Ibuprofen EG

Package leaflet: Information for the patient

IBUPROFENE EG Children 100 mg/5 ml oral suspension, strawberry sugar-free, orange sugar-free

Ibuprofen
Generic medicine
Please read this leaflet carefully before giving this medicine to your child, as it contains
important information for you.
Always give this medicine to your child exactly as described in this leaflet or as your
doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if symptoms worsen after:
  • 24 hours (in infants aged between 3 and 5 months);
  • 3 days (in infants and children older than 6 months and in adolescents).

Contents of this leaflet:

1. What Ibuprofene EG is and what it is used for
2. What you need to know before giving Ibuprofene EG to your child
3. How to give Ibuprofene EG to your child
4. Possible side effects
5. How to store Ibuprofene EG
6. Contents of the pack and other information

1. What Ibuprofene EG is and what it is used for

Ibuprofene EG contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This action helps reduce pain, fever, and inflammation.
Ibuprofene EG is indicated in children from 3 months to 12 years of age for the symptomatic treatment of fever, including post-vaccination fever, and mild to moderate pain (such as headache, toothache, sore throat, earache).

2. What you should know before giving Ibuprofene EG to the child

Do not give Ibuprofene EG to the child

• If he/she is allergic to the active substance (ibuprofen) or to any of the other components of this medicine (listed in section 6).
• If he/she has or has previously had allergic reactions such as breathlessness, rhinitis (runny nose), swelling of the face, lips and throat (angioedema), or urticaria, particularly if associated with nasal polyps and asthma, after taking other analgesics, antipyretics, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If he/she suffers from severe kidney or liver disease (renal or hepatic failure).
• If he/she suffers from severe heart problems (severe heart failure).
• If he/she has had or is experiencing gastrointestinal bleeding and/or perforation following previous treatment with NSAIDs.
• If he/she has had or currently suffers from gastric/duodenal ulcers (peptic ulcers) or recurrent or active bleeding (at least two distinct episodes of proven ulceration or bleeding).
• If he/she is currently taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors) (see section Other medicines and Ibuprofene EG).
• If he/she has any disease that increases the risk of bleeding.
• In case of unexplained blood disorders.
• If he/she is in a severe state of dehydration, for example, after severe episodes of vomiting, diarrhoea, or very low fluid intake.
• If he/she is under 3 months of age or weighs less than 5.6 kg. Do not take Ibuprofene EG during the last trimester of pregnancy (see Pregnancy and breastfeeding).

Warnings and precautions – Take special care with Ibuprofene EG
Talk to your doctor or pharmacist before using Ibuprofene EG if the child:

• has or has previously had allergies to medicines used to treat fever, pain and inflammation (non-steroidal anti-inflammatory drugs), and if he/she suffers from breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, severe respiratory or chest problems such as chronic obstructive pulmonary disease, or swelling of the face, lips and throat (angioedema);
• is taking other medicines used to treat pain, reduce fever and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors) (see section Other medicines and Ibuprofene EG);
• has previously suffered from stomach or intestinal disorders (history of ulcer), especially if complicated by bleeding or perforation, as there may be an increased risk of gastrointestinal bleeding and perforation. In such cases, your doctor may advise starting treatment with the lowest available dose and possibly concomitant use of medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if the child is taking low-dose aspirin or other medicines that may increase the risk of stomach and intestinal disorders (see section Other medicines and Ibuprofene EG). During treatment with all NSAIDs, at any time and with or without warning symptoms or previous history of serious gastrointestinal events, bleeding, ulceration, or perforation of the stomach or intestine may occur, which can be fatal. Therefore, inform your doctor of any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment. If gastrointestinal bleeding or ulceration occurs, stop treatment with Ibuprofene EG and contact your doctor immediately;
• has or has previously had inflammatory bowel disease (ulcerative colitis, Crohn’s disease), as these conditions may worsen (see section Possible side effects);
• is taking medicines that may increase the risk of ulcer or bleeding, such as medicines used to treat inflammation and certain immune system disorders (oral corticosteroids), anticoagulants such as warfarin, medicines with antiplatelet effects such as aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section Other medicines and Ibuprofene EG);
• has heart disease (uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease) or has previously had reduced blood flow to the brain (stroke), or if you think the child may be at risk for these conditions (e.g. if he/she has high blood pressure, high blood sugar levels (diabetes), high blood lipid levels, or smokes). Medicines such as Ibuprofene EG may be associated with a slight increase in the risk of heart attack or stroke: this risk is more likely at high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• has or has previously had high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling (oedema) have been reported in association with NSAID therapy;
• has an infection (see section “Infections” below);
• has chickenpox, as in this case it is recommended to avoid using Ibuprofene EG.

The use of Ibuprofene EG requires adequate precautions, especially if the child:

• has or has previously had asthma, as breathing difficulties may worsen;
• has blood clotting disorders or hypertension;
• has kidney, heart, or liver disease and is taking diuretics (medicines that increase urine production), or has recently undergone major surgery resulting in fluid loss, as in these cases your doctor may recommend periodic blood and urine tests;
• has recently undergone major surgery;
• has certain congenital disorders affecting blood formation (e.g. acute intermittent porphyria); is dehydrated (e.g. due to fever, vomiting or diarrhoea); in this case, rehydrate the child before and during treatment to avoid the risk of impaired kidney function.

During prolonged treatment with Ibuprofene EG, be particularly vigilant and inform your doctor immediately if any of the following occur:

• signs or symptoms of stomach or intestinal ulceration or bleeding (e.g. black, foul-smelling stools, vomiting blood);
• signs or symptoms of liver damage (e.g. hepatitis or jaundice);
• signs or symptoms of kidney damage (e.g. increased urine production, blood in urine);
• visual disturbances (blurred or reduced vision, areas of complete or partial blindness, altered colour perception);
• symptoms such as frequent or daily headaches despite regular use of headache medicines, as these may be caused by excessive use of such medicines;
• symptoms such as headache, confusion, nausea, vomiting, neck stiffness, and fever, as these may indicate aseptic meningitis (more common if the child has systemic lupus erythematosus or other collagen diseases).

Signs of an allergic reaction to ibuprofen have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain.
Stop Ibuprofene EG immediately and contact your doctor or emergency medical services immediately if any of these signs occur.

Skin reactions
Serious skin reactions have been reported with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using Ibuprofene EG and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Infections
Ibuprofene EG may mask symptoms of infections such as fever and pain. Therefore, Ibuprofene EG may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If this medicine is taken during an infection and infection symptoms persist or worsen, consult your doctor immediately.

Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.

Other medicines and Ibuprofene EG
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those not requiring a prescription.
Ibuprofene EG may affect or be affected by other medicines. In particular, inform your doctor if the child is taking:

• other medicines used to treat pain, reduce fever and/or treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs, including COX-2 inhibitors or acetylsalicylic acid). Such combinations should be avoided as they increase the risk of adverse effects;
• medicines used to treat inflammation and certain immune system disorders (corticosteroids);
• antibacterial agents: possible increased risk of seizures caused by antibiotics known as quinolones;
• medicines with anticoagulant effects (i.e. substances that thin the blood to prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to treat depression such as selective serotonin reuptake inhibitors;
• a medicine used to treat seizures (phenytoin);
• antidiabetic medicines to treat high blood sugar levels (sulfonylureas);
• a medicine used to treat viral infections (ritonavir);
• medicines that modulate the immune response (tacrolimus and cyclosporine);
• a medicine used in the treatment of cancer and rheumatic diseases (methotrexate);
• a medicine used for mental disorders (lithium);
• a medicine used for medical termination of pregnancy (mifepristone): do not take NSAIDs within 8–12 days after taking mifepristone;
• medicines used to treat gout (probenecid and sulfinpyrazone);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan) and diuretics;
• potassium-sparing diuretics;
• CYP2C9 inhibitors (e.g. voriconazole, fluconazole), as concomitant administration of ibuprofen and CYP2C9 inhibitors may slow down the elimination of ibuprofen (a CYP2C9 substrate), leading to increased exposure to ibuprofen;
• medicines used to treat heart conditions (cardiac glycosides such as digoxin);
• zidovudine (a medicine for the treatment of HIV/AIDS).

Ibuprofene EG with food and drinks
The medicine can be administered with or without food.
Possible stomach-related side effects, if present, may be reduced by taking the medicine with food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
It is unlikely that individuals under 12 years of age will become pregnant or breastfeed.
In such a case, do not take this medicine during the last 3 months of pregnancy, as it may cause problems for your baby and during childbirth. Avoid using this medicine during the first 6 months of pregnancy unless prescribed by a doctor.
This medicine may cause kidney and heart problems in the unborn baby. It may also affect your and your baby’s tendency to bleed and may delay or prolong labour beyond the expected duration. You should not take ibuprofen during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. If ibuprofen is taken for more than a few days from week 20 of pregnancy, it may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If prolonged treatment is required, your doctor may recommend additional monitoring.

Breastfeeding
This medicine passes into breast milk in small amounts. It may be used during breastfeeding if taken at the recommended doses and for short periods.

Fertility
This medicine belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Ibuprofene EG contains maltitol
If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

Ibuprofene EG contains sodium
This medicine contains 4.51 mg of sodium (a main component of table salt) per 2.5 ml dose of suspension. This corresponds to 0.23% of the maximum daily dietary intake recommended for an adult.
Ibuprofene EG does not contain sugar and is therefore suitable for patients who need to control their sugar and calorie intake.
This medicine contains potassium, less than 1 mmol (39 mg) per 2.5 ml dose, i.e. essentially 'potassium-free'.

3. How to give Ibuprofen EG to the child

Give this medicine to the child exactly as stated in this leaflet or as directed by the doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
The recommended daily dose is based on the child's weight and age.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If the child has an infection, contact the doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
To reduce the possibility of unwanted effects, the lowest effective dose for the shortest time needed to control symptoms should be used (see section 4).

Use in children aged between 3 and 6 months

• In children aged between 3 and 6 months, administration should be limited to those weighing more than 5.6 kg.
• The daily oral dose for infants and children aged between 3 months and 12 years can be administered using the dosing syringe supplied with the product.

The daily dose of 20–30 mg/kg of body weight, divided into three doses per day at intervals of 6–8 hours, may be administered according to the following dosing schedule (calculate the dose to be administered based on the weight and age of the child as indicated in the table below).

The graduated scale on the syringe clearly shows markings for different dosages; in particular, the 2.5 ml mark corresponds to 50 mg of ibuprofen and the 5 ml mark corresponds to 100 mg of ibuprofen.
If your child suffers from stomach problems, administer Ibuprofene EG preferably during meals.
In the case of post-vaccination fever, refer to the recommended daily dosage in the table above.
Ibuprofene EG should be administered for short-term treatment only.
The lowest effective dose for the shortest necessary duration to relieve symptoms should be used. If you have an infection, consult your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after:

• 24 hours in infants aged between 3 and 5 months;
• 3 days in infants and children over 6 months of age and in adolescents.

Instructions for using the dosing syringe:
1- Unscrew the cap by pushing it downwards and turning it to the left.
2- Insert the tip of the syringe fully into the opening of the inner cap.
3- Shake well.
4- Turn the bottle upside down, then, holding the syringe firmly, gently pull the plunger down to draw the suspension into the syringe up to the mark corresponding to the desired dose.
5- Return the bottle to an upright position and remove the syringe by gently rotating it.
6- Insert the tip of the syringe into the child’s mouth and gently press the plunger to dispense the suspension.
After use, screw the cap back on to close the bottle and wash the syringe with warm water. Let it dry, and store it out of sight and reach of children.

If you take more Ibuprofene EG than you should
If you have taken more Ibuprofene EG than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on potential risks and actions to take.
Symptoms of overdose may include: nausea, stomach ache, vomiting (possibly with traces of blood), deep sleep with reduced response to normal stimuli (lethargy), headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing problems may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, it may present: uncontrolled eye movements (nystagmus), increased acid levels in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney effects, gastrointestinal bleeding, profound loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhoea, reduced activity of the nervous system (Central Nervous System depression), and reduced respiratory activity (respiratory depression).
In addition, it may also cause: disorientation, state of excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
If significantly high doses of ibuprofen are taken, severe kidney and liver damage may occur.
If you forget to take Ibuprofene EG
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If your child experiences any of the following side effects, STOP treatment with Ibuprofene EG and contact your doctor immediately:

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• flat, red, target-shaped or circular spots on the trunk, often with central blisters, 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 rash, high body temperature and swollen 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 (generalized pustular eruption);
• allergic reactions, even severe, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), irregular heartbeat (tachycardia), low blood pressure (hypotension), anaphylaxis, shock, and worsening of asthma;
• aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, stiff neck and fever (more frequent if the child has systemic lupus erythematosus or other collagen diseases).

Other side effects include:
Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, drowsiness and seizures;
• stomach pain, nausea and indigestion (dyspepsia);
• skin rashes;
• visual disturbances.

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

• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, mood instability, hearing disturbances;
• cerebrovascular haemorrhage;
• dry eyes;
• awareness of your own heartbeat (palpitations);
• diarrhoea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia), skin becomes sensitive to light;
• serious kidney diseases including tubular necrosis, glomerulonephritis, presence of blood in urine and increased urine production;
• decreased haematocrit levels.

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

• reduction in the number of blood cells (anaemia, leucopenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) – early signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and bleeding;
• signs or symptoms of stomach or intestinal ulcers or bleeding, black and foul-smelling stools, vomiting blood;
• bleeding mouth sores, heartburn (gastritis);
• simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, liver dysfunction, hepatitis, jaundice);
• serious kidney diseases (acute renal failure, papillary necrosis), particularly following long-term treatment, associated with increased blood urea concentration and swelling (oedema);
• decreased haemoglobin levels in the blood;
• heart attack (myocardial infarction);
• severe skin infections and soft tissue complications during chickenpox infection;
• worsening of inflammation related to infections (e.g. necrotizing fasciitis) associated with the use of certain non-steroidal anti-inflammatory drugs (NSAIDs). If signs of infection appear or worsen, contact your doctor immediately to assess whether anti-infective/antibiotic therapy is needed.

Not known (frequency cannot be estimated from the available data):

• irritability;
• fluid retention and decreased appetite;
• abnormal perception of noises such as ringing, buzzing or hissing sounds (tinnitus);
• serious heart disease (heart failure) and swelling (oedema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory tract disorders including asthma, laryngeal obstruction, laboured breathing (bronchospasm), temporary cessation of breathing (apnoea) and difficulty breathing (dyspnoea);
• worsening of inflammatory bowel diseases (colitis and Crohn's disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the oesophagus (oesophagitis);
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells);
• a widespread, red, scaly rash with pustules under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Ibuprofene EG if you develop these symptoms and contact your doctor immediately. See also section 2.

The use of ibuprofen, especially at high doses (2400 mg/day), may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofene EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp". The expiry date refers to the last day of that month.
The product must be used within 6 months of first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ibuprofene EG contains
Ibuprofene EG Children 100 mg/5 ml oral suspension, strawberry flavour, sugar-free

• The active substance is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other components are: citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, strawberry flavour, maltitol syrup, glycerin, purified water.

Ibuprofene EG Children 100 mg/5 ml oral suspension, orange flavour, sugar-free

• The active substance is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other components are: citric acid monohydrate, sodium citrate, acesulfame potassium, xanthan gum, sodium benzoate, orange flavour, maltitol syrup, glycerin, purified water.

Description of the appearance of Ibuprofene EG and contents of the pack
The carton contains the oral suspension in a 150 ml amber glass bottle with child-resistant closure and a 5 ml dosing syringe.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR), Italy