Geloprofen Pediatric 40 mg/ml oral suspension: detailed information

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Geloprofen pediatric 40 mg/ml oral suspension

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

Follow exactly the instructions for use of this medicine provided in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
You should consult a doctor if you worsen or do not improve, if fever persists for more than 3 days or pain for more than 3 days in children and adolescents, or 5 days in adults.

Contents of the leaflet

What Geloprofen pediatric is and what it is used for
What you need to know before taking Geloprofen pediatric
How to take Geloprofen pediatric
Possible adverse effects
How to store Geloprofen pediatric
Contents of the pack and other information

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

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

This medicine is used in children from 3 months of age, adolescents, and adults for the symptomatic relief of mild to moderate occasional pain, as well as for febrile conditions.

2. What you need to know before taking Geloprofen pediatric

Do not take Geloprofen pediatric

if you are allergic (hypersensitive) to ibuprofen or to any of the other components of this medicine (listed in section 6), or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma,
if you have severe liver or kidney disease,
if you have active inflammatory bowel disease,
if you have had a stomach or duodenal ulcer (peptic ulcers) or bleeding (two or more episodes of confirmed ulcer or bleeding), or have experienced a perforation of the digestive tract,
if you are vomiting blood,
if you have black stools or bloody diarrhea,
if you have cerebral haemorrhage (cerebrovascular haemorrhage) or any other active bleeding or blood clotting disorders, or if you are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used simultaneously, your doctor will perform blood clotting 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 oedema (fluid retention),
if you have or have had heart problems or high blood pressure,
if you suffer from 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 diagnosis more 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 with 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 monitoring. Your doctor will advise you on how often these checks should be done,
if you experience symptoms of dehydration, e.g. severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure due to dehydration,
if you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when high doses or prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine,
if you are taking medicines that affect blood clotting, such as oral anticoagulants (e.g. warfarin) or antiplatelet agents (e.g. acetylsalicylic acid). You should also mention the use of other medicines 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 condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions (see section 4 “Possible side effects”),
if you are taking diuretics (medicines to increase urine production), as your doctor should monitor your kidney function,
if you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect various vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria) may occur,
if you have acute intermittent porphyria (a metabolic disorder affecting your blood that may cause symptoms such as reddish urine, blood in urine or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate,
if you suffer from headaches after prolonged treatment, you should not take higher doses of the medicine. If this situation occurs or is suspected, seek medical advice and discontinue treatment. Medication-overuse headache should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache medicines,
allergic reactions may occur with this medicine,
your doctor will perform closer monitoring if you receive ibuprofen after major surgery,
it is advisable not to take this medicine if you have chickenpox.
If you have an infection; see the “Infections” heading below.
Signs of allergic reaction to this medicine, such as breathing difficulties, swelling of the face and neck area (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 notice any of these signs.

Infections

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

Skin reactions

Serious skin reactions have been reported with ibuprofen treatment. Stop taking ibuprofen and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.

Serious 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. Discontinue treatment with Geloprofen pediatric and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

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

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses and for prolonged periods. Do not exceed the recommended dose or duration of treatment.

Discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

you have heart problems including heart failure, angina (chest pain), have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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 smoke.

Also, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution in 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 to adults

Elderly patients

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

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

Interference with laboratory tests

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Other medicines and Geloprofen pediatric

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained 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 inhibitors, as this could increase the risk of gastrointestinal ulcer and bleeding,
antiplatelet agents (prevent blood clot or thrombus formation in blood vessels) such as ticlopidine,
anticoagulant medicines, e.g. to treat or prevent blood clotting (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 (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine,
mifepristone (used to induce abortion),
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 output), as they may increase the risk of renal toxicity,
pentoxifylline (used to treat intermittent claudication),
probenecid (used in patients with gout or together with penicillin in infections),
quinolone antibiotics such as norfloxacin,
sulfinpyrazone (for gout),
sulfonylureas such as tolbutamide (for diabetes), which could cause hypoglycaemia,
tacrolimus or cyclosporine (used in organ transplants to prevent rejection),
zidovudine (an anti-HIV medicine),
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,
CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections),
tacrine (a medicine for Alzheimer's disease),
baclofen: baclofen toxicity may develop after starting ibuprofen treatment,
ritonavir: may increase plasma concentrations of NSAIDs.

Other medicines may also affect or be affected by ibuprofen treatment. Therefore, 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.

Alcohol consumption is not recommended 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, think you may be pregnant, or are planning 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 on precautions during pregnancy and in women of childbearing age).

Because administration of medicines like ibuprofen has been associated with an increased risk of congenital abnormalities or miscarriage, its use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Do not take Geloprofen pediatric during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour more than expected. Do not take Geloprofen pediatric during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible 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 lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Female fertility

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with reduced fertility. This effect is reversible upon discontinuation of the medicine.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances or other symptoms while taking this medicine, you should not drive or operate dangerous machinery.

If you take only a single dose or use the medicine 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 flavour).

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

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

This medicine contains 1 mg of sodium benzoate per millilitre. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

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

Benzyl alcohol has been associated with the risk of serious adverse effects including breathing problems ("gasping syndrome") in children.

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

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

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).

3. How to take Geloprofen Pediatric

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

For occasional use only and for a limited period.

It is important to use the lowest dose that relieves/controls the pain, and you should not take this medicine 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 immediately 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. Generally, the recommended daily dose is 20 to 30 mg of ibuprofen per kg of body 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 body weight. The interval between doses will depend on the course of symptoms, but must never be less than 4 hours.

Its use is not recommended in children under 3 months of age or weighing less than 5 kg.

The recommended dose in case of pain and fever is:

IBUPROFEN DOSING IN CHILDREN
Age/Weight	Frequency	Dosage	Maximum daily dose
3 to 6 months* Approx. 5 – 7.6 kg	3 times daily	50 mg (1.25 ml)/dose	150 mg (3.75 ml)
6 – 12 months* Approx. 7.7 – 9 kg	3 to 4 times daily	50 mg (1.25 ml)/dose	150–200 mg (3.75–5 ml)
1 – 3 years* Approx. 10 – 15 kg	3 to 4 times daily	100 mg (2.5 ml)/dose	300–400 mg (7.5–10 ml)
4 – 6 years Approx. 16 – 20 kg	3 to 4 times daily	150 mg (3.75 ml)/dose	450–600 mg (11.25–15 ml)
7 – 9 years Approx. 21 – 29 kg	3 to 4 times daily	200 mg (5 ml)/dose	600–800 mg (15–20 ml)
10 – 12 years Approx. 30 – 40 kg	3 to 4 times daily	300 mg (7.5 ml)/dose	900–1200 mg (22.5–30 ml)

The use of this medicine in children under 2 years of age must always be under medical advice.

Adults and adolescents (over 12 years of age)

Take a dose of 5–10 ml (equivalent to 200–400 mg of ibuprofen) every 4 or 6 hours as needed, without exceeding 1200 mg of ibuprofen within a 24-hour period.

Due to the amount of ibuprofen contained in this medicine, it is recommended to use other more appropriate formulations for the treatment of these patients.

Patients with kidney and/or liver disease

If you suffer from kidney and/or liver disease, you must reduce the dose and consult your doctor.

Elderly patients

If you are over 65 years of age, the dosage should be determined by your doctor, as it may be necessary to reduce the usual dose.

Elderly individuals are often more susceptible to the effects of this medicine, so the dose may sometimes need to be reduced. Consult your doctor.

For occasional use and for a limited period only.

Consult your doctor if symptoms persist or worsen during treatment.

For children aged 3 to 5 months, consult your doctor if symptoms worsen or persist after 24 hours.

For children from 6 months of age and adolescents up to 18 years, consult your doctor if it is necessary to administer the medicine 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 your doctor.

For oral administration.

Administration method using the syringe

Shake the bottle well.
Remove the cap by pressing down and turning counterclockwise.
Insert the syringe firmly into the port (hole) located in the neck of the bottle.
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.
Return the bottle to its upright position and remove the syringe from the port by gently twisting it.
Place the tip of the syringe into the child's mouth. Slowly press the plunger to gently release the suspension. Replace the cap after use. Wash the syringe with lukewarm water and allow it to dry. Keep the syringe out of sight and reach of children.

In patients experiencing stomach discomfort, it is recommended to administer the medicine during meals.

If you take more Geloprofen pediatric than 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 at 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you have taken more Geloprofen pediatric than you should, or if a child has accidentally ingested the medicine, consult a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the necessary measures.

Symptoms of overdose include nausea, vomiting, abdominal pain (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements, or more rarely, diarrhea. At higher doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (elevated sodium levels in blood), prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, and worsening of asthma in asthmatic patients have been reported. Other symptoms include drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low potassium levels in blood, chills, and breathing difficulties.

If you forget to take or give your child Geloprofen pediatric

Do not take or administer a double dose to make up for a missed dose. If you forget to take or administer a dose, take it as soon as you remember, and then take the next dose at the previously indicated interval.

If you stop treatment with Geloprofen pediatric

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

The frequencies shown below refer to short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

Frequent adverse effects (may affect up to 1 in 10 patients)

Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools or blood in vomit which may exceptionally lead to anaemia, mouth 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 bowel disease (colitis or Crohn's disease).
Skin redness, itching or swelling of the skin, purpura (purple spots on the skin), skin reactions due to light exposure, hypersensitivity.
Disorders of the central nervous system, such as paraesthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), headache and drowsiness, insomnia, anxiety, agitation, irritability or tiredness.
Auditory 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 (pulsations or noises in the ear).
Reversible toxic amblyopia, optic neuritis.
Liver injury, oedema.
Increased blood urea concentrations, pain in the sides and/or abdomen, blood in urine and fever may be signs of kidney damage (papillary necrosis).
Increased blood uric acid concentrations.
Decreased haemoglobin levels.

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

Pancreatitis, oesophagitis and formation of intestinal diaphragm-type strictures.
Heart failure, heart attack, hypertension and swelling of face and hands (oedema).
Psychotic-type reactions, depression.
Elevated blood pressure, vasculitis.
Palpitations.
Hepatic dysfunction, liver damage (initial signs may include skin discoloration), especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis).
Very serious blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple lesions, mainly on the trunk) and toxic epidermal necrolysis / Lyell's syndrome (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion), hair loss (alopecia).
In case of severe generalized hypersensitivity reaction, swelling of the face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock) may occur, as well as aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria).
Symptoms of aseptic meningitis have been observed during treatment with ibuprofen, particularly in patients with some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which constitutes a risk factor. The observed symptoms of aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation.
Problems in 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) and agranulocytosis (severe decrease in neutrophils), aplastic anaemia (failure of the bone marrow to produce various types of blood cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds and skin bleeding. In such cases, treatment must be stopped immediately and a doctor consulted. Do not self-medicate with analgesics or antipyretic medicines.
Interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling) and renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea. If you experience any of the symptoms mentioned above or feel depressed, stop taking Junifen and consult your doctor immediately, as these may be early signs of kidney damage or failure.
Exacerbation of infection-related inflammation has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, prompt medical attention is recommended.

Frequency not known (cannot be estimated from available data)

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cell).
Widespread red, scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen if you experience these symptoms and seek immediate medical attention. See also section 2.
Skin becomes sensitive to light.
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

Rare but serious allergic reactions such as worsening of asthma, wheezing or unexplained shortness of breath, swelling of the face, tongue or throat, chest tightness or breathing difficulty, rapid heartbeat, reduced blood pressure causing shock. These disorders may occur even when using this medicine for the first time. If you notice any of these symptoms, consult a doctor immediately.
Signs of intestinal bleeding: vomiting blood or material resembling coffee grounds, blood in stools or bloody diarrhoea.
Severe stomach pain.
Serious skin reactions: blisters, rash or extensive skin peeling.
Severe or persistent headache.
Yellowing of the skin (jaundice).
Signs of severe hypersensitivity (see above in this section).
Swelling of limbs or fluid accumulation in arms or legs.
Flat, non-elevated red spots, target-shaped or circular, on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Widespread skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Geloprofen Pediatric

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

After opening the container, store below 30°C for a maximum of 6 months.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Package contents and additional information

Composition of Geloprofen paediatric

The active substance 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, maltitol liquid (E-965), glycerol (E-422), strawberry flavour, thaumatin (E-957), purified water.

Appearance of the product and contents of the pack

Geloprofen paediatric is an oral, viscous suspension, white or almost white in colour, with a strawberry odour. It is supplied in 150 ml amber-coloured PET bottles with a child-resistant closure.

The package includes a 5 ml graduated syringe.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028, Barcelona (Spain)

Manufacturer

DELPHARM BLADEL BV
Industrieweg 1
5531 AD Bladel
The Netherlands

ZINEREO PHARMA, S.L.U.
A Relva - Torneiros, s/n, O Porriño,
36410 Pontevedra
Spain

FARMALIDER, S.A.
C/ Aragoneses 2 - Polígono Industrial Alcobendas
28108 Alcobendas
Madrid
Spain

FARMASIERRA MANUFACTURING S.L
Ctra de Irun Km 26,200
28700 (San Sebastian de los Reyes)
Madrid
Spain

EDEFARM S.L.
Polígono Industrial Enchilagar del Rullo, 117
Villamarchante, Valencia, 46191, Spain

Local Representative

Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 – Barcelona (Spain)

Date of latest revision of this leaflet: November 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es