Levifen

Package leaflet: Information for the patient

LEVIFEN Bambini 100mg/5ml sugar-free strawberry-flavoured oral suspension, Bambini 100mg/5ml sugar-free orange-flavoured oral suspension

Ibuprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine 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 you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contact your doctor if you do not notice improvement or if you notice 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 adolescents).

Contents of this leaflet:

1. What LEVIFEN Bambini is and what it is used for
2. What you need to know before taking LEVIFEN Bambini
3. How to take LEVIFEN Bambini
4. Possible side effects
5. How to store LEVIFEN Bambini
6. Contents of the pack and other information

1. What LEVIFEN Bambini is and what it is used for

LEVIFEN Bambini contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by reducing pain, fever, and inflammation.
LEVIFEN Bambini is indicated in children from 3 months to 12 years of age for the symptomatic treatment of fever and mild to moderate pain.

2.

2. What you should know before using LEVIFEN Bambini

Do not use LEVIFEN Bambini if the child

• is allergic to ibuprofen or to any of the other components of this medicine (listed in section 6);
• has had or currently has allergic reactions such as shortness of breath, rhinitis (runny nose), swelling of the face, lips, or throat (angioedema), or hives, particularly if associated with nasal polyps and asthma, after taking other painkillers, antipyretics, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs);
• suffers from severe kidney or liver disease (renal or hepatic insufficiency);
• suffers from severe heart disease (heart failure);
• has had or currently has gastrointestinal bleeding and/or perforation following previous treatment with NSAIDs;
• has had or currently has gastric/duodenal ulcers (peptic ulcers) or active or recurrent bleeding (at least two distinct episodes of proven ulceration or bleeding);
• is currently taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors)
  (see section “Other medicines and LEVIFEN Bambini”);
• has any disease that increases the risk of bleeding;
• has unexplained blood disorders;
• is severely dehydrated, for example due to severe episodes of vomiting, diarrhoea, or very low fluid intake;
• is under 3 months of age or weighs less than 5.6 kg;
• is in the last trimester of pregnancy (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Consult your doctor or pharmacist before using Levifen if the child:

• has had or currently has allergies to medicines used to treat fever, pain, and inflammation (non-steroidal anti-inflammatory drugs), or suffers from breathing difficulties (asthma), seasonal allergies (hay fever), nasal polyps, severe respiratory or chest problems, e.g. 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 LEVIFEN Bambini”);
• has had stomach or intestinal disorders (history of ulcer), especially if complicated by bleeding or perforation, as this may increase the risk of gastrointestinal bleeding and perforation. In such cases, your doctor may advise starting treatment with the lowest available dose and possibly using concomitant medicines that protect the stomach (misoprostol or proton pump inhibitors). This should also be considered if low-dose aspirin or other medicines that may increase the risk of stomach and intestinal disorders are being taken (see section “Other medicines and LEVIFEN Bambini”). During treatment with all NSAIDs, at any time and 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 Levifen and contact your doctor immediately;
• has had or currently has 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 like aspirin, or medicines used to treat depression (selective serotonin reuptake inhibitors) (see section “Other medicines and LEVIFEN Bambini”);
• has heart disease (uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease) or has had reduced blood flow to the brain (stroke), or if you think the child may be at risk for these conditions (e.g. if they have high blood pressure, high blood sugar levels (diabetes), high blood lipid levels, or smoke). Medicines such as LEVIFEN Bambini may be associated with a slight increase in the risk of heart attack or stroke: the risk is higher at high doses and with prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• has 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;
• has an infection (see section “Infections” below);
• has chickenpox, as the use of LEVIFEN Bambini should be avoided in this case.

The use of LEVIFEN Bambini requires adequate precautions, especially if the child:

• has had or currently has asthma, as breathing difficulties may worsen;
• has coagulation disorders or hypertension;
• has kidney, heart, or liver disease and is taking medicines that increase urine production (diuretics), or has undergone major surgery resulting in fluid loss, as in these cases your doctor may recommend periodic blood and urine tests;
• has 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); rehydrate the child before and during treatment to avoid the risk of impaired kidney function.

During prolonged treatment with LEVIFEN Bambini, pay particular attention and inform your doctor immediately if any of the following occur:

• signs or symptoms of stomach or intestinal ulceration or bleeding (e.g. black, tarry, foul-smelling stools, vomiting blood);
• signs or symptoms of liver damage (e.g. hepatitis, jaundice);
• signs or symptoms of kidney damage (e.g. increased urine output, 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, which could be due to overuse of these medicines;
• symptoms such as headache, disorientation, nausea, vomiting, stiff neck, and fever, as these could indicate aseptic meningitis (more common if the child has systemic lupus erythematosus or other collagen diseases).

Skin reactions
Serious skin reactions have been reported with LEVIFEN Bambini treatment. Stop taking LEVIFEN Bambini and consult your doctor immediately if a skin rash, mucosal lesions, blisters, or other signs of allergy appear, as they may be early signs of a very serious skin reaction. See section 4.

Infections
LEVIFEN Bambini may mask symptoms of infections such as fever and pain. Therefore, LEVIFEN Bambini could 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 you take this medicine while having an infection and the symptoms of infection persist or worsen, contact your doctor immediately.

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

Other medicines and LEVIFEN Bambini
Inform your doctor or pharmacist if the child is taking, has recently taken, or might take any other medicines.
LEVIFEN Bambini may affect or be affected by other medicines. In particular, inform your doctor or pharmacist 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);
• medicines used to treat bacterial infections (quinolone antibiotics);
• medicines with anticoagulant effects (i.e. substances that thin the blood and 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 illnesses (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 high 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 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).

LEVIFEN Bambini with food and drinks
The medicine can be taken with or without food.
Possible gastrointestinal 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 girls 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 the baby and during childbirth. Avoid using this medicine during the first 6 months of pregnancy unless prescribed by a doctor.
Do not take Levifen Bambini during the last 3 months of pregnancy, as it may harm the fetus or cause complications during childbirth. (See “Do not take Levifen Bambino”).
NSAIDs may cause kidney and heart problems in the fetus. They may affect the bleeding tendency in both mother and baby and delay or prolong labour. You should not take Levifen Bambini during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used. From the 20th week of pregnancy, NSAIDs may cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing constriction of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, 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 of time.

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

LEVIFEN Bambini contains:

• Maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine;
• less than 1 mmol (23 mg) of sodium per dose (2.5 ml), i.e. it is practically ‘sodium-free’;
• Benzoate salt. LEVIFEN Bambini contains 1 mg of benzoate salt (sodium benzoate) per ml, equivalent to 2.5 mg in 2.5 ml. Benzoate salt may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

LEVIFEN Bambini does not contain sugar and is therefore suitable for patients who need to control their sugar and calorie intake.

3.
How to use LEVIFEN Bambini
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

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

The daily dose of 20–30 mg/kg body weight, divided into 3 doses per day at 6–8 hour intervals, may be administered according to the following dosing schedule (calculate the dose based on the weight and age of the child as shown in the table).

The graduated scale on the syringe clearly shows markings for different dosages; in particular, the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen.
The dosing spoon has two markings for two different dosages: the 2.5 ml mark corresponding to 50 mg of ibuprofen and the 5 ml mark corresponding to 100 mg of ibuprofen.
If your child suffers from stomach problems, administer LEVIFEN Bambini preferably during meals.
In case of post-vaccination fever, follow the dosage instructions indicated above, administering a single dose (2.5 ml), followed, if necessary, by another dose after 6 hours. Do not administer more than two doses within 24 hours. Consult your doctor if fever does not subside.
LEVIFEN Bambini should be administered for short-term treatment only.
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).
Contact 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:
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 – Invert the bottle, then, holding the syringe firmly, gently pull the plunger downwards to draw the suspension into the syringe until the mark printed on the plunger reaches 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. Allow it to dry and keep it out of the reach and sight of children.

If you take more LEVIFEN Bambini than you should
If you have taken more LEVIFEN Bambini than you should, or if your child has accidentally ingested this medicine, always contact a doctor or the nearest hospital for advice on potential risks and guidance on necessary actions.
Symptoms may include: nausea, stomach ache, vomiting (possibly with traces of blood), deep drowsiness 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, dizziness, blood in the urine, feeling cold, and breathing difficulties may occur.
Symptoms of overdose may appear within 4–6 hours after taking ibuprofen.
Rarely, it may cause: uncontrolled eye movements (nystagmus), increased acid levels in the blood (metabolic acidosis), lowered body temperature (hypothermia), kidney problems, bleeding in the stomach and intestines, profound loss of consciousness (coma), temporary interruption of breathing (apnea), diarrhea, reduced activity of the nervous system (central nervous system depression), and reduced respiratory activity (respiratory depression).
Additionally, it may also cause: disorientation, agitation, fainting, low blood pressure (hypotension), and 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 LEVIFEN Bambini
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
STOP treatment with LEVIFEN Bambini and consult a doctor immediately if the child experiences any of the following side effects:

• 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), breathing difficulties (bronchospasm or dyspnea), irregular heartbeat (tachycardia), low blood pressure (hypotension), anaphylaxis, severe shock, and worsening of asthma;
• aseptic meningitis with symptoms such as confusion, headache, nausea, vomiting, neck stiffness, and fever (more frequent if the child suffers from systemic lupus erythematosus or other collagenopathies).

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

• headache, dizziness, drowsiness, and convulsions;
• stomach pain, nausea, and difficulty digesting (dyspepsia);
• skin rashes;
• vision disturbances.

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

• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, mood instability, hearing disturbances;
• cerebral hemorrhage;
• dry eyes;
• awareness of heartbeat (palpitations);
• diarrhea, flatulence, dry mouth, constipation, and vomiting;
• hair loss (alopecia);
• skin becoming sensitive to light (photosensitivity);
• serious kidney diseases including tubular necrosis, glomerulonephritis, presence of blood in urine (hematuria), 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, 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 mouth lesions, 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 after long-term treatment, associated with increased blood urea concentration and swelling (edema);
• decreased hemoglobin levels in 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, consult a doctor immediately to determine whether anti-infective/antibiotic therapy is needed.

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

• irritability;
• fluid retention and decreased appetite;
• abnormal perception of noises such as ringing, buzzing, or hissing sounds (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 breathing interruption (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 appearing in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Stop using Levifen 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 small increased 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, consult your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) 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 LEVIFEN Bambini

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 and applies to the product in its original unopened packaging, stored correctly.
Usable period after first opening: 6 months.
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. Contents of the package and other information

What LEVIFEN Bambini contains
LEVIFEN Bambini 100mg/5ml oral suspension, orange-flavoured, sugar-free

• The active substance is ibuprofen. Each ml of 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.

LEVIFEN Bambini 100mg/5ml oral suspension, strawberry-flavoured, sugar-free

• The active substance is ibuprofen. Each ml of 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.

It is possible that not all pack sizes are marketed.
Description of the appearance of LEVIFEN Bambini and contents of the pack
Oral suspension, 150 ml bottle with dosing syringe.
Marketing Authorization Holder
EXIPHARMA S.R.L. - Via Del Giglio, 40/A - 35133 Padova (PD)
Manufacturer
Special Product’s Line S.p.A. - Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)