DECAFLU 100 mg /5 Ml Oral Suspension

Зміст інструкції

1. Decaflu Febbre e Dolore Bambini 100 mg/5 ml oral suspension orange flavour sugar-free, strawberry sugar-free
   1. What is Decaflu Febbre e Dolore and what is it used for?
   2. What you need to know before using Decaflu Febbre e Dolore
   3. How to take Decaflu Fever and Pain
   4. Possible side effects
   5. How to store Decaflu Febbre e Dolore
   6. Contents of the pack and other information

Decaflu Febbre e Dolore Bambini 100 mg/5 ml oral suspension orange flavour sugar-free, strawberry sugar-free

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.

• 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.
• Talk to your doctor if you do not feel better or if you feel worse:
• after 24 hours if the infant is between 3 and 5 months old
• after 3 days if the infant or child is over 6 months old

Contents of this leaflet:

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

1. What is Decaflu Febbre e Dolore and what is it used for?

Decaflu Febbre e Dolore 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.
Decaflu Febbre e Dolore is indicated in children from 3 months to 12 years, in adolescents and in adultsfor the symptomatic treatment of fever, and mild or moderate pain.

2. What you need to know before using Decaflu Febbre e Dolore

Do not use Decaflu Febbre e Dolore if the child:

• is allergic to ibuprofen, or to any of the other ingredients of this medicine (listed in paragraph 6)
• has experienced or has had in the past allergic reactions such as shortness of breath, 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 (severe renal or hepatic insufficiency);
• suffers from a severe heart disease (severe 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 COX-2 inhibitors) (see paragraph “Other medicines and Decaflu Febbre e Dolore”);
• 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 Decaflu Febbre e Dolore 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 they suffer from breathing difficulties (asthma), nasal polyps, swelling of the face, lips and throat (angioedema);
• is taking other medicines used for the treatment of pain, to lower fever and/or to treat inflammation (non-steroidal anti-inflammatory drugs, NSAIDs including COX-2 inhibitors) (see paragraph “Other medicines and Decaflu Febbre e Dolore”);
• has suffered from disorders of the stomach and intestines (history of ulcer), especially if complicated by bleeding or perforation as this may increase gastrointestinal bleeding and perforations. In these cases, your 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 Decaflu Febbre e Dolore”). 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 can 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 bleeding or gastrointestinal ulceration occurs, stop treatment with Decaflu Febbre e Dolore Children 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 certain 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 Decaflu Febbre e Dolore”);
• has heart disease (uncontrolled high blood pressure, 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 you or the child may be at risk for these conditions (for example if you have high blood pressure, if you have high levels of sugars (diabetes) or fats in the blood or if you smoke). Medicines such as Decaflu Febbre e Dolore 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 in 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 (congestive heart failure) as, in association with therapy with NSAIDs, fluid retention, high blood pressure and swelling (edema) have been reported;
has an infection (see paragraph “Infections” below).
has chickenpox, in which case, it is advisable to avoid the use of Decaflu Febbre e Dolore.

The use of Decaflu Febbre e Dolore requires adequate precautions, in particular if:

• 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 them before and during treatment to avoid the risk of impaired kidney function.

During prolonged treatments, with Decaflu Febbre e Dolore, you must pay particular attention and
immediately warn your doctor if the following appear:

• signs or symptoms of ulcerations or bleeding of the stomach and intestines (for example black and foul-smelling stools, vomiting blood);
• signs or symptoms of liver damage (for example hepatitis and jaundice);
• signs or symptoms of kidney damage (for example increased urine production, blood in the urine);
• visual disturbances (blurred or reduced vision, areas of complete or partial blindness, alteration of color perception);
• symptoms such as frequent or daily headaches despite regular use of headache medicines, as these may be caused by excessive use 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 Decaflu Febbre e Dolore.
Stop treatment with Decaflu Febbre e Dolore and immediately consult your doctor if you
develop rash, mucous membrane lesions, blisters or other signs of allergy, as these may
be the first signs of a very serious skin reaction. See paragraph 4.

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

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

Other medicines and Decaflu Febbre e Dolore
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other
medicines.
Decaflu Febbre e Dolore can affect or be affected by other medicines, in particular tell your
doctor or pharmacist if you are taking:

• other medicines used for the treatment of pain, to lower fever and/or to treat 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;
• medicines used to treat inflammation and certain diseases of the immune system (corticosteroids);
• medicines used to treat infections caused by bacteria (quinolone antibiotics);
• medicines that have an anticoagulant effect (that is, 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 taking mifepristone;
• a medicine to treat gout (probenecid and sulfinpyrazone);
• medicines that lower 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 increased exposure to ibuprofen.
• medicines used to treat heart disease (cardiac glycosides such as digoxin).
• Zidovudine (a medicine for the treatment of HIV/AIDS)

Decaflu Febbre e Dolorewith food and drink
The medicine can be taken both with or without food.
Possible side effects on the stomach, if present, can be reduced by taking the medicine with
a full stomach.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.
It is unlikely that subjects aged 12 years or less will become pregnant, or breastfeed.

Pregnancy
Do not takethe medicine if you are in the last 3 months of pregnancy, because it may harm the unborn child or
cause problems at the time of delivery. It can cause kidney and heart problems in the unborn child. It can affect the
tendency to bleeding both yours and the baby's and make labor longer or later than
expected. It should not be taken during the first 6 months of pregnancy unless absolutely necessary and
on the advice of a doctor. If treatment is necessary during this period or while trying to
become pregnant, the lowest dose should be used for the shortest possible time. If taken for more than
a few days from the twentieth week of pregnancy, it can cause kidney problems in the unborn child
which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or constriction of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is
necessary for more than a few days, your doctor may advise further monitoring.

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
Decaflu Febbre e Dolore with food and drink
The medicine can be taken both with or without food.
Possible side effects on the stomach, if present, can be reduced by taking the medicine with
a full stomach.

Decaflu Febbre e Dolore contains:

• maltitol: if the doctor has diagnosed the child with an intolerance to certain sugars (for example fructose), contact them before using this medicine.
• Sodium: this medicine contains less than 1mmol (23) mg of sodium per dose, i.e. essentially ‘sodium-free’
• 4.51 mg of sodium for each 2.5 ml dose of suspension;
• 9.02 mg of sodium for each 5 ml dose of suspension;
• 13.53 mg of sodium for each 7.5 ml dose of suspension;
• 18.04 mg of sodium for each 10 ml dose of suspension;

For doses of 15 ml of suspension this medicine contains 27.06 mg of sodium which is equivalent to 1.35%
of the maximum daily intake recommended by the WHO, which corresponds to 2 g of sodium for an adult.

• Sodium benzoate:
• 0.025mg of sodium benzoate for each 2.5 ml dose of suspension;
• 0.05mg of sodium benzoate for each 5 ml dose of suspension;
• 0.075mg of sodium benzoate for each 7.5 ml dose of suspension;
• 0.1mg of sodium benzoate for each 10 ml dose of suspension;
• 0.15mg of sodium benzoate for each 15 ml dose of suspension.

Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4
weeks).

3. How to take Decaflu Fever and Pain

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 recommended daily dose is based on the child's weight and age.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If your child has an infection, consult a doctor immediately if the symptoms (e.g. fever and pain) persist or worsen (see section 2).
To reduce possible side effects, the minimum effective dose should be used for the shortest time necessary to control the symptoms (see section 4).

Use in children aged between 3 and 6 months

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

A 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 following scheme (calculate the dose to be administered based on the weight shown in the table and the child's age).

The graduated scale on the syringe highlights the markings for different dosages; in particular, the 2.5 ml mark corresponds to 50 mg of ibuprofen and the 5 ml mark corresponds to 100 mg of ibuprofen.
If you suffer from stomach problems, take Decaflu Fever and Pain 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.
Decaflu Fever and Pain 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 a 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 you notice a worsening of symptoms 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 measuring syringe. Unscrew the cap by pushing it down and turning it to the left.

• Insert the tip of the syringe fully into the hole in the stopper.
• Shake well.
• 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 corresponding to the desired dose. Put the bottle back in an upright position and remove the syringe by gently rotating it.
• Insert the tip of the syringe into the mouth and exert slight pressure on the plunger to dispense 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 sight and reach of children.

If you use more Decaflu Fever and Pain than you should
If you have taken more Decaflu Fever and Pain than you should or if your child has taken this medicine by mistake, always contact a doctor or the nearest hospital to get advice on the risk and recommendations on what to do.
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 kidney, bleeding from the stomach and intestines, deep unconsciousness (coma), temporary interruption of breathing (apnea), diarrhea, reduction of the 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 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.

Decaflu Fever and Pain
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Decaflu Febbre e Dolore can cause side effects, although not everyone will experience them.
If you experience any of the following side effects STOPtreatment with Decaflu Febbre e Dolore and consult your doctor:

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

Further 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.

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

• cystitis, rhinitis;
• depression, insomnia, difficulty concentrating, unstable mood, hearing and vision disorders;
• cerebrovascular hemorrhage;
• dry eyes;
• perception of your heartbeat (palpitations);
• diarrhea, flatulence, dry mouth, constipation and vomiting;
• hair loss (alopecia);
• the skin becomes sensitive to light;
• severe 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 hemorrhages;
• 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);
• severe 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;
• severe skin infections and complications to soft tissues during varicella infection;
• worsening of inflammations related to infections (for example necrotizing fasciitis) associated with the use of some non-steroidal anti-inflammatory drugs (NSAIDs). If you experience or worsen signs of an infection, you should immediately contact your doctor to assess whether antibiotic/antimicrobial therapy is necessary.

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

• irritability;
• fluid retention and decreased appetite;
• abnormal perception of noises 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 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 severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS include: 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 Decaflu Febbre e Dolore 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 experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can contribute to providing more information on the safety of
this medicine.

5. How to store Decaflu Febbre e Dolore

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 package and on the blister after SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
After opening the bottle, store for a maximum of 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 Decaflu Febbre e Dolore 100 mg/5 ml oral suspension contains

Decaflu Febbre e Dolore orange flavour
One ml of oral suspension contains:

• active ingredient: ibuprofen 20 mg
• The other ingredients are: citric acid monohydrate, sodiumcitrate, sodiumbenzoate(see paragraph “Decaflu Febbre e Dolore contains”), acesulfame of potassium, xanthan gum, orange aroma, maltitolsyrup (see paragraph “Decaflu Febbre e Dolore contains”), glycerol, purified water.

Decaflu Febbre e Dolore strawberry flavour
One ml of oral suspension contains:

• active ingredient: ibuprofen 20 mg
• The other ingredients are: citric acid monohydrate, sodiumcitrate, sodiumbenzoate(see paragraph “Decaflu Febbre e Dolore contains”), acesulfame of potassium, xanthan gum, strawberry aroma, maltitolsyrup (see paragraph “Decaflu Febbre e Dolore contains”), glycerol, purified water.

Description of the appearance of Decaflu Febbre e Dolore 100 mg/5 ml oral suspension and contents of the pack
Decaflu Febbre e Dolore is presented as an oral suspension of white or almost white colour.
It is available in 150 ml bottle with dosing syringe.

Marketing Authorisation Holder
Laboratorio Chimico Deca Dr. Capuani S.r.l.
Via Giotto 1
30172 Venezia (VE)

Manufacturer

Decaflu Febbre e Dolore orange flavour

• Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1- 03012 Anagni (FR)

Decaflu Febbre e Dolore strawberry flavour

• Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1- 03012 Anagni (FR)
• Marco Viti Farmaceutici S.p.A. - Via Tarantelli, 13/15-22076 Mozzate (CO)