Geloprofen pediatrico 40 mg/ml suspension oral

Leaflet: information for the user

Geloprofen pediatric 40 mg/ml oral suspension

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 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 3 days in children and adolescents or 5 days in adults.

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

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

3.How to take Geloprofen pediatric

4.Possible side effects

5.Storage of Geloprofen pediatric

6.Contents of the package and additional information

Geloprofen pediatric contains ibuprofen as the active ingredient and belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

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

Do not take Geloprofen pediatric

• if you are allergic (hypersensitive) to ibuprofen or any of the other components of this medicine (listed in section 6) or to other nonsteroidal 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 an active inflammatory bowel disease,
• if you have had two or more episodes of stomach or duodenal ulcers or bleeding confirmed, or if you have had a perforation of the digestive tract,
• if you vomit blood,
• if you have black stools or bloody diarrhea,
• if you have a cerebral hemorrhage (cerebrovascular accident) or other active bleeding or coagulation disorders, or if you are taking anticoagulants (medicines used to "thin" the blood). If necessary, your doctor will perform blood coagulation tests,
• if you have severe heart failure,
• if you have significant dehydration (caused by vomiting, diarrhea, or inadequate 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, an important sign of infection, making its diagnosis difficult,
• if 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), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done,
• if you present symptoms of dehydration, e.g. 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 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 disease, and in elderly patients. In these cases, your doctor may consider associating a stomach protector medicine,
• if you are taking anticoagulant medicines such as warfarin and antiplatelet agents such as acetylsalicylic acid. You should also inform your doctor about the use of other medicines that may increase the risk of bleeding, such as corticosteroids (e.g. prednisolone) and selective serotonin reuptake inhibitors (SSRIs) used for depression,
• 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-type medicines may worsen these conditions (see section 4 "Possible side effects"),
• if you are receiving diuretic treatment (medicines 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 urine discoloration, blood in urine, or liver disease), so that 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 medicineIf this situation occurs or is suspected, seek medical advice and discontinue treatment. 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 medicines,
• it is possible that allergic reactions may occur with this medicine,
• your doctor will perform a more strict 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 heading "Infections" below.
• Signs of allergic reaction to this medicine, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using Geloprofen pediatric immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Infections

Geloprofen pediatric may mask the signs of an infection, such as fever and pain. Consequently, Geloprofen pediatric may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay

Skin reactions

Severe skin reactions associated with ibuprofen treatment have been reported. Stop taking ibuprofen and see your doctor immediately if you present 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.

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 psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue Geloprofen pediatric treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

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

Cardiovascular Precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses and for prolonged periods. Do not exceed the recommended dose or treatment duration.

You should inform 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, coronary bypass surgery, peripheral artery disease (problems with circulation 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, a family history of heart disease or stroke, or if you are a smoker.

These types of medicines may also 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 asthma, bronchial asthma, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in these 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

Older patients

Older patients are at a higher risk of adverse events when taking NSAIDs, especially of gastrointestinal and intestinal origin. See section 4 "Possible side effects" for more information.

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

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, 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 used recently, or may need to use any other medicine, including those purchased without a prescription.

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

• other nonsteroidal anti-inflammatory drugs such as aspirin, and COX-2 inhibitors, as the risk of gastrointestinal ulcers and bleeding may increase,
• antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine,
• anticoagulant medicines (used to prevent blood clotting) such as acetylsalicylic acid, warfarin, ticlopidine,
• cholesterol-lowering medicine (cholestyramine),
• selective serotonin reuptake inhibitors (SSRIs) used for depression,
• 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 medicine,
• mifepristone (abortion inducer),
• digoxin and cardiac glycosides (used to treat heart disorders),
• 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 the risk of kidney toxicity may increase,
• pentoxifylline (used to treat intermittent claudication),
• probencid (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),
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan),
• thrombolytic agents (medicines that dissolve blood clots),
• aminoglycoside antibiotics such as neomycin,
• herbal extracts: from the Ginkgo biloba tree,
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections),
• tacrine (used to treat Alzheimer's disease),
• baclofen: toxicity may develop after starting ibuprofen treatment,
• ritonavir: may increase the plasma concentrations of NSAIDs.

Other medicines may also affect or be affected by ibuprofen treatment. 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 food, or immediately after eating, to reduce the possibility of stomach discomfort.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 fertile women).

Due to the association of ibuprofen-type medicines with an increased risk of congenital anomalies/abortions, it is not recommended to administer them during the first and second trimesters of pregnancy, unless strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

Do not take Geloprofen pediatric if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do 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 should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Geloprofen pediatric may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer 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 fertile women, it should be noted that ibuprofen-type medicines have been associated with a decrease in the ability to conceive.This effect is reversible upon discontinuing the administration of the medicine.

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 the medicine or take it for a short period, no special precautions are necessary.

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 are intolerant to certain sugars, consult with them before taking this medicine.

Patients with 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 associated with the risk of severe adverse effects, including respiratory problems ("choking") in children.

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

This medicine should not be used for more than a week in children under 3 years old unless your doctor or pharmacist has recommended it.

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

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

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.

For occasional use only and for a limited period.

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

You should use the most effective dose at the lowest dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children

The recommended dose of ibuprofen depends on the age and weight of the child. Generally, 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 it will never be less than 4 hours.

It is not recommended to use in children under 3 months or with a weight less than 5 kg.

The recommended dose in case of pain and fever is:

*The use of this medication in children under 2 years will always be done under medical advice.

Adults and adolescents (over 12 years)

Take a dose of 5-10 ml (equivalent to 200-400 mg of ibuprofen) 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, it is recommended to use other presentations more suitable for the treatment of these patients.

Patients with kidney and/or liver diseases

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

Older adults

If you are over 65 years old, the amount to be taken should be established by your doctor, as there may be a possibility of needing a reduction in the usual dose.

Older adults are more prone to its effects, so sometimes you may need to reduce the dose. Consult your doctor.

For occasional use only and for a limited period.

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

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

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

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

For oral administration.

Method of administration with the syringe

1. Shake the bottle well.
2. Remove the cap from the bottle by pressing it down and turning it counterclockwise.
3. Insert the syringe firmly into the port (hole) located at the neck of the bottle.
4. To fill the syringe, invert the bottle. While holding the syringe, pull the plunger down slowly 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 turning it gently.
6. Place the tip of the syringe in the child's mouth. Press the plunger slowly to release the suspension gently. Replace the cap after use. Wash the syringe with warm water and let it dry. Store it out of sight and reach of children.

In patients withstomach discomfortit is recommended to administer the medication during meals.

If you take moreGeloprofen pediatricthan you should

If you take or accidentally administer a dose of ibuprofen greater than the recommended dose, 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 bring the packaging and the leaflet of the medication to the healthcare professional.

If you have taken moreGeloprofen pediatricthan 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.

The symptoms of overdose include nausea, vomiting, abdominal pain (which may contain blood),headache, ringing in the ears, confusion, and involuntary movement of the eyes or less frequently diarrhea. At high doses, vertigo, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (elevated sodium levels in the blood), increased prothrombin time / INR, acute renal failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatics, 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 problems.

If you forgot to take or give your childGeloprofen pediatric

Do not take or administer a double dose to compensate for the missed doses. If you forget to take or administer a dose, take it as soon as you remember and then take the next dose according to the previous administration interval.

If you interrupt treatment withGeloprofen pediatric

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The incidence of side effects is lower in short-term 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 1,200 mg of oral ibuprofen:

Common side effects(may affect up to 1 in 10 patients)

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

Uncommon side effects(may affect up to 1in 100 patients)

• Gastritis, peptic ulcers, inflammation of the buccal 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 influenced by light, hypersensitivity.
• Central nervous system disorders, such as paresthesia (numbness, tingling, aching, etc. more frequent in hands, feet, arms, or legs), headache, and somnolence, insomnia, anxiety, agitation, irritability, or fatigue.
• Auditory disorders.
• Vision disturbances.
• Rhinitis (inflammation of the nasal mucosa).

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

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

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

• Pancreatitis, esophagitis, and formation of diaphragmatic intestinal stenosis.
• Cardiac failure, myocardial infarction, hypertension, and facial and hand edema.
• Psychotic reactions, depression

• High blood pressure, vasculitis

• Palpitations.
• Liver dysfunction, liver damage (the first signs may be skin discoloration), especially during long-term treatment, liver insufficiency, acute liver inflammation (hepatitis).
• Very severe skin reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis / Lyell syndrome (erosions in mucous membranes and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesion), hair loss (alopecia).
• In case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx, dyspnea (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).
• Severe meningitis-like symptoms 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 (decreased neutrophils), agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow insufficiency 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, flu-like symptoms, extreme fatigue, nasal and cutaneous bleeding. In these cases, discontinue treatment immediately and consult a doctor. Do not self-medicate with analgesics or antipyretics.
• Interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and acute renal failure, and papillary necrosis (especially in prolonged use) associated with increased urea. If you experience any of the symptoms mentioned above or feel sad, stop taking Junifen and consult your doctor immediately, as it may be the first signs of kidney damage or failure.
• Exacerbation of inflammation related to infections coinciding with the use of NSAIDs. If there are signs of infection or they worsen during ibuprofen use, it is recommended to consult a doctor as soon as possible.

Unknown frequency(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 located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See section 2.
• The skin becomes sensitive to light.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

If any of the following side effects appear, discontinue treatment and seek immediate medical attention:

• Rare but severe allergic reactions such as asthma exacerbation, wheezing, or unexplained shortness of breath, facial swelling, tongue, or throat, chest tightness, or difficulty breathing, rapid heartbeat, reduced blood pressure that causes shock. These disorders may occur even when using this medicine for the first time. If you observe any of these symptoms, consult a doctor immediately.
• Signs of intestinal bleeding: vomiting blood or coffee ground-like vomit, blood in stools or diarrhea with blood.
• Severe abdominal pain.
• Severe skin reactions: blisters, rash, or significant skin peeling.
• Intense or persistent headache.
• Yellow skin discoloration (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the extremities or accumulation of fluid in the arms or legs.
• Reddish spots not elevated, in the form 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 flu-like symptoms (dermatitis exfoliativa, 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 (generalized acute pustular exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use,www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Once the container 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 container after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Geloprofen pediatric

• 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, taumatine (E-957), purified water.

Appearance of the product and contents of the packaging

Geloprofen pediatric is an oral, viscous suspension, white or almost white in color, and with a strawberry odor. It is presented in PET topaz-colored containers of 150 ml, equipped with a child-resistant closure.

It contains a 5 ml graduated syringe.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028, Barcelona (Spain)

Responsible for manufacturing

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- Industrial Park Alcobendas

28108- Alcobendas

Madrid

Spain

or

FARMASIERRA MANUFACTURING S.L

Ctra de Irun Km 26,200

28700 (San Sebastian de los Reyes)

Madrid

Spain

Last review date of this leaflet: November 2024

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