Ibufen Infantil 20 mg/ml oral suspension: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibufén Infantil 20 mg/ml oral suspension

ibuprofen

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

Follow exactly the instructions for taking this medicine as described in this leaflet or as advised by your doctor, pharmacist or nurse.

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 reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
You should consult a doctor if your condition worsens or does not improve after 3 days, or after 24 hours in children aged 3 to 5 months.

Contents of the leaflet

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

1. What Ibufén Infantil is and what it is used for

Ibufén Infantil 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 infants over 3 months of age and children up to 12 years of age for the symptomatic relief of mild to moderate occasional pain, as well as for febrile conditions.

2. What you need to know before taking Ibufén Infantil

Do not take Ibufén Infantil

if you are allergic (hypersensitive) to ibuprofen or to any of the other ingredients 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 had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
if you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulants must be used simultaneously, your doctor will perform blood coagulation tests.
if you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
if you have severe heart failure.
if you are in the third trimester of pregnancy.

Warnings and precautions

Tell your doctor:

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 already being treated with this medicine, as it may mask fever, an important sign of infection, making diagnosis more difficult.
If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be performed.
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 greater 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 coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve 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 the 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.
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” section below.
Signs of allergic reaction to this medicine, such as breathing problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibufén Infantil immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

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.

Skin reactions

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

Stop taking Ibufén Infantil and contact your doctor immediately if you develop any skin rash, mucosal lesions, blisters or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

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 or for prolonged periods. Do not exceed the recommended dose or duration of treatment.

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

you have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary 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 ischaemic attack "TIA").
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

In addition, these medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Children and adolescents

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

Precautions during pregnancy and in women of childbearing age

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

Administration of this medicine is contraindicated during the third trimester.

For women of childbearing age, it should be noted that medicines like Ibufén Infantil have been associated with reduced fertility.

Infections

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

Taking Ibufén Infantil with other medicines

Tell 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.

Ibufén Infantil may interact with or be affected by other medicines. For example:

Other non-steroidal anti-inflammatory drugs such as aspirin, which may increase the risk of gastrointestinal ulceration and bleeding.
Antiplatelet agents (which prevent blood clot formation) such as ticlopidine.
Anticoagulant medicines, e.g. for treating coagulation disorders/preventing clotting (e.g. acetylsalicylic acid, warfarin, ticlopidine).
Cholestyramine (used to treat high cholesterol).
Selective serotonin reuptake inhibitors (used in depression).
Lithium (used to treat depression). Your doctor may need to adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to 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).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.
Pentoxifylline (for intermittent claudication).
Probenecid (used in gout patients or together with penicillin in infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycaemia.
Tacrolimus (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 blood 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).

Other medicines may also interact with or be affected by treatment with Ibufén Infantil. Therefore, always consult your doctor or pharmacist before using Ibufén Infantil with other medicines.

Taking ibuprofen may alter the following laboratory tests:

Bleeding time (may be prolonged for up to 1 day after stopping treatment)
Blood glucose concentration (may decrease)
Creatinine clearance (may decrease)
Haematocrit or haemoglobin (may decrease)
Blood levels of blood urea nitrogen and serum levels of creatinine and potassium (may increase)
Liver function tests: increased transaminase values

Inform your doctor if you are scheduled for a clinical test and are taking or have recently taken ibuprofen.

Taking Ibufén Infantil with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

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

Do not take Ibufén Infantil during 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 unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labour more than expected. Do not take Ibufén Infantil 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, take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibufén Infantil 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.

Pregnancy

Because administration of medicines like Ibufén Infantil has been associated with an increased risk of congenital abnormalities/miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless considered strictly necessary. In such cases, the dose and duration should be kept to a minimum.

Administration of Ibufén Infantil is contraindicated during the third trimester.

Fertility

For women of childbearing age, it should be noted that medicines like Ibufén Infantil have been associated with reduced fertility.

Breastfeeding

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

Driving and use of machines

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

Ibuprofen may slow your reaction time, which should be taken into account before performing activities requiring high alertness, such as driving and operating machinery.

This is especially relevant when combined with alcohol.

Ibufén Infantil contains maltitol liquid, sodium, sodium benzoate, benzyl alcohol and ethanol

This medicine contains liquid maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may have a mild laxative effect. Calorific value: 2.3 kcal/g of maltitol.

This medicine contains 3.60 mg of sodium (a key component of table/cooking salt) per millilitre. This corresponds to 0.18% of the maximum daily sodium intake recommended for an adult.

This medicine contains 1 mg of sodium benzoate (E-211) per millilitre.

Sodium benzoate (E-211) may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains 0.00021 mg of benzyl alcohol per millilitre. 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 advised by your doctor.

This product 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, or 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).

This medicine contains less than 0.00007 mg of alcohol (ethanol) per millilitre. The amount of alcohol per dose of this medicine is much less than in 1 ml of beer. The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to take Ibufén Infantil

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

For occasional use only and for limited periods.

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).

Children from 3 months to 12 years:

The recommended dose of ibuprofen depends on the child's age and weight.

Generally, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight, depending on the severity of symptoms, divided into three doses.

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

As a general guide, the doses in the following table may be followed:

<游戏副本>

10.2 ml (204 mg)

DOSE IN CHILDREN
Approximate age	Body weight	Recommended dose per single administration (x3 daily)	Maximum daily dose (within 24 hours)
from 3 to 6 months	5 kg	1.8 to 2.4 ml	7.2 ml (144 mg)
6 kg	2 to 3 ml	9 ml (180 mg)
7 kg	2.4 to 3.4 ml
from 6 to 12 months	8 kg	2.8 to 4 ml	12 ml (240 mg)
9 kg	3 to 4.4 ml	13.2 ml (264 mg)
from 12 to 24 months	10 kg	3.4 to 5 ml	15 ml (300 mg)
12 kg	4 to 6 ml	18 ml (360 mg)
from 2 to 3 years	14 kg	4.8 to 7 ml	21 ml (420 mg)
from 4 to 5 years	16 kg	5.4 to 8 ml	24 ml (480 mg)
18 kg	6 to 9 ml	27 ml (540 mg)
from 6 to 9 years	20 kg	6.8 to 10 ml	30 ml (600 mg)
22 kg	7.4 to 11 ml	33 ml (660 mg)
24 kg	8 to 12 ml	36 ml (720 mg)
26 kg	8.8 to 13 ml	39 ml (780 mg)
from 10 to 12 years	28 kg	9.4 to 14 ml	42 ml (840 mg)
30 kg	10 to 15 ml	45 ml (900 mg)
32 – 36 kg	10.8–12 to 16–18 ml	48–54 ml (960–1080 mg)
36 – 40 kg	12–13.4 to 18–20 ml	54–60 ml (1080–1200 mg)

The suspension may also be dosed according to a schedule of 4 doses per day. In this case, the maximum daily doses (see last column of the table above) must not be exceeded within 24 hours. The dose to be administered every 6 hours should be recalculated/reduced proportionally.

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

Patients with kidney, liver, or heart disease

Dosage must be reduced and medical advice sought. Ibuprofen should not be used in patients with severe heart, renal, or hepatic insufficiency.

If this medicine is required for more than 3 days, or if symptoms worsen in children aged 6 months to 12 years, medical advice must be sought.

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

Method of administration

Ibufén Infantil is an oral suspension that may be administered directly or diluted in water.

Shake the container before use.
Insert the syringe into the hole in the pierced cap.
Invert the bottle and withdraw the required dose.
Administer the contents of the syringe directly into the mouth or onto a spoon.
The syringe should be washed after each use and may be sterilized by boiling in water or by immersion in the sterilizing solution used for baby bottles.

A burning sensation in the mouth or throat may occur when taking ibuprofen oral suspension; ensure that the bottle has been shaken well before administering the medicine.

Patients experiencing stomach discomfort should take the medicine with milk and/or during meals. Administration of the medicine should be based on the presence of pain or fever. As these symptoms resolve, the medication should be discontinued.

If you take more ibufén infantil than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested, or go to the nearest hospital to learn about the risks and obtain advice on the measures to be taken.

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), diarrhea, headache, tinnitus (ringing in the ears), confusion, involuntary eye movements, and lack of muscle coordination. Agitation or disorientation may also occur. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. In addition, prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, transient cessation of breathing (apnea), central nervous system depression, and respiratory depression have been reported. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been observed.

In cases of severe poisoning, kidney failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatic patients.

If you forget to take Ibufén Infantil

Do not take a double dose to make up for missed doses.

If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.

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

4. Possible adverse effects

Like all medicines, Ibufén Infantil 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 maximum recommended dose.

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

Frequent adverse effects (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling unsteady, fatigue have also been observed.

Uncommon adverse effects (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple spots on the skin), skin reactions due to light exposure, hypersensitivity, paraesthesia (numbness, tingling, pins and needles sensations, more frequent in hands, feet, arms or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (liver inflammation), abnormalities in liver function and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnoea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea levels.

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

Disorientation or confusion, depression, dizziness, tinnitus (ringing or noises in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, oedema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include swelling of the face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock)), aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which constituted a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), neutropenia (decreased neutrophils) and agranulocytosis (severe decrease in neutrophils), aplastic anaemia (bone marrow failure to produce various types of cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, pseudoinfluenza-like symptoms, extreme fatigue, unexplained bleeding and bruising.

Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver deterioration), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to consult a doctor as soon as possible.

Frequency not known (cannot be estimated from available data):

Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhoea).

A serious skin reaction known as DRESS syndrome (an acronym in English) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cell).

Generalized 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 Ibufén Infantil if you experience these symptoms and seek immediate medical attention. See also section 2.

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

If any of the adverse effects listed below occur, stop treatment immediately and consult your doctor:

Allergic reactions such as skin rashes, facial swelling, wheezing or difficulty breathing.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhoea.
Severe stomach pain.
Blisters or extensive peeling of the skin.
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 center, 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].
Generalized skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
Generalized, 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibufén Infantil

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

This medicine does not require any special storage conditions.

After opening the container, store below 25°C and use within a maximum of 6 months.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Ibufén Infantil

The active substance is ibuprofen. Each ml of suspension contains 20 mg of ibuprofen.
The other components are: Sodium benzoate (E-211), citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, glycerol (E-422), strawberry flavour (containing benzyl alcohol and ethanol), and purified water.

Appearance of the product and contents of the pack

Ibufén Infantil is an oral, viscous suspension, white or almost white in colour, with a strawberry odour.

It includes a 5 ml graduated oral syringe with a polypropylene barrel and a polyethylene plunger.

It is available in pack sizes of 100 ml, 150 ml and 200 ml. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Farmasierra Manufacturing, S.L.

Ctra. Irún, Km 26,200

San Sebastián de los Reyes

Madrid

Spain

“or”

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191 Spain

“or”

DELPHARM BLADEL BV

Industrieweg 1

5531 AD Bladel

The Netherlands

“or”

FARMALIDER, S.A.

C/ Aragoneses 2

28108 Alcobendas

Madrid

Spain

“or”

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10.

Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent revision of this leaflet: November 2024

Other sources of information

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