FEVRALT CHILDREN 100 MG/5 ML ORAL SUSPENSION 1 100 ML PET BOTTLE WITH MEASURING SPOON

Name
FEVRALT Children 100 mg/5 ml oral suspension
Equivalent medicine
Ibuprofen


What is it and what is it used for?
Fevralt Children 100 mg / 5 ml oral suspension contains 100 mg of the active ingredient Ibuprofen in 5 ml.
Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (also known as NSAIDs), which relieve pain and reduce inflammation.

Fevralt is used in infants (weighing more than 5 kg) and children up to 12 years of age for:
- reduce fever (including vaccination fever);
- relieve cold and flu symptoms;
- reduce mild to moderate pain such as teething pain, sprain pain, sore throat, toothache, earaches, headaches;
- reduce the symptoms of Juvenile Rheumatoid Arthritis (juvenile arthritis).


What you need to know before taking the medicine
Do not use Fevralt if the infant/child:
- is less than 3 months old and weighs less than 5 kg (unless your doctor advises otherwise);
- are allergic ( hypersensitive ) to ibuprofen or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include redness of the skin, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue;
- have had asthma attacks, hives or rhinitis ( inflammation of the nasal mucosa ) after taking aspirin or NSAIDs (other non-steroidal anti-inflammatory drugs);
- are taking other NSAIDs or a daily dose of aspirin greater than 75 mg ;
- have or have had a gastrointestinal ulcer , perforation (lesion) or bleeding of the stomach or intestine ( loss of blood from the stomach or intestine ).


Warnings and precautions
Take special care with Fevralt.

Signs of an allergic reaction to ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Fevralt immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

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

Talk to your doctor or pharmacist before using Fevralt if your infant/child:
- have or have suffered from asthma;
- had allergies;
- suffers from Systemic Lupus Erythematosus (a serious disease that affects the joints, kidneys and skin);
- are taking other NSAIDs or a low dose of aspirin (up to 75 mg daily);
- has blood clotting defects;
- is in a state of severe dehydration resulting from fever, vomiting, diarrhea;
- has visual disturbances (blurred or reduced vision, altered color perception);
- have liver, intestinal, kidney or heart problems;
- have an infection – see section “Infections” below.

Infections
Fevralt may hide the symptoms of infections such as fever and pain. Therefore, Fevralt may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If your infant/child takes this medicine while having an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.
In dehydrated children and adolescents there is a risk of impaired renal function.

Fevralt is indicated in infants, children and adolescents, however, if the medicine is used by adults or elderly people, they should pay particular attention if they suffer from any of the conditions listed in the paragraph "Do not use Fevralt if you are an infant/child" and in the paragraph "Talk to your doctor or pharmacist before using Fevralt if you are an infant/child".

Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a small increased risk of heart attack ( myocardial infarction ) or stroke ( acute brain injury ), especially when given in high doses.

Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Fevralt if you have:
- heart problems including heart attack, angina (chest pain) or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "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.
If you are trying to get pregnant, you may need to stop taking Fevralt.


Possible side effects
Like all medicines, Fevralt can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Tell your doctor immediately if you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if it affects your whole body).

Stop using ibuprofen and see your doctor immediately if you notice any of the following symptoms:
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and ulcers of the mouth, throat, nose, genitals, and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];
• widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome);
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

The following description of the frequency of side effects was used to establish a ranking of the side effects:
- Very common (more than one in ten);
- Common (less than one in ten, but more than one in a hundred);
- Uncommon (less than one in a hundred, but more than one in a thousand);
- Rare (less than one in a thousand, but more than one in ten thousand);
- Very rare (less than one in ten thousand);
- Not known (frequency cannot be estimated from the available data).

The following side effects have been reported:

Common
- Gastric (stomach) ulcer with or without bleeding and/or perforation (lesion) which can be fatal in the elderly;
- Nausea;
- Vomiting or blood in vomit;
- Diarrhea or blood in the stool;
- Flatulence (wind) or constipation;
- Dyspepsia (digestive problems) or abdominal pain;
- Stomatitis (inflammation of the mouth) or worsening of colitis;
- Crohn's disease (inflammation of the digestive tract);
- Heachache;
- Irritability;
- Tinnitus (ringing in the ears);
- Vertigo (dizziness).

Uncommon
- Gastritis (inflammation of the stomach);
- Heartburn;
- Bronchospasm (asthma-like symptoms);
- Dyspnea (shortness of breath);
- Reduction of appetite;
- Edema (swelling);
- Fluid retention;
- Hypertension (high blood pressure);
- Heart failure.

Rare
Allergic reactions including hives, with or without angioedema (swelling), dyspnoea (shortness of breath) caused by throat obstruction or bronchospasm (spasm of the lungs), shock, abdominal pain, fever and chills, nausea and vomiting.

Pancreatitis (inflammation of the pancreas), duodenitis (inflammation of part of the intestine), esophagitis (inflammation of the esophagus), dry mouth, hepatitis (inflammation of the liver), jaundice (yellowing of the skin and eyes), liver disorders, death of liver tissue, hepatorenal syndrome (kidney failure in patients with liver disease), liver failure, depression, insomnia, difficulty concentrating, emotional fragility, weakness, drowsiness, meningitis (inflammation of the lining of the brain), convulsions, dry eyes, apnea (stopping breathing), rhinitis (inflammation of the nasal membranes), various skin conditions, itching, hair loss, peeling skin, and sensitivity to light.

Blood changes including reduced red and white blood cells and platelets, stroke, hypotension (low blood pressure), heart failure in patients at risk, papillary/tubular necrosis (death of kidney cells), glomerulonephritis (inflammation of the kidney), changes in kidney function tests, polyuria (increased urinary frequency), cystitis (bladder infections), hematuria (blood in the urine), and kidney failure in patients at risk.

Very rare
Skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (very severe peeling or blistering of the skin).

Not Known
- Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
- Skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) and acute generalized exanthematous pustulosis (AGEP).

Drugs like Fevralt may carry a small risk of causing a heart attack or acute brain damage.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.