LEVIFEN 100 mg /5 Ml Oral Suspension

Зміст інструкції

1. LEVIFEN Bambini 100mg/5ml oral suspension strawberry flavour sugar-free, LEVIFEN Bambini 100mg/5ml oral suspension orange flavour sugar-free
   1. Cos’è LEVIFEN Bambini e a cosa serve
   2. Possible side effects
   3. How to store LEVIFEN Bambini
   4. Contents of the pack and other information

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

Ibuprofen

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. See a doctor if you do not feel better or if your 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).

Contents of this leaflet:

• 1. What LEVIFEN Bambini is and what it is used for
• 2. What you need to know before you take 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. Cos’è LEVIFEN Bambini e a cosa serve

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

• 2.What you need to know before usingLEVIFEN Bambini

Do not useLEVIFEN Bambini if the child

• is allergic to ibuprofen or to any of the other components of this medicine (listed in paragraph 6);
• experiences or has experienced in the past allergic reactions such as wheezing, rhinitis (runny nose), swelling of the face, lips and throat (angioedema) or urticaria, especially if associated with nasal polyps and asthma, after taking other analgesics, other antipyretics, acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs);
• suffers from a severe kidney or liver disease (renal or hepatic insufficiency);
• suffers from a severe heart disease (heart failure);
• suffers from or has suffered from bleeding of the stomach and/or intestines (gastrointestinal hemorrhage) or perforation following previous treatments based on NSAIDs;
• suffers from or has suffered from gastric/duodenal ulcers (peptic ulcers) or ongoing or recurrent bleeding (at least two distinct episodes of demonstrated ulceration or bleeding);
• is taking other non-steroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors)

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(see paragraph “Other medicines and LEVIFEN Bambini”);

• has any disease that increases the risk of bleeding;
• in case of unexplained blood disorders;
• is in a severe state of dehydration, for example has had severe episodes of vomiting, diarrhea or drinks very little
• is under 3 months of age or weighs less than 5.6 kg;
• in the last trimester of pregnancy (see paragraph “Pregnancy and breastfeeding”).

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

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

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

• suffers from or has suffered from asthma because breathing difficulties may worsen;
• suffers from blood clotting problems or hypertension;;
• suffers from kidney, heart, liver diseases if taking medicines that increase urine production (diuretics), or if has undergone major surgery with consequent fluid loss, as in these cases your doctor may advise you to perform periodic blood and urine tests on the child;
• has undergone major surgery;
• suffers from some congenital diseases that affect blood formation (for example, acute intermittent porphyria); is dehydrated (for example due to fever, vomiting or diarrhea), in this case rehydrate him before and during treatment to avoid the risk of impaired kidney function.

During prolonged treatments, with LEVIFEN Bambini, you must pay particular attention and immediately warn the doctor if the following appear:

• signs or symptoms of ulcerations or bleeding of the stomach and intestines (e.g. black and foul-smelling stools, vomiting blood);
• signs or symptoms of liver damage (e.g. hepatitis and jaundice);
• signs or symptoms of kidney damage (e.g. increased urine production, blood in the urine);
• visual disturbances (blurred or reduced vision, areas of complete or partial blindness, altered color perception);
• symptoms such as frequent or daily headaches despite regular use of headache medicines, as they may be caused by overuse of these medicines;
• symptoms such as headache, disorientation, nausea, vomiting, stiff neck and fever as these may be symptoms due to aseptic meningitis (more frequent if the child suffers from systemic lupus erythematosus or other collagen diseases). Skin reactions Serious skin reactions have been reported in association with treatment with LEVIFEN Bambini. Stop taking LEVIFEN Bambini and consult your doctor immediately if you experience rash, mucous membrane lesions, blisters or other signs of allergy, as they may be the first signs of a very serious skin reaction. See section 4.

Infections
LEVIFEN Bambini can mask the symptoms of infections such as fever and pain. It is therefore possible that LEVIFEN Bambini may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.

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

Other medicines andLEVIFEN Bambini
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
LEVIFEN Bambini can affect or be affected by other medicines, in particular tell your doctor or pharmacist if the child is taking:

• other medicines used for the treatment of pain, to lower fever and/or to cure inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors or acetylsalicylic acid). In this case such associations should be avoided as they increase the risk of possible side effects;

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• medicines used to treat inflammation and some diseases of the immune system (corticosteroids);
• medicines used to treat infections caused by bacteria (quinolone antibiotics);
• a medicine that has an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, 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 to treat viral infections (ritonavir);
• medicines that modulate the immune response (tacrolimus and cyclosporine);
• a medicine used in the treatment of cancer and rheumatism (methotrexate);
• a medicine used for mental illness (lithium);
• a medicine for interrupting pregnancy (mifepristone): do not take NSAIDs in the 8-12 days following the intake of mifepristone;
• a medicine 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) because the concomitant administration of ibuprofen and CYP2C9 inhibitors may slow down the elimination of ibuprofen (a CYP2C9 substrate) resulting in an increased exposure to ibuprofen.
• medicines used to treat heart disease (cardiac glycosides such as digoxin).
• Zidovudine (a medicine for the treatment of HIV/AIDS)

LEVIFEN Bambini with food and drink
The medicine can be given both with or without meals.
Possible side effects on the stomach, if present, can be reduced by taking the medicine on a full stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
It is unlikely that girls under 12 years of age will become pregnant or breastfeed. In this event, 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 your doctor.
Do not take Levifen Bambini during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. (see “Do not take Levifen Bambino”).
NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect the tendency to bleed in the mother and the baby and delay or prolong labor more than expected. You should not take Levifen Bambini in the first 6 months of pregnancy, unless absolutely necessary and under the advice of your doctor. If treatment is needed in this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, NSAIDs can 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 the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may advise additional monitoring.
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Breastfeeding
This medicine passes in small amounts into breast milk. It can be used during breastfeeding if taken at the recommended doses and for short periods of time

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

LEVIFEN Bambini contains:

• maltitol.If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine;
• less than 1 mmol (23 mg) of sodiumper dose (2.5 ml), meaning 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 indicated in patients who need to control their sugar and calorie intake.

How to useLEVIFEN Bambini
Use this medicine following the instructions provided in this leaflet, or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

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

The daily dose of 20-30 mg/kg of body weight, divided into 3 times a day at intervals of 6-8 hours, can
be administered based on the scheme below (calculate the dose to be administered based on the weight
shown in the table and the child's age).

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The graduated scale on the syringe highlights the 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 measuring 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 the child suffers from stomach problems, administer LEVIFEN Bambini preferably during meals.
In the case of post-vaccination fever, refer to the dosage 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 in 24
hours. Consult your doctor if the fever does not decrease.
LEVIFEN Bambini should be administered for short-term treatments.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If
you have an infection, consult your doctor immediately if the symptoms (e.g. fever and pain)
persist or worsen (see section 2).
Consult your doctor if you do not notice any improvement or if your 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 down and turning it to the left.
• 2 – Insert the tip of the syringe fully into the hole in the tamper-evident 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 on the plunger corresponding to the desired dose.
• 5 – Return the bottle to the vertical position and remove the syringe by gently twisting it.
• 6 – Insert the tip of the syringe into the child's mouth, and apply gentle pressure to the plunger to administer the suspension. After use, screw the cap back on to close the bottle and wash the syringe with warm water. Let it dry, keeping it out of reach and sight of children.

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If you take more LEVIFEN Bambini than you should
If you have taken more LEVIFEN Bambini than you should or if your child has taken this medicine by
mistake, always contact a doctor or the nearest hospital to obtain advice on the risk and
recommendations on the actions to be taken .
Symptoms may include: nausea, stomach pain, 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, feeling cold to the body and breathing problems have been reported.
Symptoms of an overdose may appear within 4 – 6 hours of taking ibuprofen.
Rarely, it may present: uncontrolled eye movements (nystagmus), increased acids in the blood
(metabolic acidosis), lowering of body temperature (hypothermia), effects on the kidneys,
bleeding of the stomach and intestines, deep unconsciousness (coma), temporary interruption
of breathing (apnea), diarrhea, reduced activity of the nervous system (depression of the Central Nervous
System) and respiratory activity (depression of the respiratory system).
In addition, it may also manifest: disorientation, excited state, fainting, lowering of the
blood pressure (hypotension), decrease or increase in heart rate (bradycardia or tachycardia).
If you take significantly high doses of ibuprofen, you may experience serious damage to the kidneys and
liver.

If you forget to takeLEVIFEN Bambini
Do not use a double dose to make up for a missed dose.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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If the child experiences any of the following side effects STOPtreatment with LEVIFEN
Children and consult a doctor:

• severe skin and mucous membrane changes characterized by rashes, redness, itching and blisters (bullous and exfoliative dermatitis including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• allergic reactions, even serious, which may include: hives, itching, purpura, swelling of the face, mouth and throat (angioedema), difficulty breathing (bronchospasm or dyspnea), altered heartbeat (tachycardia), low blood pressure (hypotension), anaphylaxis, severe shock and worsening of asthma;
• aseptic meningitis with symptoms such as disorientation, headache, nausea, vomiting, stiff neck and fever (more frequent if the child suffers from systemic lupus erythematosus or other connective tissue diseases).

Further side effects include:

Uncommon( may affect up to 1 in 100 people):

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

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

• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, unstable mood, hearing disorders;
• cerebrovascular hemorrhage;
• dry eyes;
• perception of heartbeat (palpitations);
• diarrhea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia),
• the skin becomes sensitive to light;
• serious kidney diseases including tubular necrosis, glomerulonephritis, appearance of blood in the 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, thrombocytopenia, eosinophilia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and bleeding;
• signs or symptoms of ulcers or bleeding in the stomach and intestines, black and foul-smelling stools, vomiting blood;
• lesions with bleeding of the mouth, heartburn (gastritis);
• simultaneous disease of the kidneys and liver (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 treatments, associated with an increase in blood urea concentration and swelling (edema);
• decrease in hemoglobin levels in the blood;
• heart attack (myocardial infarction)
• severe skin infections and soft tissue complications during varicella infection;
• worsening of infections-related inflammation (e.g. necrotizing fasciitis) associated with the use of some non-steroidal anti-inflammatory drugs (NSAIDs). If signs or symptoms worsen,

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you should immediately consult a doctor to assess whether anti-infective/antibiotic therapy is necessary.

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

• irritability;
• fluid retention and decreased appetite;
• abnormal perception of noises such as ringing, buzzing or whistling (tinnitus);
• serious heart disease (heart failure) and swelling (edema);
• increased blood pressure (hypertension) and reduced blood flow to the body (shock);
• respiratory 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);
• it is possible that a serious 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 and scaly rash, with the formation of pustules under the skin and blisters mainly on the skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Levifen if you develop these symptoms and contact your doctor immediately. See also paragraph 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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the Italian Medicines Agency at the address 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 which is stated on the pack after Exp. The expiry date
refers to the last day of that month and to the product in intact packaging, correctly
stored.
Period of validity after first opening: 6 months.
Do not dispose of any medicine in 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 pack and other information

What LEVIFEN Bambini contains
LEVIFEN Bambini100mg/5ml oral suspension orange flavour sugar-free

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

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LEVIFEN Bambini100mg/5ml oral suspension strawberry flavour sugar-free

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

Not all pack sizes may be marketed.

Description of the appearance of LEVIFEN Bambini and contents of the pack
Oral suspension, 150 ml bottle with dosing syringe.

Marketing Authorisation 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)
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