FEVRALT 100 mg /5 Ml Zawiesina Doustna

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1. FEVRALT Bambini 100 mg/5 ml oral suspension
   1. What Fevralt is and what it is used for
   2. What you need to know before using Fevralt
   3. How to use Fevralt
   4. Possible side effects
   5. How to store Fevralt
   6. Contents of the pack and other information

FEVRALT Bambini 100 mg/5 ml oral suspension

Equivalent medicine
Ibuprofen

Read this leaflet carefully before using this medicine as it contains important
information for you
Always use this medicine exactly as described in this leaflet or as your Doctor or Pharmacist
has told you to do.

• 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 get worse.

Contents of this leaflet:

• 1. What Fevralt is and what it is used for
• 2. What you need to know before using Fevralt
• 3. How to use Fevralt
• 4. Possible side effects
• 5. How to store Fevralt
• 6. Contents of the pack and other information

1. What Fevralt is and what it is used for

Fevralt Bambini 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 non-steroidal 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:

• reducing fever (including vaccine fever)
• relieving symptoms of colds and flu
• reducing mild to moderate pain such as teething pain, sprain pain, sore throat, toothache, earache, headache.
• reducing the symptoms of Juvenile Rheumatoid Arthritis (juvenile arthritis)

2. What you need to know before using Fevralt

Do not use Fevralt if the infant/child

• is less than 3 months old andweighs less than 5 kg(unless your doctor advises otherwise)
• is allergic(hypersensitive)to ibuprofenor any of the other ingredients of this medicine(listed in section 6). An allergic reaction can include skin rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• has had asthma attacks, urticariaor rhinitis(inflammation of the nasal mucous membranes)after taking aspirinor NSAIDs(other non-steroidal anti-inflammatory drugs)
• is taking other NSAIDsor a dailydose of aspirin greater than 75 mg.
• has or has had gastrointestinal ulcer, perforation (lesion) or bleeding of the stomach or intestine (loss of blood from the stomach or intestine).

Warnings and precautions
Take particular care with Fevralt.
Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with ibuprofen. Stop Fevralt immediately and contact your doctor or emergency health service 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), 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 the infant/child:

• has or has suffered from asthma
• has had allergies
• suffers from Systemic Lupus Erythematosus (a serious disease that affects the joints, kidneys and skin)
• is taking other NSAIDs or a low dose of aspirin (up to 75 mg per day)
• has blood coagulation defects
• is in a state of severe dehydration resulting from fever, vomiting, diarrhea.
• has visual disturbances (blurred or reduced vision, altered perception of colors)
• has problems with the liver, intestines, kidneys or heart
• has an infection - see section «Infections» below.

Infections
Fevralt can mask 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 varicella. If your infant/child is taking this medicine while they have an infection and the symptoms of the infection persist or worsen, contact your doctor immediately.
There is a risk of impaired kidney function in dehydrated children and adolescents
Fevralt is indicated in infants, children and adolescents, however, if the medicine should be used by adults or the elderly, they should take particular care if they suffer from any of the conditions reported in the section “Do not use Fevralt if the infant/child” and in the section “Talk to your doctor or pharmacist before using Fevralt if the infant/child” .
Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a modest increase in the risk of heart attack (myocardial infarction)or stroke (acute brain damage), especially if administered in high doses.
Do not exceed the recommended dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking Fevralt if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary 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 “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 become pregnant, you may need to stop Fevralt.

Other medicines and Fevralt
Tell your doctor or pharmacist if the infant/child is taking or has recently taken or may take any other medicines. Fevralt can influence or be influenced by other medicines.
For example:

• medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
• Diuretics
• Quinolones (antibiotics)
• Antidepressants
• Sulfonylureas (for the treatment of diabetes)
• Corticosteroids (medicines that reduce inflammation such as hydrocortisone)
• Lithium (a treatment for mental illness)
• Methotrexate (used for rheumatoid arthritis and cancer)
• Ritonavir or Zidovudine (antiviral treatments)
• Cyclosporine, tacrolimus, (treatments to prevent rejection after transplantation)
• Aspirin
• Cardiac glycosides
• Probenecid (used to increase the elimination of uric acid)

Even some other medicines can influence or be influenced by treatment with Fevralt. Therefore, always consult your doctor or pharmacist before using Fevralt with other medicines.

FEVRALT with food and drink and alcohol
Fevralt can be taken with food if it causes stomach upset.

Pregnancy and breastfeeding and fertility
Fevralt should not be taken by women who are pregnant, with a possible risk of pregnancy or who are breastfeeding.

Driving and operating machinery
Fevralt does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.

This medicine contains:

• Liquid MaltitolIf your doctor has diagnosed your child with an intolerance to some sugars, contact them before giving this medicine to your child.

It may have a mild laxative effect .
The caloric value of maltitol is 2.3 kcal/g.

• SodiumThis medicine contains less than 1 mmol (23 mg) of sodiumper dose of 2.5 ml, 5 ml, 7.5 ml, 10 ml and 15 ml of oral suspension, i.e. essentially sodium-free
• Sodium benzoate (E211)This medicine contains 15 mg of sodium benzoateper 5 ml dose of oral suspension, equivalent to 3 mg/ml. Sodium benzoate can increase jaundice (yellowing of the skin and eyes) in newborns up to four weeks of age.
• Ethanol (ethyl alcohol)This medicine contains 0.05 mg of alcohol (ethanol) in each 5 ml dose of oral suspension, equivalent to 0.01 mg/ml. The amount in 5 ml of oral suspension is equivalent to 0.001 ml of beer and 0.0005 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to use Fevralt

Dosage
Use this medicine following exactly as stated in this leaflet or as instructed by your Doctor,
or Pharmacist. If you have any doubts, consult your doctor or pharmacist.
Fevralt must be taken orally
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If your
infant/child has an infection, consult a doctor immediately if the symptoms (e.g. fever and
pain) persist or worsen (see paragraph 2).
Shake the bottle well before use.

For fever and mild to moderate pain
Fevralt can be given to infants over 3 months of age and weighing more than 5 kg

For infants between > 3 and < 5 months of age weighing more than 5 Kg
In infants between 3 and 5 monthsof age, consult a doctor if symptoms persist for
more than 24 hours or if the symptoms worsen

In infants and children (between > 6 months and < 12 years of age)
If the medicine is needed for more than 3 days in infants and children over 6 months of age, or
if the symptoms worsen, consult a Doctor
The recommended daily dose is 20-30 mg/kg of body weight in divided doses.
Using the supplied 2.5 ml and 5 ml measuring spoon, this can be achieved as follows:
Age Weight (Kg) Dose Daily dosage
3-5 months 5.6 – 7.7 2.5 ml 3 times a day 150 mg
6-12 months 7.8 – 10 2.5 ml 3-4 times a day 150-200 mg
>1-≤3 years 11 –15 5 ml 3 times a day 300 mg
4-6 years 16 – 20 7.5 ml 3 times a day 450 mg
7-9 years 21 – 28 10 ml 3 times a day 600 mg
10-12 years 29 – 40 15 ml 3 times a day 900 mg
Normally the dose should be administered every 6-8 hours. This time can be reduced to 4 hours, if
necessary, without exceeding the maximum daily dose of 30 mg/kg of body weight.

For fever caused by vaccination

• Administer Fevralt to an infant under 6 months of age only on the recommendation of a Doctor.
• The usual dose is 2.5 ml.
• Only if necessary, administer another 2.5 ml 6 hours later.
• Do not administer more than 5 ml in 24 hours in any case.
• If the fever does not subside, do not administer a third dose and consult a Doctor.

For the symptomatic treatment of Juvenile Rheumatoid Arthritis

• The usual daily dose is 30 to 40 mg/Kg divided into 3 - 4 doses

INSTRUCTIONS FOR USE
The container must be shaken before use for appropriate administration of the medicine.
The bottle must be tightly closed after each use.
This medicine must be administered orally, using the measuring spoon.
After use, close the bottle by screwing on the cap and wash the measuring spoon with warm water. Wait for the
spoon to dry.
Keep the medicine out of the sight and reach of children.
The spoon must only be used for administering Fevralt oral suspension.

If you use more FEVRALT than you should
If you have taken more Fevralt 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 what actions to take.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), headache, ringing in the ears (tinnitus),
confusion, uncontrolled eye movements (nystagmus). At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially
in children), weakness and dizziness, severe kidney damage with blood in the urine, feeling of coldness to the body and breathing problems, severe liver damage, a deep sleep state with reduced response to normal
stimuli (lethargy) have been reported.
Symptoms of an overdose may appear within 4 – 6 hours of taking ibuprofen.
Rarely, it may occur: increased acids in the blood (metabolic acidosis), bleeding from the stomach
and intestines, profound loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhea,
reduction of nervous system (Central Nervous System depression) and respiratory activity
(respiratory system depression).
Also, it may manifest: disorientation, state of excitement, fainting, low blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
If you have any doubts about the use of Fevralt, consult your doctor or pharmacist.

If you forget to use Fevralt
If you forget to give a dose of Fevralt to the infant/child, give it as soon as possible and then return to the regular doses.
Do not use a double dose to make up for the missed dose.

If you stop using Fevralt
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. 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 immediatelyif you experience sudden wheezing, difficulty in breathing,
swelling of the eyelids, face or lips, skin rash or itching (especially if it spreads all over
the body).
Stop using ibuprofen and consult your doctor immediately if you notice any of the following symptoms:
skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe
skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema
multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis];

• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The following description of the frequency of side effects has been used to establish an order of them:

• Very common (more than one in ten)
• Common (less than one in ten, but more than one in one hundred)
• Uncommon (less than one in one hundred, but more than one in one thousand)
• Rare (less than one in one thousand, but more than one in ten thousand)
• Very rare (less than one in ten thousand)
• Not known (the frequency cannot be estimated from the available data)

The following side effects have been reported:

Common

• Gastric ulcer (stomach ulcer) with or without bleeding and/or perforation (injury) which can be fatal in the elderly.
• Nausea
• Vomiting or blood in the vomit
• Diarrhoea or blood in the stools
• Flatulence (gas) 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)
• Headache
• Irritability
• Tinnitus (ringing in the ears)
• Dizziness

Uncommon

• Gastritis (inflammation of the stomach)
• Heartburn
• Bronchospasm (asthma-like symptoms)
• Dyspnoea (shortness of breath)
• Decreased appetite
• Edema (swelling)
• Fluid retention
• Hypertension (high blood pressure)
• Heart failure

Rare
Allergic reactions including urticaria, with or without angioedema (swelling), dyspnoea (shortness of breath) caused by
obstruction of the throat 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, liver tissue death, hepato-renal syndrome (kidney failure in
patients with liver disease), liver failure, depression, insomnia, difficulty concentrating, emotional lability,
weakness, drowsiness, meningitis (inflammation of the membranes of the brain), convulsions, dry
eyes, apnea (stopping of breathing), rhinitis (inflammation of the nasal membranes), various skin conditions,
itching, hair loss, skin peeling and sensitivity to light.
Changes in blood levels including reduction of red blood cells 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 (kidney inflammation), changes in kidney function tests, polyuria (increased frequency of urination), 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 scaling 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).

Medicines like Fevralt may determine a modest risk of causing heart attack or acute brain damage.

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 national reporting system: 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 Fevralt

Do not refrigerate or freeze
Keep Fevralt out of sight and reach of children.
Do not use Fevralt after the expiry date which is stated on the package and the bottle. The expiry date refers to
the last day of that month.
The product must be used within 6 weeks after first opening
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment

6. Contents of the pack and other information

What Fevralt contains
The active ingredient is ibuprofen: 5 ml of suspension contains 100 mg of ibuprofen
The other ingredients are: Purified water, Liquid Maltitol, Glycerol, Xanthan Gum, Sodium Benzoate,
Sodium Cyclamate, Citric Acid, Orange Aroma, Acesulfame Potassium, Polysorbate 80 and Sodium Edetate

Description of the appearance of Fevralt and contents of the pack
Fevralt Bambini 100 mg/5 ml oral suspension is a dense, whitish-colored suspension contained in an
amber bottle of 100 ml with a measuring spoon of 2.5 ml and 5 ml.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:

NEOPHARMED GENTILI S.p.A– Via San Giuseppe Cottolengo 15 – 20143 Milano
Manufacturer:

TEMMLER ITALIA Srl
Via delle Industrie, 2
20061 Carugate (MI)
ITALY

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Italy: Fevralt Bambini 100 mg/5 ml oral suspension

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