Package leaflet: Information for the user

IBULEV Children 100 mg/5 ml oral suspension, strawberry flavour, sugar-free, Children 100 mg/5 ml oral suspension, orange flavour, sugar-free

Equivalence medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If your child experiences any of the side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after:
24 hours in infants aged 3 to 5 months
3 days in infants and children over 6 months of age and in adolescents.

Contents of this leaflet:

What IBULEV is and what it is used for
What you need to know before using IBULEV
How to use IBULEV
Possible side effects
How to store IBULEV
Contents of the pack and other information

1. What IBULEV is and what it is used for

This medicinal product contains the active substance ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) that work by relieving pain and reducing fever.
IBULEV is indicated for the treatment of fever and mild to moderate pain.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before using IBULEV

Do not use IBULEV

if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
in children under 3 months of age or weighing less than 5.6 kg;
if you are allergic (hypersensitive) to acetylsalicylic acid or to other painkillers (analgesics), fever-reducing (antipyretic) drugs, or non-steroidal anti-inflammatory drugs (NSAIDs), particularly when the allergy is associated with nasal congestion due to mucus membrane secretion in the nose (nasal polyps) and asthma;
if you have stomach or intestinal problems due to lesions (active peptic ulcer);
if you have severe kidney or liver problems (severe renal or hepatic insufficiency);
if you have severe heart problems (severe heart failure);
if you have previously experienced stomach or intestinal problems associated with bleeding or lesions (recurrent peptic ulcer);
if you are already taking other anti-inflammatory medicines (NSAIDs, including selective COX-2 inhibitors);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Use special caution with IBULEV.
Talk to your doctor or pharmacist before using IBULEV.
The risk of adverse effects caused by using this medicine can be reduced by using the lowest effective dose for the shortest possible duration of treatment.

Allergic reactions (hypersensitivity)
The use of this medicine may cause allergic-type reactions (hypersensitivity), even severe ones, even if this is the first time you are taking it.
The risk of such reactions increases if:

you have previously experienced them after taking medicines similar to IBULEV (NSAIDs);
you suffer from breathing problems (asthma);
you suffer from nasal problems (nasal polyps);
you have had allergic-type reactions manifested by facial swelling (angioedema).

Allergic-type reactions may occur especially at the beginning of treatment (within the first month of treatment).

Stomach and/or intestinal problems
During treatment with anti-inflammatory medicines (NSAIDs), bleeding in the stomach and/or intestines may occur. These effects can be fatal and may occur at any time during treatment, with or without symptoms. The risk increases if your child has previously suffered from stomach or intestinal problems due to lesions (ulcer); in such cases, use this medicine with great caution and start treatment with the lowest possible dose.

In these cases, consult your doctor, who may recommend adding to IBULEV medicines that have a protective effect on the stomach, especially if you are taking other medicines (e.g., aspirin or other medicines that increase the risk of gastrointestinal problems).

During treatment with this medicine, especially at the beginning, pay close attention to symptoms your child may experience, particularly related to the stomach and intestines, and especially if they have previously had the problems described.

The risk of stomach or intestinal problems is also higher if the patient is elderly. These patients should also start treatment with the lowest possible dose.

If bleeding or formation of ulcers in the stomach and/or intestines occurs, discontinue treatment with this medicine.

Anti-inflammatory/painkillers such as ibuprofen may be associated with a modest increase in the risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.

Consult your doctor or pharmacist if you have an infection – see section <> below

Infections
IBULEV may mask symptoms of infections such as fever and pain. Therefore, IBULEV may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.

You should discuss treatment with your doctor or pharmacist before taking IBULEV if you have:

heart problems including heart attack, angina (chest pain), or history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowing or blockage of arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischemic attack);
high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Use this medicine with caution if:

you are taking other medicines (see section “Other medicines and IBULEV”);
you have previously suffered from intestinal disorders (ulcerative colitis, Crohn’s disease);
you have previously or currently suffer from high blood pressure (hypertension);
you suffer from heart problems (heart failure);
you suffer from breathing problems (asthma);
you suffer from blood clotting disorders;
you suffer from kidney, heart, or liver problems;
you have chickenpox, as in this case, it is recommended to avoid using IBULEV.

During treatment with IBULEV:

if you develop fever, vomiting, or diarrhea, rehydrate with an adequate amount of fluids. If you have low fluid levels before starting treatment, rehydrate before beginning therapy;
pay attention to symptoms that may appear (signs or symptoms of stomach and/or intestinal lesions);
watch for signs and symptoms indicating liver or kidney toxicity;
if you experience vision problems (blurred or reduced vision, altered color perception), stop treatment and consult your doctor;
watch for signs or symptoms of a type of meningitis (aseptic meningitis, inflammation of the brain); consult your doctor, who will need to evaluate the rare possibility that it is due to the use of this medicine (more frequent in patients with systemic lupus erythematosus or other collagen diseases).

Treatment with this medicine should be carefully evaluated by the doctor if:

you suffer from heart problems;
you have a predisposition to develop heart and circulatory problems, for example, if you have high blood pressure, diabetes, high levels of fat in the blood (hyperlipidemia), or if you smoke.

Other medicines and IBULEV
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicine.
Avoid using IBULEV if you are taking other similar medicines (called non-steroidal anti-inflammatory drugs, NSAIDs, including selective COX-2 inhibitors), because the risk of adverse effects may increase.
IBULEV may affect or be affected by other medicines. For example:

corticosteroids, medicines used to reduce inflammation and treat allergies;
quinolone antibacterials, used to treat bacterial infections;
medicines with anticoagulant effect (i.e., substances that thin the blood and prevent clot formation, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines used to treat certain mental disorders (antidepressants, selective serotonin reuptake inhibitors);
sulfonylureas, used to treat diabetes;
ritonavir and zidovudine, medicines used to treat AIDS;
cyclosporine and tacrolimus, used to treat immune system disorders;
methotrexate, used to treat certain tumors;
lithium-containing medicines, used to treat certain mental disorders;
mifepristone, a medicine for termination of pregnancy: do not take NSAIDs in the 8–10 days following mifepristone intake;
probenecid, used to treat high levels of uric acid;
medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenololo, angiotensin II receptor antagonists such as losartan) and diuretics;
medicines used to treat heart diseases (cardiac glycosides).

During treatment in combination with other medicines, you must take an adequate amount of fluids.
Other medicines may also affect or be affected by treatment with IBULEV.
Therefore, always consult your doctor or pharmacist before using IBULEV with other medicines.

Pregnancy and breastfeeding
This medicine must not be used during pregnancy or breastfeeding.
It is unlikely that girls under 12 years of age are pregnant or breastfeeding. However, in such cases, it should be noted that taking IBULEV may have harmful effects on the fetus.

IBULEV contains maltitol syrup and sodium

This medicine contains maltitol syrup. If your doctor has diagnosed intolerance to certain sugars, contact him before using this medicine.
This medicine contains 1.8 mg of sodium (a main component of table salt) per 1 ml of oral suspension. This corresponds to 0.09% of the maximum daily dietary intake recommended for an adult.

3. How to use IBULEV

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose to be administered depends on the child's weight and age.
It is recommended to limit the use of this medicine to children older than 3 months of age and weighing more than 5.6 kg.
In infants and children aged between 3 months and 12 years, this medicine should be administered using the graduated oral syringe provided in the package.
To facilitate dosing, the syringe has two marked notches: one at 2.5 ml (corresponding to 50 mg of ibuprofen) and one at 5 ml (corresponding to 100 mg of ibuprofen).
Gastrointestinal side effects may be reduced by administering the medicine with food.

Children aged between 3 and 6 months (5.6–7 kg body weight) and children aged between 6 and 12 months (7–10 kg body weight)
The recommended dose is 2.5 ml taken three times daily at intervals of 6–8 hours.
In children aged between 3 and 5 months, consult your doctor if symptoms persist after 24 hours of treatment or if you notice a worsening of symptoms.

Children aged between 1 and 3 years (10–15 kg body weight)
The recommended dose is 5 ml taken three times daily at intervals of 6–8 hours.

Children aged between 4 and 6 years (15–20 kg body weight)
The recommended dose is 7.5 ml (5 ml + 2.5 ml) taken three times daily at intervals of 6–8 hours.

Children aged between 7 and 9 years (20–28 kg body weight)
The recommended dose is 10 ml taken three times daily at intervals of 6–8 hours.

Children aged between 10 and 12 years (28–43 kg body weight)
The recommended dose is 15 ml taken three times daily at intervals of 6–8 hours.

Use in the treatment of fever following vaccination
If you develop fever after vaccination, follow the dosing instructions provided in this leaflet by administering a single dose and, if necessary, a second dose 6 hours after the first. Do not administer more than two doses within 24 hours.
If the fever does not decrease, consult your doctor.
IBULEV should be used only for short-term treatment. Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The lowest effective dose for the shortest necessary period should be used to relieve symptoms. 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 improvement or if symptoms worsen 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 (see figure below):

Unscrew the cap by pushing down and turning it to the left.
Insert the tip of the syringe fully into the opening of the inner cap.
Shake well.
Invert the bottle, 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.
Return the bottle to an upright position and remove the syringe by gently rotating it.
Insert the tip of the syringe into the child’s mouth and gently press the plunger to administer the suspension. After use, screw the cap back on to close the bottle and wash the syringe with warm water. Allow the syringe to dry and keep it out of the reach and sight of children.

If you use more IBULEV than you should
If you have taken more than the recommended dose or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately for advice on the risk and actions to take.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), 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, dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.

Symptoms
Most patients who ingest significant amounts of ibuprofen will show symptoms within 4–6 hours.
The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy (deep sleep), and drowsiness.
Central nervous system (CNS) effects include headache (cephalalgia), tinnitus (perception of annoying ringing in the ears), dizziness, seizures, and loss of consciousness.
Rarely reported are nystagmus (involuntary oscillatory movement of the eyeballs), metabolic acidosis (increased blood acidity), hypothermia (lowered body temperature), renal effects, gastrointestinal bleeding, coma, apnoea (absence of breathing), diarrhoea, and CNS and respiratory depression.
If you suffer from respiratory problems (asthma), your condition may worsen.
Disorientation, excited state, fainting, and cardiovascular toxicity including hypotension (low blood pressure), bradycardia (slowed heart rate), and tachycardia (increased heart rate) have also been reported.
In cases of significant overdose, blood coagulation disorders, kidney failure, and liver damage may occur.

Treatment
There is no specific antidote to counteract the effects of ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated.
If an excessive dose of IBULEV has been accidentally ingested, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to use IBULEV
Do not give your child a double dose to make up for a missed 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 medicinal product can cause side effects, although not everyone experiences them.
If the child experiences any of the following side effects, STOP treatment with IBULEV and consult a doctor immediately:

severe skin and mucous membrane reactions characterized by rashes, redness, itching, and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis);
allergic reactions, even severe ones, which may include: urticaria, itching, purpura, swelling of the face, mouth, and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), irregular heartbeats (tachycardia), low blood pressure (hypotension), anaphylaxis, shock, and worsening of asthma;
aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, neck stiffness, 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):

hypersensitivity reactions, urticaria, and itching
headache, dizziness, drowsiness, and convulsions
stomach pain, nausea, and difficulty digesting (dyspepsia)
skin rashes

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

cystitis, rhinitis
depression, insomnia, difficulty concentrating, mood instability
hearing and vision disturbances
cerebral hemorrhage
dry eyes
awareness of one's own heartbeat (palpitations)
diarrhea, flatulence, dry mouth, constipation, and vomiting
hair loss (alopecia), skin reaction due to exposure to sunlight (photosensitivity dermatitis)
serious kidney diseases including tubular necrosis, glomerulonephritis, presence of blood in urine, and increased urine production
decreased hematocrit levels

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

reduction in the number of blood cells (anemia, leucopenia, neutropenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) – early signs include: 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 lesions in the mouth, stomach burning (gastritis)
simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, hepatic dysfunction, hepatitis, jaundice)
serious kidney diseases (acute renal failure, papillary necrosis), particularly following long-term treatment, associated with increased blood urea concentration and swelling (edema)
decreased hemoglobin levels in the blood
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, consult a doctor immediately to determine whether anti-infective/antibiotic therapy is needed
cerebrovascular events, congestive heart failure in individuals with compromised cardiac function

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

irritability
fluid retention and loss of appetite
abnormal perception of sounds such as ringing, buzzing, or humming (tinnitus)
severe heart disease (heart failure) and swelling (edema)
increased blood pressure (hypertension) and reduced blood flow to the body (shock)
respiratory tract disorders including asthma, laryngeal obstruction, labored breathing (bronchospasm), temporary cessation of breathing (apnea), and difficulty breathing (dyspnea)
worsening of inflammatory bowel diseases (colitis and Crohn’s disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the esophagus (esophagitis)
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 subcutaneous pustules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using IBULEV 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 modest increase in the risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult 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 IBULEV

Shelf life after first opening of the packaging
This medicinal product can be used for up to 6 months after first opening.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
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 IBULEV contains
IBULEV Children 100 mg/5 ml sugar-free strawberry-flavoured oral suspension:

The active substance is ibuprofen. Each ml of oral solution 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.

IBULEV Children 100 mg/5 ml sugar-free orange-flavoured oral suspension:

The active substance is ibuprofen. Each ml of oral solution 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 IBULEV and contents of the pack
The pack contains one bottle of 150 ml oral suspension and a dosing syringe.
Marketing Authorization Holder
FARTO S.R.L. - FARMACO BIOCHIMICO TOSCANO
VIA DEI CAB OTO, 49
50127 FIRENZE
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1- 03012 Anagni (Frosinone).

Patient Information Leaflet: Information for the User

IBULEV 200 mg oral suspension sachet, orange flavour

Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, 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 you experience worsening of symptoms after 3 days.

Contents of this leaflet:

What IBULEV is and what it is used for
What you need to know before taking IBULEV
How to take IBULEV
Possible side effects
How to store IBULEV
Package contents and other information

1. What IBULEV is and what it is used for

This medicine contains the active substance ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs) that work by relieving pain and reducing fever.
IBULEV is indicated for the treatment of fever and mild to moderate pain.
Use IBULEV for short-term treatment only.

2. What you need to know before using IBULEV

Do not use IBULEV if:

you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
you are allergic (hypersensitive) to acetylsalicylic acid or to other pain-relieving medicines (analgesics), fever-reducing (antipyretic) medicines, or non-steroidal anti-inflammatory drugs (NSAIDs), especially when the allergy is associated with nasal congestion due to mucus secretion from the nasal mucosa (nasal polyps) and asthma;
you have an active lesion of the inner lining (mucosa) of the stomach or the first part of the intestine (active peptic ulcer);
you suffer from severe impairment of kidney or liver function;
you have severe heart problems (severe heart failure);
you suffer or have suffered from bleeding or perforation of the stomach or intestine due to previous treatments, or have experienced bleeding/lesions of the inner lining of the stomach/intestine occurring in two or more separate episodes (recurrent peptic ulcer);
you have brain bleeding (cerebrovascular haemorrhage) or other active bleeding;
you suffer from severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake);
you suffer from unexplained blood disorders such as low platelet count;
you are currently taking other medicines from the same family as non-steroidal anti-inflammatory drugs (NSAIDs), including those that selectively inhibit the action of an enzyme called COX-2 (see section "Other medicines and IBULEV");
you are in the last trimester of pregnancy (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Take special care with IBULEV
Consult your doctor or pharmacist before using IBULEV if:

you do not feel better or feel worse after 3 days of treatment, consult your doctor;
you suffer or have suffered from allergies to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs), and if you experience breathing difficulties (asthma), nasal polyps, or swelling of the face, lips, and throat (angioedema);
you are already taking the following medicines:
non-steroidal anti-inflammatory drugs (NSAIDs), including those that selectively inhibit the action of an enzyme called COX-2;
medicines that increase the risk of bleeding or ulcer formation, such as orally administered corticosteroids, medicines that prevent blood clotting (anticoagulants such as warfarin), antidepressants, and antiplatelet agents like aspirin (see “Other medicines and IBULEV”);
you have suffered from stomach or intestinal disorders (history of ulcers), 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 you are taking low-dose aspirin or other medicines that may increase the risk of stomach and intestinal diseases (see section “Other medicines and IBULEV”). During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, bleeding, ulceration, and 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 IBULEV and contact your doctor;
you suffer from gastrointestinal diseases such as Crohn’s disease or ulcerative colitis, inform your doctor because the use of NSAIDs could worsen these conditions (see section 4);
you are taking medicines that could 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 like aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and IBULEV”);
you have heart diseases (uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease) or have suffered from reduced blood flow to the brain (stroke), or if you think you may be at risk for these conditions (for example, if you have high blood pressure, elevated blood sugar levels (diabetes), high blood lipid levels, or if you smoke). Medicines like IBULEV may be associated with a slight increase in the risk of heart attack or stroke: the risk is more likely at high doses and with prolonged therapy. Do not exceed the recommended dose or duration of treatment;
you suffer or have suffered from high blood pressure and/or severe heart disease (heart failure), as fluid retention, high blood pressure, and swelling (edema) have been reported in association with NSAID therapy;
you have chickenpox, as it is recommended to avoid using IBULEV in this case;
you have an infection – see section “Infections” below.

The use of IBULEV requires adequate precautions, especially if:

you suffer or have suffered from asthma, as bronchoconstriction may occur;
you have coagulation disorders, as reduced clot formation may occur;
you have kidney, heart, or hypertension diseases: possible severe reduction in kidney function (especially in patients with impaired kidney or liver function, heart failure, or on diuretic therapy), renal toxicity (nephrotoxicity), or fluid retention may occur;
you have liver disease, possible liver toxicity may develop;
you are dehydrated due to fever, vomiting, or diarrhoea; your doctor will advise you to restore hydration status both before and during treatment.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a modest increase in the risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss treatment with your doctor or pharmacist before taking IBULEV if you have:

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

During prolonged treatment with IBULEV, you should pay particular attention and immediately inform your doctor if you experience:

signs or symptoms of stomach or intestinal lesions (ulcerations) or bleeding (e.g., black, tarry, foul-smelling stools, vomiting blood);
signs and symptoms of liver damage (e.g., hepatitis with jaundice);
signs and symptoms of kidney damage (e.g., increased urine output, blood in urine);
visual disturbances such as blurred or reduced vision, partial or complete blindness (scotomas), altered colour perception: in this case, stop treatment immediately and consult an ophthalmologist;
symptoms such as headache, disorientation, nausea, vomiting, neck stiffness, and fever, as these may be symptoms of aseptic meningitis (more frequent if you have systemic lupus erythematosus or other collagen diseases).

Skin reactions
Serious skin reactions have been reported in association with treatment with IBULEV. Stop taking IBULEV and consult your doctor immediately if you develop a 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.
Infections
IBULEV may mask symptoms of infections such as fever and pain. Therefore, IBULEV may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms of infection persist or worsen, consult your doctor immediately.
To reduce the possible adverse effects mentioned above, the lowest effective dose should be used for the shortest duration necessary to control symptoms.
Children and adolescents
Do not give this medicine to children under 12 years of age.
Other medicines and IBULEV
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
IBULEV may affect or be affected by other medicines, particularly inform your doctor if you are 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). In this case, such combinations should be avoided as they increase the risk of possible adverse effects;
corticosteroids, medicines used to treat inflammation and certain immune system disorders: possible increased risk of gastrointestinal ulceration or bleeding (see “Warnings and precautions”);
antibacterial agents: possible increased risk of seizures caused by antibiotics known as quinolones;
medicines with anticoagulant effects (i.e., substances that thin the blood and prevent clot formation, e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine);
medicines used to treat depression such as selective serotonin reuptake inhibitors;
diabetes medicines: concomitant use may increase the effect of these medicines;
antivirals (ritonavir): increase NSAID blood concentrations;
cyclosporine (antibiotic) and tacrolimus (immunosuppressive medicine): increase the risk of kidney toxicity;
cytotoxic medicines (medicines that induce cellular toxicity, e.g., methotrexate), lithium: cause reduced excretion (increased risk of toxicity);
mifepristone, a medicine for termination of pregnancy: do not take NSAIDs within 8–10 days after taking mifepristone;
uricosuric medicines (medicines that increase urinary excretion of uric acid) such as probenecid: slow down NSAID excretion and consequently increase their blood concentrations;
zidovudine (a medicine used in the treatment of AIDS): increases the risk of haemarthrosis (blood accumulation in a joint cavity due to sprain, dislocation, or bone fracture) and haematoma formation in HIV-positive patients with a condition known as haemophilia;
medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) and diuretics;
medicines used to treat heart conditions (cardiac glycosides).

In some patients with kidney problems (e.g., dehydrated patients or elderly patients with impaired kidney function), the concomitant administration of ACE inhibitors or angiotensin II antagonists with agents that inhibit the cyclooxygenase system (i.e., with the same mechanism as NSAIDs) may lead to further deterioration of kidney function, including possible severe kidney impairment, usually reversible. These interactions should be considered in patients taking IBULEV concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be used with caution.
Patients starting this concomitant therapy should be adequately hydrated and their kidney function closely monitored by the doctor.
All the interactions listed above are common to ibuprofen, acetylsalicylic acid, and other analgesics, antipyretics, and other non-steroidal anti-inflammatory drugs (NSAIDs).
Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when both drugs are administered concomitantly. However, only limited clinical data are currently available, and uncertainties remain regarding their clinical relevance; therefore, no definitive conclusions can be drawn regarding the continuous use of ibuprofen. Occasional use of ibuprofen appears not to have clinically relevant effects.
IBULEV with food and drinks
The medicine can be taken either with or without food.
Possible stomach-related adverse effects, if present, may be reduced by taking the medicine with food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
In such circumstances, consider the following:

do not take IBULEV during pregnancy, as the mechanism of action of ibuprofen (inhibition of prostaglandin synthesis) may negatively affect pregnancy and/or embryonic-fetal development;
do not take IBULEV during early pregnancy, as epidemiological studies suggest an increased risk of miscarriage and cardiac malformations and gastroschisis (a defect during embryonic development of the abdominal wall causing incomplete closure of abdominal muscles and skin, resulting in protrusion of internal organs) after use of a prostaglandin synthesis inhibitor. The absolute risk of cardiac malformations increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animal studies, administration of prostaglandin synthesis inhibitors showed a higher incidence of pre- and post-implantation losses and embryonic-fetal mortality. Furthermore, in animals administered prostaglandin synthesis inhibitors during organ formation, an increased incidence of various malformations, including cardiovascular ones, was observed.

The use of IBULEV (generally all medicines acting by inhibiting prostaglandin synthesis) may expose:
during the third trimester of pregnancy, the fetus to:

heart and lung damage (with premature closure of the ductus arteriosus and pulmonary hypertension);
kidney problems that may lead to renal failure with reduced amniotic fluid volume (oligo-hydramnios); at the end of pregnancy, the mother and newborn to:
possible prolonged bleeding time, an antiplatelet effect that may occur even at very low doses;
inhibition of uterine contractions, which may delay or prolong labour.

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
Avoid taking this medicine if you are trying to become pregnant, as it may affect ovulation. This effect reverses upon discontinuation of treatment.
Driving and using machines
IBULEV does not affect or affects negligibly the ability to drive or use machinery, when taken for short treatment periods.
IBULEV contains maltitol liquid
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before using this medicine.
IBULEV contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially 'sodium-free'.
IBULEV does not contain sugar and is therefore suitable for patients who need to control their sugar and calorie intake.

3. How to take IBULEV

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).
To reduce the risk of possible side effects, the lowest effective dose should be used for the shortest time needed to control symptoms (see section 4).
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Use in adults and adolescents over 12 years of age
The recommended dose is 1–2 sachets up to 3–4 times daily. The interval between doses should not be less than 4–6 hours.
Do not exceed 1200 mg (6 sachets) within 24 hours.

Use in children and adolescents
IBULEV must not be taken by children under 12 years of age.

Use in the elderly
No dose adjustment is required.

Method of administration
If you have stomach problems, you may take the medicine during meals.

If you take more IBULEV than you should
If you have taken more IBULEV than you should, or if your child has accidentally taken this medicine, contact a doctor or the nearest hospital immediately to obtain advice on the risk and the necessary actions to take.
Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, tinnitus, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, feeling cold, and breathing difficulties have been reported.
Symptoms of overdose may occur in children who have ingested more than 400 mg/kg. The time required to reduce drug concentrations in the blood after excessive intake is 1.5–3 hours.

Symptoms
Most patients who ingest significant amounts of ibuprofen will develop symptoms within 4–6 hours.
The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy (deep sleep), and drowsiness.
Central nervous system (CNS) effects include headache, tinnitus (perception of persistent ringing or buzzing in the ears), dizziness, seizures, and loss of consciousness.
Rarely, nystagmus (involuntary oscillatory movement of the eyeballs), metabolic acidosis (increased blood acidity), hypothermia (lowered body temperature), renal effects, gastrointestinal bleeding, coma, apnoea (lack of breathing), diarrhoea, and CNS and respiratory depression have also been reported.
If you suffer from respiratory problems (asthma), your condition may worsen.
Disorientation, excitement, fainting, and cardiovascular toxicity including hypotension (low blood pressure), bradycardia (slowed heart rate), and tachycardia (increased heart rate) have also been reported.
In cases of significant overdose, blood clotting disorders, kidney failure, and liver damage may occur.

Treatment
There is no specific antidote to reverse the effects of an ibuprofen overdose. Therefore, symptomatic and supportive treatment is indicated in case of overdose.
In case of acute overdose, gastric emptying (induced vomiting or gastric lavage) is more effective the sooner it is performed; administration of alkaline substances and induction of diuresis may also be helpful. Taking a substance known as activated charcoal may help reduce drug absorption.
If an excessive dose of IBULEV has been accidentally ingested, contact your doctor immediately or go to the nearest hospital.

If you forget to take IBULEV
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following side effects, STOP treatment with IBULEV and contact your
doctor immediately:

severe skin and mucous membrane reactions characterized by rashes, redness, itching, and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis);
allergic reactions, even severe ones, which may include: urticaria, itching, purpura, swelling of the face, mouth, and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), irregular heartbeats (tachycardia), low blood pressure (hypotension), anaphylaxis, shock, and worsening of asthma;
aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, neck stiffness, and fever (more frequent if you have 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

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

cystitis, rhinitis
depression, insomnia, difficulty concentrating, mood instability
hearing and vision disturbances
cerebral hemorrhage
dry eyes
awareness of your own heartbeat (palpitations)
diarrhea, flatulence, dry mouth, constipation, and vomiting
hair loss (alopecia), skin reaction caused by exposure to sunlight (photosensitivity dermatitis)
severe kidney diseases including tubular necrosis, glomerulonephritis, presence of blood in urine, and increased urine production
decreased hematocrit levels

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

reduction in blood cell counts (anemia, leucopenia, neutropenia, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) – early signs include: 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 lesions in the mouth, stomach burning (gastritis)
simultaneous kidney and liver disease (hepatorenal syndrome), death of some liver cells (hepatic necrosis), liver disease (liver failure, hepatic dysfunction, hepatitis, jaundice)
severe kidney diseases (acute renal failure, papillary necrosis), particularly after long-term treatment, associated with increased blood urea concentration and swelling (edema)
decreased hemoglobin levels in blood
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 determine whether anti-infective/antibiotic therapy is needed
cerebrovascular events, congestive heart failure in patients with compromised cardiac function

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

irritability
fluid retention and decreased appetite
abnormal perception of sounds such as ringing, buzzing, or hissing (tinnitus)
severe heart disease (heart failure) and swelling (edema)
increased blood pressure (hypertension) and reduced blood flow to the body (shock)
respiratory tract disorders including asthma, laryngeal obstruction, labored breathing (bronchospasm), temporary cessation of breathing (apnea), and difficulty breathing (dyspnea)
worsening of inflammatory bowel diseases (colitis and Crohn's disease), inflammation of the pancreas (pancreatitis), inflammation of the duodenum (duodenitis), inflammation of the esophagus (esophagitis)
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 cell)
A widespread, red, scaly rash with pustules under the skin and blisters mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using IBULEV 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 effects, including those not listed in this leaflet, contact 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 IBULEV

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 IBULEV contains

The active substance is ibuprofen. Each sachet contains 200 mg of ibuprofen.
The other components are: citric acid monohydrate, sodium citrate, potassium acesulfame, xanthan gum, sodium benzoate, orange flavour, liquid maltitol, glycerin, purified water.

Description of the appearance of IBULEV and the contents of the pack
Single-dose sachets with a capacity of 10 ml, made of a polyester/aluminum/polyethylene laminate.
The pack contains 6 or 12 sachets of 10 ml oral suspension.
Marketing Authorization Holder
FARTO S.R.L. - FARMACO BIOCHIMICO TOSCANO
VIA DEI CAB OTO, 49
50127 FIRENZE
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1- 03012 Anagni (Frosinone).

Ibulev

Package leaflet: Information for the user

IBULEV Children 100 mg/5 ml oral suspension, strawberry flavour, sugar-free, Children 100 mg/5 ml oral suspension, orange flavour, sugar-free

1. What IBULEV is and what it is used for

2. What you need to know before using IBULEV

3. How to use IBULEV

4. Possible side effects

5. How to store IBULEV

6. Package contents and other information

Patient Information Leaflet: Information for the User

IBULEV 200 mg oral suspension sachet, orange flavour

1. What IBULEV is and what it is used for

2. What you need to know before using IBULEV

3. How to take IBULEV

4. Possible side effects

5. How to store IBULEV

6. Package contents and other information