric and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increase in the risk of suffering a heart attack or stroke, especially when used in high doses and in prolonged treatments. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA"),
• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker.

Similarly, this type of medicine can produce 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 a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Children and adolescents

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

In case of administration of this medicine in adults

Elderly patients

Elderly patients have a higher risk of adverse events when taking NSAIDs, especially of a stomach and intestinal type. See section 4 "Possible side effects" for more information.

Patient with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment.

Interference with analytical tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Other medicines and Geloprofen pediatric

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, even those purchased without a prescription.

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

• other non-steroidal anti-inflammatory drugs such as aspirin and COX-2, as the risk of ulcer and gastrointestinal bleeding may increase,
• antiplatelet agents (which prevent the formation of thrombi or clots in blood vessels) such as ticlopidine,
• anticoagulant medicines, e.g. to treat coagulation problems/prevent coagulation, (e.g. acetylsalicylic acid, warfarin, ticlopidine),
• cholestyramine (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 (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine,
• mifepristone (abortion inducer),
• digoxin and cardiotonic 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 production), as they may increase the risk of kidney toxicity,
• pentoxifylline (to treat intermittent claudication),
• probenecid (used in patients with gout or with penicillin in infections),
• quinolone antibiotics such as norfloxacin,
• sulfinpyrazone (for gout),
• sulfonylureas such as tolbutamide (for diabetes), as they may cause hypoglycemia,
• tacrolimus or cyclosporin (used in organ transplants 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 fluticonazole (used to treat fungal infections),
• tacrine (a medicine for Alzheimer's disease),
• baclofen: baclofen toxicity may develop after starting treatment with ibuprofen,
• ritonavir: may increase the plasma concentrations of NSAIDs.

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

Taking Geloprofen pediatric with food, drinks, and alcohol

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

It is not recommended to drink alcohol during treatment, as it increases the risk of gastrointestinal or central nervous system side effects.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Because the administration of ibuprofen-like medicines 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.

Do not take Geloprofen pediatric if you are in the last 3 months of pregnancy, as it could harm the fetus or cause problems during delivery. It can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take Geloprofen pediatric during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you will take the minimum dose for the shortest time possible. From the 20th week of pregnancy, Geloprofen pediatric may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of the fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Breastfeeding

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

Female fertility

For patients of childbearing age, it should be taken into account that ibuprofen-like medicines have been associated with a decrease in fertility. This effect is reversible upon discontinuation of the medicine.

Driving and using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medicine, you should not drive or use hazardous machinery.

If you only take one dose of the medicine or take it for a short period, it is not necessary to take special precautions.

Geloprofen pediatric contains maltitol liquid (E-965), sodium, sodium benzoate (E-211), and benzyl alcohol (in the aroma).

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

Patients on low-sodium diets should note that this medicine contains 5.79 mg (0.25 mmol) of sodium per milliliter.

This medicine contains 1 mg of sodium benzoate per milliliter.

This medicine contains 0.0002 mg/ml of benzyl alcohol (in the aroma). Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (metabolic acidosis).

3. How to Take Pediatric Geloprofen

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

For occasional use only and for a limited period.

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

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).

Use in Children

The recommended dose of ibuprofen depends on the child's age and weight. As a general rule, the recommended daily dose is 20 to 30 mg of ibuprofen per kg of the child's weight, divided into three or four individual doses. It is recommended not to exceed the maximum daily dose of 40 mg of ibuprofen per kg of weight. The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours.

Use in children under 3 months or weighing less than 5 kg is not recommended.

The recommended dose for pain and fever is:

• The use of this medication in children under 2 years of age should always be under medical advice.

Adults and adolescents (over 12 years)

A dose of 5-10 ml (equivalent to 200-400 mg of ibuprofen) should be taken every 4 or 6 hours, if necessary, without exceeding 1200 mg of ibuprofen in a 24-hour period.

Due to the amount of ibuprofen contained in this medication, the use of other more suitable presentations for the treatment of these patients is recommended.

Patient with kidney and/or liver disease

If you have kidney and/or liver disease, you should reduce the dose and consult your doctor.

Elderly patients

If you are over 65 years old, the amount to be taken should be established by your doctor, as it may be necessary to reduce the usual dose.

Elderly people are often more prone to its effects, so sometimes the dose needs to be reduced. Consult your doctor.

For occasional use and for a limited period.

Consult your doctor if during the treatment period the symptoms persist or worsen.

Children from 3 to 5 months, consult a doctor if symptoms worsen or if after 24 hours they persist.

In children from 6 months of age and adolescents up to 18 years, consult a doctor if it is necessary to administer the medication for more than 3 days or if symptoms worsen.

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

For oral administration.

Administration method with the syringe

1. Shake the bottle well.
2. Remove the cap from the bottle by pressing it down and twisting it counterclockwise.
3. Firmly insert the syringe into the port (hole) located on the neck of the bottle.
4. To fill the syringe, invert the bottle. While holding the syringe, gently pull the plunger down until the suspension reaches the appropriate mark on the syringe.
5. Return the bottle to its normal position and remove the syringe from the port by gently twisting it.
6. Place the end of the syringe in the child's mouth. Slowly press the plunger to release the suspension gently. Replace the cap after use. Wash the syringe with warm water and let it dry. Keep it out of sight and reach of children.

In patients with stomach upset, it is recommended to administer the medication during meals.

If you take morePediatric Geloprofenthan you should

If you accidentally take or administer a dose of ibuprofen higher than recommended, consult your doctor or pharmacist immediately or call the toxicology information service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and the prospectus of the medication to the healthcare professional.

If you have taken more Pediatric Geloprofen than you should, or if a child has accidentally ingested the medication, consult immediately with a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose include nausea, vomiting, abdominal pain, (which can contain bloody stools), headache, ringing in the ears, confusion, and involuntary eye movement or, more rarely, diarrhea. At high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (elevated sodium levels in the blood), increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatics, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties.

If you forget to take or give your childPediatric Geloprofen

Do not take or administer a double dose to make up for forgotten doses. If you forget to take or administer a dose, do so as soon as you remember and then take the next dose according to the previously indicated administration interval.

If you stop treatment withPediatric Geloprofen

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

4. Possible Adverse Effects

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

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

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1200 mg of oral ibuprofen:

Common Adverse Effects(may affect up to 1 in 10 patients)

• Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools or vomiting with blood that can cause anemia in exceptional cases, oral ulcers, dizziness or feeling of instability, fatigue.

Uncommon Adverse Effects(may affect up to 1 in 100 patients)

• Gastritis, peptic ulcers, inflammation of the oral mucosa with ulcer formation, gastrointestinal perforations, worsening of existing intestinal disease (colitis or Crohn's disease).
• Redness of the skin, itching or swelling of the skin, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity.
• Central nervous system disorders, such as paresthesia (sensation of numbness, tingling, etc., more frequent in hands, feet, arms, or legs), headache, and drowsiness, insomnia, anxiety, agitation, irritability, or fatigue.
• Hearing disorders.
• Visual disturbances.
• Rhinitis (inflammation of the nasal mucosa).

Rare Adverse Effects(may affect up to 1 in 1,000 people)

• Disorientation or confusion, dizziness.
• Tinnitus (beats or sounds in the ear).
• Toxic amblyopia, optic neuritis.
• Liver damage, edema.
• Increased urea concentrations in the blood, pain in the sides and/or abdomen, blood in the urine, and fever may be signs of kidney damage (papillary necrosis).
• Increased uric acid concentrations in the blood.
• Decreased hemoglobin levels.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Pancreatitis, esophagitis, and formation of intestinal stenosis of the diaphragm type.
• Heart failure, heart attack, hypertension, and swelling of the face and hands (edema).
• Psychotic reactions, depression.

• Hypertension, vasculitis.

• Palpitations.
• Liver dysfunction, liver damage (the first signs may be skin discoloration), especially during long-term treatment, liver failure, acute liver inflammation (hepatitis).
• Severe blistering reactions such as 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/Lyell syndrome (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), erythema multiforme (skin lesion), hair loss (alopecia).
• In case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• Symptoms of aseptic meningitis have been observed during ibuprofen treatment, 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.
• Problems with blood cell production: decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (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 ulcers in the mouth, pseudo-flu symptoms, extreme fatigue, nosebleeds, and skin bleeding. In these cases, treatment should be stopped immediately, and a doctor should be consulted. Do not self-medicate with pain relievers or antipyretic medications.
• Interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and swelling of the body), and kidney failure (sudden loss of kidney function), acute kidney failure, and papillary necrosis (especially with prolonged use) associated with an increase in urea. If you experience any of the symptoms mentioned above or if you have a feeling of sadness, stop taking Junifen and consult your doctor immediately, as it may be the first signs of kidney damage or failure.
• An exacerbation of inflammation-related infections has been observed with the use of NSAIDs. If signs of infection or worsening of symptoms during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

Frequency Not Known(cannot be estimated from available data)

• 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 scaly rash, with bumps under the skin and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen if you present these symptoms and seek medical attention immediately. See also section 2.
• The skin becomes sensitive to light.
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

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

• Rare but severe allergic reactions such as worsening of asthma, wheezing, or unexplained shortness of breath, swelling of the face, tongue, or throat, wheezing in the chest, or difficulty breathing, rapid heartbeat, decreased blood pressure that causes shock. These disorders can occur even when using this medication for the first time. If you observe any of these symptoms, consult a doctor immediately.
• Signs of intestinal bleeding: vomiting blood or coffee grounds-like, blood in stools, or bloody diarrhea.
• Severe stomach pain.
• Severe skin reactions: blisters or rash or significant skin peeling.
• Severe headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Reddish, non-elevated, target-like, or circular spots 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 or pharmacist, 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, ww.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Pediatric Geloprofen

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Once the package is opened, store below 30°C for a maximum of 6 months.

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

Medications should not be thrown away through the sewers or in the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Pediatric Geloprofen

• The active ingredient is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen.
• The other components are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin (E-954), sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), glycerol (E-422), strawberry flavor, thaumatin (E-957), purified water.

Product Appearance and Package Contents

Pediatric Geloprofen is a viscous oral suspension, white or almost white in color, and with a strawberry flavor. It is presented in 150 ml PET containers, with a child safety cap.

It contains a 5 ml graduated syringe.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028, Barcelona (Spain)

Manufacturer

DELPHARM BLADEL BV

Industrieweg 1

5531 AD Bladel

Netherlands

or

ZINEREO PHARMA, S.L.U.

A Relva - Torneiros, s/n, O Porriño,

36410 Pontevedra

Spain

or

FARMALIDER, S.A.

c/ Aragoneses 2- Polígono Industrial Alcobendas

28108- Alcobendas

Madrid

Spain

Or

FARMASIERRA MANUFACTURING S.L

Ctra de Irun Km 26,200

28700 (San Sebastian de los Reyes)

Madrid

Spain

Or

EDEFARM S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191, Spain

Date of the last revision of this prospectus: November 2024

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